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QSEAL® Pre-Validated Packaging

Pre-validated sterile packaging for medical devices offers a faster track to market

QSEAL can reduce packaging development costs by approximately 30% and development time by as much as 50% (depending on device and customer specifications).

Customize our pre-validated medical packaging to fit your specific device

Customized QSEAL package designs are available for both pouch and tray based packaging systems.

  • QSEAL trays can be customized 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.

QSEAL Highlights:

  • Variety of package sizes, materials and configurations to choose from
  • Tooling and seal nests
  • Seal validations
  • 5-year real time aging

PETG Trays

Our QSEAL Pre-Validated, Sterile Packaging product line has been designed to meet rigorous requirements of medical devices. QTS is pleased to offer PETG, thermoformed trays with corresponding Tyvek® lids as part of our QSEAL family of medical device packaging products.

Thermoformed sterile packaging trays offer a rigid and strong, protective package for medical devices that require extra care. QSEAL trays are a perfect solution for devices with critical surfaces, special coatings, heavy components, or sharp edges.

Medical Device Packaging to Fit Your Needs
Our QSEAL trays are widely used throughout the industry for a variety of sterile, medical device packaging applications.

Not only do we offer standard sizing of our PETG tray solutions, we also have the ability to customize trays to meet your specific medical device packaging needs. QSEAL trays may be customized within the validated seal flange parameters to accommodate a wide range of devices and retention features that ensure the contents are protected. QTS can collaborate with you to develop a customized QSEAL package that fits your specifications for medical device packaging.

Poly/Tyvek Pouches

QTS offers Poly/Tyvek®, flexible pouches as part of our QSEAL Pre-Validated Medical Packaging product line. Our Poly/Tyvek pouches are widely used throughout the Medical Device industry for a variety of sterile, medical device applications.

QSEAL Poly/Tyvek pouches offer a lower cost alternative to rigid, thermoformed trays. Poly/Tyvek pouches can be used in a variety of package configurations to create single or double barrier systems, and be used in sterile applications.

Utilizing Custom Pouches
In addition to standard sizing of Poly/Tyvek pouches, custom pouches are also available. All QSEAL pouches may be customized to the needs of a specific component by adjusting the length and width of the pouch. QTS can collaborate with you to develop a customized QSEAL package to fit your specific device. This flexibility offers a wide range of options forPoly/Tyvek pouches and pre-validated medical device packaging.

Nylon/Tyvek Pouches

Our Nylon/Tyvek® pouches, part of the QSEAL Pre-Validated Medical Packaging product line, deliver the enhanced durability of custom nylon packaging. These pouches offer a cost-effective alternative to thermoformed trays, making them ideal when durability is essential.

Nylon/Tyvek Medical Pouches
Utilizing Nylon/Tyvek medical pouches provides an affordable option for durability without compromising functionality. Paired with our other QSEAL family of products, QTS can collaborate with you to provide a custom package solution to fit your medical device needs.

Although we offer standard sizing of our Nylon/Tyvek Pouches, QSEAL pouches may be customized to the needs of a specific component by adjusting the length and width of the pouch. This flexibility offers a wide range of options for pre-validated custom nylon packaging and Tyvek medical pouches.

Possible Nylon/Tyvek pouch applications include:

  • Robust Orthopedic Implants
  • Surgical Instruments
  • Surgical Procedure Kits
  • Tubing Sets

Foil Pouches

QSEAL Foil/Foil pouches are a simple solution for your sterile barrier packaging needs. Our Foil/Foil pouches are ideal for medical devices and implants sensitive to moisture, light, oxygen, or other gases.

Our Foil/Foil Pouches are also available with an optional Tyvek® header to support specific sterilization methods.

Custom Foil Packaging
QTS can collaborate with you to develop a QSEAL system utilizing custom foil packaging to fit your specific device. Although we offer standard sizing of our Foil/Foil Pouches, QSEAL pouches may be customized to the needs of a specific component by adjusting the length and width of the pouch. This flexibility offers a wide range of options for pre-validated custom foil packaging.

Possible Foil/Foil Pouch applications include:

  • Vacuum-Sealed Products
  • Biological or Drug Combination Devices
  • Pre-filled Syringes
  • Highly-Engineered Materials

Stock Packaging Program

Off-the-shelf solutions to fit your unique needs

With our QSEAL pre-validated packaging products we leverage trusted and reliable medical device packaging designs to help you reduce unknown supply chain risks. Our stock packaging can cut an additional 10-16 weeks of packaging material lead time from the already accelerated QSEAL offering.

Our pre-validated stock materials are available in single or double-barrier options. Our inventory is compatible with a wide variety of medical devices, including orthopedic implants, single-use instruments, fasteners, surgical kits, and more!

Stock Packaging options include:

  • PETG Trays
  • Tyvek® Lids
  • Poly/Tyvek® Pouches
  • Nylon/Tyvek® Pouches
  • Shelf Boxes
  • Patient and Packaging Labels
  • Patient Implant Cards

QSTERILE® Pre-Validated EO Sterilization Cycle

Save time and money with our pre-validated EO cycle

Adopt our QTS-owned, pre-validated ethylene oxide (EO) sterilization cycle to save time and money by not having to complete your own full EO sterilization validation. Normally a full EO cycle validation encompasses multiple half-cycle and full-cycle testing incorporating biological indicators and temperature/humidity mapping, along with product-specific testing of microbial resistance and product EO residuals.

When utilizing the QSTERILE pre-validated EO cycle, cycle testing is already completed in accordance with ISO11135 requirements, and our customers are only required to perform product-specific testing to adopt into the cycle.

QSTERILE is compatible with a wide variety of medical device products, including plates, screws, spinal cages, and single-use instrument kits.

Included with QSTERILE:

  • Sterilization of products utilizing the QTS pre-validated cycle
  • Access to the Microbiological/Physical PQ reports
  • Requalification of the sterilization cycle every two years (MPQ/PPQ)