Our Capabilities
FDA Registered cGMPs 21 CFR part 820
STERILIZATION
Partners with EO, E-Beam, and Gamma Sterilizers.
By partnering with companies providing E-Beam, Gamma, and Ethylene Oxide (EO) Sterilization methods, we can provide turnkey sterilization validation. We perform quarterly dose audits. Our knowledgeable staff assists customers daily with process and product validation activities.
COMPLIANCE STANDARDS
- FDA CFR 21 Part 820 – Quality System Regulation – Medical Devices
- ISO 13485 – Medical Devices – Quality management systems – Requirements for regulatory purposes
- ISO 11607-1 – Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging
- ISO 11607-2 – Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes
- ISO 11137-1 – Sterilization of health care products
- ISO 11137-2 – Radiation, establishing a sterilization dose
- ISO 14937 – Routine control of sterilization process
- ISO 14971 – Medical devices – application of risk management to medical devices
- ISO 14698 – Cleanrooms and associated controlled environments – Biocontamination control (as of Jan 2009)
- ISO 14644-1 – Cleanrooms and associated controlled environments, Certified ISO Class 7 Cleanrooms
CONTRACT DEVICES
MEDICAL MANUFACTURING
Offering finished medical device manufacturing and packaging services.
CONTACT US NOWQUALITY AND INNOVATION
OUR SERVICES
IPAX facility is FDA Registered and ISO 13485:2003 certified.
ISO CERTIFICATIONABOUT IPAX
WHAT WE DO
We help speed customers time through regulatory filings and market validation.
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