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 samples can be generated. That is a lot of data to collate and track. But without proper measures, data can become corrupted and the cleanroom could be considered...
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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 embrace the power of the internet and digitization in its entirety. At the peak...
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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 that is exactly how important risk mitigation is: we start practicing it and recognizing the importance of it before we even have conscious thoughts. It’s an instinct. As we...
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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 winter up on the hill, and you had just bought the perfect truck to get through the winter weather. The next morning, you wake up to a beautiful blanket of thick, fluffy snow....
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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 school science class comes to mind: osmosis is the diffusion of water through a semipermeable membrane. Now what exactly does...
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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, we know that the water coming out of our tap is clean enough to drink and that’s the end of it. But how does that water...
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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 of ultrapure water! For example, processing a single wafer uses over 1,000 gallons of ultrapure water. For many...
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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 over 40 years, we think this needs to change. That is why we developed the SHIELD-95-MEDI Surgical N95 Respirator: the most innovative N95 on the...
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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 used for the production of water for injectables (WFI), semiconductors, and other processes that require water in cleanrooms. Semiconductors and WFI...
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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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