Texwipe Cleanroom Swabs are renowned for their precision and quality in cleanroom environments. They are manufactured with a complete thermal bond, eliminating adhesive contamination and ensuring consistent tolerances through high-precision automated processes. Each lot is coded for traceability and quality control, making Texwipe swabs a reliable choice for cleaning validation.
Cleaning Validation Process
In the pharmaceutical manufacturing environment, cotton swab wiping is the preferred method for verifying cleaning effectiveness, which can detect trace pollutants.
Swabbing Material (TOC/HPLC):
- Use Texwipe Cleanroom Swabs designed for TOC (Total Organic Carbon) and HPLC (High-Performance Liquid Chromatography) analysis to ensure no interference from the swab material itself.
Swabbing Techniques:
- Points to Consider:
- Substances being removed: Understand the nature of residues to select appropriate swab materials and methods.
- Sampling Method: Consistently use the same technique to ensure repeatability and reliability of results.
- Analytical Method: Choose a validated analytical method (e.g., TOC or HPLC) for detecting the specific residues.
- Timing of Cleaning and Testing: Define a schedule for cleaning and subsequent testing to ensure timely and accurate results.
- Cleaning Parameters Studied: Evaluate various cleaning parameters (e.g., detergent concentration, scrubbing method) to optimize the process.
- Final Levels of Residuals: Determine acceptable residual levels based on regulatory standards or internal quality criteria.
- Acceptable Levels of Residuals: Establish threshold limits for residuals to ensure compliance with quality standards.
- Points to Consider:
Sampling Procedure:
- Defined Region: Identify and document specific areas to be swabbed to ensure consistency across samples.
- Swab with Overlap: Use a systematic overlapping pattern to cover the entire surface area and ensure thorough sampling.
- Damp (not very wet or dry) Swab: Moisten the swab appropriately; it should be damp to pick up residues without being too wet to avoid dilution or too dry to miss residues.
- Store Effectively: Place swabs in a clean, sealed container to prevent contamination before analysis.
- Transfer for Analysis: Ensure swabs are transferred to the laboratory under conditions that prevent degradation or contamination of the sample.
The ITW Texwipe TX3340 TOC Cleaning Validation Kit provides a secure and organized method for sampling in cleaning validation protocols, featuring low TOC levels in both vials and swabs, cleanroom-compatible components, and a proprietary cleaning process for optimal Total Organic Carbon (TOC) analysis.
For further information and guidance, please contact Texwipe for support tailored to your region, including Europe, the Middle East, and Africa.