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 cleanroom monitoring. We will first look at how it is currently regulated (per the 2008 revisions) and how the 2020 draft suggests change. Monitoring As Per Current GMP Annex 1 2008 There are 9 clauses, from clause 8 to clause 16, in GMP Annex 1 2008 that defines...
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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 version in 2008. While not officially published yet, we can expect only minor changes from the 2020 draft. Stakeholder feedback will be considered in these changes, so keep that in mind. Here, we have broken down the clauses surrounding classification per the current...
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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 and design. Whether your cleanroom is one room or a network of rooms connected by hallways, you need...
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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 to check the liquid for contamination. The Food and Drug Administration...
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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 always available immediately because it requires time for microbiological tests to be performed. Thus, it is critical...
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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 outlined six of the most popular and effective water purification methods used in cleanrooms. Microporous Filters A microporous filter is exactly...
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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 deserve to know that your equipment does not need you constantly checking in on it for it to do its job. That's where the ApexZ comes in. Built from over 40 years of...
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Case Study: Compatibility Of Lighthouse Particle Counters With Vaporized Hydrogen Peroxide
Executive Summary The purpose of this case study was to evaluate the durability of Lighthouse Worldwide Solutions’ ApexZ3 and ApexR5p in a cleanroom where live microorganisms are processed and then decontaminated with Vaporized Hydrogen Peroxide (VHP). When exposed to VHP, the equipment needed to be able to deliver accurate readings while maintaining its integrity. VHP cycles started on April 6 and ended on June 17. The equipment was checked on April 5 upon...
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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 difference and present in your cleanroom, you need to employ viable and nonviable sampling. What Is Viable Sampling? A viable...
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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 offer protection from large droplets. Depending on your purpose for wearing a mask, one option will work better than others. Each one...
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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 to ensure your data is accurate and reliable. What Does Your Particle Counter's Laser Do? Your particle counter's...
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How to Validate Your Cleanroom? ( Webinar available )
HVAC Performance Qualification Basics
HVAC Performance Qualification Roadmap, Application Guidance, and Tips as per ISO 14644-3:2019; Cleanroom Test Methods and Cleanroom Classification as per ISO 14644-1:2015.
Cleanroom HVAC performance qualification, known as “cleanroom validation,” is the most critical set of tests to ensure that the cleanroom is...
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 contain the illness in the hospital to protect the staff. So what’s the...
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Introducing The Knowledge Center
The Best Way To Learn About Contamination Control! We are very excited to announce our new Knowledge Center: the tool to make you the smartest person in the room! Over the last 40 years, we’ve become known as the clean room monitoring experts of the world. So we’ve decided to put our heads together and publish as much information as possible to equip you with the knowledge you need to make the best possible decisions for your cleanroom and business. What Will...
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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 particles on them from your home, your car, the Starbucks you stopped at this morning, the woman who...
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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 more affordable. Portable cleanrooms can also be expanded when needed. Portable cleanrooms might not be the perfect...
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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 and counted using a process called light scattering. The laser sensor block is made up of: ● Sensor...
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What Are Fine Particles?
Fine particles are a form of particulate matter (pm) that have diameters below 2.5 micrometers in size. They can be solids or liquids and are formed both indoors and outdoors through chemical reactions. In human interactions, they can be harmful to health or just a nuisance. What Is The Difference Between Fine & Coarse Particles? The main difference between fine and coarse particles is size. Coarse particles (sometimes referred to as PM10-2.5) have a...
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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 complete, consistent, and...
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 applications. . For many companies and industries, they serve a valuable purpose, as they also monitor air temperature and humidity. But the...
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