Tag Archives: Medical Device

Particles on Surfaces: Part 4 – Optimum Wiping Techniques


Before we address wiping techniques, we might well question the need for wiping. After all, if capillary forces hold particles to surfaces strongly enough that the particles can’t easily get airborne, why the great concern to remove the particles by wiping? The simple answer is embodied in two words:  Contact Transfer. That’s the means by which [Read More…]

“Lint-Free” Wipes: Available Only Through Your Fairy Godmother

Lint Free Wipes

Web searches for “Lint Free Wipes” provide some interesting information.  A Google search returns 82,300 hits. A search of “lint-free” on the American Society for Testing Materials (ASTM) site returns 265 hits, and a search of “lint-free” on the United States Pharmacopeia (USP) site returns 737 hits. Of these, three are contained in the <797> document on [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…]