- InnovaPax now covers medical and pharmaceutical packaging alongside its industrial and food content.
- The medical section is presented at trade shows as MedicoPax by InnovaPax, using a teal colour treatment while remaining one brand.
- It covers sterile barrier systems, medical-grade materials such as Tyvek and coated films, sterilisation compatibility, and validation.
- The regulatory framework — ISO 11607, EU MDR, and FDA quality-system requirements — runs through every guide.
- The aim is the same vendor-neutral depth InnovaPax applies to food and industrial packaging, extended to the highest-stakes packaging discipline.
InnovaPax now covers medical and pharmaceutical packaging alongside its industrial and food content. Presented at industry events as MedicoPax by InnovaPax, the medical section brings the same independent, technical approach to the most demanding packaging discipline of all — where a packaging failure is a patient-safety failure. This article outlines what the medical section covers, from sterile barrier systems and materials to sterilisation, validation, and the regulatory framework that ties them together.
Table of Contents
- What the medical section covers
- Sterile barrier systems
- Medical-grade materials
- Sterilisation and compatibility
- Validation and ISO 11607
- One brand, a distinct look
- Industry insight
- Frequently asked questions
What the medical section covers
Medical and pharmaceutical packaging protects a sterile product from manufacture to the point of use, and it must do so with a level of assurance that food and industrial packaging rarely require. The InnovaPax medical section addresses the whole chain: the packaging system, the materials it is built from, the sterilisation method it must survive, and the validation and regulatory evidence that prove it works.
Sterile barrier systems
A sterile barrier system is the minimum packaging that prevents micro-organism ingress and allows aseptic presentation of the product. It is the heart of medical packaging, and everything else — material selection, sealing, testing — exists to guarantee its integrity through the product’s entire shelf life and distribution.
Preformed systems and pouches
Common formats include Tyvek–film pouches, header bags, and preformed trays with lidding, each suited to different device geometries and sterilisation methods.
Medical-grade materials
Tyvek and porous webs
Flash-spun high-density polyethylene (Tyvek) and medical-grade coated papers provide a microbial barrier while allowing sterilant gas or steam to pass — essential for EO and steam sterilisation.
Films and foils
Barrier films and laminates form the non-porous side of a pouch or the forming web of a tray, chosen for their barrier properties, sealability, and compatibility with the chosen sterilisation route.
Sterilisation and compatibility
The packaging material must match the sterilisation method. Ethylene oxide (EO) and steam require a porous web to let the sterilant in and out; gamma and electron-beam irradiation are dry processes but can affect certain polymers over time. Choosing a material without confirming sterilisation compatibility is one of the most common — and most expensive — mistakes in medical packaging.
Validation and ISO 11607
Under ISO 11607, both the sterile barrier system (Part 1) and the processes that make it (Part 2) must be validated. That means qualifying the sealing and forming processes through IQ/OQ/PQ, and supporting shelf-life claims with accelerated aging (ASTM F1980) confirmed by real-time data, plus seal-strength and leak testing (ASTM F88, F1929). The regulatory umbrella — EU MDR in Europe, FDA quality-system requirements in the US — expects this evidence on file.
One brand, a distinct look
At medical and pharmaceutical trade shows the section appears as MedicoPax by InnovaPax, with a teal colour treatment that signals the clinical context. It is a visual cue, not a separate company: the same InnovaPax logo, the same library, and the same editorial independence. One brand serving every industry, with a look that adapts to the audience.
Industry insight
Frequently asked questions
Is MedicoPax a separate company from InnovaPax?
No. MedicoPax by InnovaPax is the name used for the medical and pharmaceutical section at industry events. It is the same library, brand, and standards.
What is a sterile barrier system?
The minimum packaging configuration that prevents micro-organism ingress and allows aseptic presentation of the product at the point of use.
Why does material have to match the sterilisation method?
Porous webs like Tyvek are needed to admit gas or steam for EO and steam sterilisation, while irradiation methods can degrade certain polymers. Compatibility must be confirmed before selection.
Which standard governs medical packaging validation?
ISO 11607 (Parts 1 and 2), supported by ASTM and EN test methods and the applicable regional regulations.
Explore the Standards & Regulations hub for the regulatory detail, or the Knowledge Base for guides on Tyvek, films, and sterile barrier design.
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Packaging glossary expanded to 36 searchable terms