4,200 sqft ISO 14644 Class 7 cleanroom.
Manufacturing is performed in our controlled environment room. We are proud of our 4,200 sq. ft. cleanroom which is certified to the ISO 14644 Class 7 standard. Our process has a strong quality history, and we maintain an ISO certified 13485:2003 quality system.
Solvent, cyanoacrylate, and UV cure bonding.
Our assembly capabilities include solvent, cyanoacrylate and UV cure bonding.
Pouch or tray packaging: Sterile Barrier validation, in process testing.
We also provide assistance and information for any customer-specific packaging requirements. We conduct all the required work for sterile barrier validation and in process testing.
Label design to meet all regulatory requirements
We can assist or completely design your labeling to ensure regulatory compliance.
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. We also partner with a nationally recognized full service lab to perform any testing needed for sterility validation.
We manage all your audit requirements.
Attention to detail is demonstrated by our management and manufacturing staff. We manage a large variety of audits to include purchasing, vendor and dose audits and supply you with all the necessary documentation. In addition, we are audited by regulatory agencies and welcome and accommodate all levels of customer audits.
Sourcing vendors and/or components.
We are always happy to assist with, or completely manage customer’s world-wide sourcing of components that meet your specifications. Our staff will also conduct vendor approval on your behalf.
Pad printing capability with the latest technology. We can print on a variety of surfaces with an easy, flexible system that can accommodate your needs.
We offer a variety of pouch or tray sealing options that will accommodate most configurations
Offering finished medical device manufacturing and packaging services.
CONTACT US NOWIPAX facility is FDA Registered and ISO 13485:2003 certified.
ISO CERTIFICATIONWe help speed customers time through regulatory filings and market validation.
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