Custom Package Engineering
End-to-end packaging design and development for the medical device industry. From initial concept through material selection, prototyping, validation, and production launch — built to regulatory standards from day one.
Medical device packaging is a critical component of the product itself — not just its container. At Primary Packaging Resources, our custom package engineering service takes a compliance-first approach, working with manufacturers from earlystage concept through production-ready design. Founded in 1997, we've built the certifications, systems, and manufacturing relationships to support the full packaging lifecycle.
Package Design & Concept Development
We translate device specifications, sterilization requirements, and use context into packaging concepts. Feasibility assessments identify the right format — pouch, tray, blister, or combination system — before materials are committed.
Material Selection & Specification
Selection of appropriate substrates — Tyvek®, medical-grade foil laminates, PETG, HDPE, or paper — based on sterilization method (ETO, gamma, steam), device geometry, and shelf-life requirements. Fully documented and traceable.
Prototype & Tooling Development
Rapid prototyping of thermoform trays, pouches, and rigid structures to evaluate fit, seal quality, and opening characteristics. Tooling coordination across our manufacturing network reduces lead time and cost.
Validation Support (IQ / OQ / PQ)
Structured validation protocols aligned to ISO 11607 and ASTM standards. We support IQ, OQ, and PQ documentation and can facilitate third-party accelerated aging and distribution simulation testing.
Regulatory Documentation
Package history records, design history files, and risk assessments prepared in formats suitable for FDA 510(k) submissions and CE technical files. Documented correctly from the first step.
Supplier Qualification & Audit Support
As an ISO 13485:2016-certified distributor, PPR welcomes facility audits and can coordinate manufacturing partner qualifications. Audit-ready documentation packages available on request.
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
- ISO 11607
Primary standard governing sterile barrier system design, materialselection, and validation - ASTM F2097
Standard guide for design andevaluation of flexible packaging - ASTM D4169
Distribution simulation testing - ASTM F1980
Accelerated aging for sterile packages - ISO 13485:2016
PPRQMS certification - ISO 9001:2015
Quality management certification
Device Categories We Support
Custom Package Engineering
We're not a consulting firm — we're a distributor with manufacturing relationships. Engineering solutions we design move directly into production without a supplier handoff. Possibly the only company in the US offering fully integrated packaging services under one roof.
Our sister company Novem Medical CM provides contract manufacturing. Designs move directly to production without a supplier handoff.
Ready to start your packaging project?
Tell us your size, gauge, quantity, and any print requirements. We'll get back to you within one business day.
