The last breakthrough in cleanroom air filtration, microglass media, occurred 75 years ago. Using HEPA filters with microglass media, even as part of a Standard Operating Procedure, can lead to decreased production time, increased repair time, and increased energy consumption, not to mention FDA 483 Warning Letters and potentially disastrous recalls. The costs and issues associated with using microglass may be viewed as a cost of doing business, but the ultimate risks are often unrecognized.
Overexposure to PAO
At least four Fortune 500 companies have recently reported problems with gel degradation, the liquefaction of the substance used to install and seal microglass filters. When this gel becomes liquefied and drops to the floor of a cleanroom, the cleanroom is no longer sterile. This presents a major risk. Gel liquefaction also initiates an unplanned shutdown with enormous financial ramifications.
Reducing Your Risk
The costs associated with failed media can be staggering:
- Complete loss of production for unspecified periods
- Costly FDA 483 citations, warning letters, and consent decrees
- Expensive follow-up qualifications/validations
- Catastrophic recalls
Effectively managing the risks associated with successful operation requires utilizing HEPA filters with dramatically higher tensile strength that are highly resistant to chemical degradation, thereby eliminating premature leaking and failure. The only HEPA filter media with these properties is ePTFE (expanded polytetrafluoroethylene).
Check out our materials below regarding the issues surrounding microglass media and the value you gain by using ePTFE media filters instead. Saving yourself money and time - isn't that the best business solution?