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
- 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
Learn more about our sterilization process by reading a few of the most common questions we hear from our customers.
Are you able to perform additional testing required for product releases such as endotoxin or bioburden?
While J-Pac Medical does not perform the actual testing of the samples we do have a laboratory that is on our approved supplier list that performs any required test.
Can J-Pac sterilize our product?
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.
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.
Let’s Get Started.
A conversation with J-Pac is your first step to having a manufacturing partner you can count on.