Engineering Controls for USP

  1. There is an enormous amount of information and it is broken down into Engineering Controls, Garbing, Certification, types of Barrier Isolators, Certification and training for certifiers.
  2. The area generally consists of two rooms, one for entering and gowning, the second for the actual compounding.
  3. We will only be highlighting necessary controls, meaning the environment the testing is to be performed in.
  4. The equipment normally in the room where the compounding of the chemicals is as follows:
  5. The compounding room is a Class 7 and the surrounding area is a Class 8, a LAFW, a Biosafety Cabinet, or a barrier isolator.
  6. The floors are vinyl with heat welded seams, with no floor drains.
  7. The requirement for ACPH depends on the reference IEST-RP121, Table 1 for an ISO Class 7 is 60 – 90 and for the room housing the work equipment hoods is ISO Class 8 ACPH of 5-48.
  8. ISO-14644-4 ACPH for the Class 7 is 30-70 with the minimum of 15 Fresh Air air changes and Class 8 is 10-20.
  9. FDA Septic Guidelines are – Class 7 >20 and Class 8 is >20.
  10. The airflow, supply and exhaust is through a HEPA filter Type ‘C’ 99.99% on 0.3 micron particles.
  11. The filtered supply is normally located in the ceiling and the exhaust is near the floor.
  12. The pressure differential is normally 0.03 iwc. The testing and recertification of rooms and equipment is normally six months.
  13. The rooms are pressure tested daily.
  14. The HEPA filters are normally leak tested using a PAO and a photometer scan of the filter surface.
  15. The humidity varies from 30% to 60% RH.
  16. The Clean Room temperature range is 66⁰F to 72⁰F.

Any specific questions regarding USP<797> please contact Systems Testing and Analysis, Inc.