contract sterilization

Andersen Sterilizers, Inc. is a family-owned, American manufacturer based in Haw River, North Carolina, founded by Dr. H.W. Andersen. The company designs, develops and delivers FDA-cleared ethylene oxide (EO) gas sterilizers featuring its award-winning EO-Flexible Chamber Technology, which uses up to 90% less EO than conventional rigid chamber systems. It serves healthcare, veterinary, research and manufacturing customers worldwide.

EO-Flexible Chamber Technologyethylene oxide gas sterilizationfield service and preventative maintenanceterminal sterilization

Clordisys provides contract sterilization services using chlorine dioxide gas technology for complex medical devices, pharmaceuticals, and combination devices. The company operates an FDA-registered, ISO 13485-certified contract sterilization facility and offers services including feasibility studies, cycle development, validation per ISO 14937, regulatory support, and EO-to-CD conversion services.

chlorine dioxide gas sterilizationcycle developmentEO to CD conversionregulatory supportvalidation per ISO 14937

Eagle Medical provides contract sterilization, packaging, contract manufacturing, new product introduction, and validation services for medical device manufacturers. It is ISO 13485:2016 certified and operates ISO Class 7 cleanrooms and laminar flow benches in Paso Robles, CA. The company offers sterilization via Hydrogen Peroxide Gas Plasma, E-beam, EtO, and Gamma, along with sterile barrier packaging, device assembly, and FDA regulatory support.

3D printingbonding and fasteningcleanroom assemblyincoming inspectionpackaging developmentregulatory supportstatistical process controlsterile barrier packagingvalidation (IQ/OQ/PQ)