On the cause of performance variation of biological indicator used for sterility assurance

PDA Journal of Pharmaceutical Science and Technology

Volumn 54, Issue 4, 2000, Pages 332-342

  Shintani, H ^a   Akers, J E ^a  

^a NATIONAL INSTITUTE OF HEALTH SCIENCES   (Japan)

Author keywords

Biological indicator (BI); Carrier material; Culture medium; Primary packaging material; Sterility assurance

Indexed keywords

BIOLOGICAL MARKER;

ARTICLE; CULTURE MEDIUM; DRUG PACKAGING; GEOBACILLUS STEAROTHERMOPHILUS; INSTRUMENT STERILIZATION; PACKAGING MATERIAL; QUALITY CONTROL;

DRUG PACKAGING; SPORES, BACTERIAL; STERILIZATION;

EID: 0033849503     PISSN: 10797440     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (12)

1. Factors in the preparation of biological indicators that affect the decimal reduction time
2. Ethylene oxide sterilization: III-Influence of carrier nature in a biological monitor performance
3. Comparison of European and US biological indicators for ethylene oxide sterilization
4. Contributing factors to variability in biological indicator performance data
5. Comparison of D10-value accuracy by the limited Sperman-Karber procedure, the Stumbo-Murphy-Cochran procedure and the Survivor-curve method
6. On the difference in attaining sterility assurance between lots and/or manufacturers of soybean casein digest culture medium
7. The reason of D-value difference between survivor curve method and fraction negative method
8. Validation of D-value by different SCD culture medium manufacturer and/or different SCD culture medium constituent
9. The effects of recovery medium and test methodology on biological indicators