Validating Sterility Assurance Level (SAL 10^-6) in Contract Packaging
For single-use medical devices and surgical packs, achieving a validated Sterility Assurance Level (SAL) of 10^-6 (a one-in-a-million probability of a non-sterile unit) is mandatory under ISO 13485 and European MDR guidelines.
Ethylene Oxide (EtO) Gas Sterilization
EtO is the primary sterilization modality for multi-component surgical packs containing diverse materials (plastics, rubber tubing, electronics, and stainless steel). Because it operates at low temperatures (45–55°C), it preserves heat-sensitive polymers. Rigid aeration protocols ensure ethylene oxide and ethylene chlorohydrin residuals comply strictly with ISO 10993-7 limits.
Gamma Irradiation (Cobalt-60) Penetration
Gamma sterilization provides deep radiation penetration through sealed corrugated cartons without requiring breathable Tyvek headers. However, materials must be screened to prevent radiation embrittlement and yellowing of sensitive polypropylenes.