A non-biased discussion regarding cleanroom garment solutions as an adjunct to our previous blog regarding the significance of sample integrity in the qualification process.
Many of our clients in the biomanufacturing and pharmaceutical industries are continuously reviewing their quality metrics as well as their spend on sterile garments and may be looking for better outcomes. However, with so many garments to consider, where should they start?
When considering all of the alternatives, we believe that our clients should take the time to consciously force rank what attributes are most important to them. However, the most crucial element to consider is what the garments are being utilized for….to prevent personnel generated contamination from being introduced into the cleanroom.
According to the recommended practice of the Institute of Environmental Sciences and Technology RP-CC003.4 (Garment System Considerations for Cleanroom and other Controlled Environments), the tests that garments /material can be subjected to are as follows:
- Particle Penetration – The ability of the fabric to filter particles generated by wearer.
- Equivalent Pore Diameter – The air pressure to determine the relative pore size of the garment.
- Helmke Drum – Measures particles 0.1-10 micrometer on material/garment usually to simulate particle shedding.
- Releasable Large Particles – Air is filtered through a membrane filter for particle analysis of particles > 5.0 micrometer and fibers.
- Particle Dispersion (Body Box) – Useful in determining relative differences between various sets of apparel.
- Microbial Penetration – Assesses Microbial penetration of the garment.
Many of the companies involved in garment manufacturing and processing (i.e. mills, converters, launderers, disposable garment producers, etc.) may suggest one (or more) test method(s) from the list above that may support their particular product/process that they provide which may (or may) not be what is most critical for a given client/user.
Once the testing methods(s) as stated above are established for the client/user there are many other factors that need to be considered (based upon the specific needs and considerations in place) which may include (but not limited to) some of the following potential parameters:
- Static control
- Ease of Donning
- Total Cost
- Environmental “friendliness”
- Availability of product
- Reproducibility of product (garment to garment quality)
- Sterility (validated/certified)
- Cross contamination
- Change control/notification
- Splash protection