Sterile Flexible Packaging
Sterile pouches, header bags, forming film, and sterile barrier systems for medical device packaging. ISO 11607 compliant, full validation support. ISO 9001:2015 & ISO 13485:2016 certified. Primary Packaging Resources.
Sterile flexible packaging is the primary containment system for the majority of single-use medical devices. At PPR, we supply a comprehensive range of sterile flexible packaging components — from standard Tyvek® pouches to custom rollstock and multi-layer laminate structures — engineered and validated to ISO 11607.
Tyvek® Pouches
Distributor of DuPont Tyvek® convertors. 1073B, 2FS and 1059B material in standard and custom sizes. Chevron (peel) and flat configurations. Compatible with ETO, gamma, and e-beam sterilization. Peel-open design for aseptic presentation.
Header Bags
Poly/Tyvek® header bags for devices requiring open-end loading. Tyvek® header provides sterilization breathability while the poly body provides barrier. Available in custom widths and lengths.
Clear Film-to-Film Pouches
Clear polyester, polyethylene or nylon for film-to-film pouches for ETO and e-beam applications where full device visibility is required on both sides.
Rollstock & Form-Fill-Seal Materials
Custom made Tyvek or forming film rollstockfor use on automated form-fill-seal (FFS) packaging or multi-vac equipment.
Custom Laminate Structures
Multi-layer laminates combining barrier films, foil layers, and sterilization-compatible substrates for devices requiring extended shelf life, moisture barrier, or light protection.
Validation Support
Seal strength testing, integrity testing, accelerated aging per ASTM F1980, and distribution simulation per ASTM D4169. Third-party testing coordination available.
Standard Process:
Discovery & Requirements
Device specs, sterilization method, use environment, and regulatory pathwayreviewed with your team.
Design + Development
Artwork and specification sheets provided, or new packaging concepts engineeredby our team.
Prototypes + Proposal
Prototypes available for testing and validation. Once approved, pricing and termsare determined.
Validation
IQ/OQ/PQ executed. Accelerated aging and distribution simulation testingcompleted per ISO 11607.
Final Approval + Production
Proofs made to match drawings and specifications. Validated design transferred tofull production.
Materials & Options
- DuPont Tyvek® 1073B
Standard medical grade; ETO/Gamma/e-beam compatible - DuPont Tyvek® 2FS
Cleanroom grade; reduced fiber/particle levels - ISO 11607-1 & 2
Materials and packaging systems; Validation of forming, sealing and assembly - Clear Sterile Barriers
Polyethylene, Nylon materials - Printing
Directly print IFU; space for EXP/LOT variable printing - ASTM F1929 & F2096
Dye penetration testing; Gross leak testing
Device Categories We Support
Sterile Flexible Packaging
Sterile barrier system failures are among the most serious packaging nonconformances a medical device company can face. We take a rigorous, documentation-first approach — ensuring your system is validated, traceable, and compliant before it goes to market.
Our sister CMO helps with all packaging validation and qualifications systems. We can bring products to market faster with our vertical approach.
