Tag Archives: USP 797

Sources of Cleanroom Contamination

sources-of-contamination

SOURCES OF CLEANROOM CONTAMINATION What Are The Most Common Sources Of Contamination In A Cleanroom? People & Personnel – saliva, skin flakes, human hair, cosmetics, perspiration Objects – floating particles from aerosols, moisture Fluids – process residues: grease, lubricant oil residue, solvent residue, process chemicals Tools -stagnant water in water lines and tanks is prone [Read More…]

Things You Didn’t Know You Needed to Know About Lint-Free Wipes

A recent search on Google for the term lint-free wipe returned over 18 million results. A further refinement to “lint-free wipes” returned over 330,000 results. And another search for “lint free wiper” produced over 1.5 million results. A simple change in characters or adding a letter churned out different results. The one thing they have [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…]

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

Disinfection of Cleanroom Surfaces With Hydrogen Peroxide

Disinfection of Surfaces with Hydrogen Peroxide

Disinfection of Surfaces with Hydrogen Peroxide Of all the contamination control activities in a cleanroom, perhaps the most critical are disinfection procedures. That’s because human health depends on the quality and thoroughness of a surface disinfection wipedown. Many solutions can be considered for surface disinfection, but hydrogen peroxide and sodium hypochlorite (bleach) rate special attention. [Read More…]