Validating a filter for microbiology
In that same report, on page 22, section 6.5, paragraphs 1 and 7, we are told, “Successful validation centers on the removal of a standard test organism (Brevundimonas diminuta ATCC® 19146™) at minimum challenge level of 107 cfu/cm2 of filter area.
Sterile filtration plays a critical role in patient safety and thus is highly regulated, being the last unit operation of a drug manufacturing process.
Stacey constantly strives for innovation and process improvements, leading to an interest in providing the best possible quality deliverable to clients.
Regulations and regulatory guidance for the qualification and validation of sterile filtration processes are specific and well developed.
In order to be able to filter out microorganisms, the filter has to have such small pores that it excludes bacteria and, theref Filter validation plays an essential role in the drug development process.
It’s required by the regulatory bodies in support of product submissions that require a sterilizing filter.
To restore access and understand how to better interact with our site to avoid this in the future, please have your system administrator contact [email protected]
26, revised 2008, Sterilizing Filtration of Liquids, page 2, paragraph 1.
Test data can also be used as an effective marketing tool.
Nelson Labs has significant experience using a wide range of microorganisms, working with multiple industries, and performing tests in compliance with both the ASTM F838-05 and HIMA guidance documents.
Additionally, we have an advantage in that we are supporting filter validations for our internal drug products.
Having our own labs that are associated with our manufacturing sites creates more collaboration and fewer performs integrity testing of filters.