Sterilizing Filtration of Liposome and Related Lipid-Containing Solutions: Enhancing Successful Filter Qualification

References

1. 1.↵
   Parenteral Drug Association (PDA). PDA Technical Report No 26. Sterilizing Filtration of Liquids. PDA J. Pharm. Sci. Technol. 2008, 62 (Suppl 5), 1– 60.

   OpenUrlAbstract/FREE Full Text
2. 2.↵
   American Society for Testing and Materials (ASTM). ASTM Standard F838-05. Standard Test Method for Determining Bacterial Retention of Membrane Filters Utilized for Liquid Filtration, 2005.
3. 3.↵
   FDA. Sterile Drug Products Produced by Aseptic Processing. In FDA Guidance for Industry, 2004.
4. 4.↵
   1. Onraedt A.,
   2. Folmsbee M.,
   3. Kumar A.,
   4. Martin J.

   Sterilizing filtration of adjuvanted vaccines: ensuring successful filter qualification. BioPharm Int. 2010 (October).
5. 5.↵
   1. Weissig V.

   1. ElBayoumi T. A.,
   2. Torchilin V. P.

   Current Trends in Liposome Research. In Liposomes Methods and Protocols, Weissig V. Ed.; Humana Press: New York, 2010; Vol. 1, pp 1– 27.

   OpenUrl
6. 6.↵
   1. Torchilin V. P.

   Recent advances with liposomes as pharmaceutical carriers. Nat. Rev. Drug Discov. 2005, 4 (2), 145– 160.

   OpenUrlCrossRefPubMedWeb of Science
7. 7.↵
   1. Parsek M.,
   2. Singh P.

   Bacterial biofilms: an emerging link to disease pathogenesis. Anu. Rev. Microbiol. 2003, 57, 677– 701.

   OpenUrl
8. 8.↵
   1. Weissig V.

   Liposomes Methods and Protocols. Volume 1: Pharmaceutical Nanocarriers. Humana Press: New York, 2010.
9. 9.↵
   1. Sundaram S.,
   2. Lewis M.,
   3. Eisenhuth J.,
   4. Howard G. J.,
   5. Larson B.

   Method for qualifying microbial removal performance of 0.1 micron rated filters. Part IV: retention of Hydrogenophaga pseudoflava (ATCC 700892) and Ralstonia pickettii (ATCC 700591) by 0.2 and 0.22 micron rated filters. PDA J. Pharm. Sci. Technol. 2002, 56 (3), 150– 171.

   OpenUrlAbstract/FREE Full Text
10. 10.↵
    1. Kaesler I.,
    2. Haake G.,
    3. Hennig H.,
    4. Rosenhagen A.,
    5. Meltzer T.,
    6. Jornitz M.

    The importance of accurate microorganism identification in microbial challenge tests of filter membranes—Part I. PDA J. Pharm. Sci. Technol. 2011, 65 (2), 92– 99.

    OpenUrlAbstract/FREE Full Text