Tag Archives: Pharmaceutical

Advanced Research in the Era of the Chimera

animal human chimera

What do you get if you cross a parrot with a centipede? Take a moment…A walkie-talkie! Yes, as anyone with a kindergartener knows, the old jokes really are the best. But when it comes to crossing one animal with another – also known as hybridization – it’s time to get serious. Although the idea of [Read More…]

How Many Passes With a Cleanroom Wipe Will Get a Surface Clean and Sterile?

Cleanroom Wiping How Many Passes

Answer: Berkshire cannot provide specific recommendations regarding how many swipes/passes of a wiper on a surface will make the surface clean or free of microorganisms.The main reason for this is each situation where wipers are used is different and has many variables, each of which will have an impact on the outcome of any cleaning. [Read More…]

Cleaning an Aseptic Isolator

cleaning isolator

Do you clean from top to bottom, left to right, cleanest to dirtiest? There are specific steps involved with cleaning an aseptic isolator. Watch the video for cleaning techniques that can supplement your current SOPs and assist in training.

How To Clean a Biological Safety Cabinet

How To Clean a Biological Safety Cabinet

Do your operators use IPA and Deionized Water on their gloves prior to cleaning a biological safety cabinet? Are they cleaning top to bottom, left to right, cleanest to dirtiest? There are specific steps involved with cleaning a biological safety cabinet. Watch the video for cleaning techniques that can supplement your current SOPs and assist [Read More…]

What is a Low Endotoxin Cleanroom Wipe?

Low Endotoxin

A low endotoxin cleanroom wipe has a guaranteed endotoxin limit of <20 EU/device – <0.5 EU/mL. This is especially important when you read the FDA Guidance for Industry: Pyrogen and Endotoxins Testing.  A 3rd party lab should perform the testing and the testing must be on a lot to lot basis. Printed documentation must be [Read More…]

Has Berkshire or a 3rd Party Performed Any Microbial Efficacy/kill Studies on the Satpax® Line of Presaturated IPA Wipers?

Satpax Canister

Question: Has Berkshire or a 3rd party performed any microbial efficacy/kill studies on the SatPax® line of presaturated IPA wipers? Answer: An efficacy/kill study has not been performed by Berkshire or a 3rd party lab for SatPax®.  Because of the number of variables involved when using wipes, it would be very difficult to produce meaningful [Read More…]

I Can See Clearly Now Part III

MPNW_photo_zoom

Figure 1.  Randomly dispersed ultra-fine polyester strands within a non-woven microfiber wiper. In their pursuit of superior materials, textile scientists have been able to engineer a new type of nonwoven microfiber fabric.  Traditional microfiber materials are comprised of very fine threads of polyester or polyester and nylon in which wedge-shaped strands are held within a [Read More…]

Human-Generated Particle Contamination

particle contamination

CLEANROOM PERSONNEL Cleanroom garments cannot contain all human detritus Particles (µm) travel up through the garments toward the head Particles (µm) fall down the legs during activity Gowning SOPs and continuous training is crucial  

Proper Wiper Folding and Surface Cleaning Video

Cleanroom Wiper folding

Berkshire’s Guide to properly fold and use a low-linting wiper for maximum efficiency and effectiveness in a controlled environment.   Download our Cleanroom Proper Wiper Folding and Surface Cleaning Poster Today! Shop our Cleanroom Wipes

How Small is a Micron?*

how_small-is-a-micron

HEPA VS. ULPA IN A CLEANROOM 1. This large circle represents the cross section of a human hair, with an average visible diameter of 75μm. 2. This smaller circle, still visible to the human eye, represents a 50μm diameter particle. 3. This represents a 0.3μm diameter particle. HEPA filters remove over 99.97% 4. This represents [Read More…]

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