Method for qualifying microbial removal performance of 0.1 micron rated filters: Part III: Bacterial challenge tests on 0.2/0.22 and 0.1 micron rated filter cartridges with hydrogenophaga (formerly pseudomonas) pseudoflava

PDA Journal of Pharmaceutical Science and Technology

Volumn 55, Issue 6, 2001, Pages 393-416

  Sundaram, S ^a   Eisenhuth, J ^a   Lewis, M ^a   Howard G , Jr ^a   Brandwein, H ^a  

^a NONE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ACHOLEPLASMA LAIDLAWII; ARTICLE; BACTERIUM CONTAMINATION; BACTERIUM ISOLATION; BREVUNDIMONAS DIMINUTA; CONTROLLED STUDY; DRUG CONTAMINATION; EVALUATION; HYDROGENOPHAGA PSEUDOFLAVA; MEMBRANE FILTER; MYCOPLASMA; NONHUMAN; PERFORMANCE; PERMEABILITY; POROSITY; PRODUCTIVITY; PSEUDOMONAS; STANDARDIZATION;

ACHOLEPLASMA; BACTERIOLOGICAL TECHNIQUES; BETAPROTEOBACTERIA; CAULOBACTER; CELLULOSE; CULTURE MEDIA; DRUG CONTAMINATION; MICROPORE FILTERS; NYLONS; POLYVINYLS; STERILIZATION; ULTRAFILTRATION;

EID: 0035652381     PISSN: 10797440     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (26)

1. Diminutive bacteria - Implications for Sterile Filtration
2. Diminutive bacteria - Implications for validating sterile filtration processes
3. A quantitative method for challenging 0.1μm rated filters with A. laidlawii
4. Methods used to validate microporous membranes for the removal of mycoplasma
5. Ensuring effective sterile filtration of drug products by selecting and validating appropriate sterilizing grade membrane filters
6. Application-directed selection of 0.1-μm or 0.2μm rated sterilizing filters
7. Sterile double filtration
8. Preparation and evaluation of bacterial stocks for filter validation
9. "Sterilizing filtration of liquids," PDA Technical Report No. 26
10. Cloning and filtration techniques for mycoplasmas
11. A quantitative method for challenging 0.1 μm rated filters with A. laidlawii
12. Methods used to validate microporous membranes for the removal of mycoplasma
13. Methods for determining mycoplasmal retention of membrane filters utilized for filtration of tissue culture media and sera
14. Retention of water-borne bacteria by membrane filtration: Part III - Bacterial challenge tests on 0.1 μm rated filters
15. Microbial retention testing in the validation of sterilizing filtration
16. Use of a simulated sterile filtration operation to evaluate the capability of sterilizing grade filters to remove Burkholderia pickettii
17. Pseudomonas pseudoflava, a new species of hydrogen-oxidizing bacteria: Its differentiation from Pseudomonas flava and other yellow-pigmented, Gram-negative, hydrogen-oxidizing species
18. Hydrogenophaga, a new genus of hydrogen-oxidizing bacteria that includes Hydrogenophaga flava comb. nov. (formerly Pseudomonas flava), Hydrogenophaga palleronii (formerly Pseudomonas palleronii), Hydrogenophaga pseudoflava (formerly Pseudomonas pseudoflava and "Pseudomonas carboxydoflava"), and Hydrogenophaga taeniospiralis (formerly Pseudomonas taeniospiralis)
19. Correlation of biologic retention, latex particle retention and physical tests on 0.1 micron pore rated membrane filters