Tuesday, 2 June 2015

ISO 14698 for non-sterile environments?

ISO 14698 (parts 1 and 2) has been in place since 1998. The document is applicable to a range of environments, although it has tended to be referred to by those involved with the manufacture of sterile pharmaceuticals. That said, in my experience, few institutions are using it and instead turn to EU GMP, the FDA aseptic processing guidance or to the USP. Moreover, the standard is in need of an update.

With considerations about what a revised version of parts 1 and 2 might look like, some national standards bodies are considering where a version of non-sterile pharmaceutical manufacturing environments is needed.

ISO have reserved a part 9 in the ISO 14698 series for this purpose. National standards bodies are currently considering the need for such a document and, if so needed, what the main contents should be.

Then justification for such a document is, according to ISO:

“The most critical consideration in facility design, equipment selection, cleaning, validation, production operation and maintenance in the manufacture of non-sterile healthcare products is the active avoidance of conditions that would favour microbial proliferation. Avoidance of these conditions requires a scientific understanding of facility and operational situations that favor microbial presence and proliferation. This part of ISO 14698 will provide principles and guidance for the assessment of microbial risk and will discuss manufacturing validation requirements and the identification of control points which can prevent or eliminate conditions that are favorable to the apperance of microbial contamination.”

If approved, the document would be known as:

ISO 14698-9 Cleanrooms and associated controlled environments--Biocontamination control Microbiological contamination control of facilities used for the manufacture of non-sterile healthcare.

Posted by Tim Sandle