Category Archives: Cleanroom News

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

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…]

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

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…]

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

What are Pyrogens and Endotoxins?

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…]

Surface Sampling for ISO Class 5 Primary Engineering Controls


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…]

Do Gloves Impact Your Work and Health?

Two blue medical latex gloved hands palms out fingers spread

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…]

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


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, ‘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…]

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 [Read More…]

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

Fungemia, systemic fungal infection, Candida fungi in blood

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…]

Revisiting the Unsanitary/Insanitary Conundrum of Custom Biopharmaceuticals

Machine for making capsules

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…]