Category Archives: Aseptic Cleaning

Pharmaceutical Manufacturing, Revisiting the Unexpected with Growth


To ensure that the manufacturing of pharmaceuticals is free from contamination, implementing a comprehensive cleaning and disinfection program is essential. Any modifications to the manufacturing process, such as introducing new equipment or materials, should be evaluated to confirm that the cleaning program prevents contamination. Maintaining a standardized change control process to document these updates is [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…]

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

Endotoxins: A Danger to Pharmaceutical & Medical Device Manufacturing Industries

Bacteria low endo

Introduction Pharmaceutical and medical device manufacturing personnel must cope with endotoxins – a contamination source unique to their industries.  Endotoxins, also known as pyrogens, originate from dead (!) gram negative bacteria. When this strain of bacteria are killed by antibacterial reagents (say phenolic or quaternary ammonium compounds), radiation, steam sterilization, etc. the cell wall detritus [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…]

USP <797> Best Practices: Suggested Cleaning Frequency for Compounding Pharmacies


ISO Class 5 – Primary Engineering Controls (PECs) LAFWs – BSCs – CAIs – CACIs At the beginning of the each shift Before each batch No longer that 30 minutes after previous disinfection (during ongoing compounding) After spills When a surface contaminate is known or suspected Clean area after surface sampling (i.e. Contact Rodac Agar [Read More…]