USP Chapter <797> Regulations
| Process/Control | USP Chapter <797> Regulations (Effective June 1, 2008) |
PharMEDium |
| Verification of all Compounded Preparations |
Verification of Compounding |
EXCEEDS 200% verification includes a Batch Verification Scanning System linking batch documents and applicable components through bar code technology |
| Personnel Qualifications on Aseptic Technique |
Annual Qualifications |
EXCEEDS Quarterly Qualification |
| Clean Room / Compounding Area |
ISO 7/ISO 5 |
MEETS/EXCEEDS |
| Gowning | Change after each shift |
EXCEEDS Fresh sterile coveralls upon reentry to clean room |
| Gloves | Intermittently resanitize sterile gloves |
EXCEEDS Sanitize sterile gloves prior to all aseptic manipulation |
| Glove Microbial Monitoring | Annual | EXCEEDS Monthly |
| Microbial Sterility Testing with Media Fills | Not Mentioned | EXCEEDS Daily |
| Sterility Container / Closure Integrity System | Not Mentioned | EXCEEDS All Container Closure Systems |
| Port / Vial Stopper Sanitization | Sterile 70% IPA | EXCEEDS Two-step sanitization method, last step is Sterile 70% IPA |
| Ongoing Sterility Monitoring | Batch Testing | Weekly Testing - Most demanding processes |
| Process Flow based on Design of Clean Room and Support Areas |
Recommends Primary Engineering Controls |
EXCEEDS Design includes hands-free entry and pass-through doors |
| Nonviable Particles |
Semiannual |
EXCEEDS Monthly |
| Viable Air Sampling |
Routine Using Volumetric Air Samplers |
EXCEEDS Daily |
| Viable Surface Testing |
Routine | EXCEEDS Daily |
| Process Validation Through Media Fills |
Not Mentioned |
EXCEEDS Initial and semiannual validating all aseptic processes incorporating process flow, all container closure types, equipment, maximum batch size, etc. |
