What are Pyrogens and Endotoxins…and How Can They Be Controlled in a Cleanroom

Low-endo-pyrogen

Often, we use the terms’ bacterial endotoxin’ and ‘pyrogen’ interchangeably. They refer to phospholipid-polysaccharides (also termed lipopolysaccharides, or LPS). And there’s a chance that these pyrogens may be released from decaying Gram-negative bacteria such as E. coli. Following cell death, these complex macromolecules emanate from compromised outer cell walls. If unchecked, it can induce and […]

Surface Sampling for ISO Class 5 Primary Engineering Controls

In the compounding of pharmaceuticals, Primary Engineering Controls (PECs) are critical in ensuring final product integrity and public safety. Equipment such as compounding aseptic isolators (CAIs) and biological safety cabinets (BSCs) must be contamination free, and this requires diligent monitoring to maintain standards to PEC ISO 5 classification. According to USP <797> guidelines, flat interior […]

Do Gloves Impact Your Work and Health?

Two blue medical latex gloved hands palms out fingers spread

While essential to ensure safety, wearing these items can sometimes be uncomfortable and annoying. But given their necessity, is there a way to make the oftentimes prolonged wearing of gloves less unwieldy? We think so. And if you’ve been impacted by Sweaty Palm Syndrome or have a new respect for those quietly battling the itch […]

Smart Fungus Among Us – Can Mushrooms Architect the Materials of the Future?

Biosensing Technology When we think of fungi – and who doesn’t when we all have so much extra time to ponder the bizarre? – we tend to think of either the mushrooms we add to our Friday night pizza or the trippy psilocybin-laden ‘magic mushrooms’ that are, we understand, enjoying something of a renaissance as […]

Double Masking in a Cleanroom?

CDC-mask-recommendations

The Centers for Disease Control and Prevention (CDC) updated their website today. Read about the new recommendation for Double Masking protocols. The CDC is suggesting wearing a single use disposable mask underneath a launderable cloth mask. Berkshire does not recommend bringing a launderable cloth face mask into a cleanroom, just as we don’t recommend relaundering wipers.

Revisiting the Unsanitary/Insanitary Conundrum of Custom Biopharmaceuticals

Machine for making capsules

If we were called upon to characterize last year in just two words, we would undoubtedly select unprecedented and pandemic as the most obvious watchwords of 2020. And at this point in time their definition is abundantly clear. But, as we start 2021, a couple of terms have resurfaced that apparently remain somewhat opaque, among […]

Cleanroom News: Top 5 Articles of 2020

All year we have brought you stories that inform, inspire, and uplift, some – we hope – even bringing you a wry smile. Last year, our ‘Best of…’ saw research on India’s lunar lift off, Apple’s super-fast A12 bionic chipset, and the thrifty romance of lab-grown diamonds. This year, the trend is for our primers […]

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