The Case for Qualifying More Than One Sterilization Modality

Abstract

Due to its complexity, sterilization has been perceived by some professionals who lack sterility assurance expertise as a “black box” process. Historically, medical device manufacturers have selected one of the available industrial sterilization options: dry heat, moist heat, gamma, or ethylene oxide (EO). The preselection of a sterilization modality (method) typically is made without understanding its impact based on qualified sterilization processes for existing products, capability, or resources required for the specific processes. Early engagement with sterilization subject matter experts (SMEs) can redirect the decision to preselect a legacy modality and help foster innovation and operational agility. Recent focus on supply chain flexibility and sustainability by the medical device industry has been affected by concerns surrounding cobalt-60 shortages and EO emissions. These factors drive the need for early involvement with sterility assurance SMEs in the product development process and the exploration of multiple sterilization modalities. This article highlights the importance of exploring multiple sterilization modalities during the product development stage to support sustainable business continuity plans.

Impact of X‐ray irradiation as an equivalent alternative to gamma for sterilization of single‐use bioprocessing polymers

“…Moreover, security of supply, challenges associated with the complex Cobalt-60 (Co-60) supply chain, potential security concerns with Co-60, and business decisions supporting similar, now mature alternative irradiation technologies (such as X-ray and e-beam) have limited expansion of gamma irradiation facilities. The rapidly growing demand for irradiated SU systems in bioprocessing, combined with the forecasting and capacity challenges associated with Co-60 dependent gamma irradiation, 1,2 have led to increasing business continuity and supply chain risks in securing the critical irradiation capacity for SU systems. This has driven the bioprocess industry to seek alternative sterilization methods to supplement gamma irradiation.…”

“…This has driven the bioprocess industry to seek alternative sterilization methods to supplement gamma irradiation. 3 Through collaboration within industry working groups, for example, BioPhorum and the Bio-Process Systems Alliance (BSPA), X-ray irradiation has been identified as a highly similar alternative sterilization technology to gamma irradiation, 2,4 as it employs a highly similar photon-based irradiation with the same units of dose, expected to impact the materials and kill microorganisms via the same fundamental physics mechanisms. [4][5][6] Both X-ray and gamma deposit energy largely by Compton scattering effects, in which the incident high-energy photons trigger a cascade of electrons, and the electrons ultimately disrupt genetic material of the microorganisms.…”