Feb 16, 2024

Saving Energy in a Pharmaceutical Cleanroom

Feb 7, 2024

The Future of Cleanroom Air Filtration: Advanced Systems for Enhanced Compliance

In the world of cleanrooms, where the highest standards of cleanliness and contamination control are paramount, air filtration systems play a pivotal role. The evolution of these systems, especially with the integration of advanced features, has significantly improved compliance with stringent industry standards. In this blog, we delve into the intricacies of these advanced air […]

Feb 2, 2024

Going Paperless in the Cleanroom

Jan 31, 2024

Continuous Microbial Monitoring

Jan 18, 2024

21 CFR Part 11 – Electronic Records Signature

Dec 26, 2023

Establishing a PHARMA Environmental Monitoring Program

Dec 26, 2023

The Basics of Liquid Particle Counting

Dec 26, 2023

Understanding 4-20mA Data Accuracy in Particle Counting

Dec 26, 2023

Cleanroom Gowning

Dec 26, 2023

Cleanroom Grades A,B,C,D Explained

Dec 26, 2023

Cleanroom Air Changes

Dec 26, 2023

The Impact of Low Counting Efficiency Explained

Dec 21, 2023

Cleaning & Wipedown

Dec 20, 2023

Going Paperless in the Cleanroom with the ApexZ Portable Particle Counter

Dec 20, 2023

Types of Contamination

Dec 20, 2023

EV Battery Manufacturing: A Journey of Precision and Particle Contamination Control

The rapid rise of electric vehicles (EVs) has brought about a surge in demand for high-quality lithium-ion batteries. These batteries are the heart of EVs, providing the power needed to propel these vehicles. However, manufacturing lithium-ion batteries is a complex process that demands meticulous control over various factors, including particle contamination. Particle Contamination: A Hidden […]

Dec 19, 2023

Cleanroom Design Considerations from a NASA Engineer

Dec 19, 2023

EU GMP Annex 1 Continuous Viable Monitoring

Dec 19, 2023

Pharma 4.0: Revolutionizing the Aseptic Manufacturing Process

Dec 13, 2023

EU GMP Annex 1:2022 and Microbial Monitoring for Viable Particulates

The 2022 update of the EU GMP Annex 1 has placed significant emphasis on the concept of continuous environmental monitoring (EM), highlighting it as a critical component in reducing the risk of contamination during the manufacture of sterile products.  This shift towards continuous EM requires manufacturers to adopt specific techniques and align their monitoring programs […]

Dec 6, 2023

Lighthouse Active Air Sampler Technology and d50

Air Sampler impaction technology has been around for decades. However, the d50 is a little known aspect of air sampler technology design and it plays a critical role in air sample capture. Aerosol Impaction is the process in which particles are removed from an air stream by forcing the gases to make a sharp bend. […]

Nov 29, 2023

Elevating Pharmaceutical Quality: Navigating Regulatory Compliance and Environmental Monitoring Systems (EMS)

Introduction In the realm of pharmaceuticals, the pursuit of excellence in product quality is a never-ending journey. Governments and private industries have diligently crafted recommendations and regulations over the years, evolving in response to the dynamic landscape of the pharmaceutical sector, particularly in the digital age. In this comprehensive paper, we delve into the fundamental […]

Nov 21, 2023

Safeguarding Biopharma Cleanrooms: Lighthouse Apex Particle Counters and the Power of Vaporized Hydrogen Peroxide (VHP)

Introduction Cleanrooms in the Pharmaceutical industry are sanctuaries of precision, where the highest standards of cleanliness are not just expected but demanded. A key player in the sterilization arsenal of these cleanrooms is Vaporized Hydrogen Peroxide (VHP), a potent chemical used to disinfect surfaces and equipment. However, the nature of VHP, while highly effective at […]

Nov 15, 2023

Gas Sampling in Biopharma Cleanrooms: Ensuring Contamination Control

Introduction In the high-stakes realm of Pharmaceutical manufacturing, precision and adherence to stringent cleanliness standards are non-negotiable. Compressed gases are a staple in cleanroom environments, but they also present a potential risk of contamination. This article delves into the pivotal role of compressed gas sampling in pharma cleanrooms, emphasizing the unique challenges and regulatory considerations […]

Nov 14, 2023

PARTICLE COUNTING SAMPLE TUBING GUIDANCE AND BEST PRACTICES

Nov 14, 2023

HOW TO PERFORM A PQ ON A PARTICLE MONITORING SYSTEM

Nov 14, 2023

Manifold Monitoring Systems Explained

Nov 13, 2023

MTBF of LWS Particle Counters

Nov 8, 2023

Understanding Airborne Particle Counters in Pharmaceutical Facilities

Introduction Airborne particle counters play a crucial role in ensuring the environmental integrity of pharmaceutical, bio-pharmaceutical, and radiopharmaceutical facilities worldwide. In an increasingly globalized pharmaceutical industry, cooperation and harmonization have become the norm, driving the demand for continuous monitoring in these facilities as well as the drive for digital solutions to meet your Contamination Control Strategy. In this […]

Nov 2, 2023

USP 797 AND ITS IMPLEMENTATION IN ASEPTIC COMPOUNDING ENVIRONMENTS

Oct 25, 2023

Understanding ISO TR 14644-21

Oct 25, 2023

Liquid Contamination Control in Semiconductor Manufacturing: A Deep Dive

Semiconductor manufacturing is a highly intricate process, comprising numerous steps and stages, with each one presenting the potential for contamination. Contamination in this context can be particularly costly, leading to yield losses and time wastage. To address these challenges, Real-Time Monitoring Systems offer a powerful solution, providing immediate detection and enabling rapid mitigation in potential […]

Oct 18, 2023

Simplifying USP 788

Compliance with USP 788 standards doesn’t have to be a complex and laborious process. Recent advancements in liquid sampling technology have made achieving USP 788 compliance both simple and effective. Liquid sampling plays a crucial role in contamination control strategies, ensuring that particulate contaminants are kept out of injectable pharmaceutical products and, ultimately, the bodies of end-users. […]

Transforming Ultrapure Water
Oct 11, 2023

Transforming Ultrapure water quality monitoring with the Vertex50

The Vertex50: A Brief Introduction The Vertex50 is a liquid particle counter equipped with multiple size channels, including nanometers. It has undergone a meticulous testing process to achieve verification, ensuring its reliability and accuracy. One of its standout features is its ability to provide online, real-time monitoring, a critical tool in reducing yield loss in […]

Oct 4, 2023

The Importance of Liquid Particle Counters for Pharmaceutical Water Quality

Water quality plays a critical role in the pharmaceutical industry, where stringent requirements must be met to ensure the safety and efficacy of pharmaceutical products. Different pharmaceutical processes demand varying levels of water quality, making it essential to have precise control over water purification systems. Contaminated water can jeopardize product quality and, ultimately, patient safety. […]

Sep 27, 2023

Ensuring Sterility and Quality: A Deep Dive into Aseptic Manufacturing of Pharmaceutical Injectable Products

Pharmaceutical injectable aseptic injections are essential medical products that are administered through injections, directly into the body. The manufacturing process for these injectable drugs is a meticulous endeavor, requiring stringent control measures to ensure they remain free from any microbial contamination or particles that could compromise patient safety. In this article, we’ll delve into the intricate process […]

Tech Paper - Medical Devices and Environmental Monitoring
Sep 26, 2023

MEDICAL DEVICES AND ENVIRONMENTAL MONITORING

Sep 20, 2023

The Power of Particle Counters: Certifying Cleanrooms and Testing HEPA Filters According to ISO Standards

In the meticulous realm of pharmaceuticals and controlled environments, precision is paramount. Particle counters emerge as indispensable tools in maintaining stringent quality standards. This blog elucidates the critical role of particle counters in cleanroom certification, routine monitoring, and HEPA filter testing while adhering to ISO standards. Certifying Cleanrooms using Particle Counters as per ISO 14644-1:2015 […]

THE DIFFERENCE BETWEEN ZERO COUNTS AND FALSE COUNTS Lighthouse
Sep 15, 2023

USING PARTICLE COUNTERS -THE DIFFERENCE BETWEEN ZERO COUNTS AND FALSE COUNTS

Sep 13, 2023

The Vital Role of Contamination Control Strategy and Environmental Monitoring

In the complex landscape of pharmaceutical manufacturing, where the safety and efficacy of medicinal products are paramount, Annex 1 of the EU Guidelines for Good Manufacturing Practice (GMP) for Medicinal Products 2022 stands as a crucial document. One of its core components, the Contamination Control Strategy (CCS), plays a pivotal role in ensuring the production […]

Sep 6, 2023

The Role of Calibration in Environmental Monitoring

In our rapidly evolving world, environmental monitoring has become a critical aspect of safeguarding our planet’s health. From air and water quality to soil conditions and climate patterns, the data collected through environmental monitoring systems provide valuable insights that guide policies, research, and decision-making. However, the accuracy of these measurements is paramount, and that’s where […]

Aug 30, 2023

GMP Annex 1 In Action: Designing A Cleanroom for Aseptic Manufacturing

In 2022, GMP Annex 1 was revised to reflect the changing landscape of technology, discoveries, best practices, and needs. At the time of publication, this is the first and only, but far from the last, regulatory body to make a large update in several years. We do expect to see similar guidelines from the FDA […]

Aug 23, 2023

10 Ways To Mitigate Risk In Aseptic Manufacturing

“Risk mitigation” is one of our favorite phrases. The best way to prevent yield loss, ensure end user safety, and high quality is to avoid risk from the beginning. What exactly poses a risk to aseptic manufacturing? First and foremost, contamination. Next, human error and faulty equipment. All combined, these can be a recipe for […]

Scale weighing an ApexZ and Handheld 3016
Aug 16, 2023

How Should You Choose An Environmental Monitoring System For Aseptic Manufacturing?

Environmental Monitoring Systems (EMSs) are important and hefty investments that require typically large amounts of infrastructure; however, modern EMSs are becoming nimble, adaptable, and slimmer. There are so many options and factors that go into making this decision, so where exactly should you start?  Here at LWS, we specialize in helping manufacturers make educated decisions […]

Magnifying glass looking down on people working on a microchip
Aug 9, 2023

Environmental Monitoring Systems in Aseptic Manufacturing

Aseptic manufacturing is one of the most difficult forms of manufacturing. From the processes to the inspections to the documentation, this is not an easy task. The right Environmental Monitoring System (EMS), though, can make it simpler. An EMS is made up of a system of filters and sensors that connect to a processing software. […]

Jul 26, 2023

Cleanroom Behavior According to ISO 14644

Car Microchip being lowered into a car
Jul 26, 2023

Why Are Semiconductors So Sensitive To Contamination?

Semiconductors are the backbone of our world and the technology that runs our lives, businesses, health systems, entertainment, and more. They do an incredible number of often unappreciated tasks from conducting electricity to processing information. While we have semiconductors to thank for so much in our lives, for them to function in the cell phones […]

Jul 19, 2023

11 Things To Consider When Choosing a Semiconductor Manufacturing Particle Counter

Choosing a particle counter for semiconductor manufacturing is not a small decision. It is a massive investment that has ramifications throughout your systems and cleanroom. When you choose one, you should consider all these implications, as well as the particle counter’s functionality in your cleanroom. As clean air and particle counter experts, we’ve compiled a […]

Jul 13, 2023

PARTICLE COUNTERS AND WAFER MANUFACTURING IN A SEMICONDUCTOR CLEANROOM

Cutting, Production, Control, and Testing in Semiconductor
Jul 12, 2023

Preventing Contamination & Risk Mitigation During Semiconductor Manufacturing

One of the most important things you can do during semiconductor manufacturing is practice proper risk mitigation to reduce contamination. Contamination puts semiconductors at serious risk. It can cause them to underperform, consume too much energy, malfunction, or completely fail. This can result in profit loss, recalls, customer complaints, and damaged reputation. The good news […]

Jul 6, 2023

OVERVIEW OF COMPOUNDING ASEPTIC PRODUCTS AND MONITORING FOR VIABLE AND NON-VIABLE PARTICLE CONTAMINATION.

Two cleanroom workers inspect a microchip.
Jul 5, 2023

5 Ways Particle Counters Enhance Semiconductor Manufacturing Quality Control

Quality control in semiconductor manufacturing is superficially simple: create consistent quality products. That statement is easy enough to say, but incredibly difficult to truly implement. Quality control involves an in depth understanding of the products you are designing, the processes you have in place, and what can go wrong. In a cleanroom, there are added […]

Jun 26, 2023

Lighthouse Worldwide Solutions Expands Presence with New Facility in the UK  

Lighthouse Worldwide Solutions, a renowned global leader in the manufacturing of cutting-edge contamination control equipment, is proud to announce the opening of its newest facility in Milton Park, Oxfordshire, United Kingdom. This expansion marks a significant milestone for the company as it aims to bring its state-of-the-art technology and expertise closer to its UK-based clients. […]

Jun 22, 2023

ADVANCEMENTS IN PARTICLE COUNTER BASED TESTING AND MONITORING FOR CLEANROOMS, FILTERS, AND SEPARATIVE DEVICES

Jun 21, 2023

5 Reasons Why You Should Use A Life Cycle Approach To Implement A RTMS

We talk a lot about life cycles, but have you used this approach to implementing a new system, especially a large one, such as Real Time Monitoring System (RTMS)? If you are familiar with GAMP5, you probably have used a life cycle approach or at least considered it. The 5th edition of Good Automated Manufacturing […]

Jun 15, 2023

Fill in the GAP Good Application Practices – How to classify cleanrooms?

Jun 14, 2023

6 Benefits To Using GAMP5 In Your Cleanroom

GAMP5: another day, another acronym. So let’s break it down! GAMP5 stands for the Good Automated Manufacturing Practices 5th version. This publication is monitored by the GAMP committee of the International Society for Pharmaceutical Engineering (ISPE), who also publishes the GAMP guidelines.  GAMP5 outlines best practices for computerized system validation in the pharmaceutical industry; however, […]

Jun 8, 2023

OVERVIEW OF EU GMP ANNEX 1:2022

Jun 7, 2023

The 5 GAMP5 Key Concepts

Good Automated Manufacturing Practices (GAMP) has been defining IT validation since 1991. Since then, it has gone through 5 revisions, the most recent of which was in 2008. This version of the guidelines is called GAMP5. It is published by the International Society for Pharmaceutical Engineering (ISPE), specifically for pharmaceutical cleanrooms. GAMP is both a […]

May 31, 2023

What is GAMP5 and the GAMP V Model?

GAMP5 refers to the fifth publication of Good Automated Manufacturing Practices published by the International Society for Pharmaceutical Engineering (ISPE). GAMP5 is not a set of regulations, but instead a collection of guidelines developed through evidence-based decision making that reinforces the standards set by many regulations, including Annex 11 and 21CFR11. These guidelines outline a […]

May 24, 2023

International Pharmacopeia Collaboration

At this point, we are no stranger to global health crises. But these crises extend outside of pandemics to regular everyday access to quality healthcare, as well. Standardization of care following evidence-based best practices across the globe improves the world population’s health. Pharmacopeias work across borders to collaborate on best practices and knowledge, improve access […]

The Future of Pharmacopeias
May 17, 2023

The Future of The USP-NF

In the wake of Pharma 4.0 – the term coined by ISPE to identify the fourth industrial revolution relationship with the pharmaceutical industry – it is critical to look at all elements of an industry for areas of advancement. One of the pillars of standards for the pharmaceutical industry is the United States Pharmacopeia. So […]

May 11, 2023

Lighthouse ScanAir Pro – Filter Integrity Test Method

May 11, 2023

USP Overview with guest USP speakers: Rebecca Cambronero and Desmond Hunt Part 2

Scientists working with medications and a magnifying glass on a contamination particle
May 10, 2023

The Drug Development Process & Pharmacopeias Roles In It (Part 2)

The United States Pharmacopeia – National Formulary (USP-NF) is comprised of 6,800 monographs for over-the-counter and prescription products, medical devices, supplements, and other related particles and it is a resource for every step along the drug development process. There are four stages to drug development: R&D, regulatory review, manufacturing and distribution, and medication use. This […]

Two scientist inspecting medication with a magnifying glass and looking at a contamination particle
May 3, 2023

The Drug Development Process & Pharmacopeias Roles In It (Part 1)

The United States Pharmacopeia – National Formulary (USP-NF) serves as a resource for drug manufacturers, researchers, and anyone else involved in the development of pharmaceuticals with quality standards for ingredients and manufacturing processes. The USP-NF itself contains over 6,800 monographs for over-the-counter and prescription products, medical devices, supplements, and other related particles. It is revised […]

Apr 26, 2023

USP Overview with guest USP speakers: Rebecca Cambronero and Desmond Hunt – Part 1

Apr 26, 2023

The Importance of Monitoring Particle Generation In Lithium-Ion Batteries

The article is mainly focused on the impact, causes and reduction of particle generation during the manufacturing of Li-ion cells. Therefore, it is sub-divided into three sections as each aspect is equally important to study the topic in detail. Sections are listed below. 1.      Effect on the cell 2.      Sources of generation 3.      Mitigation techniques We are going […]

Apr 19, 2023

The Pharma 4.0 Culture

Every revolution is, well, revolutionary. Processes and people massively change in a way that rocks the world to its core, in a way that makes it so the world is never the same again. We have witnessed these sorts of transcending changes throughout the last three industrial revolutions and, now, we are arguably experiencing the […]

An Apex Z with icons that show the capability of the unit
Apr 12, 2023

Environmental Monitoring Systems in Pharma 4.0

ISPE’s Pharma 4.0 initiative points to everything the pharmaceutical industry could be if it embraced the same advancements of the fourth industrial revolution: digitization, empowerment, and automation. This is achieved through the integration of Industry 4.0 technology, originally spurred by the internet and now encompassing artificial intelligence, advanced robotics, and automation. Pharma 4.0 is sometimes […]

Pill bottles going down an assembly line with a environmental monitoring unit (ApexR) attached to the machine.
Apr 5, 2023

Automation, Robotics, & Pharma 4.0: Technology’s Impact on Drug Manufacturing

For years now, robots and automation have been making their way into pharmaceutical production. Lately, though, the power of Artificial Intelligence (AI) has taken the world by storm in the form of ChatGPT: a uniquely human AI bot that will have conversations with you, research for you, and adapt to what you ask it to […]

Mar 30, 2023

How To Prepare A Contamination Control Strategy Document as Per New GMP Annex 1

An ascending graph of the evolution of Pharma 4.0. Starting from 1760 and ending in 2023.
Mar 29, 2023

The History Of Pharmaceutical Manufacturing: Industry 1.0 to Pharma 4.0

A lot has changed since the 1700s in the whole world, but especially in the pharmaceutical industry. Over the past 250 years, four industrial revolutions have swept the world, drastically changing the way we manufacture items and their availability – including pharmaceuticals.  Industry 1.0 The first industrial revolution spanned from 1760 to 1830, with its […]

Mar 22, 2023

How To Develop and Document a Contamination Control Strategy

Your Contamination Control Strategy (CCS) is the foundation of your cleanroom. This is where you plan how to avoid contamination, what to do in the event there is a breach, and prove that you have done your homework.  For too many years, a CCS has been an afterthought. The cleanroom was developed, protocols put in […]

Mar 8, 2023

Risk Management and GMP Annex 1: Strategies for Minimizing Contamination

The European Union (EU) Good Manufacturing Practice (GMP) for Medicinal Products for Human and Veterinary Use – Annex 1, commonly referred to as GMP Annex 1, released a new update in 2022. At the time of publishing, we have not yet seen updates in the United States, but should expect to see similar guidelines published […]

Two people looking at an ApexZ that has Data Integrity written across the screen.
Mar 1, 2023

What Happens When You Fail To Meet FDA Data Integrity Standards

We talk a lot about data integrity, but what happens, in the real world, when US Food and Drug Administration (FDA) data integrity protocols are not met? In December, we got to see this scenario play out. Between November 22, 2022 and December 2, 2022, FDA inspectors visited a large pharmaceutical manufacturer’s facilities in India […]

Nurses with PPE stand together
Feb 22, 2023

Best Practices for PPE Education for Healthcare Workers

It’s not a secret: PPE is important in every healthcare setting. But in the intensity of a hospital setting, amidst staffing shortages and sky-high hospitalization rates, proper PPE protocols might not always be followed. While trying to save lives and stay afloat in the overwhelm, healthcare workers might slip up. They theoretically know and understand […]

A nurse wearing an N95 Mask is about to give a covid test to a patient
Feb 15, 2023

How Personal Protective Equipment Keeps Healthcare Workers and Patients Safe

Do you remember the last time you went to a show where there was a “splash zone”? Maybe it was a nautical show with seals or an art exhibit or concert. When you’re seated in a splash zone, you usually are supposed to wear some kind of poncho to serve as a barrier between you […]

An illustration showing how the pre-filter, carbon filter, and HEPA filter work.
Feb 8, 2023

How Filtrations Systems Can Help Reduce the Spread of Infection in Hospitals

No one goes into medicine to cause harm. Doctors, nurses, techs, administrators, PAs, CNAs, and all other staff come together to bring life and give hope. Hospitals should be places of healing – not new illnesses. But for many patients, that’s the unfortunate reality. Hospital Acquired Infections (HAIs) present threats to patients, staff, and the […]

An operating table with an ApexZ and AC100 for environmental monitoring.
Feb 1, 2023

The Importance of Environmental Monitoring in Healthcare

Did you know that approximately 1 out of every 31 hospital patients in the U.S. are expected to contract a Healthcare-Associated Infection (HAI)? That’s right – the Centers for Disease Control and Prevention (CDC) reported that this alarming number of patients contract an HAI every year, totaling almost 2 billion nosocomial infections and 90,000 deaths […]

Jan 26, 2023

LMS Express 4 Walkthrough

Jan 26, 2023

How Do Compounding Pharmacies Utilize Environmental Monitoring.

Jan 18, 2023

Why Does USP <800> Require An N95 Mask?

USP <800> provides guidelines that “describes requirements including responsibilities of personnel handling hazardous drugs; facility and engineering controls; procedures for deactivating, decontaminating and cleaning; spill control; and documentation.” These standards are applicable to anyone in healthcare who is responsible for receiving, preparing, administering, or transporting hazardous drugs. This guideline follows the National Institute for Occupational […]

Jan 11, 2023

Why Do Dogs Need Compounded Medications?

Our furry family members sometimes go down for the count and need some medication to help pick them up. But what happens when they won’t take a pill? Or need specialized medication? Or have to take multiple medications? The answer for you and your pet might be compounded drugs! Compounded medications are prescribed by your […]

Jan 4, 2023

10 Things Every Compounding Pharmacist Should Know

Whether you are a new compounding pharmacist or have been around for a while, you know that compound pharmacies are unique. In your workspace, you have to gown and operate under strict contamination control protocols, but do you know why? As the world’s clean air experts, we’re here to help explain exactly what’s going on […]

Dec 28, 2022

What Is A Compounding Pharmacy? And Why Are They Monitored?

You probably don’t think of pharmacies as cleanrooms or controlled environments, but that’s because you are most likely thinking of community pharmacies! Community pharmacies are generally where generic prescriptions are sent and are readily available throughout the United States. There are roughly 56,000 community pharmacies in the states, but only 7,500 of those specialize in […]

Dec 21, 2022

EN ISO 14698-1 & -2:2003 vs EN 17141:2020

In 2020, a vote found EN ISO 14698 no longer suitable for use in Europe, and, thus, it was replaced by EN 17141. Now, there is a push to accept EN 17141 as the international standard, as it is significantly more up to date and applicable than EN ISO 14698.  EN ISO 14698 was last […]

Dec 14, 2022

Getting From EN ISO 14698 to EN 17141

After 17 years of no revisions, a formal vote in 2019 replaced EN ISO 14698 with EN 17141 in Europe. Shortly after, confusion ensued. While CEN/TC243 (the technical committee in CEN) had found EN ISO 14698 obsolete and replaced it with a new guidance (under a new number, to avoid confusion), old versions still existed […]

Dec 7, 2022

Data Integrity In Your Contamination Control Strategy

You will hopefully not be shocked to learn that data integrity is an integral part of a properly running cleanroom. If this does come as a surprise to you, we highly recommend you read on and take notes. But for many cleanroom or particle counter professionals, the term “data integrity” has been drilled into our […]

Cleanroom Guy standing next to board that says "Year End Review"
Nov 30, 2022

2022 Cleanroom Trends: Looking Back

At the start of 2022, we outlined some trends we expected to see grow in popularity and necessity throughout the year. They included paperless cleanrooms, advanced self diagnostics, multiple transfer options, and smart batteries. Now, as 2022 comes to a close, we want to consider how these trends have played out in the last year […]

Nov 23, 2022

Microbiology & Bio contamination Control in Cleanrooms From EN ISO 14698 to a new EN 17141

Nov 23, 2022

How Do Cleanroom Active Air Samplers Work?

Have you ever heard the old wives’ tale that if you water your garden at night, mushrooms will grow by morning? While there’s some truth to this timing, because mushrooms grow when there’s a certain moisture content and the night prevents water from evaporating at the same rate, there is a deeper, hidden, much more […]

Nov 22, 2022

Remote Particle Counters For Pharmaceutical Applications

Nov 17, 2022

How to Choose Cleanroom Monitoring Instruments

effect of wildfires
Nov 16, 2022

How Do Wildfires Affect Air Quality?

During the 2020 fire season, more than 106 large wildfires occurred in the states of Oregon and California. The fires were battled by tens of thousands of wildland firefighters, but still burned more than 6.7 million acres. While thousands of people lost their homes, almost every resident of the state was able to see the […]

Nov 16, 2022

What Is EN 17141?

EN 17141 Cleanrooms and controlled environments – Biocontamination control is a relatively new European standard, introduced in 2020, that establishes and demonstrates best practices to control airborne and surface microbiological contamination in controlled environments, such as cleanrooms. This standard applies specifically to European cleanrooms in the pharmaceutical and biopharmaceutical, hospital, and food industries, as identified […]

ApexZ3
Nov 15, 2022

Is The ApexZ The Right Airborne Particle Counter For You?

An airborne particle counter only needs to know two things to begin sampling: where it is and how long to sample. From there, it should be built around ease of use and reliability. You should be able to trust that your airborne particle counter is working for you and not the other way around. You […]

Nov 14, 2022

ApexZ Tutorial with Davis – Quick Certs

cleanroom gowning protocal
Nov 10, 2022

10 Ways To Improve Your Cleanroom’s Gowning Protocols

What is a foundational piece of your cleanroom contamination control strategy? Your gowning protocol. Humans, by far, produce the most particles in a cleanroom and your gowning protocol can limit that number.  While we have a number of ways to improve your gowning protocol across the board, it is important to recognize that different ISO classifications require […]

Nov 10, 2022

Basics Of Particle Counting

Nov 9, 2022

8 Features To Look For In An Active Air Sampler

An active air sampler is one of the tools you can use in your cleanroom to monitor contamination, but, specifically, it is the tool you can use to monitor viable contamination. These are live microbes, so they have the potential to grow, like mold or fungi. While a particle counter can tell if contamination is […]

Nov 7, 2022

Overview of GMP Annex 1 and its impact on Environmental Monitoring

Nov 3, 2022

Indoor Air Quality And Its Impact On Our Health And How To Improve It

Nov 2, 2022

The History Of Particle Counting Technology

This year, Lighthouse Worldwide Solutions is celebrating its 40th anniversary. Over the last 40 years, we have seen massive changes in particle counters and cleanroom monitoring technology intertwined with advances in technology outside the cleanroom. Today, we’re looking back at where it all started and the influences on the industry that have progressed it to […]

Nov 1, 2022

ApexZ Tutorial with Davis – Grid View

Oct 26, 2022

GMP Annex 1 2022 Update Breakdown: Part 2

In 2017, GMP released a draft update to Annex 1, which received a lot of feedback. Now, GMP has released a finalized version of the updated Annex 1, which addresses many of the concerns and questions raised about the draft version. The largest changes and shifts in this document are found in the increased focus […]

cleanroom-classifications chart
Oct 19, 2022

Cleanroom Classifications Explained

A cleanroom classification basically tells you how clean a cleanroom is. While we typically consider cleanrooms to use HEPA filters and multiple layers of protection, cleanrooms can really be any room where precautions are taken to ensure that the product stays clean from contaminants. But if that’s the case, then what makes one cleanroom stand […]

GMP Annex
Oct 19, 2022

GMP Annex 1 2022 Update Breakdown: Part 1

The European Union (EU) Good Manufacturing Practice (GMP) for Medicinal Products for Human and Veterinary Use – Annex 1, commonly referred to as GMP Annex 1, was originally published as a draft in 2017. This draft left many people operating in the pharmaceutical industry wondering at some of the proposed changes to the regulations that […]

Oct 14, 2022

Vertex50 Where Gamma Immunity and Sensitivity Meet

Oct 13, 2022

How to Gas Sample Using a Particle Counter

Testing of compressed gases is a GMP requirement when such gases are used in cleanroom applications. It is critical for such testing to occur since product process zones in ISO 5 cleanrooms and zones require tight control on contamination and compressed gases used may also if not checked correctly be an avenue for particulate contamination […]

Gas Sampling in a cleanroom
Oct 8, 2022

The Basics Of Gas Sampling In A Cleanroom

It is no mystery that cleanrooms need to be, well, clean. From the surfaces and tools to the air in the cleanroom, everything needs to remain at a certain level of cleanliness depending on the cleanroom’s classification and application. Those criteria extend to the compressed gasses used in cleanrooms, as well, like oxygen, hydrogen, methane, […]

Oct 8, 2022

The Ultra Pure Water Qualification of the Vertex50

Qualification of Vertex50 to measure and detect ≥50nm trends in UPW systems The Vertex50 has TRUE sensitivity at 50nm has been qualified to measure and detect ≥50nm particles in Ultra-Pure Water Systems (UPW). UPW systems are used in many industries worldwide to provide high purity water. Ultrapure water is a commonly used term in the […]

Oct 6, 2022

Gas Sampling Applications

Lighthouse offers an opportunity to sample the contamination level in compressed gases.  In the electronics industry as well as the Pharma industry contamination control of compressed gas has been getting more important over the last few years. 

Cleanroom gas sampling basics instructions
Oct 5, 2022

Basics Of ISO 8573

If you use compressed gasses in your cleanroom, ISO 8573 is an important set of guidelines and regulations for your cleanroom, specifically ISO 8573-1:2010. This set of guidelines is maintained and governed by the International Organization for Standardization (ISO), an international, non-governmental organization dedicated to creating worldwide standards for a variety of industries. ISO standards […]

Sep 22, 2022

GAMP5’s Impact On Developing Monitoring Systems

Good Automated Manufacturing Practices (GAMP). GAMP is both a technical subcommittee of the International Society for Pharmaceutical Engineering (ISPE) and a set of guidelines for manufacturers and users of automated systems in the pharmaceutical industry. ISPE is the world’s largest not-for-profit association serving its members by leading scientific, technical and regulatory advancement throughout the entire […]

Sep 22, 2022

Cleanroom Validation from URS to PQ; ISPE GAMP5 2022 Edition & V Scheme Application for Cleanroom Monitoring Systems

Data_Integrity_Blog
Sep 21, 2022

The Basics Of 21CFR11 And GAMP5 For Data Integrity In A Cleanroom

If you know us, then you know that clean air and water is our passion in life. But what happens when you cannot prove to the regulatory authorities that your air and water is clean? Cleanrooms and monitoring systems generate a lot of data. In an 8 hour shift, as many as 5,000 individual count […]

Sep 19, 2022

Setting Presets For The ApexZ

Sep 15, 2022

Creating A Compliant Environmental Monitoring Program

With the never ending shift towards continuous quality improvements within the manufacturing of pharmaceutical products it is worth looking at the current requirement of GMP and also 21CFR11 in the context of GAMP 5 requirements. How a Company creates, maintains, retrieves, corrects and controls data can affect product quality. How a company reacts to out […]

Pharma 4.0
Sep 14, 2022

What is Pharma 4.0?

Welcome to the age of the internet! Pharma 4.0 is the International Society for Pharmaceutical Engineering’s (ISPE) version of Industry 4.0, also called Smart Factory. Essentially, Industry 4.0 is the fourth industrial revolution. It encapsulates the changes we are seeing happen in the world because of the internet. Pharma 4.0 is ISPE’s roadmap for pharmaceutical companies to also […]

Sep 9, 2022

Performance Quality Testing And Environmental Monitoring

A PQ is a performance qualification which is conducted prior to a system becoming operational. The PQ tests the system to ensure it meets its operational objectives in a real world operational environment. It is the final step in equipment and systems qualification. A PQ should never be a re-execution of the vendor supplied Operational […]

mitigate risk management
Sep 7, 2022

5 Ways To Mitigate Risk In A Cleanroom

Did you know we start to mitigate risk in our lives as early as 6 months old? That’s right: at 6 months old, an infant can recognize a stranger and knows – in their gut – that the unfamiliar person could pose a risk. The following cries are the baby’s form of risk mitigation. But […]

Aug 31, 2022

Performance Qualification vs Operational Qualification

What does your dream home look like? Maybe it’s a beautiful home way up in the mountains, where the air is fresh and the land is quiet. You sit on your porch, enjoying a hot coffee as the weather turns brisk… And the first snowflake of the year falls. How exciting! This is your first […]

Aug 26, 2022

Using Real Time Monitoring Systems in the Semiconductor Industry to Increase Product Yield

Aug 17, 2022

Reverse Osmosis In Cleanrooms

If you are relatively new to the cleanroom world, you’ve probably heard the word “reverse osmosis” thrown around a few times. You might have also heard it used in marketing and advertising of different purified water brands. What does it bring to mind? For many of us, a phrase we learned long ago in high […]

Aug 10, 2022

How Does Water Treatment Work?

We often throw around the word “contamination” and how dangerous it can be in a cleanroom. And if you work in or around cleanrooms, you know how true this is. But to the everyday consumer, products being free from contamination is often taken for granted. We often don’t even think about contamination control! For many, […]

Pharma 4.0
Aug 3, 2022

Cleanroom Basics: What Is Ultrapure Water?

If you are working with a pharmaceutical or semiconductor manufacturing cleanroom, you most likely have seen ultrapure water in action. This water is used for water for injectables (WFI) in pharmaceuticals and as a chisel for semiconductors. While it has many other purposes, these are the primary two. And those two industries use a lot […]

shield 95 medi mask
Aug 3, 2022

Introducing The New “Fit Test Champion”: SHIELD-95-MEDI Surgical N95 Respirator

Anyone who has used an N95 face mask knows that they are far from comfortable: they pinch in all the wrong places, they fail fit tests, and they limit your vision. As you have to fiddle with your face mask, its functionality and protection comes into question. As the world’s leading clean air experts for […]

Jul 27, 2022

Cleanroom Monitoring Explained ; How, when, and why do we do the monitoring in cleanrooms?

Liquid Particle Counters And Cleanrooms
Jul 27, 2022

The Basics of Liquid Particle Counters And Cleanrooms

If you have ever had a shot or used a cellphone, you have relied on a liquid particle counter! Liquid particle counters are used to measure the size and volume of particles in a sample of ultrapure water used in cleanrooms. Ultrapure water is water that has been specially processed to minimize contamination. It is […]

ISO 14644 Certified
Jul 20, 2022

What Is ISO 14644 And Why Does It Matter For Your Cleanroom?

ISO 14644 is a standard for cleanrooms that was developed by the International Standards for Organization (ISO). The ISO has been in existence since 1947, after 65 delegates from 25 different countries met to discuss its future the previous year. They saw the need for a non-governmental body whose sole job it was to determine […]

Jul 13, 2022

Basics On Minimizing Contamination Risk In Your Cleanroom

What is the biggest villain in the contamination control and cleanroom world? Particles. Contamination. This contamination can cause yield and financial loss, delays, frustration, and physical threats to the end user. It is something that should be avoided wherever possible.  To minimize contamination risk in your cleanroom, you first need to understand what contamination control […]

Jul 9, 2022

Basic Manual Sampling With The ApexZ

What Are Cleanroom Real Time Monitoring Systems?
Jul 6, 2022

What Are Cleanroom Real Time Monitoring Systems?

Is there a way that you can improve response times, decrease contamination delays, and reduce personnel frustration in your cleanroom? There absolutely is. The answer is a real time monitoring system. These are systems that monitor your cleanroom for particle contamination in real time. They provide continuous monitoring, alarms, and feedback for your team. The […]

Jul 1, 2022

Using RTMS To Improve Semiconductor Product Yields

Jun 30, 2022

What is 21CFR11 and why is it so important in maintaining Data Integrity?

Jun 29, 2022

Questions to Ask About The Application of 21 CFR Part 11 In Your Operations

The following questions will help you ask the right questions when implementing a system thatadheres to 21CFR Part 11. It is important to satisfy the requirements of this FDA code in order toenable Data Integrity and Data Traceability as well as the electronic signatures that verify the dataas original, valid, and accurate

cleanroom maintenance checklist
Jun 22, 2022

Cleanroom Maintenance Checklist

Cleanroom maintenance is the key to ensuring your cleanroom continues to operate at peak form. Failure to conduct regular maintenance can have devastating consequences for your cleanroom. For instance, in 2018, a NASA cleanroom was contaminated with fungi. While the fungi was found around the cleanroom, it was heavily concentrated around a filter that had been installed […]

Jun 16, 2022

21 CFR part 11 Overview

21 CFR Part 11 outlines the federal requirements that help to ensure that electronic records are trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper. 21 CFR Part 11 has 10 chapters over 3 subsections. These subsections are General Provisions, Electronic Records, and Electronic Signatures.

Jun 15, 2022

3 Automations To Improve Your Cleanroom Workflow

At the end of the day, in a cleanroom: time is money. Cleanrooms are expensive to operate and, while they are running, they have a lot to do. Technicians gown up and put their expertise to work on various applications. But due to the nature of cleanrooms, SOPs and regulations must be minded. So there […]

Jun 8, 2022

Lighthouse Active Air Sampler Technology and d50

Air Sampler impaction technology has been around for decades. However the d50 is a little know aspect of air sampler technology design and it plays a critical role in air sample capture. Aerosol Impaction is the process in which particles are removed from an air stream by forcing the gases to make a sharp bend. […]

Jun 3, 2022

Lighthouse Apex Particle Counters compatibility with Vaporized Hydrogen Peroxide

Vaporized Hydrogen Peroxide (VHP) is a powerful chemical used to sterilize surfaces andequipment in the cleanroom, specifically in the medical equipment and pharmaceuticalindustries. It can cause deterioration and breakdown of equipment. Due to the nature of theindustries in which it is used, VHP is often used to sterilize equipment while the cleanroomis in use. Thus, […]

May 27, 2022

The Selection of the right Air Sampling Equipment for Your Process and Quality Assurance

May 25, 2022

Good Automated Manufacturing Practices 5 (GAMP5) And Your Cleanroom

The Good Automated Manufacturing Practices (GAMP) were developed by the International Society for Pharmaceutical Engineering (ISPE) for pharmaceutical cleanrooms. The ISPE remains the governing body for GAMP. According to ISPE, GAMP is, “A system for producing quality equipment using the concept of prospective validation following a life cycle model. Specifically designed to aid suppliers and users […]

May 19, 2022

Cleanrooms Explained

A cleanroom is a specifically designed room that controls contamination. Cleanrooms are used in practically every industry where small particles can adversely affect the manufacturing process and product. The main components of a cleanroom are what keeps the cleanroom clean. To control contamination in a cleanroom clean air is required, access is limited and outside […]

May 18, 2022

Fill the “GAP” Good Application Practice “How to Test HEPA Filters ”

May 18, 2022

4 Cleanroom Particle Filtration Techniques

How many times have you heard us say, “your cleanroom filtration is critical”? Probably more than once if you’ve spent any time interacting with us. But not all filtration is the same! Depending on your filter and application, there are different cleanroom particle filtration techniques. Today, we’ll be covering 4 of them. Straining/Sieving This technique is […]

May 11, 2022

Your Ultimate Guide To Cleanroom Air Distribution Strategy

We talk a lot about contamination control strategies in a cleanroom, but there is another type of strategy you need to consider: air distribution. This strategy is typically put into place during the planning and building of a cleanroom because it has a lot to do with infrastructure. But understanding your cleanroom’s air distribution strategy […]

what is a cleanroom
May 5, 2022

Cleanroom Particle Filtration Basics

Your filters are what separates your cleanroom from just some ordinary, run-of-the-mill room. They stop potentially harmful contaminants from entering the room. They prevent yield loss and harm to the end-user. Most importantly, the filters’ MPPS defines your cleanroom’s potential classification. This classification limits your cleanroom’s applications. Cleanroom filtration is defined by the type of […]

May 4, 2022

Cleanroom Air Filters: Controlling Contamination in The Cleanroom

Cleanrooms require air filters in order to trap contaminants from entering the cleanrooms air supply through its HVAC system. Cleanrooms are controlled environments where the control of temperature/humidity, pressure and particles are essential for optimum operational performance.

Apr 28, 2022

What is GAMP and why is it so important in Cleanroom Manufacturing?

Apex Z3 Front
Apr 22, 2022

Photometer vs Particle Counter: Which Is Right For Your Cleanroom?

When you need to classify your cleanroom, do you reach for your trusty photometer or particle counter? Both photometers and particle counters are devices used in cleanrooms to measure particles, but they go about it in different ways and report different data. According to ISO 14644, both are acceptable forms of testing for classification, especially […]

Apr 21, 2022

Best Practices in Particle Counter Management To Increase Data Integrity Reliability

Particle Counter management is a critical process in ensuring particle counter health and data integrity. The accuracy of the data from particle counters is critical in regulated industries. Particle Counters should be calibrated regularly based on their use. Manufacturers recommend that Particle Counters are calibrated at a minimum on an annual basis.

Apr 13, 2022

What Does “As Received Data” Mean During Particle Counter Calibration?

What does a perfect cleanroom look like? Zero contamination, immaculately gowned personnel, and no malfunctioning equipment, ever. That’s the dream, right? While perfection might not be attainable, we can work to get as close as possible to it. Not only will operating your cleanroom by these “nearly perfect” standards keep your data in line for […]

Apr 10, 2022

Shield N95 Respirator Donning

viable monitoring
Apr 5, 2022

Aseptic Environment: Nonviable vs Viable Monitoring

Does it matter what kind of particles exist in your cleanroom? Isn’t all contamination bad? On the surface, yes. You just need to know if your cleanroom is contaminated or not. Any contamination poses a risk to the contents of the cleanroom and, in some industries, a threat to the end-user or product. But we […]

Apr 1, 2022

Airborne Particle Counters and How They Work

Mar 30, 2022

Good Automated Manufacturing Practices (GAMP) In A Cleanroom

In an ever changing world, we are constantly seeing new regulations and expectations. This is especially true in the area of computerized system compliance and validation. GAMP was designed to address these needs. GAMP (Good Automated Manufacturing Practices) is a system designed specifically for suppliers and users in pharmaceuticals. GAMP certifies a system that produces quality […]

Mar 23, 2022

Good Application Practice: How to Perform Proper Cleanroom Classification

Mar 14, 2022

Particle Count Cleanroom Certification versus Routine Particle Monitoring and current GMP requirements

Cleanroom Certification is a process of validation. This validation process certifies that the Cleanroom operating conditions meet the intended design parameters. Room Particle Counts are tested using a Portable Particle Counter sampling at a defined volume at evenly spaced test locations around the cleanroom based on current Cleanroom Standards. The most accepted and widely used […]

Mar 8, 2022

How To Choose Your Cleanroom Classifying & Monitoring Tools

So you’re going to classify your cleanroom. But what cleanroom classifying tools can you use that will make the process painful and easy? First things first, let’s define cleanroom classification. The International Standards for Organization (ISO) is one organization that sets cleanroom classifications. ISO is a non-governmental agency that sets standards in a number of industries. These […]

cleanroom classification
Mar 1, 2022

Cleanroom Classification: What Makes  A Cleanroom

So what exactly makes a cleanroom… A cleanroom? First and foremost, a cleanroom needs to be clean. You are able to communicate just how clean it is through its cleanroom classification. But you cannot attain the classification without first making sure your cleanroom is really that clean. You do this through a proper cleanroom contamination control strategy […]

Feb 26, 2022

What is a Cleanroom

Feb 23, 2022

Understanding and Applying USP 788 Best Practices

Feb 23, 2022

Water For injection Liquid Monitoring for Pharmaceuticals

Water is one of the major utilities used by the pharmaceutical industry. Different grades of water quality are required depending on the different pharmaceutical uses. Control of the quality of water, in particular the microbiological quality, is a major concern and the pharmaceutical industry devotes considerable resources to the development and maintenance of water purification […]

batch sampler
Feb 21, 2022

USP <788> Regulations For Liquid Particle Counters In Cleanrooms

What happens if an injectable is contaminated? Infections, complications, vein irritation, local tissue infarction, anaphylactic shock, other health risks, and potentially death… The end-user is put in jeopardy. That is why it is vital we prevent contamination at the source: in the cleanroom during the manufacturing of the pharmaceuticals. This involves utilizing a liquid particle counter  […]

water storage
Feb 14, 2022

GMPs For Ultrapure Water In Pharmaceutical Cleanrooms

Water is an essential part of everyday life, and certain cleanrooms are no different – especially in pharmaceuticals. But water is unique apart from other products and process ingredients because ultrapure water is not subject to testing or batch-lot release before use and is drawn from on-demand systems. Additionally, results from water testing are not […]

Pharma 4.0
Feb 8, 2022

6 Water Purification Methods For Cleanrooms

Water. It makes up 70% of our bodies, but, even more importantly, it serves as a vital ingredient and manufacturing component in cleanrooms. Before we are able to introduce it into the cleanroom setting – especially as part of the product, such as in injectables and other pharmaceuticals – it needs to be purified. We’ve […]

Feb 2, 2022

USP 788 Testing for Particles in Injectable Products

We are all too well aware of the adverse effects of particulate matter contamination within parenteral injectable pharmaceutical products and the consequences for patient safety. Here, particulate matter refers to the small, sub visible particles. The United States Pharmacopoeia, USP <788> provides two tests for detecting such particulates: light obscuration and microscopic assay. Both are […]

particle deposition
Jan 27, 2022

Particle Deposition And Ways To Prevent It

As the world’s clean air experts, we talk a lot about monitoring your cleanroom’s cleanliness by keeping an eye on airborne particles. But what happens when airborne particles are no longer airborne? That is what we call particle deposition. When a particle deposits, it causes contamination and chaos in a cleanroom. So it is important […]

Jan 20, 2022

5 Ways A Portable Particle Counter Will Improve Your Cleanroom

Everyone with a cleanroom could use a particle counter, right? But which particle counter is right for you, and WHY is that particle counter a portable one? First and foremost, a portable particle counter creates its own vacuum, can be moved, and typically displays its reading on a built-in screen. This prevents you from leaving […]

Jan 9, 2022

Building Management Systems (BMS), Environmental Management Systems (EMS), and GMP Requirements

An Environmental Monitoring System (EMS) is very different from a Building Management System (BMS). A building management system (BMS), also known as a building automation system (BAS), is a computer-based control system installed in buildings that controls and monitors the building’s mechanical and electrical equipment such as ventilation, lighting, power systems, fire systems, and security […]

electric vehicle batteries
Jan 6, 2022

Cleanrooms & Electric Vehicle Batteries

How It’s Made: Electric Vehicle Batteries Myth or truth: electric vehicle batteries are just as bad for the environment as driving a gas-powered car. Do you have your answer? Do you think it’s a myth or the truth? It’s a myth! This myth comes from the fact that electric vehicles have large batteries that can […]

Dec 21, 2021

Digitalize Your Environmental Monitoring Contamination Control Strategy

Dec 15, 2021

How to Effectively Implement an Environmental Monitoring System Part 2: The Validation and Handover Process

Validation of environmental monitoring system
Dec 9, 2021

Validation Of An Environmental Monitoring System

Your Environmental Monitoring System (EMS): the frontline between your product and contamination. Or, at least, letting you know there is contamination so you can determine what the problem is and fix it! This means that an effective EMS is able to recognize when things are going wrong. The cornerstone of this process is conducting a Performance […]

Nov 29, 2021

Choosing & Installing An Environmental Monitoring System

Your Environmental Monitoring System stands between you and system failure, product recalls, contamination, and potential lawsuits. Sounds intense? We think so, too. But as the world’s clean air experts, we know it can be done right so at the end of the day you save time, money, and stress. Today, we’ve outlined the steps you […]

Nov 24, 2021

How to Effectively Implement an Environmental Monitoring System Part 1: The Installation Process

auto tech painter in a cleanroom setting
Nov 22, 2021

How Do Manufacturers Get The Perfect Car Paint Job

Imagine you’ve been rear-ended. There’s a little dent in your fender, but the paint has been damaged. When you go to get it fixed, what will matter more to you? The exact specifications of the process used to repair the dent or the guarantee that the paint will match your car’s paint job? Probably the […]

Nov 15, 2021

The Liquid Intrusion Resistant ApexZ

viable sampling
Nov 10, 2021

Viable Sampling Vs. Nonviable Sampling

Does it matter what kind of particle exists in your cleanroom? Yes, it does! Two types of contamination include viable and nonviable particles. Depending on which is present in your cleanroom, you will be able to determine where your cleanroom contamination control strategy is suffering and how to build a cleaner cleanroom. To determine the […]

Cleanroom at NASA
Nov 3, 2021

3 Ways NASA Uses Cleanrooms

When we think of cleanrooms, we usually think of manufacturing, technology, food processing, research, etc. But have you considered how those processes are used by NASA for space exploration? That’s right! NASA uses cleanrooms – and quite often, too! Not only is their equipment highly tuned, so it needs to be manufactured in a clean […]

Nov 3, 2021

Particle Counting Fundamentals

Oct 27, 2021

Microbiology & Bio contamination Control in Cleanrooms

SHIELD-95-MEDI Surgical N95 Disposable Respirator
Oct 14, 2021

Your Complete Guide To Face Masks

In many industries, face masks have played a significant role for many years! Surgeons wear them in surgeries. Scientists wear them in cleanrooms. Construction workers wear them on the job. And many more! But which face mask is best for which job? Some offer filtration from very small particles (viruses and bacteria), while others only […]

micro plastics
Oct 8, 2021

Microplastics In Water

What is something that is truly indestructible? Comic book fans will say a vibranium-metal alloy, while others might say that diamonds are about as close as we’ll get in reality. But something is being manufactured on our planet today that is genuinely indestructible. Plastic. That’s right: the plastic we are making today is here to […]

Oct 5, 2021

3 Things To Look For In Your Particle Counter to Mitigate Risk.

Your particle counter is a foundational part of your cleanroom contamination control strategy, as it stands between you and contamination notification. But your particle counter has a wide array of electronics that should be monitored to ensure the reported data is accurate. There are a few things you can look for in your particle counter […]

Sep 27, 2021

Active Air Sampling Technology & ISO 14698

Sep 22, 2021

How to validate your Cleanroom. HVAC Performance Qualification Basics.

Sep 21, 2021

Using Clean Room Technology To Fight COVID-19

It’s no secret that COVID-19 has drastically impacted the world around us. Throughout August 2021, the illness has overrun hospitals. To combat the spread of COVID-19 amongst hospital staff and patients, hospitals have been paying extra attention to their contamination control procedures. Aside from HEPA filters, hospitals have been using a piece of cleanroom technology to […]

Rogue Valley Breathe Easy program
Sep 10, 2021

Southern Oregon Air Quality: Introducing Rogue Valley Breathe Easy

Southern Oregon Air Quality: Introducing Rogue Valley Breathe Easy Here in Southern Oregon, air quality is a common topic of conversation. During the summer, we are plagued by smoke from wildfires. Since smoke is able to travel so far, it doesn’t matter if the fire is in Northern California, Western Oregon, or somewhere else in […]

Sep 8, 2021

ISO 14644-1:2015 and ISO 14644:2-2015 Review

what is not allowed in a cleanroom
Aug 20, 2021

What is not allowed in a cleanroom?

Cleanrooms are just that: clean. Therefore, there are strict requirements around what is allowed in a cleanroom and what is not. While exact guidelines might change in different cleanrooms, the following are considered general guidelines and best practices about what should not be allowed in a cleanroom. Street Clothes Your street clothes carry billions of […]

portable cleanroom with remote air particle counter
Aug 13, 2021

Portable Cleanrooms and You

Looking for an affordable alternative to a permanent cleanroom? Portable cleanrooms (also called modular cleanrooms) are usually constructed with a rigid frame such as steel and have panels made from plastic, vinyl or clear flat materials. They offer many of the benefits of a permanent cleanroom, but with the added versatility of being movable and […]

Aug 6, 2021

How Do You Measure Air Particles?

Air particles are measured by forcing air through a cavity in a particle counter which uses a laser to measure and count the particles. This is done through a process called light scattering.  Parts Of A Particle Counter Inside a particle counter, you will find a laser sensor block. This is where the particles are sized […]

Data Integrity
Jul 23, 2021

Data Integrity in Environmental Monitoring

Features to look for in your particle monitor to ensure compliance of your cleanroom Environmental monitoring lies at the heart of regulatory compliance for cleanrooms used in pharmaceutical, bio-pharmaceutical, and healthcare facilities. Facility managers need to understand what components are needed for a monitoring program, but they must also ensure the data they produce is […]

cleanroom tech
Jul 17, 2021

The Guide to Creating A GMP Training Program

Good Manufacturing Practices (GMPs – sometimes referred to as Current Good Manufacturing Practices or CGMPs) are federal regulations set by the FDA to cover how pharmaceuticals and food products are manufactured. They are guidelines taken for granted by many consumers – they assume what they put in their body will have been safely produced – but […]

Jun 29, 2021

Using a Risk Assessment to Build a Monitoring System Focusing on Data Integrity

Laser beams used in light scattering
Jun 25, 2021

How Do Light Scattering Airborne Particle Counters Work?

Light scattering is a technology that revolutionized the airborne particle counter industry, because it is able to quickly, efficiently, and accurately determine the size and number of particles that pass through an airborne particle counter in real time. Today, it is used in the airborne particle counters that set industry standards, because it is the […]

Jun 23, 2021

EN17141 “Bio contamination Control” and Microbiology in Cleanrooms & Controlled Environments

Jun 16, 2021

Let’s Prepare an ISO 14644-1 and GMP Annex 1 Cleanroom Classification Report Together

Jun 16, 2021

Fill in the “GAP”; Good Application Practices – “How to Test HEPA Filters?”

Foundations of a Cleanroom Contamination Control Strategy
Jun 4, 2021

Foundations of a Cleanroom Contamination Control Strategy

Your cleanroom contamination control strategy is the frontline between you and contaminated products, which can lead to yield loss, slowed production, and possible reputation damage. So when was the last time you really dove into your cleanroom contamination strategy? We highly recommend reviewing your strategy yearly to make sure you are still meeting industry best […]

May 28, 2021

Which Is Right For You: Handheld Particle Counter vs Remote Particle Counter vs Portable Particle Counter

Are you considering a new particle counter for your cleanroom? There are a number of options that might be right for you. Before reading through the pros and cons of each particle counter, we recommend you create a list of what you are looking for in your particle counter. On this list, we recommend you […]

May 26, 2021

Preventing Downtime With Liquid Particle Counting Technology

Ultrapure water
May 20, 2021

4 Industries That Use An Ultrapure Water System

Did you know that water might be clean enough to drink but not clean enough to use in your food? When it comes to water used in a cleanroom and manufacturing setting, it’s critical that the water is free of all contaminants and particles to maintain consumer safety. But what industries exactly need an ultrapure […]

paper in a cleanroom
May 14, 2021

What is Cleanroom Paper anyway?

What Is Cleanroom Paper? [Case Study] Do you use print-outs in your cleanroom? What kind of paper do you use? Could we be doing better than current industry standards? We think so. This is why we’ve started to investigate “cleanroom paper” and how this paper can impact the number of particles in a cleanroom while […]

May 13, 2021

GMP Annex 1 2020 Draft: Effects on cleanroom classification and monitoring

May 7, 2021

What Is An Ultrapure Water System?

Water is an extremely powerful force. We see it carve its way through land to form amazing geographical features like the Grand Canyon. So what can water do in your system? Ultrapure water systems clean water – keeping it particle free – so it can be used to clean and etch in manufacturing, especially in […]

preventing contamination in pharmaceuticals
Apr 29, 2021

8 Ways To Prevent Contamination In Pharmaceuticals

Contamination in pharmaceuticals can quickly turn into a nightmare with yield loss, recalls, bad press, and harmed consumers. Thus, it’s critical to stop contamination from ever being an issue during production in your cleanroom. Here at Lighthouse Worldwide Solutions – the world’s clean air experts – we’re pros at keeping cleanrooms extra clean. It’s our […]

Apr 22, 2021

Your Key to Success: Building a Contamination Control Strategy

Apr 15, 2021

Particle Monitoring- How To Go Paperless in The Cleanroom

particles and pharmaceuticals
Mar 22, 2021

How Do Particles Impact Pharmaceuticals?

As clean air experts, we talk a lot about making sure that the air in a cleanroom stays as clean as possible. We do this to meet Food and Drug Administration (FDA) Good Manufacturing Practices (GMPs) in pharmaceuticals and keep our products on the shelves and helping people. When we bring contaminants into a cleanroom, […]

Mar 17, 2021

How to Prepare a Risk Based Cleanroom Monitoring Plan as per ISO 14644-2:2015

Mar 9, 2021

10 Facts About Indoor Air Quality You Might Not Know

In the COVID-19 era, indoor air quality has become a hot button topic. There are a lot of interesting facts about indoor air quality that you might not know, but one of the most surprising facts is that your indoor air quality was impacting you long before COVID. As the world’s clean air experts, we […]

Mar 1, 2021

Women in STEM: Cleanroom Edition

March is Women’s History month: dedicated to recognizing the critical contributions of women throughout history. As those who work in the STEM community, we are thoroughly thankful for and impressed by the women who have changed the shape of the world – in the past and today. Today, we wanted to take a few moments […]

Feb 17, 2021

Understanding Particle Counter Calibration in Less Than 45 Minutes

Feb 5, 2021

ISO 14644-3:2019 Cleanrooms and Associated Controlled Environments-Test Methods

hand held particle counter
Feb 4, 2021

What Are Handheld Particle Counters?

Handheld particle counters are just what it sounds like: particle counters that you can hold in your hand. They are typically use to spot check a cleanroom or to test air temperature and humidity. Handheld particle counters are a versatile, ergonomic tool that deserves its place in the modern cleanroom, along with indoor air quality […]

Jan 22, 2021

GMP Annex1 2020 Draft and its Effect on Cleanroom Classification and Monitoring

Jan 5, 2021

What Is A Cleanroom? And How Using A Cleanroom Can Benefit You

If you’re working for a company already using a cleanroom, you’re well aware of the benefits of a cleanroom and how important they are. But if you’re wondering how you can improve your production, then a cleanroom might be the answer. Either way, a cleanroom is not a simple beast. It is a multi-layered room […]

remote particle counter sensor
Jan 3, 2021

5 Fundamentals Of Particle Counters

Particle counters do just that: they count particles. They are used in cleanrooms to count and size the particles in the air so the cleanroom can stay in proper working function and meet crucial certification criteria. The fundamentals of particle counters are relatively simple. You need to know how and why they work. If you have a […]

Jan 1, 2021

Integrating ApexZ with LMS Pharma8

This Whitepaper is intended to assist users that are looking to integrate their ApexZ unit into LMS Pharma’s facility control/monitoring system. This document covers the following topics: 1. Establishing a connection to the ApexZ unit via the Configuration Tool 2. Establishing a connected unit into LMS Pharma’s Database Tree 3. Adding a connected unit to […]

Aug 26, 2020

Prevent Failure by Designing Your Cleanroom Monitoring System to Meet cGMP

Aug 17, 2020

Selecting Air Sampling Equipment

Jul 22, 2020

Performance Qualification of Environmental Monitoring Systems

Jul 7, 2020

Annex 1 2020 Draft and Cleanroom Monitoring

Jun 26, 2020

Annex 1 2020 Draft and Cleanroom Classification

Jun 10, 2020

ApexZ From Lighthouse Worldwide Solutions

May 10, 2020

ApexZ Part 4: Paths to Paperless Data

May 10, 2020

ApexZ Part 3: GMP Workflow Activation

May 10, 2020

ApexZ Part 2: Technologically Advanced System

May 10, 2020

ApexZ Part 1: Physical Features

Apr 15, 2020

Particle Monitoring – Going Paperless in the Cleanroom

Jan 24, 2020

An Introduction to EU GMP (European Union Good Manufacturing Practices) Annex 1 – Part 2 of 2

Jan 22, 2020

An Introduction to EU GMP ( European Union Good Manufacturing Practices) Part 1 of 2

Oct 15, 2019

Introduction to Sample Volumes & Flow Rates

Oct 15, 2019

ISO 14644 Family Overview

Jul 17, 2019

ISO 14644:2-2015 Creating, Implementing, and Maintaining a Monitoring Plan

Jun 8, 2019

Understanding the basics of ISO 14698-1 / Biological Contamination

May 25, 2019

Brief introductory overview of ISO 14644-2 / Part 3 of 3 – Sampling Locations and Considerations

May 19, 2019

Brief introductory overview of ISO 14644-2 / Part 2 of 3 – Cleanroom Particle Sampling Methods

May 18, 2019

Quick How To: ApexRemote || How to Connect with a Mobile Device

May 17, 2019

Lighthouse Environmental Monitoring Systems for Hospitals, Surgery Centers & Clinics

May 8, 2019

Brief introductory overview of ISO 14644-2 / Part 1 of 3 – Cleanroom Monitoring

May 4, 2019

Introduction to ISO 14644-1 Room Classifications

Apr 19, 2019

Handheld Particle Counter || The Most Dependable & User Friendly Handheld Particle Counter

Apr 19, 2019

Handheld Particle Counter || The Most Dependable & User Friendly Handheld Particle Counter

Apr 19, 2019

Handheld Particle Counter || The Most Dependable & User Friendly Handheld Particle Counter

Apr 10, 2019

Introduction to Viable Sampling

Mar 6, 2019

Introduction to Particle Sizes

Mar 6, 2019

ActiveCount25H – Viable Sampler with HEPA Filter Exhaust

Feb 13, 2019

Quick How To: Liquid Sampler LS20 – Audit Trail Function

Feb 13, 2019

Quick How To: Liquid Sampler LS20 – Reports

Jan 18, 2019

Quick How To: Liquid Sampler LS20 – How to Change Thresholds – Liquid Particle Counter

Jan 3, 2019

Quick How To: Liquid Sampler LS20 – Initial User Set-Up – Liquid Particle Counter

Dec 15, 2018

Quick How To: Liquid Sampler LS20 – Home Screen Set-Up – Liquid Particle Counter

Dec 11, 2018

ApexRemote Series Particle Counting’s Latest Technology

Dec 8, 2018

Quick How To: Liquid Sampler LS20 – Initial Set-Up Liquid Particle Counter

Jan 4, 2018

Liquid Sampler LS-20 Lighthouse Worldwide Solutions

Nov 13, 2017

Quick How To: ActiveCount100H Mounting Petri Dish

Oct 28, 2017

Quick How To: ActiveCount100H Assigning Locations & Users

Oct 20, 2017

Quick How To: ActiveCount100H Setting Up a Password

Oct 20, 2017

Quick How To: ActiveCount100H Home Screen Orientation

Oct 1, 2017

Quick How To: ActiveCount100H Gas Sampling

Sep 9, 2017

Quick How To: ActiveCount100H Periodic Sampling

Sep 2, 2017

Quick How To: ActiveCount100H Constant Sampling

Aug 18, 2017

Solair 1100/3100/5100 Tutorial Series | Configure Security Settings

Aug 18, 2017

Solair 1100/3100/5100 Tutorial Series | Configure Alarm Settings

Aug 18, 2017

Solair 1100/3100/5100 Tutorial Series | Configure Sample Settings

Aug 18, 2017

ActiveCount100H Tutorial Series | Sampling Modes & Parameters

Aug 18, 2017

ActiveCount100H Tutorial Series | General Instrument Settings

Aug 18, 2017

ActiveCount100H Tutorial Series | Gas Sampling

Aug 18, 2017

Handheld 2016/3106/5016 | Training Getting Started

Aug 17, 2017

ActiveCount100H Tutorial Series | Main Screen Overview, Records, Users & Locations

Apr 11, 2017

Quick How To: ActiveCount100H Exporting Data

Aug 15, 2016

ApexR5 Remote Particle Counter-Addressing Risks in Airborne Particle Counting

Apr 3, 2016

Introduction to Demarcation Lines in USP 797 Regulated Cleanroom Environments

Mar 16, 2016

Lighthouse Partner At The New Training Facility

The new Biotech Training Facility (BTF) is a state-of-the-art training center where students can learn how to produce (bio) pharmaceuticals, under GMP and biosafety conditions, in a realistic environment. The cleanrooms in the BTF 2000m² (37000ft²) consist of gowning rooms, Class A to D grades. The facility is built in the heart of the Dutch […]

guests at Interphex exhibit 2016
Feb 26, 2016

Interphex Osaka Japan Exhibition

Lighthouse Worldwide Solutions attended the Interphex Osaka Japan exhibition on February 24-26, 2016. The AC100 and the new Apex P3 with bigger screen on this exhibition were presented. Both units were very well received by the customers! Also, they trained Kondoh on the AC100 and Lighthouse is ready to sell this unit in Japan! What […]

Oct 1, 2015

Airborne Particle Deposition in Cleanrooms

Abstract This article discusses the mechanisms of particle deposition onto cleanroom surfaces.  The main mechanism for particles above 0.5 µm is gravitational settling.  Turbulent deposition and electronstatic attraction can also occur at all particle sizes, and for particles below 0.5 µm Brownian diffusion is important.

Sep 4, 2015

Locations Function

Sep 4, 2015

Reports Function

Aug 12, 2014

ApexR5 Remote Particle Counter Introduction