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Overview of Processing
Procedures:
All processes are carried out under strict Class
100 U.S. Pharmacopoeia and Federal Code of Regulations methodologies.
1. Vials are washed with deionized water to
removed any particulate matter, rinsed with Water for Injection @ 70oC
and blasted with cleaned compressed air to remove residual moisture.
2. Vials are placed in stainless steel pans and
sterilized in dry heat for 5 hours @ 200oC. This accomplishes
the sterilization and depyrogenation process.
3. Closures (stoppers) are steam sterilized @ 121oC
for 30 minutes, then dried for 2 to 8 hours @105oF.
4. Vials and closures are then mechanically
assembled in a Class 100 vial and diluent production room.
5. Each lot is held in quarantine for 14 days at
which time samples are tested by an independent laboratory for sterility and
endotoxins. Once passed, the lot is released for sale. |
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