Many small medical device manufacturers find it difficult to secure ethylene oxide (EtO) sterilization and still meet project timelines.
While the industry today favors pallets over units, J-Pac bucks the trend with in-house, quick-turn low-temperature EtO sterilization and validation services for small-lot programs.
EtO sterilization is the most common method in the industry, but J-Pac Medical also offers gamma and E-beam sterilization when specifications require.
EtO sterilization from development to production
As a turnkey medical device outsourcing partner, J-Pac Medical leverages its sterilization capabilities to fill the gap between early commercialization and longer-term scale-up. Sterilization validation is expensive and involves validating a specific chamber and lot size. This can be difficult for early stage companies that may not know their longer-term volumes.
Unlike large-scale sterilizers, J-Pac can sterilize packaged devices prior to placing them into their corrugated packaging. This allows some smaller or lower-volume medical devices to be perfect candidates for our in-house EtO capabilities.
Early on, our team conducts both worst-case and 2x exposure studies on products and packaging to qualify your medical device sterilization process.
Upon commercialization, we provide ongoing sterilization for small lots and potentially for larger lots of small-sized products.
Our full range of sterilization services includes:
- Engineering runs
- Protocol development
- Final reports
- Batch release qualification
- EtO cycle development
- Sample preparation for transit and shelf life studies
- Clinical trial support
- Comparative resistance studies
- Small-load processing
- Dose audits
- Annual revalidations
If you have questions about our sterilization equipment or in-house capacity, contact us.