In the realm of cleanroom operations, humans are both a crucial asset and a potential source of contamination. Understanding and mitigating human factors are essential for maintaining optimal cleanliness and efficiency in sterile manufacturing processes. 1. Human-Induced Contamination: Humans are significant producers of particles within cleanroom environments, shedding up to 40,000 skin cells per minute and […]
In the realm of sterile manufacturing processes, the Environmental Monitoring System (EMS) serves as a crucial barrier between success and potential disasters like system failures, product recalls, and contamination, which could lead to product shortages. Selecting the right environmental monitoring software and hardware is paramount to the success of your cleanroom operations. The software serves as the […]
The rapid rise of electric vehicles (EVs) has brought about a surge in demand for high-quality lithium-ion batteries. These batteries are the heart of EVs, providing the power needed to propel these vehicles. However, manufacturing lithium-ion batteries is a complex process that demands meticulous control over various factors, including particle contamination. Particle Contamination: A Hidden […]
Introduction In the realm of pharmaceuticals, the pursuit of excellence in product quality is a never-ending journey. Governments and private industries have diligently crafted recommendations and regulations over the years, evolving in response to the dynamic landscape of the pharmaceutical sector, particularly in the digital age. In this comprehensive paper, we delve into the fundamental […]
In the meticulous realm of pharmaceuticals and controlled environments, precision is paramount. Particle counters emerge as indispensable tools in maintaining stringent quality standards. This blog elucidates the critical role of particle counters in cleanroom certification, routine monitoring, and HEPA filter testing while adhering to ISO standards. Certifying Cleanrooms using Particle Counters as per ISO 14644-1:2015 […]
In the complex landscape of pharmaceutical manufacturing, where the safety and efficacy of medicinal products are paramount, Annex 1 of the EU Guidelines for Good Manufacturing Practice (GMP) for Medicinal Products 2022 stands as a crucial document. One of its core components, the Contamination Control Strategy (CCS), plays a pivotal role in ensuring the production […]
In our rapidly evolving world, environmental monitoring has become a critical aspect of safeguarding our planet’s health. From air and water quality to soil conditions and climate patterns, the data collected through environmental monitoring systems provide valuable insights that guide policies, research, and decision-making. However, the accuracy of these measurements is paramount, and that’s where […]
In 2022, GMP Annex 1 was revised to reflect the changing landscape of technology, discoveries, best practices, and needs. At the time of publication, this is the first and only, but far from the last, regulatory body to make a large update in several years. We do expect to see similar guidelines from the FDA […]
You will hopefully not be shocked to learn that data integrity is an integral part of a properly running cleanroom. If this does come as a surprise to you, we highly recommend you read on and take notes. But for many cleanroom or particle counter professionals, the term “data integrity” has been drilled into our […]
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 number. While we have a number of ways to improve your gowning protocol across the board, it is important to recognize that different ISO classifications require […]
An active air sampler is one of the tools you can use in your cleanroom to monitor contamination, but, specifically, it is the tool you can use to monitor viable contamination. These are live microbes, so they have the potential to grow, like mold or fungi. While a particle counter can tell if contamination is […]
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 is the process in which particles are removed from an air stream by forcing the gases to make a sharp bend. […]
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 […]
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 […]
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 […]
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 […]
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 […]
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