Texwipe TOC Cleaning Validation Kit & Swabs

During the process of manufacturing pharmaceutical or biomedical products there can traces of contaminants which can be present due the previous manufacturing or the actual cleaning process itself.

Typically swabs are used for sampling.

Swabs can be analyzed using the following distinct analytical techniques:

• HPLC (Hi Performance Liquid Chromatography)
• IMS (Ion Mobility Spectrometry)
• UV-VIS Ultraviolet Visual Imaging Spectrograph
• TOC (Total Organic Carbon)

Which swab is the most effective for the application?

The following important parameters must be considered:

1. Eluding minimal "background material" (background is the amount of contaminant on a swab and is measured by the analytical technique after testing has been performed.
    
2. Hi Recovery Rate- The percentage of the contaminant actually measured by the specific analytical technique when the swab is “spiked” with a known quantity of that species. One should have a minimum of a 60% recovery rate or better.
    
3. Low Particle Generation: After the swab is utilized on respective surface, the material swabbed is free from particles which could further contaminate the surface.

Texwipe has analyzed the different types of polyester fabric which would most appropriate for the respective validation analytical processes.

Validation Kits

The TOC Cleaning Validation Kits have been designed to simplify sampling for cleaning validation. Packaged in cleanroom-compatible polypropylene boxes, these unique kits contain the components necessary to sample 12 or 72 different areas in the production area, and provide for efficient transport of the samples from production to laboratory with minimal chance of contamination.

The TOC Sampling Kit for Cleaning Validation can be used with Sievers Model 800/900, Anatel ANATOC™, Teledyne Tekmar, OI Analytical Model 1010 and Shimadzu TOC-V Series* TOC Analyzers.

For more information, please see TOC Cleaning Validation Kits on Texwipe.com