Page 124 - Assurance of Sterility for Sensitive Combination Products and Materials

108 Assurance of sterility for sensitive combination products and materials

establishes scientific evidence that a process is capable of consistently delivering quality
product.” A key to this approach is to understand the drivers of product varia-
tion and take the appropriate control based on risk. ISO 11607-2 “Packaging
for terminally sterilized medical devices” part 2 defines the validation requirements
for forming, sealing, and assembly processes for SBSs [2]. It also addresses the
various packaging system life cycles including process control and monitor-
ing. Further guidance is available in ISO/TS 16775: packaging for terminally
sterilized medical devices—Guidance on the application of ISO 11607-1 and
ISO 11607-2 [38].

5.3.5.1 Process design
Annex A of ISO 11607-2 “Packaging for terminally sterilized medical devices”
part 2 [2] provides guidance on process development. ISO 11607-2 [2]
requires the definition of critical process parameters, their set points, and
tolerances to produce packaging that meets the establish specifications. The
FDA guidance [86] takes a different approach by evaluating parameters
commensurate with their risk to the process and the process output, re-
garding “criticality as a continuum rather than a binary state.” In that sense, the
2019 version of ISO 11607-2 will require the establishment of a process
specification and will discontinue the concept of critical process parameters.
ISO TS 16775 [3] proposes a structured process for the packaging design
including process development. Annex Q provides guidance on establishing
process parameters and Annex S provides guidance on process design evalu-
ation. This is aligned with a quality-by-design approach for pharmaceutical
and medical products which focuses the effort at the front-end of the proj-
ect instead of inspecting quality into the product.

5.3.5.2 Installation, operational, and performance qualifications
The Global Harmonization Task Force (GHTF) guidance [85], the US FDA
guidance [86], and ISO 11607-2 propose slightly different definitions to the
concepts of installation qualification (IQ), operational qualification (OQ),
and performance qualification (PQ). A major initiative has started in 2013
within the ISO TCs for sterilization to harmonize definitions throughout
the suite of sterilization, aseptic processing, and packaging standards [75].
ISO 11607-2 defines IQ and OQ as the process of obtaining and doc-
umenting evidence that equipment adheres to its specification and operates
within predetermined limits when used in accordance with its operational
procedures. The language of the definitions has slightly changed in the 2018
version based on ISO 11139 [75]. The PQ demonstrates that the process