Cleanroom Wipes for Pharmaceuticals: Pyrogen Testing Methods

Cleanroom wipes and gloves undergo LAL and Agar Overlay Analysis when testing for pyrogen and endotoxin levels. This post details the methodology, historical relevance, and explores cleanroom solutions for pyrogen-free and low-endotoxin gloves and garments.

Particulate and Molecular Contamination Tests for Cleanroom Wipes and Fibers

clean-room-particle-testing-methods

The majority of wiper contamination tests probe for particles, fibers, ions, nonvolatile residue, and bio-contaminants. Cleanroom wipe test methods detail and measure the extraction and enumeration particles, fibers, and other contamination released from wipers (or other materials), usually in a wetted state, under conditions of moderate mechanical stress.

Cleanroom Wipe Contamination Profiles for Medical Device Wipedown & Electronics

The ideal cleanroom wipe must meet industrial and regulatory standards concerning chemical, physical, and biological compatibility. Wipe fabrics undergo a strict examination to simulate manufacturing outcomes in the real world.

Stretch and strength, chemical compatibility, task efficiency, sorbency, shed, retention, and biological harmony have unique consequences in both high-tech cleanrooms and general manufacturing floors.

Cleanroom Wipe Testing Standards for ASTM, IEST & ISO Organizations

ISO cleanroom wipe classification is important, but is it enough? A clean room wipe selection criteria should meet baseline particulate shed thresholds for the end-user environment. Like any cleanroom rated product, cleanroom wipe manufacturers qualify ISO wipers between ISO Class 1 – ISO Class 9 as specified in step with cleanroom classifications of the International Standards Organization (ISO). The majority of cleanroom classifications fall between ISO 5 – ISO 8.

Mars Air Shower Curtains – Industrial Air Curtains for Doorways and Restaurants

mars air curtain install

What’s an air curtain and what should I consider before buying one? There are a handful of different air curtain distributors and manufacturers. MARS air curtains offer additional accessories and configurations for HEPA filtration, heated blowers, and insect control.

Medical Device Cleanroom Build Part 7: Cleanroom Validation Steps | Processes

What are the steps for medical device cleanroom validation? Cleanroom validation ensures cleanroom construction meets the performance standards set forth during cleanroom planning, cleanroom installation, and cleanroom calibration.

Cleanroom Sticky Rollers and Foam Mops for Walls Ceilings, and Floors

cleanroom stick film roller with adhesive film

Cleanroom tacky rollers and sticky foam rollers remove particulate from flat and slightly textured surfaces within a cleanroom. Extendable mop handles with adhesive rollers on the ends allow easy access to cleanroom, floors, ceilings, and walls.

Stereo Inspection Microscopes for Stem Cell Research and Laboratory Samples

Here we’ll cover advantages of stereo inspection microscopes for stem cell and cellular biology use. Specifically, you’ll learn about advantages of more robust eyepiecesless microscope systems which allow further viewing distances and reduce strain and fatigue. The result is a more comfortable and casual posture when the task requires direct observation, quick reference, or observation … Read moreStereo Inspection Microscopes for Stem Cell Research and Laboratory Samples

USP 800 Cleanroom Construction Hazardous Compounding: Options and Alternatives

There are a few options available to cleanroom facilities who require new upgrades for USP 800 compliance. The best option will depend on the variables of the facility and cleanroom in question. Option A: Convert an existing clean area into a negative pressure compounding room and storage area Option B: Build a new structure specifically … Read moreUSP 800 Cleanroom Construction Hazardous Compounding: Options and Alternatives

Polycellulose & Polyester Cleanroom Wipe Supplies

Here’s the guide to buying cleanroom wipes that stay on-budget. Differing package sizes, bulk counts, edge types, material options, cloth size, weights, ISO class, substrates, ionic levels…comparing cleanroom wipes is mind numbing. 50% of leading cleanroom wipe advertisers don’t even offer prices online!

The Truth about Cleanroom Air Change Rates, Charts & Methods of Calculation

Cleanroom Directional Air Flow Design Velocity

Why Can’t Anyone Agree on Benchmarks for Cleanroom Air Change Rates? There are a number of best practice guides and benchmarks for cleanroom air change rates (ACR). Many of which reference charts dating back as far as 20+ years. Most commonly referenced are ISO 146144-4 for hourly air changes and air velocity rates, and Federal … Read moreThe Truth about Cleanroom Air Change Rates, Charts & Methods of Calculation