Validation of Microbial Limit Test Method of 29 Kinds of Hospital Preparations
- VernacularTitle:29种医院制剂微生物限度检查方法验证
- Author:
Xi WEI
- Publication Type:Journal Article
- Keywords:
Microbial limit;
Validation of method;
Recovery rate
- From:
China Pharmacy
1991;0(01):-
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To establish a method for the microbial limit test of 29 hospital preparations.METHODS:A validation on the microbial limit test method was conducted in accordance with the counting method of bacteria,mycetes and yeasts and the control bacteria test method stated in the Appendix of China Pharmacopoeia(2005 edition).RESULTS:The recoveries of test organisms in 16 of the total 29 preparations by routine method were less than 70%,and the test organisms were failed to be detected in 6 preparations in the control bacteria test.For test organisms to meet the standard in recovery rate,medium dilution method,membrane-filter procedure,centrifugal method,neutralization method or the combination of these methods were needed.CONCLUSION:The test sample should undergo validation on the microbial limit test method to ensure the correctness of test result.
