Monday - Friday: 8:00am - 5:00pm MST
303-975-2444
FDA Registered and ISO certified

OUR SERVICES

ENVIRONMENT

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.

BONDING

Solvent, cyanoacrylate, and UV cure bonding.

Our assembly capabilities include solvent, cyanoacrylate and UV cure bonding.

PACKAGING

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.

 LABELING

Label design to meet all regulatory requirements

We can assist or completely design your labeling to ensure regulatory compliance. 

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. We also partner with a nationally recognized full service lab to perform any testing needed for sterility validation.

 AUDIT MANAGEMENT

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.

SUPPLY CHAIN MANAGEMENT

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.

PRINTING

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.

SEALING

We offer a variety of pouch or tray sealing options that will accommodate most configurations

CONTRACT DEVICES

MEDICAL MANUFACTURING

Offering finished medical device manufacturing and packaging services.

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QUALITY & INNOVATION

OUR SERVICES

IPAX facility is FDA Registered and ISO 13485:2003 certified.

ISO CERTIFICATION
ABOUT IPAX

WHAT WE DO

We help speed customers time through regulatory filings and market validation.

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