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 […]
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 […]
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, […]
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 […]
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 […]
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