About MedicoPax

MedicoPax is an independent medical device packaging knowledge portal — a structured, technical reference for professionals working with sterile packaging in the pharmaceutical and medical device industries.

We cover sterile packaging standards (ISO 11607), regulatory requirements (EU MDR, EU IVDR, FDA 21 CFR 820), packaging materials and material science, testing and validation methods, and product-specific packaging considerations — without a paywall, without a sales pitch, and without content shaped by commercial relationships.

Who We Are For

MedicoPax is designed for professionals who work with medical device and pharmaceutical packaging in a technical or regulatory capacity. Our primary audience includes packaging engineers responsible for designing and validating sterile barrier systems for medical devices, surgical instruments, in vitro diagnostic products, and combination products. Regulatory affairs specialists preparing technical documentation for EU MDR, FDA 510(k), PMA, and equivalent submissions will find detailed coverage of the packaging documentation requirements within each framework. Quality assurance managers responsible for packaging process validation, incoming inspection, and post-market surveillance of packaging system performance will find content aligned with current validation methodology and good manufacturing practice requirements.

R&D engineers selecting packaging materials and formats for new product development and product line extensions will find material comparison content and design consideration guides for common sterile barrier system configurations. Procurement professionals specifying packaging materials and evaluating supplier qualification requirements will find content on material standards, supplier audit criteria, and specification development.

What We Cover

Content is structured around the technical and regulatory disciplines that govern medical device packaging. ISO 11607 is covered in depth across both parts: Part 1 defines the requirements for materials, sterile barrier systems, and packaging systems, and Part 2 defines the validation requirements for forming, sealing, and assembly processes. We explain how these requirements apply in practice to common sterile barrier system configurations including Tyvek-film pouches, foil-film pouches, and thermoformed tray-and-lid systems.

Regulatory content covers EU MDR 2017/745 and IVDR 2017/746, including the role of packaging in the technical file, essential requirements relating to packaging, and the implications of post-market surveillance and field safety corrective actions on packaging change control. FDA content covers 21 CFR Part 820 design controls as they apply to packaging, the role of packaging in 510(k) and PMA submissions, and how ASTM test methods are cited in regulatory submissions.

Materials content covers the major sterile barrier system substrates in detail: Tyvek grades (1073B, 1059B, 2FS), medical-grade thermoform films (PETG, PP, HDPE, oriented nylon combinations), aluminium foil laminates, coated papers, and heat-seal coating chemistry. Sterilisation compatibility — the relationship between sterilisation method (EO, gamma, e-beam, steam) and material selection — is covered as a cross-cutting topic because it constrains material and process choices before any other design criterion is applied.

Validation content addresses IQ/OQ/PQ methodology in the context of ISO 11607 Part 2, covering seal strength testing (ASTM F88), burst testing (ASTM F1140, F2054), dye penetration testing (ASTM F1929), microbial barrier testing (ASTM F1608), accelerated ageing (ASTM F1980), and distribution simulation (ISTA, ASTM D4169).

Editorial Standards

All content on MedicoPax is written to be technically accurate and directly applicable to real engineering and compliance work. We reference applicable standards by clause number, cite test methods by ASTM and ISO designation, and distinguish clearly between normative requirements — what a standard mandates — and informative guidance, which explains intent without imposing obligation. We do not publish sponsored content, product promotions, or advertorial of any form.

Where standards or regulations have been updated since an article was published, we flag the revision status and update content to reflect the current version. Readers preparing regulatory submissions should always verify against the current version of the applicable standard, as revision cycles in ISO and ASTM standards are ongoing.

Get in Touch

If you have found an error in our content, want to suggest a topic for coverage, have a question about how a standard applies to a specific packaging configuration, or want to discuss contributing technical content, please use the contact page. We review all messages and aim to respond within one working day.