|The European speciality medical packaging market is the focus of considerable growth, forecast to continue at 5% pa to 2012 as per AWA Alexander Watson Associates. The speciality medical packaging industry is moving forward at a pace that other packaging niches envy, and innovation is a key factor at all levels. Advanced packaging solutions for ‘difficult’ products, such as orthopaedic implants and electromechanical devices, are the fastest-growing segments at an estimated 7% pa.
Packaging medical devices – from original equipment, devices, tubing, dressings and sutures to drapes, gowns, and gloves – may be an integrated part of a product manufacturer’s in-house capabilities. The items may alternatively be passed to specialist contract packers, who pack and sterilise them, sourcing components from principal or specialist converters, or via the established industry distribution channel. Device manufacturers may also purchase packaging at raw material or semi-converted level from general or specialist converters, or from distributors.
Most of the basic packaging supplied to the medical market (56%) comes in the form of flexible rollstock – a single- or multi-ply material manufactured by lamination or co-extrusion to provide specific functionalities such as barrier properties or heat-sealability.
Rollstock can combine film and paper, as well as specialist medical grid-lacquered papers, Tyvek plastic from DuPont and aluminium foils. It is prevalent in dressings and woundcare, where barrier properties are required. Advanced adhesive formulations are a major area for growth. Converters also use rollstock for making procedure kits; form-fill-seal, shallow-draw, blister packs for syringes/needles and catheters/tubing; and clamshell packs.
Pouches and tubing represent 18% of the medical packaging market. Pouches are fabricated from two or more different materials – Tyvek, film, paper, and laminates of these materials – sealed together to form a three-sided, peel-open package, or from a single material sealed to itself to form a three-sided tear-open package. 'Tubes’ are semi-converted pouches, supplied in the reel for cutting to length, sealing and sterilisation for use in hospital packaging.
The last major segment of the medical packaging market is the catch-all wrappings, bags and miscellaneous category, in which wrappings take the greater share. They may be made of paper, paper/film and nonwovens, and typical uses include compact, sterile, pocketed wrappings to present procedure kit instruments in order of use. Speciality bags are used for bulk delivery of medical components.
As far as materials go, both governmental regulations – including the new ISO standard 11607-1:2006 for sterile packaging systems for medical devices – and the commercial medical device manufacturing industry are re-evaluating material choices. Plastics are seen as ‘cleaner’ than medical papers, since there is no chance of films shedding fibres or lint, and they are stronger. Choice of material is also driven by the type of sterilisation to be used, and by manufacturers’ requirements for printed logos and CE numbers on commercial product packaging. Syringes, needles, catheters, stents, dressings and other woundcare products together consume the majority of medical packaging in Europe.
While these devices and their packs are regularly sourced for European use from lower-cost geographical production areas, manufacturers cannot afford to take risks with packaging for ‘high tech’ devices destined to replace body parts. Manufacturing for this market segment is still firmly in place in Europe.
Cardiovascular implants are generally packed in pouches or ‘breathable bags’, which are made from a mixture of polyethylene and Tyvek, all Tyvek, or nylon (to the inside) plus Tyvek. Tyvek is porous, which allows gas sterilisation (the preferred medium) to penetrate. However, pouches are thin, and manufacturers still seek a ‘bullet proof’ material that will provide the same strength and integrity as the heavier-weight blister packs.
The ability to withstand sterilisation is a key requirement of packaging any medical equipment Electromechanical devices require protection, so heart valves are packed in polypropylene jars with Tyvek lids, and heart repair products use flexible amorphous PET plastic trays with Tyvek lids. Pacemakers use double hard-tray blister packs made from polyethylene terephthalate glycol (PETG) sealed with Tyvek lids.
For heavy orthopaedic implants, rigid-tray blister packs, usually PETG with Tyvek lids, are used. For extra protection, an inner and outer blister – each with its own Tyvek lid – may be employed. This segment of the speciality medical packaging market has above market growth. However, there is need for innovation to reduce bulk, lower packaging costs and save storage space, particularly in hospitals.
As in the rest of the packaging industry, there is an all-round focus on developing thinner, lower-cost, more environmentally-friendly materials without compromising quality and performance. The key requirements are the ability to withstand sterilisation, the appropriate degree of porosity, being lint free, ensuring peelability of plastic webs, and microbial barrier properties. While medical-grade paper currently remains the most commonly-used packaging medium, rigid and flexible films are growing at a faster rate. Both are more versatile in terms of design, and increasing use of radiation techniques for sterilisation means a greater need for materials that are impermeable or non-porous, which mitigates against paper or nonwovens. That growth reflects a complex mix of materials, technologies, distribution channels, and the overarching drive for single use medical disposable products.