Absolute or sterilizing grade filtration - What is required?

PDA Journal of Pharmaceutical Science and Technology

Volumn 54, Issue 6, 2000, Pages 485-492

  Kawamura, K ^a   Jornitz, M W ^a   Meltzer, T H ^a  

^a Capitola Consulting Co   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADSORPTION; ARTICLE; BACTERIUM CONTAMINATION; BIOFILTRATION; BREVIBACTERIUM; DENSITY; DRUG CONTAMINATION; FLOW RATE; IONIC STRENGTH; MEMBRANE FILTER; NONHUMAN; PARTICLE SIZE; TEMPERATURE; VALIDATION PROCESS; VISCOSITY;

ADSORPTION; DRUG CONTAMINATION; EQUIPMENT DESIGN; FILTRATION; MEMBRANES, ARTIFICIAL; STERILIZATION; TECHNOLOGY, PHARMACEUTICAL;

EID: 0033667217     PISSN: 10797440     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (32)

1. Sterilizing filtration of liquids
2. Production and control of a stable penicillinase
3. Microbiological methods for quality control of membrane filters
4. The adsorptive retention of pseudomonas diminuta by membrane filters
5. Bacterial cell size and surface charge characteristics relevant to filter validation studies
6. The matrix approach: Microbial retention testing of sterilizing-grade filters with final parenteral products, Part II
7. Surrogate attributes and use conditions: Effects on bacterial cell size and surface charge relevant to filter validation studies
8. Validation of bacterial retention capabilities of membrane filters
9. Preparation and evaluation of bacterial stock for filter validation
10. Comments on organism challenge levels in sterilizing efficiency testing
11. The retention mechanism of sterilizing and other submicron high efficiency filter structures
12. 2 challenge
13. Retention of 'diminutive' water-borne bacteria by membrane filtration
14. Evaluation of microbial/endotoxin contamination using the LAL test
15. Microbial retention testing in the validation of sterilizing filtration
16. Detection of L-forms of Pseudomonas aeruginosa during microbiological validation of filters
17. Fetal bovine serum: Discovery of nanobacteria
18. Opinion: Kajander's nanobacteria
19. Viable but non-culturable bacteria and their implications for water purification
20. It just doesn't matter
21. Relative efficiencies of double filters or tighter filters for small-organism removals
22. Application of membrane filtration for removal of diminutive bioburden organisms in pharmaceutical products and processes
23. Parameters covering steam sterilization of deadlegs
24. Operational considerations in the steam sterilization of cartridge filters
25. 0.1 (m versus 0.2 / 0.22 (m final filtration in BFS operations
26. Liquid flow through filter media
27. Meeting the new challenges of sterilizing by filtration