Tag Archives: USP 797

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…]

Disinfection of Cleanroom Surfaces With Bleach

Disinfection-Surfaces-With-Bleach-_1_

A previous article in this series discussed disinfection of surfaces with hydrogen peroxide.  We turn our attention now to bleach as another very effective treatment agent. Most people understand that ordinary household bleach – a 5.5% solution of sodium hypochlorite (NaOCl) in water – is a strong disinfecting agent.  In neutral or slightly acidic solutions the active [Read More…]

How Do You Clean A Laminar Flow Hood?

laminar flow hood cleaning

The EasyClean® 360 is the most efficient way to clean a laminar flow hood. It’s unique triangular shaped head allows it to clean the difficult tight corners in the hood.  The tool is delivered with two handles, a 14” (35cm) and 24” (61cm).  There is also another ordering option for a telescoping handle that will extend from 35 [Read More…]

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