Phase 2 provides sterilization management services for our assembly and packaging clients. Validation of sterilization is a requirement of good manufacturing practices in accordance with Part 820 of the U.S. Code of Federal Regulations - Title 21 (21 CFR Part 820).
There are multiple sterilization methods currently approved by the U.S. FDA including Ethylene Oxide (EtO or EO), Radiation (Gamma), Steam, Dry Heat, Moist Heat, E-Beam, and others. The sterilization method of a product is primarily determined by material compatibility with the sterilization method. Ninety percent of our manufactured products are terminally sterilized using Ethylene Oxide (EtO or EO), with an additional five percent of our products being sterilized using Radiation (Gamma).
Phase 2 works closely with our key sterilization partners to develop the validation strategy for our clients as part of the Master Validation Plan (MVP). This plan will encompasses unit volumes required to complete both sterilization and packaging validation. Since material compatibility with the sterilization method is the primary driver of this decision one of the key risk mitigation strategies is to expose/process the assembled device using the specified materials early in the development cycle.
EtO or EO Sterilization
ISO 11135:2014 governs the sterilization of medical devices using EtO. One the key advantages of EtO sterilization is the variability in size of sterilization chambers available to process your product. These chambers can fit as small as 1/2 pallet of product all the way up to 28 pallet or truckload size sterilization.
The most common reason for choosing EtO is the materials required for your product to perform. For instance, polyethylene (PE) sutures can change in material properties if you use Gamma sterilization and not perform as intended. Additionally, polypropylene (PP) tubing and other plastic materials can change color or craze when exposed to Gamma, which may not affect performance but may be undesirable for the cosmetic aspectics of your product.
EtO can be one of the more expensive validation methods because of the long-term benefit of high volume production costs.
Radiation (Gamma) Sterilization
ISO 11137:2013 governs the sterilization of medical devices using radiation. Gamma sterilization has been used for irradiating food since the 1920s. The advantage of this method is that a product sees the same radiation dose based on proximity to the radiation source and therefore can be more predictable that using a gas, and is therefore less expensive.
The most common reason for choosing Gamma is the materials required for your product to perform. Many products can degrade or change properties when irradiated. Plastics can discolor, crack or craze, and performance of your assembled product and/or packaging can degrade after exposure to radiation. The plastics industry has developed many gamma-stable materials for use that prevent this degradation and since materials are the primary factor in choosing your sterilziation method, it is important for companies to factor this into their development plans.