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…]
Tag Archives: Pharmaceutical
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…]
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…]
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.
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…]
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…]
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…]
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…]
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
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