Cobetter Filtration participated in drafting the newly released BPOG (2023) “Guidance for risk evaluation of X-ray irradiation of single-use systems“

Single-use technology (SUT) used in the pharmaceutical industry mainly uses Gamma irradiation (GI) for sterilization. With the growth of market size and the limited growth in the production of Cobalt-60, the source for gamma rays, Western Europe has seen a situation that the demand for Gamma-irradiation sterilization nearly exceeds its demand as of 2022. The imbalance between supply and demand has gradually become apparent, resulting in insufficient supply and price growth in the Gamma-irradiation sterilization market. New sterilization technologies are urgently needed to fill the expanding demand gap. [1]

According to the technical guide "X-RAY STERILIZATION OF SINGLE-USE BIOPROCESS EQUIPMENT PART I - INDUSTRY NEEDS, REQUIREMENTS, AND RISK EVALUATION" [2] released by the Bio-Process Systems Alliance (BPSA) in 2021, X-ray irradiation (XI) can be one of the candidate technologies that is effective and comparable to GI sterilization.

As part of the 2023 release "X-RAY STERILIZATION OF SINGLE-USE BIOPROCESS EQUIPMENT PART II - REPRESENTATIVE QUALIFICATION DATA", [3] BPSA presented representative data on the comparability of physical properties and functional performance of different single-use systems after GI and XI radiation for scientific evaluation and risk assessment, as well as support related to change work.

On the basis of the above two BPSA guidelines released in 2021 and 2023, as well as the BioPhorum platform (the alliance affiliated with BPOG for the biopharmaceutical industry), Cobetter and ten other renowned international pharmaceutical companies (AZ, BMS, Eli Lily, GSK, Pfizer, Sanofi, etc.) and suppliers have jointly drafted "X-RAY STERILIZATION RISK ASSESSMENT - Guidance for risk evaluation of X-ray irradiation of single-use systems", aiming to provide guidanceon how the risk assessment is specified during the GI to XI change process for different single-use systems and how the risk level of the proposed change is defined. Theguidance is based on consensus among international pharmaceutical companies and full communication with FDA, EMA and relevant Japanese drug regulatory organizations. The document is quite authoritative and also provides an interactive risk assessment toolkit for XI impact levels of different SU components to help facilitate the change assessment process for pharmaceutical companies.

The release of this guidance provides experience for pharmaceutical companies to prepare for the changes in sterilization methods from GI to XI irradiation for single-use systems that may be faced in the near future. By providing prior knowledge and establishing comparability, the relevant risk assessment required for changes from GI to XI irradiation is reduced, this allows pharmaceutical companies to proactively conduct change risk assessments in an orderly manner as soon as they receive notification of supplier changes.

To request full document of the The Guidance, please contact [email protected]

References:

1.??? Introduction to x-ray and gamma sterilization methods; BioPhorum: 2021.

2.??? X-RAY STERILIZATION OF SINGLE-USE BIOPROCESS EQUIPMENT PART I – INDUSTRY NEED, REQUIREMENTS AND RISK EVALUATION; Bio-Process Systems Alliance, 2021.

3.??? X-RAY STERILIZATION OF SINGLE-USE BIOPROCESS EQUIPMENT PART II – REPRESENTATIVE QUALIFICATION DATA; Bio-Process Systems Alliance, 2023.