Page 243 - Assurance of Sterility for Sensitive Combination Products and Materials

Developing new products 219

life. Scientists and engineers from both industry and regulatory bodies have
worked together to ensure that the treatments offered to patients are safe
and effective. Both terminal sterilized as well as aseptic processed single
use medical products have a long history of patient safety. The theoretical
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benefits of a sterile product processed to a 10 SAL over an aseptic process
product are clear: minimizing the risk to the patient. From a practical per-
spective, however, aseptic processed products, with the appropriate controls
in place, are extremely effective and safe. Although these innovative prod-
ucts provide new treatment options to patients, it is becoming increasingly
challenging to sterilize them to the same SAL. ISO/TS 19930-1:2017 and
ISO 13408-1:2008 provide a framework where due diligence to ensure risk
is minimized is balanced with the challenges of the difficulties in sterilizing
the new sensitive combination products.

References
[1] FDA, Submission and Review of Sterility Information in Premarket Notification
[510(k)]. Submissions for Devices Labeled as Sterile Guidance for Industry and Food and
Drug Administration Staff, 2016, https://www.fda.gov/downloads/ucm109897.pdf.
[2] AAMI TIR17, Compatibility of Materials Subject to Sterilization, 2017.
[3] C. Quianzon, I. Cheikh, History of insulin, J. Community Hosp. Intern. Med. Perspect.
2 (2) (2012) https://doi.org/10.3402/jchimp.v2i2.18701.
[4] ISO 13408-1, Aseptic Processing of Health Care Products—Part 1: General
Requirements, 2008.
[5] European Medicines Agency, EMA/CHMP/CVMP/QWP/BWP/850374/2015 Draft:
Guideline on the Sterilization of the Medicinal Product, Active Substance, Excipient
and Primary Container Aseptic Processing, 2016.
[6] ISO/TS 19930:2017 Guidance on aspects of a risk-based approach to assuring sterility
of terminally sterilized, single-use health care product that is unable to withstand pro-
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cessing to achieve maximally a sterility assurance level of 10 .