Tag Archives: Medical Device

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…]

Proper Cleanroom Wiper Folding & Surface Cleaning Poster


DOWNLOAD POSTER: An updated guide to properly folding and utilizing a low-linting wiper for maximum cleaning efficiency in a cleanroom, controlled or critical environment.

Why Is Isopropyl Alcohol the Choice for Cleanroom Cleaning?


ISOPROPYL ALCOHOL (IPA) is widely accepted as a good liquid for keeping cleanroom surfaces in pristine condition. But what about methyl, ethyl, or butyl alcohol? Why aren’t these types of alcohols considered for cleanroom cleaning, too? It all comes down to performance, safety, and price. Methyl Alcohol And Evaporation At room temperature, methyl alcohol has three [Read More…]

Cleanroom Supply Standards in Aseptic Manufacturing Environments


IF YOU ARE MANUFACTURING in an aseptic environment, it’s important for your cleanroom supplies to be sterilized with a validated process. This whitepaper, written by Lynn Stanard, Berkshire’s Senior Quality Manager, will help you understand the sterilization methods used by consumables suppliers and what to look for when procuring supplies Sterile Cleanroom Management This whitepaper provides [Read More…]

How and When to Use Bleach in Cleanroom Cleaning


HOUSEHOLD BLEACH is well known for its ability to remove stains and whiten clothes during laundering. Bleach also finds application in health care facilities with cleanrooms. Such applications include aseptic pharmaceutical suites, biomedical device manufacturing and compounding pharmaceutical facilities that require the biocidal and sterilant capabilities of bleach. Bleach solutions, which are active against bacteria, viruses, [Read More…]

Cleaning Tips for Removing Mixed Residue Types


YOU MAY KNOW that polar solvents, such as water, are used to remove polar soils, such as salts, from surfaces. You may also know non-polar solvents, like hexane, remove oils and greases. But what about removing mixed residues, made up of both types of soils? Avoid ‘Mixed Results’ With A Miscible Mixed Solvent When it comes [Read More…]

What Are Validated Sterile Wipers?

TO BE USED in a sterile environment, production consumables, like wipers, must conform to high standards and be documented as validated sterile. Meeting Manufacturing & Documentation Standards This Technical Brief presents an overview of: The concept of sterility. Good Manufacturing Practices (cGMPs). Validated procedures for sterile manufacturing. ANSI / AAMI / ISO standards for sterility. Sterility [Read More…]

Medical Device Contamination


HERE’S A LOOK at the types of contaminants that can be found on medical devices during manufacturing and the optimal methods for removing them. Particle Contamination & Removal Techniques This Technical Brief presents an overview of: Contamination control concerns in medical device manufacturing scenarios. Optimal contaminant removal techniques. FDA trends and guidelines. In addition, frequently asked [Read More…]