01-16-2018 03:58 PM
Our facility is designing a new positive pressure cleanroom. The facility project manager told me that the proposed USP 797 revision to be published in 2019 states that the HEPA filters need to be placed in the ceiling where the cleanroom is located. The current design has the HEPA filters located at the air handler. He wants to know whether we should change the design to meet the future requirement now before it is finished by the end of this year? If this change is adopted in 2019, will facilities be required to renovate their HEPA filter placement? Eric, any thoughts on this.
01-16-2018 06:31 PM
The short answer is YES. Most likely, the filters in your air handler are not TRUE HEPA filters, but MERV filters and they have probably never been leaked tested as required by the chapter. Despite what your certifier might say or document, in my travels over the past several years, more times than not, the certifier has falsified their report and reported they did a test they never did or could do. I will change my opinion on a case by case basis, only after I have reviewed a specific certification report, but that would sadly be the exception and not the rule, Hope this helps.
01-17-2018 10:37 AM
Eric, the filters are true HEPA filters and not MERV. Let me clarify my question. Our new cleanroom built in a separate location in our ffacility has an air handler with banks of HEPA filters and the project manager obtained information from a Ceta meeting stating the following. "Air must be introduced through HEPA filters located at the ceiling of the fuffer area containing the PEC and remote HEPA filter banks are no longer recognized as acceptable." Since the construction is nearing completion, the project manager wants to know if they should change the HEPA filtration to meet the future requirements or will the 2019 USP guidance exempt exisiting contructiion.
01-21-2018 02:09 PM
Yes, you need to get the HEPA filters intalled the ceiling and not in the air handler. No one will be exempt from this requirement once it is official in Dec 2019.