Technical Briefs

TechnotesTo 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.

DISINFECTANTS

TechNote TitleDescription

Stability Data for NaDCC

A summary of the stability data for NaDCC Bleach Tablets (Bru-Clean TbC™).

Hydrogen Peroxide Stability
(for Shelf Life Determination)

Since end users need a consistent product for their use, it is important to document the hydrogen peroxide concentration stability as a function of time. A study was implemented to monitor the hydrogen peroxide concentration over a period of time at an elevated temperature of 50°C to simulate storage at room temperature for three years.

Bru-Clean: The Better Bleach

Liquid bleach, despite its common use, is not a particularly suitable disinfectant for use in critical cleaning applications due to limited shelf life and corrosiveness. Bru-Clean TbC™ is a convenient and less corrosive alternative to Liquid Bleach and has a longer shelf life. It produces a more stable concentration of the available chlorine at 937 ppm which results in more reliable germicidal activity.

TexQ® Protocol for Chemodrugs Removal

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

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.

Bags Used as a Component

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

ISOPROPYL ALCOHOL

TechNote TitleDescription

In-Use 70% Isopropyl Alcohol Level

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

Bags Used as a Component

Integrity Test Results for Bags Used as a Component of Sterile 70% IPS, 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.

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.

OTHER

TechNote TitleDescription

In Use 70% Ethanol Percentage Level

A study monitoring the in-use 70% Ethanol Percentage Level in a Denatured Alcohol Solution by a Specific Gravity Test Method

CRW - 6

Texwipe Sterile Products: Sterilized, Validated, Documented and Pyrogen Tested

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

ST - 1

TexWrite MP Products: Next Generation Cleanroom Stationery

Autoclaving Synthetic and Cellulose-Based Paper

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