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 best practices for different industries. To this day, they do just that. And cleanrooms and contamination control falls under their...
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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 is. What Is Contamination Control? Contamination...
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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 essence of their design is to reduce repetitive work and stress on your team while improving...
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What Is 21 CFR 11?
How much time do you spend each day hunting down signatures? Or do you get to use a digital system to endorse documents? If you get to record, verify, and store data digitally, you can thank 21 CFR 11. 21 CFR 11 refers to Code of Federal Regulations Title 21 Part 11: the Food and Drug Administration’s guidance on maintaining data integrity in digital applications. It requires certain attributes from digital systems that are used to gather signatures and...
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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 40 years previously and not checked since. As a result, many scientists who had worked in that...
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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 is constant documentation. This tedious documentation - when done by humans - not only slows down and impedes your workflow, but allows for human error. Thus, it is valuable to...
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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 cleanrooms of around 75% of life science companies.
A particle counter spits out a printout with dozens of data points on it. A technician tears the printout from the...
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 can yield up to 700 print outs. Each of these printouts needs to be reviewed. But before they can be reviewed, there is a whole process they must go through. When the particle counter prints out the information, someone must go retrieve the ticket. They have to rip...
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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 in the pharmaceutical industry”. In our experience, we see...
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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 exactly what it sounds like: the filter strains particles out of the air. Similar to the...
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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 will give you a better understanding of your cleanroom’s overall environment. Why Does Air Distribution...
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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 filters you use. There are 4 main types of filters you...
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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 after the 2019 updates. Yet the needs of each cleanroom are unique! But which one proves right for your cleanroom?...
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Your Basic Guide To Aseptic Filling
Your Basic Guide To Aseptic Filling Did you know that aseptic (or sterile) processing in pharmaceutical manufacturing is relatively new? Sterility requirements were established in the 1920s. Later, during World War II, requirements were created around large scale biological manufacturing of plasma and blood products. Previously, some blood products required post-fill pasteurization, where they underwent the low heat treatment of 60°C for 10 hours. While this does...
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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 easy tracing, but it will also decrease yield loss and increase productivity. So how do we make sure your...
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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 need to go a layer deeper: what kind of contamination is present? Not only will this determine the severity and type of threat to your cleanroom and product,...
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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 products following a life cycle model. Following GAMP best practices, manufacturers are able...
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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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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 standards are widely respected throughout the world. In the US,...
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