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Cleanroom Maintenance Checklist Small Image
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...

3 Automations To Improve Your Cleanroom Workflow Small Image
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...

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...

Your Path To A Paperless Cleanroom Part 2 Small Image
Jun 8, 2022

Your Path To A Paperless Cleanroom Part 2

How To Improve Your Cleanroom Data Integrity   What does particulate data collection in your cleanroom look like? Let’s paint a picture together of the current system - or close to it - in the...

Jun 3, 2022

Lighthouse Apex Particle Counters compatibility with Vaporized Hydrogen Peroxide

Vaporized Hydrogen Peroxide (VHP) is a powerful chemical used to sterilize surfaces and equipment in the cleanroom, specifically in the medical equipment and pharmaceutical industries. It can cause...

Your Path To A Paperless Cleanroom part 1 Small Image
Jun 1, 2022

Your Path To A Paperless Cleanroom part 1

Did you know 75% of life science companies still use a paper based system in their cleanrooms? That means in an 8 hour shift, you need someone to look at as much as 5,000 individual count data samples which...

May 27, 2022

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

In our cleanrooms where sterile products are manufactured biocontamination needs to be controlled and monitored frequently and in risk zones continuously during production. The goal is to produce safe and...

Good Automated Manufacturing Practices 5 (GAMP5) And Your Cleanroom Small Image
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....

May 18, 2022

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

May 4, 2022

Cleanroom Air Filters: Controlling Contamination in The Cleanroom

Apr 28, 2022

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

Apr 21, 2022

Best Practices in Particle Counter Management To Increase Data Integrity Reliability

Good Automated Manufacturing Practices (GAMP) In A Cleanroom Small Image
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...

Your Guide To GMP Annex 1: Part 2 Small Image
Mar 23, 2022

Your Guide To GMP Annex 1: Part 2

Welcome back to your guide to GMP Annex 1! Previously, we discussed how GMP Annex 1 defines and regulates cleanroom classification. In this article, we’re going to address how it defines and regulates...

Your Complete Guide To GMP Annex 1: Part 1 Small Image
Mar 15, 2022

Your Complete Guide To GMP Annex 1: Part 1

The GMP Annex 1 describes the best practices for classifying and monitoring your cleanroom and clean air equipment. In 2020, a new version was drafted with some changes and clarifications from the original...

How To Choose Your Cleanroom Classifying & Monitoring Tools Small Image
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...

Cleanroom Classification: What Makes  A Cleanroom Small Image
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...

Dec 15, 2021

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

Choosing & Installing An Environmental Monitoring System Small Image
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...

Nov 24, 2021

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

Sep 22, 2021

How to validate your Cleanroom. HVAC Performance Qualification Basics.

Jun 29, 2021

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

10 Ways To Improve Your Cleanroom’s Gowning Protocols Small Image
Jun 11, 2021

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...

Foundations of a Cleanroom Contamination Control Strategy Small Image
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...

ISO 17025 Calibration Small Image
Feb 16, 2021

ISO 17025 Calibration

What It Means And Why It’s Important Lighthouse Worldwide Solutions is proud to announce that all of our manufacturing and service facilities have been accredited for the ISO 17025 testing and...

What Is Particle Counter Calibration? And why is it important? Small Image
Feb 11, 2021

What Is Particle Counter Calibration? And why is it important?

What Is Particle Counter Calibration? And why is it important? Particle counters are a fundamental part of any properly maintained cleanroom. They are intricate tools used to count the number of...

Jul 22, 2020

Performance Qualification of Environmental Monitoring Systems

Apr 16, 2020

Particle Counting Sample Tubing Guidance and Best Practices

Airborne Particle Counters are used for a variety of purposes in pharmaceutical cleanrooms for such applications: Filter testing Cleanroom certification and testing Isolator certification and...

Apr 15, 2020

Particle Monitoring - Going Paperless in the Cleanroom

Jan 15, 2020

How to Perform a Performance Qualification On a Particle Monitoring System

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...

Nov 13, 2019

Cleanroom Gowning Best Practices

What are the regulatory requirements? Although there are no federal regulations for sterile cleanroom garments used in the pharmaceutical industry, guidance for the industry is available from The Institute...

Oct 25, 2019

Selecting the Right Monitoring Instruments for Cleanroom Classification and Routine Reclassification Following current cGMP

One of the biggest challenges in any cleanroom is setting up a suitable environmental monitoring (EM) program. Which instruments are used for sampling, how frequent samples should be, how much sampling is...

Aug 26, 2019

Manifold Monitoring Systems Explained

Manifold systems have been used for many years in particle monitoring in controlled environments. A manifold system uses one particle counter and a mechanical system to align the sample inlet of the particle...

Jul 25, 2019

Cleanroom Gas Sampling 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...

Jun 5, 2019

Cleaning and wipedown best practices

Controlling cleanroom contamination is mission critical for sterile manufacturing processes. It is vital the equipment taken into the cleanroom and used in the cleanroom are easy to wipe down and keep free...

Jan 1, 2019

Cleanroom Air Changes Best Practices

Cleanrooms are defined by their cleanliness level based on the absence of airborne particles present in a sample of a giving volume. ISO 14644-1 is an international standard for cleanroom classification....

Jan 1, 2019

Establishing a PHARMA Environmental Monitoring Program

"In aseptic processing, one of the most important laboratory controls is the environmental monitoring program. The EM program provides meaningful information on the quality of the aseptic processing...

Jan 1, 2019

Cleanroom Gas Sampling Using an Active Air Sampler

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...

Apr 1, 2017

Particle Count Strategies on Alarm Settings

Setting inappropriate Alert and Action alarms on your Environmental Monitoring System (EMS) could be a big contributor to lost revenue, longer downtimes, and a lot of discarded products. Misinterpretation of...

Aug 23, 2016

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...

Aug 16, 2016

Maintaining Validation and Calibration

A wide variety of scientific instruments are used on a regular basis to assist in our daily IAQ investigations. Moisture meters, temperature and relative humidity probes, infrared cameras, and particle...

Aug 16, 2016

Particle Transport in Tubing

Airborne Particle Counters (APC) are used for a variety of purposes such as: • Filter testing • Cleanroom certification and testing • Isolator and minienvironment testing and certification....

Aug 16, 2016

What do Particle Counts Mean?

When using particle counters, one needs to be aware of certain terms or phrases that are commonly used when describing functions of the instrument, or how the data is viewed and reported. Data are displayed...

Aug 16, 2016

Real Time Process Monitoring

A common approach to controlling contamination in high technology manufacturing cleanrooms is the continuous monitoring of particles. Either dedicated, discrete, “real-time” particle counters or a...

Jul 4, 2012

How to Select a Particle Counter for my Cleanroom

Often, the selection of a particle counter for use in a cleanroom is done based upon the specifications of the instrument and the purchase price. Before getting into the details of the specifications, it is...