Pre-validated Sterile Packaging for Medical Devices offers a Faster Track to Market
QSEAL® Pre-validated Sterile Packaging for medical devices offers you an innovative, alternative approach to custom medical package design.
QSEAL is our exclusive line of sterile packaging created in standard sizes for both tray and pouch-based systems, offering a variety of choices to fit your needs. Because the packaging system has already been designed, sourced and validated to ISO and medical industry standards, manufacturers can bring new products to market much faster – and at the same time, lower costs significantly. QSEAL can reduce packaging development costs by approximately 30% and development time by as much as 50% (depending on device and customer specifications).
These sterile packaging systems include pre-validated packaging trays, lids and pouches in a broad range of sizes and materials for Gamma, Ethylene Oxide (EtO) and Electron Beam (e-beam) sterilization processing with 5 year accelerated and real time aging. Single or double barrier package configurations involving foam, polyurethane, shelf boxes and other protective packaging materials are also available with the use of QSEAL. When faster-to-market is better, QSEAL sterile medical packaging is the answer.
Customized Sterile Medical Packaging
Our pre-validated, sterile medical packaging may be customized to fit your specific medical device. Customized QSEAL package designs are available for both pouch and tray based packaging systems. QSEAL trays can be customized within the seal flange to accommodate various devices and retention features that ensure the contents are protected. QSEAL pouches can be customized to the needs of a specific component by adjusting the length and width of the pouch. This flexibility of customization offers a wider range of options for pre-validated packaging. QTS will collaborate with you to develop a customized QSEAL pre-validated package that is ideal for your specific medical device.
Included in the QSEAL Package Offering
- Variety of existing Package Sizes, Materials and Configurations to choose from
- Tooling and Seal Nests in place
- Seal Validations completed
- 5 Year Accelerated and Real Time Aging completed
- Validation Reports and Documentation available
- Cross-validation on multiple QTS Sealers
Packaging Design Expertise
- Custom Packaging
- QSEAL® Pre-validated Packaging
- Package Validations
- Seal Validation
- Accelerated and Real Time Aging
- Distribution Simulation
- Bubble Leak, Dye and Burst Testing
- Sourcing of Packaging Materials
- Trays and Pouches
- Backer Cards, Inserts, Foam, Polyurethane
- Shelf Boxes
- IFUs and Labels
- Shrink Wrap
- Shippers
- Complete package configuration from sterile barrier to pallet loads
