Turn Key Sterile Contract Manufacturing and Assembly
As part of the “single source” service that Pacific Plastics & Engineering offers our OEM medical device customers, we host partnerships with fully ISO certified sterilization facilities. Devices are packaged at one of our PPE sites and then shipped where an appropriate system of sterilization will take place.
E-Beam
Electron beam processing is an effective method that renders microorganisms inactive by causing microbial destruction. E-Beam radiation is a very fast process which can occur in the original packaging, thereby saving time and money. This method of sterilization is a favorite, as it does not alter the composition of plastic. Our partner facilities meet all international standards for product, process, and installation qualification for e-beam systems that have been set forth and established in ANSI/AAMI/ISO 11137 (1994) and EN 552.
Gamma
This sterilization process can effectively kill microorganisms and vital molecules in the product and packaging without concern for temperature changes. Gamma creates no residue and does not store irradiation energy. We are able to offer small volume processing for market testing of prototypes with this sterilization service.
Ethylene Oxide
This method is somewhat more complicated than the two above but for some instances, it is the correct course of action. When mixed with a small percentage of air, EO becomes a flammable gas. It is used in a vacuum chamber, from which the air has been removed. A small amount of moisture, usually in the form of steam is released into the vacuum before the EO concentration enters the chamber. Once the medical device has soaked for a predetermined amount of time, a sequence of washes take place to remove all traces of the EO.
PPE's dedicated team of experts will assist you with the necessary selection of your product's proper sterilization needs.
Our Gamma sterilization and Ethylene Oxide sterilization facilities are FDA 21 compliant, meet CFR part 820 requirements, are ISO 13485 registered, and meet standards set by AAMI/ANSI/ISO 11135-1:2007, and AAMI/ANSI/ISO 11137-1:2006. For compliance of product acceptance in domestic and international markets, they meet EN 550 requirements.
