ASTM International's manufacture of pharmaceutical and biopharmaceutical products committee (E55) has announced the approval of a new standard (E3469) that it says will help to "ensure sterilisation processes during drug manufacturing processes are effective and contribute to patient safety."
The new standard will provide manufacturers with guidance for bacterial challenge validation of sterilising-grade filters, demonstrating the membrane filter's ability to completely retain the challenge organism.
The organism is typically a suitable bacterium under process-specific conditions, utilising either the actual process fluid or a surrogate fluid when necessary, with the specified filter membranes material and composition.
"Process validation of sterilising filtration is required by industry standards and regulatory agencies," said ASTM member Russell Madsen.
It works to ensure that process fluid contact with the filter under worst-case process-use conditions does not adversely affect the composition of the filtered material or the retentivity and integrity of the filter.
Madsen believes that the new standard will be widely applicable to manufacturers of pharmaceutical, biopharmaceutical and biological products that require sterilising filtration at various stages of their processes.
Additionally, regulatory bodies should find the proposed standard useful as a basis for understanding how and why manufacturers use and validate sterilising filtration processes.