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. […]
During the 2020 fire season, more than 106 large wildfires occurred in the states of Oregon and California. The fires were battled by tens of thousands of wildland firefighters, but still burned more than 6.7 million acres. While thousands of people lost their homes, almost every resident of the state was able to see the […]
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 […]
A cleanroom classification basically tells you how clean a cleanroom is. While we typically consider cleanrooms to use HEPA filters and multiple layers of protection, cleanrooms can really be any room where precautions are taken to ensure that the product stays clean from contaminants. But if that’s the case, then what makes one cleanroom stand […]
It is no mystery that cleanrooms need to be, well, clean. From the surfaces and tools to the air in the cleanroom, everything needs to remain at a certain level of cleanliness depending on the cleanroom’s classification and application. Those criteria extend to the compressed gasses used in cleanrooms, as well, like oxygen, hydrogen, methane, […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
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 […]
A cleanroom is a specifically designed room that controls contamination. Cleanrooms are used in practically every industry where small particles can adversely affect the manufacturing process and product. The main components of a cleanroom are what keeps the cleanroom clean. To control contamination in a cleanroom clean air is required, access is limited and outside […]
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 […]
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 […]
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 […]
Cleanrooms require air filters in order to trap contaminants from entering the cleanrooms air supply through its HVAC system. Cleanrooms are controlled environments where the control of temperature/humidity, pressure and particles are essential for optimum operational performance.
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 […]
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 […]
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 […]
Cleanroom Certification is a process of validation. This validation process certifies that the Cleanroom operating conditions meet the intended design parameters. Room Particle Counts are tested using a Portable Particle Counter sampling at a defined volume at evenly spaced test locations around the cleanroom based on current Cleanroom Standards. The most accepted and widely used […]
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 […]
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 […]
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 […]
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 […]
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 […]
As the world’s clean air experts, we talk a lot about monitoring your cleanroom’s cleanliness by keeping an eye on airborne particles. But what happens when airborne particles are no longer airborne? That is what we call particle deposition. When a particle deposits, it causes contamination and chaos in a cleanroom. So it is important […]
Your Environmental Monitoring System (EMS): the frontline between your product and contamination. Or, at least, letting you know there is contamination so you can determine what the problem is and fix it! This means that an effective EMS is able to recognize when things are going wrong. The cornerstone of this process is conducting a Performance […]
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 […]
What is something that is truly indestructible? Comic book fans will say a vibranium-metal alloy, while others might say that diamonds are about as close as we’ll get in reality. But something is being manufactured on our planet today that is genuinely indestructible. Plastic. That’s right: the plastic we are making today is here to […]
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 […]
Light scattering is a technology that revolutionized the airborne particle counter industry, because it is able to quickly, efficiently, and accurately determine the size and number of particles that pass through an airborne particle counter in real time. Today, it is used in the airborne particle counters that set industry standards, because it is the […]
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 you really dove into your cleanroom contamination strategy? We highly recommend reviewing your strategy yearly to make sure you are still meeting industry best […]
Are you considering a new particle counter for your cleanroom? There are a number of options that might be right for you. Before reading through the pros and cons of each particle counter, we recommend you create a list of what you are looking for in your particle counter. On this list, we recommend you […]
What Is Cleanroom Paper? [Case Study] Do you use print-outs in your cleanroom? What kind of paper do you use? Could we be doing better than current industry standards? We think so. This is why we’ve started to investigate “cleanroom paper” and how this paper can impact the number of particles in a cleanroom while […]
Water is an extremely powerful force. We see it carve its way through land to form amazing geographical features like the Grand Canyon. So what can water do in your system? Ultrapure water systems clean water – keeping it particle free – so it can be used to clean and etch in manufacturing, especially in […]
If you’re working for a company already using a cleanroom, you’re well aware of the benefits of a cleanroom and how important they are. But if you’re wondering how you can improve your production, then a cleanroom might be the answer. Either way, a cleanroom is not a simple beast. It is a multi-layered room […]
Particle counters do just that: they count particles. They are used in cleanrooms to count and size the particles in the air so the cleanroom can stay in proper working function and meet crucial certification criteria. The fundamentals of particle counters are relatively simple. You need to know how and why they work. If you have a […]
Abstract This article discusses the mechanisms of particle deposition onto cleanroom surfaces. The main mechanism for particles above 0.5 µm is gravitational settling. Turbulent deposition and electronstatic attraction can also occur at all particle sizes, and for particles below 0.5 µm Brownian diffusion is important.
