Brevundimonas

Although Brevundimonas (Pseudomonas) diminuta (ATCC 19146) is most commonly used for steriliziug-grade filter vaUdation, iu certain appHcations other bacteria are used. For example, when it is necessary to demonstrate removal of mycoplasma in appHcations involving sera and tissue culture media, membranes having a smaller pore size rating, eg, 0.1 p.m, are frequentiy used. For these membranes,laidlawii may be employed for vaHdation purposes (9). 

Several bacterial strains utilizing isoquinoline have been isolated, which metabolized isoquinoline via l(2H)isoquinolinone, such as Brevundimonas diminuta strain 7. 

In 1987, FDA published its guideline on validation of aseptic processing [43] specifying requirements for challenging filters with 107 cells of Pseudomonas (now Brevundimonas) diminuta per cm2 of fdter surface and for validating aseptic processes using sterile media fills. 

Hydrophilic and hydrophobic sterilization grade filters are used throughout the BFS process for the sterilization of product and air, respectively. Filters should be purchased from an approved supplier and should be certified as meeting the regulatory requirements for sterilizing grade filters. By definition this means that the filter will have full bacterial retention when subjected to an aqueous challenge of Brevundimonas diminuta (ATCC 19146) at a minimum concentration of 1 X 10 cfu/cm of filter surface area. 

The FDA defines sterilizing filters as those that have pore-size ratings of 0.22 pm or smaller and relates this to a microbiological particle passage test using Pseudomonas (Brevundimonas) diminuta ... 

Aminobacter aminovorans Brevundimonas diminuta Burkolderia cepacia... 

Even if the Cupriavidus genera remains predominant in the production of PHAscl, Other genera were also discovered and studied in recent years Bacillus cereus, Brevundimonas vesicularis, Sphingopyxis macrogoltabia, ... 

Filter tests must be performed by the manufacturer before release to the market and by the individual user also, to ensure that the membrane filter complies with the specifications, is undamaged, and is eventually placed correctly in the filter case by the user. As described before in this chapter, such a test should in fact be performed with Brevundimonas diminuta. However, in daily practice this is not possible for the user in the pharmacy, and thus test methods have been derived, which are based on the physical properties of the membrane filter. Such test methods are called filter integrity tests. 

Nishida Y, Adachi K, Kasai H, Shizuri Y, Shindo K, Sawabe A, Komemushi S, Miki W, Misawa N (2005) Elucidation of a carotenoid biosynthesis gene cluster encoding a novel enzyme, 2,2 -P-hydroxylase, from Brevundimonas sp. strain SD212 and combinatorial biosynthesis of new or rare xanthophylls. Appl Environ Microbiol 71 4286-4296... 

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