Steriliazation services.

Sterilization Services

Many small medical device manufacturers find it difficult to secure EO sterilization capacity in an ever-consolidating market with reduced capacity. The industry today favors “pallets not units.” J-Pac provides in-house, quick-turn EO capacity and sterilization validation services.

An EO Solution for Small Lots

EO is the most common sterilization method for medical devices. J-Pac offers a low-temperature EO solution for early stage and smaller lot medical devices.

From Development to Production

Medical device design engineers need to conduct worse-case exposure studies of their products and packaging. J-Pac offers both worse case and 2X. We also offer on-going sterilization of commercialized products.

Fast and Efficient

Because we are a medical device packaging company, we have the advantage of performing EO sterilization prior to final boxing and palletization. Cartons, pallets and other shipping materials absorb significant amounts of EO during the sterilization process. This extends time required for sterilization and outgassing. J-Pac sterilizes the devices without secondary packaging, reducing time and the amount of EO used.

Leadtime is typically 48 hours.

A Full Range of Services

J-Pac provides comprehensive sterilization services for all types of sterilization needs: EO, Gamma, E-Beam

Services include:

  • Engineering Runs
  • Protocol Development
  • Final Reports
  • Batch Release Qualification
  • EO Cycle Development
  • Sample Preparation for Transit and Shelf-Life Studies
  • Clinical Trial Support
  • Comparative Resistance Studies
  • Small Load Processing
  • Dose Audits
  • Annual Revalidations

FAQs

Learn more about our sterilization process by reading a few of the most common questions we hear from our customers.

Can J-Pac Medical provide sterilization for implantable products that include resorbable polymers?

Yes.  In fact, the WIP exposure of these products is minimized with the sterilization occurring under one roof with assembly and packaging as compared to a production flow requiring shipping of product to and from an off-site sterilizer.  Degradation of the resorbable polymer is minimized with J-Pac Medical’s integrated assembly, packaging and sterilization flow.

Does J-Pac Medical have capacity available for Eto Processing?

While it is true that capacity is severely challenged, J-Pac Medical has available Eto Capacity in its GS8X Sterilizer, and has the ability and space to add chambers as needed to meet customer needs.

Can J-Pac sterilize our product?

J-pac Medical - make of Medical Face Shields

J-pac Medical facilities

Medical device contract manufacturing facility

J-Pac Medical offers in-house EtO sterilization that is most useful for small-lot production or high-volume production of small footprint packages. We also manage outside sterilization service companies. Our services range from organizing sterilization validations, single-lot releases, and management of on-going sterilization release and re-validation schedules.

Medical Face Shields

Medical Face Shields

J-Pac Medical is the trusted partner for producing the highest quality medical face shields.

Medical Textiles

J-Pac Medical is the trusted partner for producing the highest quality custom, implantable biomedical textile devices.

Medical Device Assembly & Packaging

When precision counts, J-Pac Medical is the right partner to manufacture, assemble, and package your sterile single-use medical devices.

Diagnostic Reagent Blisters

Partner with J-Pac Medical to produce your custom diagnostic reagent blisters to speed processing and reduce errors.

Latest News

May 08, 2021


Medical device packaging and sterilization: a price you won't want to pay twice

Outsourced guidance on medical device packaging and sterilization comes at a cost many wish to avoid. Read about why that’s a bad idea.

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603.692.9955

info@j-pacmedical.com