Category Archives: Cleanroom News

Cleanroom News, Contamination Control

Current EU GMP Annex 1 Update: What Does It Mean for Your Socks?

Posted on by Berkshire Corporation
15
Sep

Have you been keeping track of the recent developments in cleanroom apparel requirements? Have you already begun incorporating the updated EU GMP Annex 1 chapter regarding personal protective equipment (PPE) into your Contaminations Control Strategy (CCS)? If not, please read on and learn about the impact of the new specifications regarding PPE for cleanroom personnel, [Read More…]

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Berkshire Products, Contamination Control, Knowledge Base

Nonwoven or Knitted? When It Comes to Wipes, What’s the Difference?

Posted on by Berkshire Corporation
19
May

Within the cleanroom or contamination-controlled environment, one of the most useful pieces of equipment is the wiper. From preparing work surfaces to cleaning up after spills, the wiper is expected to perform perfectly whatever the task. We depend on them every day, but how much do we really know about them? What’s the difference between [Read More…]

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Cleanroom News, Cleanrooms, Knowledge Base

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

Posted on by Berkshire Corporation
What are Pyrogens and Endotoxins?
08
Nov

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 [Read More…]

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Cleanroom News, USP 797

Surface Sampling for ISO Class 5 Primary Engineering Controls

Posted on by Berkshire Corporation
contact_plate_surface_sampling
24
Jun

Contact Plates and Clean-Up 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 [Read More…]

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Cleanroom News, Cleanroom Technology, Hospitals

Do Gloves Impact Your Work and Health?

Posted on by Berkshire Corporation
Two blue medical latex gloved hands palms out fingers spread
24
Mar

We’ve Got You Covered It has been said that one of the (arguably very few) upsides of the COVID pandemic has been the opportunity to step out of our own reality and appreciate another person’s perspective, to walk, metaphorically at least, in their shoes. During the last year, for instance, we have certainly been given [Read More…]

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Cleanroom News

Isopropyl Alcohols – How Much Do You Really Know About the Mogul of the Cleanroom?

Posted on by Berkshire Corporation
isopropyl-alcohols
04
Mar

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. They are used as sweeteners and in making perfumes, are valuable intermediates in the synthesis of other compounds, and are [Read More…]

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Cleanroom News

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

Posted on by Berkshire Corporation
mycelium
12
Feb

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 [Read More…]

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Cleanroom News

Masks, Microbes, and Mushrooms – How Are You Protecting Against Fungi in the Cleanroom?

Posted on by Berkshire Corporation
Fungemia, systemic fungal infection, Candida fungi in blood
03
Feb

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. One of the main threads within our community concerned the selection and application of the most effective disinfectants to thwart the advances of the [Read More…]

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Cleanroom News, FDA

Revisiting the Unsanitary/Insanitary Conundrum of Custom Biopharmaceuticals

Posted on by Berkshire Corporation
Machine for making capsules
18
Jan

Compounding the Problem? 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 [Read More…]

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