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Pharmaceutical packaging

— APPLICATION

PP and HDPE for blisters, bottles and infusion film

Choosing PP for blister packaging, infusion film or a tablet bottle means choosing part of the medicine. A primary pack touches the drug for its whole shelf life, so its material is described in the medicine's marketing authorisation dossier. This page sets out what blisters, bottles and medical film ask of the polymer, which documents the dossier needs, and the grades we can offer for evaluation.

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Empty clear blister trays, white pharmaceutical bottles with one teal cap and an empty clear infusion bag

Requirements

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Processing

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— REQUIREMENTS

What a primary pack has to do

A blister cavity has to form evenly to full depth, hold its shape and seal cleanly to the lidding foil. It also keeps moisture away from the tablet, so what counts is the barrier of the sheet at its thinnest formed point.

A tablet bottle or a jerry can for a liquid medicine needs stiffness, drop resistance and a closure that seals. An infusion bag must stay clear enough to inspect the fluid, stay flexible and come through steam sterilisation intact. And no pack may release substances into the medicine in amounts that affect its quality or safety.

— SELECTION

Choosing polypropylene for infusion bags, blisters and bottles

  • PP homopolymer sheet is the base for thermoformed blisters. Grades made for sheet extrusion and thermoforming give the even sheet and wide forming window that deep cavities need.

  • Polypropylene keeps its shape at steam sterilisation temperatures, where low density polyethylene softens, and it needs no plasticiser. That is why polyolefin film is used for PVC-free infusion bags.

  • HDPE gives stiffness and stress-cracking resistance for extrusion blow-moulded bottles and jerry cans.

  • Nucleated PP homopolymer suits injection-moulded closures and dosing parts. Closure design is covered on caps and closures, syringes and device parts on medical devices, syringes and labware.

Then check the sterilisation routes on each data sheet: autoclave, ethylene oxide or irradiation. A grade is described for some routes, not all.

— PROCESSING

Sheet, film and blow moulding

Blister sheet is extruded and then thermoformed, so the sheet's thickness profile decides how evenly the cavities form. Infusion film is cast or blown, often in several layers, and welded into bags. Bottles and jerry cans are extrusion blow moulded. Agree trial conditions before samples are made and hold them through qualification.

Sheet extrusion/thermoforming

Film extrusion

Extrusion blow moulding

Injection moulding

— DOCUMENTATION

Documentation for the medicine's dossier

The marketing authorisation applicant documents the pack, following the EMA guideline on plastic immediate packaging materials. For tablets and other solid forms the guideline sees a low risk of interaction. For liquids, and above all injectable, eye and inhaled products, it expects extraction and interaction studies. A material that meets a European Pharmacopoeia chapter, such as 3.1.3 for polyolefins or 3.1.6 for polypropylene containers for parenteral and ophthalmic use, needs less data. The producer's regulatory summary states which chapters a grade meets.

— FAQ

Common questions

When is pharmaceutical packaging HDPE the right choice?

Which medical film PP suits infusion bags?

Do recycled-content targets apply to medicine packs?