TechNotes

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To provide a better understanding of some of the issues in the selection, use and testing of our cleanroom consumables, Texwipe has developed a number of Technical Notes, aka TechNotes.

Topics include wiper consistency, cleaning of isolators, sterility validation, cleanbuild protocols, particle testing and cleanroom stationery. Much additional information on specialized topics in contamination control can be found in the Published Papers section of the Texwipe Library.

We welcome feedback on these Technical Notes. If you have comments or questions, or feel that there are other topics that you would like to see developed as Technical Notes or publications, please contact us with any questions or feedback.

ALCOHOLS  (Isoporpyl Alcohol, Denatured Ethanol)

TechNote TitleDescription

In-Use 70% Isopropyl Alcohol Level

A study monitoring in-use 70% Isopropyl Alcohol Level using a specific gravity method test.

70% Isopropal Alcohol Sterility In-Use

A study monitoring 70% Isopropal Alcohol Sterility In-use

Bags Used as a Component

Integrity Test Results for Bags Used as a Component of Sterile 70% IPS, TexQ Disinfectant and TexP peroxide Solutions.

In Use 70% Ethanol Percentage Level in a Denatured Alcohol Solutionl

A study monitoring the in-use 70% ethanol percentage in a denatured alcohol solution. Conclusion: Texwipe's 70% Denatured Ethanol solution may be used for at least 28 days without concern for the percent ethanol concentration changing.

Denatured Ethanol Solution Sterility in Use

A study monitoring the sterility of Denatured Ethanol solution in use.  Conclusion: Texwipe 70% Denatured Ethanol solutions may be used for at least 30 days without concern for thier sterility change.

DISINFECTANTS

TechNote TitleDescription

The Effectiveness of the TexQ® Decontamination Protocol in Cleaning Surfaces Soiled with Hazardous Drugs

A Texwipe developed protocol which includes TexQ, a disinfectant and cleaner, and wipers pre-wetted with 70% USP-grade IPA solution for the decontamination of surfaces exposed to hazardous drugs. The efficacy of the protocol was assesed at Bureau Veritas North America (BVNA), an independent testing organization internationally recognized as a leader in testing, inspection and certification.

Chemo-drugs removal study

An observational study of using TexQ® Disinfectant Cleaning Protocol in Removing Hazardous Drug Contamination During Sterile Compounding.

TexQ® Protocol for Chemodrugs Removal

A step-by-step protocol for hazardous drugs removal. This one-page sheet may be placed in the work area.

Bags Used as a Component

Integrity Test Results for Bags Used as a Component of Sterile 70% IPA, TexQ Disinfectant and TexP peroxide solutions.


WIPERS

TechNote TitleDescription

Microdenier Wipers in Critical Cleaning Applications

Microdenier wipers are increasingly gaining acceptance for use in cleanroom environments because of their ability to perform well in critical cleaning applications.

Consistency As A Measure of Wiper Quality

Wipers are used to control contamination in cleanroom environments in a variety of industries, from building the next-generation microchip to manufacturing the newest vaccine. Each of these settings may have different applications for a cleanroom wiper, but measuring the wiper quality should always be the same, i.e. consistent.

STERILE PRODUCTS

TechNote TitleDescription

Packaging Shelf Life

Sterile Dry Wipers, Package Integrity Testing for Shelf Life Determination (Header Bags)

Sterile Validation

Texwipe Sterile Products, Sterilized, Validated, Documented and Endotoxin Tested

Swabs

TechNote TitleDescription

Swabs for Cleaning Validation in Pharma

Swabbing is the preferred method to validate critical cleaning within pharmaceutical manufacturing environments. As a result, the selection of a quality swab and a validated swabbing method is critical to producing sensitive, accurate, and repeatable results.

Cleanroom Paper

TechNote TitleDescription

Autoclaving Synthetic and Cellulose-Based Paper

A discussion on autoclave conditions for Texwipe's synthetic and cellulose-based paper

ST - 1

TexWrite® MP Products: Next Generation Cleanroom Stationery

OTHER

TechNote TitleDescription

CRW - 7

Yellowing of Polyurethane Foam

ICT - 1

Cleaning of Compounding Aseptic Isolators (CAIs) and Class II Biological Safety Cabinets (BSCs)

ICT - 2

Cleaning of Pharmaceutical Isolators