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Diminutive Bacteria Implications for Sterile Filtration
http://www.pall.com/34445_3813.asp
portion taken from above link..
Evolution of Filtration Standards
0.45µm filtration standard.
In the 1960s, both sterilizing sheet filters and membrane filters were used in pharmaceutical production. Membrane filters were available mostly in flat disc form and used singly or in multi-plate configuration. 0.45µm membranes were successfully used for sterile production at that time as they enabled reasonable flow rates to be achieved through the relatively low area disc systems. The membranes were qualified using Serratia marcescens, with a typical size of 0.6µm x 1µm. However, the safe use of 0.45µm filters was questioned when Bowman2 established that an organism, Pseudomonas diminuta, could consistently penetrate 0.45µm ‘sterilizing’ filters, but could be retained by the next finer grade commercially available - 0.22µm.
0.2µm/0.22µm filter standard.
Bowman2 proposed in 1967 that P. diminuta (recently reclassified as Brevundimonas diminuta) should become the industry standard organism for 0.2µm filters. In 1987, the FDA ‘Guidelines on sterile drug products produced by aseptic processing’3 incorporated P. diminuta as the standard challenge organism for a sterilizing filter and defined a minimum qualifying level of 107/cm2 of filter area.
Since that time, no further standards have been developed, even though 0.1µm sterilizing filters in cartridge form have been available commercially for almost twenty years and are being increasingly used in production processes. The primary area of application was initially in the processing of serum and tissue culture media, where removal of mycoplasma is required. These deformable bacteria are known to penetrate 0.2µm or 0.22µm filters. However, there has been an increasing use of 0.1µm filters in other applications where diminutive organisms have been identified, or are of potential concern. They are also being used for enhanced sterility assurance in certain types of products or processes.
In the absence of a defined industry standard, filter manufacturers have qualified 0.1µm filters using their own standards. PALL uses Acholeplasma laidlawii, a mycoplasma type organism, for 0.1µm filter validation4 in addition to B. diminuta.
http://www.pall.com/34445_3813.asp
portion taken from above link..
Evolution of Filtration Standards
0.45µm filtration standard.
In the 1960s, both sterilizing sheet filters and membrane filters were used in pharmaceutical production. Membrane filters were available mostly in flat disc form and used singly or in multi-plate configuration. 0.45µm membranes were successfully used for sterile production at that time as they enabled reasonable flow rates to be achieved through the relatively low area disc systems. The membranes were qualified using Serratia marcescens, with a typical size of 0.6µm x 1µm. However, the safe use of 0.45µm filters was questioned when Bowman2 established that an organism, Pseudomonas diminuta, could consistently penetrate 0.45µm ‘sterilizing’ filters, but could be retained by the next finer grade commercially available - 0.22µm.
0.2µm/0.22µm filter standard.
Bowman2 proposed in 1967 that P. diminuta (recently reclassified as Brevundimonas diminuta) should become the industry standard organism for 0.2µm filters. In 1987, the FDA ‘Guidelines on sterile drug products produced by aseptic processing’3 incorporated P. diminuta as the standard challenge organism for a sterilizing filter and defined a minimum qualifying level of 107/cm2 of filter area.
Since that time, no further standards have been developed, even though 0.1µm sterilizing filters in cartridge form have been available commercially for almost twenty years and are being increasingly used in production processes. The primary area of application was initially in the processing of serum and tissue culture media, where removal of mycoplasma is required. These deformable bacteria are known to penetrate 0.2µm or 0.22µm filters. However, there has been an increasing use of 0.1µm filters in other applications where diminutive organisms have been identified, or are of potential concern. They are also being used for enhanced sterility assurance in certain types of products or processes.
In the absence of a defined industry standard, filter manufacturers have qualified 0.1µm filters using their own standards. PALL uses Acholeplasma laidlawii, a mycoplasma type organism, for 0.1µm filter validation4 in addition to B. diminuta.
R
ruffino
Member
- Feb 13, 2012
- 85
- 5
Bag1980, go with the .22 filter. It is a pain and takes longer but if its keeping bacteria out of your body enough said. Better be safe than sorry. I found when keeping oil warn you can get a better flow. 100ml is not much, your hands will cramp up but if thats all is going to take to keep your ass out of ER then its worth the cramps.
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