Page 85 - Pharmaceutics IV (02-06-01305)
P. 85
Parenterals: Quality control testing
Sterility Pyrogen
testing testing
Leaker Clarity
testing testing
163
Parenterals: Quality control testing
Sterility testing
• The purpose of a sterility test is to determine the probable sterility of a
specific batch.
• The USP lists the procedural details for sterility testing and the
sample sizes required.
• It’s a destructive test (samples of the batch).
164 82
Salma E. EL-Habashy