MEDICAL PACKAGING
Quality, not cost, is the predominant issue when manufacturers source medical-grade packaging materials, equipment, and services.
Norbert Sparrow
The specification and manufacture of medical packaging is as challenging as the fabrication of the product the package is designed to contain. Along with a host of material-selection issues, specifiers of medical packaging must consider ease of handling, visual appeal, and, increasingly, environmental imperatives. The cost of separating laminated films with multiple layers to meet recycling goals, for instance, may end up being prohibitive for many manufacturers.
"One must take into consideration the fact that it might become more expensive to dispose of the packaging than it was to buy it in the first place," said Jan Hoburn of Mölnlycke Clinical Products Ltd. (Göteborg, Sweden) at a recent conference presented by the European Sterilization Packaging Association (ESPA; Little Kineton, Warks, UK). Despite this sobering scenario, suppliers claim that cost is not the foremost concern of device manufacturers who come to them to source packaging services, materials, and equipment. Rather, quality remains the key factor.
"Are you in a position to produce a quality product? That is the question our clients ask before all else," says Georg Kücha, managing director of Vereinigte Papierwarenfabriken (Feuchtwangen, Germany) and chairman of ESPA. "They want to know about our quality system and whether or not we have been audited by respected bodies." Per Hellman, product manager of Stora Paperboard AB (Grums, Sweden), agrees, although he does add a caveat. "Our customers expect traceability. They don't even really talk about it. It's like ISO 9000. It used to be that if you were in compliance with ISO 9000, you had a leg up on the competition," says Hellman. "Today, if you don't have it, you're out of the running." Stora, which produces sterile paper, is better able than many companies to document traceability, according to Hellman. "We are a fully integrated mill," he says, pointing out that raw materials come from the company-owned forest and are converted at the Stora facility.
It's quite natural that quality assurance should be a predominant factor in selecting a supplier, says Willi Sparakowski of Multivac (Wolfertschwenden, Germany). "A medical manufacturer is liable for his product," he says. "Consequently, quality and reliability should come before cost when sourcing materials and processes."
Aldo Artusi, president of Medipack AG (Trüllikon, Switzerland), cites one example of how a hasty packaging decision can result in a loss of market share. "Small products like bone screws are often sold to hospitals packed in polyethylene [PE] bags," says Artusi. "Hospital staff typically autoclave the product and the package. Naturally, PE can't tolerate that degree of heat, so hospitals complained to the manufacturer and, ultimately, switched suppliers." A cost-effective alternative, according to Artusi, would have been to use PA-6, an autoclavable nylon that Medipack supplies in rolls of lay-flat tubing or in 18150-mm-wide bags and pouches.
Keymark vs. CE Mark
The CE mark has been a nagging issue for packaging suppliers, many of whom feel that it does not provide the same level of customer assurance that national quality marks provided in the past. According to ESPA, which represents more than 80% of the suppliers of medical packaging materials within Europe, many of its members would welcome the development of a Keymark scheme. The mark would certify product performance against a CEN standard through third-party testing.
"The CE mark is [a suitable mechanism] for the medical device industry," says Kücha. "They have the necessary facilities to test, certify, and guarantee that their products are safe. But what about the hospitals? They are in no position to fund a lab that can test whether a product meets specifications," he says. Kücha does express ambivalence about the project, however. "As chairman of ESPA," he says, "I support it. As managing director of Vereinigte Papierwarenfabriken, I have to acknowledge the time and cost involved in establishing and publishing a new quality mark. And the fact of the matter is, I can test my product against BSI or DIN standards, and it will be accepted by customers from Ghana to Austria."
Suppliers Predict Price Stability
While the demand for a quality product may supersede cost considerations in the minds of informed manufacturers, the economics of medical packaging is a major factor when making a purchasing decision. The good news is that many suppliers predict relatively stable prices for the immediate future.
Buyers of medical-grade paper will be happy to learn that the rampant price increases of recent memory seem to have run their course. "The converters have learned their lesson, I hope," says Kücha. "A 30% increase in the space of a few months doesn't do anyone any good," he stresses, adding that he anticipates a 5% increase in the price of paper for the year ahead. "Prices peaked about one year ago," confirms Hellman, "and then they actually began to decline. There may be some small increases in the price of pulp, but it's difficult to say when that will be reflected in the price of paper."
Likewise, the cost of polymers is expected to remain relatively flat. "There may be a slight increase in the price of specialty polymers," says Kücha, "but overall I don't see much movement in the year ahead." In fact, there may even be a decrease, according to Artusi. "Competition among extruders seems to be driving costs down," he says. "I have offers on my desk for the same material from three different extruders with a price differential of more than 60 cents per kilo." In addition to heightened competition, substitute materials that offer comparable quality at a reduced cost continue to attract the attention of manufacturers. K-resin styrene-butadiene (SB) copolymers from Phillips Petroleum Co. (Overijse, Belgium) is a case in point.
Packages made of clear, tough K-resin SB copolymers are virtually unaffected by sterilization, says Phillips' technical manager Marc Heerbrant. For applications that require impact resistance as well as enhanced flexural modulus, surface hardness, and melt flow, Heerbrant suggests the moulding-grade BK10 blended with styrene methylmethacrylate. "The result is a transparent material that can compete very well with polycarbonate at half the price." For a grade with higher flow characteristics, Heerbrant suggests BK13, which Phillips has just introduced. "It is transparent and suitable for thin-wall constructions, which will make it extremely attractive to the medical sector." BK13 is currently available for developmental use and Heerbrant expects the product to be launched commercially by July.
Medical Packaging and the Environment
While compliance with the Packaging Waste Directive 94/62/EC is likely to affect the cost of medical packaging--"some costs are already built in and I expect them to increase by another 3 to 5% in the future," says Kücha--there is uncertainty about how significantly it will influence material selection and package design. "There is a recognition that there are exceptional circumstances where the medical and pharmaceutical industries are concerned," says Alan Isaacs, group chairman at Doyen Medipharm Ltd. (Barton, Cambs, UK). "As long as the environmental objective is not grossly ignored, it's more important that the integrity of the product be maintained. You have to be extremely careful in switching to another material for purely environmental reasons . . . obviously, you don't want to kill the patient," says Isaacs.
In addition, manufacturers must take into account user allegiance to traditional forms of packaging. "Users will not want manufacturers to tamper with the traditional way of presenting a sterile product, for example," says Artusi. "They want packaging that ensures the safety of the product and that is easy to handle. Everyone is talking about ecology," he adds, "but when it comes to health care, people expect safety above all else.”
For many of the same reasons, suppliers contend that double packaging is not likely to disappear entirely from the medical packaging field. "This may sound self-serving," says Kücha, "but a hospital patient expects a sterile environment. Some products simply must be double-wrapped to meet the high demands of patients." Kücha does concede that a reduction in materials is inevitable, "but I believe it is more likely to come from the use of lighter weight paper and thinner films. Perhaps one solution lies in packaging that is tailored to the individual product."
Validation Protocols, Ease of Use Inform Machine Design
Where packaging equipment is concerned, validation protocols will be a priority item, according to Isaacs. "The validation issue is one of the biggest trends I see at the moment," he says. "We have included full validation protocol with all of our machines for the past five years--not as an option, but as part of the basic equipment." This foresight will be rewarded in the very near future, says Isaacs, in particular for those companies that come into contact with the US Food and Drug Administration (FDA). "It seems to me that FDA has focused excessively on the documentary elegance of validation documents. If the validation documents look fine, then they are generally accepted. Fairly soon, however, people are going to start reading these documents properly and finding out just how shallow they are." Owners of Doyen Medipharm equipment, says Isaacs, have nothing to fear from the prospective clampdown: "We have made sure that our documents are robust." Flexibility, speed, ease of use, and cost are, of course, also high on the list of priorities among buyers of packaging equipment. Doyen can meet these demands, says Isaacs, because the company has concentrated on providing a broad range of equipment within the narrow medical packaging niche. "I don't see a huge move away from traditional materials, simply because of the arduous process of having your stability trials redone and so forth, but when new formulations do come along--such as the introduction of water-based lacquers--our product line is diverse enough to handle it. The water-based peelable lacquers need a longer dwell time, so they don't run well on rotary sealing machines. But we can steer clients toward our platen machines."
Acceding to customer demands for a low-cost, small- to mid-capacity packaging machine, Multivac recently introduced the R 230, which the company described as a "baby sister" to its popular R 530. "It is low in cost," says Sparakowski, "but it meets all of Multivac's quality standards." The R 230, which complies with the hygiene requirements of the EC Machinery Directive, is constructed of stainless steel and can be thoroughly washed down. Packaging up to 130 mm deep can be produced; the maximum cut-off length is 400 mm. Available in different lengths and able to accommodate 420-mm web widths, the machine was designed with versatility and modularity in mind. "The modular concept makes it possible to supply tailor-made solutions," says Sparakowski, "and great care has been taken to base many of the machine dimensions on the R 530. That way, manufacturers can switch to the bigger machine as their production requirements grow."
Ease of use was another key factor in the design of Multivac's machine, which includes a microprocessor control unit that displays text in a user-specified language. Simplified processes is also a crucial design issue at Doyen Medipharm, where "keep it simple" has become something of a touchstone, according to Isaacs. "We are seeing a move toward more conventional and simplistic processes," he says. "Industry went through a phase about five years ago where machines were becoming more and more sophisticated. It was a case of going for technology for the sake of technology," says Isaacs, "whereas it really makes sense to go for the appropriate technology." of a touchstone, according to Isaacs. "We are seeing a move toward more conventional and simplistic processes," he says. "Industry went through a phase about five years ago where machines were becoming more and more sophisticated. It was a case of going for technology for the sake of technology," says Isaacs, "whereas it really makes sense to go for the appropriate technology."
