Rationalization and valid scale-up of integrity test parameters for sterilizing grade membrane filter cartridges

PDA Journal of Pharmaceutical Science and Technology

Volumn 55, Issue 2, 2001, Pages 134-142

  Schroeder, H G ^a  

^a Intl Consultants Association   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BREVUNDIMONAS DIMINUTA; FILTRATION; INSTRUMENT STERILIZATION; MEMBRANE FILTER; NONHUMAN; NOTE; PARTICLE SIZE; POROSITY; PRACTICE GUIDELINE; VALIDATION PROCESS;

POROSITY; ULTRAFILTRATION; WATER MICROBIOLOGY;

EID: 0035068740     PISSN: 10797440     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Note

References (23)

1. Considerations in using 'Bubble Point' type tests as filter integrity tests Part 1
2. Experimental determination of the pore size of filters
3. Bacteria removal prediction in membrane filters
4. Evaluation of bacterial grow-through
5. Grow-through and blow-through effects in long-term sterilization processes
6. FDA update on aseptic processing guideline
7. A case of penetration of 0.2-micrometer rated membrane filters by bacteria
8. Microbes: Improved methods for recovering bacteria from HPW water
9. Dealing with the nanobacteria if we must
10. Theoretical aspects of sterile filtration and integrity testing
11. Prediction of filtration efficiency form integrity test data
12. Considerations for diffusive airflow integrity testing
13. The insufficiency of single point diffusive air flow integrity testing
14. Bacterial filtration in practice
15. Is the removal of microorganisms by filtration really a sterilization method?
16. A user's perspective on bacterial retention validation of sterilizing grade cartridges