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 […]
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 […]
In the cleanroom environment, there is none more popular than isopropyl alcohol. It wields great power and has many useful qualities. According to strict definition from Britannica.com, ‘alcohols are among the most common organic compounds.
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 […]
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.
We recently revisited the subject of fungal and microbial pathogens in contamination-controlled environments such as cleanrooms and were pleasantly excited to note the significant degree to which the topic sparked discussion.
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 […]
Biosimilars are manufactured in a cleanroom environment. Biosimilars are FDA approved. Why is there a low adoption rate? Read an interesting article in Pharmacy Practice News, “Overcoming Biosimilar Hesitancy”.
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 […]
We enjoyed this recent article in Cleanroom Technology that references some of the key components of an effective disinfectant prequalification strategy, which is critical for Microbial control in pharmaceutical manufacturing facilities.