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News & Articles
How to Perform TOC Swab Sampling for Cleaning Validation
Total Organic Carbon (TOC) analysis plays a key role in cleaning validation. The technique below outlines a validated method for TOC surface sampling using low-background swabs and standardized collection practices.
What Makes a Good TOC S...
Adhesive mats (also known as sticky mats) are used to reduce particulate contamination brought in by shoes and wheels. When positioned and maintained properly, they serve as an effective first line of defense at cleanroom entry points.
Why Not Call Them “Tacky Mats”?
“Tacky Mat” is a trademarked...
If you’ve ever thought cleaning your cleanroom feels like an inconvenient chore, you’re not alone. Asking whether it’s a convenient time to clean is a bit like asking if it’s a convenient time to have your impacted molars removed, the answer is always “no.”
Cleaning isn’t glamorous. It rarely fee...
When it comes to cleanroom operations, even the smallest contaminant can cause big problems. While many facilities routinely test for particles in the submicron range, the truth is that contamination isn’t limited to tiny particles alone—fibers and larger particles can be equally damaging.
A c...
Contamination Control Consumables to be Used in Cleaning Fume Hoods, Chemical Workstations, Biological Safety Cabinets, Laminar Flow Hoods, or Other Front Access Fixtures
This document discusses the cleaning consumables used in the cleaning process of fume hoods,chemical workstations,biological s...
More and more sustainability becomes a topic for all aspects of life – therefore also for our work environments.
How can we do it – or is it even possible – to use cleanroom wipers in a more sustainable way, without increasing the risk of contamination?
A question we can hear very often is: “Most ...
Since August 2022 it’s now published in its final version – the new Annex 1, part of the EU- GMP guidelines for aseptic manufacturing. A revision was urgently required to adapt the existing guidelines to the new technologies and methods. This new version comprises a total of 58 pages with 11 chapt...
Remove small bits of contamination in the cleanroom can be a problem, you would have to choose the right swab or even ask if it can be created for your problem. You would soon find that this little wiper on a stick would also prove invaluable in cleaning delicate mechanisms, in precision surface...
Sterile wipers were developed by Texwipe to clean sterile environments quickly and easily, without compromising the sterile nature of those environments.
Although wipers are not medical devices, ITW Texwipe has chosen to follow the guidelines of the Association for the Advancement of Medical Instrumentation (AAMI)concerning the validation of radiation sterilization and the requirements of the United States Pharmacopeia for endotoxin testing.
Swabbing is the preferred method to validate critical cleaning within pharmaceutical manufacturing environments. The 1993 FDA Guide to Inspections states that direct surface sampling (e.g., with swabs) is the “most desirable” technique. Potential contaminants eluted from the swab are tested down to ...