Dec 26, 2023

Establishing a PHARMA Environmental Monitoring Program

Dec 26, 2023

Understanding 4-20mA Data Accuracy in Particle Counting

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 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 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

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 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. […]

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

MEDICAL DEVICES AND ENVIRONMENTAL MONITORING

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

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

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. […]

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 […]

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 […]

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 […]

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 […]

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. 

Sep 22, 2022

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

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 […]

Aug 26, 2022

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

Jul 27, 2022

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

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 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

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 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 18, 2022

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

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.

Mar 23, 2022

Good Application Practice: How to Perform Proper Cleanroom Classification

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 […]

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 […]

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 […]

Dec 21, 2021

Digitalize Your Environmental Monitoring Contamination Control Strategy

Oct 27, 2021

Microbiology & Bio contamination Control in Cleanrooms

Sep 22, 2021

How to validate your Cleanroom. HVAC Performance Qualification Basics.

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 […]

Jun 29, 2021

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

Jun 16, 2021

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

May 26, 2021

Preventing Downtime With Liquid Particle Counting Technology

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, […]

Feb 17, 2021

Understanding Particle Counter Calibration in Less Than 45 Minutes

Apr 15, 2020

Particle Monitoring – Going Paperless in the Cleanroom

May 17, 2019

Lighthouse Environmental Monitoring Systems for Hospitals, Surgery Centers & Clinics