Test Method/ Specification No. of Ampoules Comments
Testing at EFMHACA
Appearance USP 3 Uses same ampoules as assay testing
Labelling USP
Assay USP Triplicate testing
Assay (spare) USP 6 To allow repeat testing if first test found ampoules to be out of specification
Testing at MIPS
Investigative Testing (descriptive) In-house methods 3 Testing to identify degradants/ impurities
Microbiological Testing
Validation (sterility) USP <71> 8 Microbiological testing subcontracted to Chemical Analysis Ltd (Melbourne)
Sterility Testing Endotoxin Testing USP <71>
Total 25