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Effects of Gamma on Packaging Material

Effects of Gamma on Packaging Material

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Published by: benyamen ac on May 30, 2009
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04/23/2011

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Page 1 of 7
Gamma Radiation Processing:Effects on Packaging Materials
Abstract
This paper will highlight the need for selecting appropriate plastic polymers for packaging materials. Gammaradiation processing is becoming an important means for the terminal sterilization/sanitization of many end-userproducts. These range from medical devices through pharmaceuticals, cosmetics and foods. The physical changesthat occur with irradiation are well documented. However, the potential chemical interactions between the plasticpolymer and what it contains are less well known. An understanding of these reactions is essential for both thedevelopment of new polymers and of appropriate packages. This paper will identify the factors which should beevaluated to qualify a packaging material for radiation sterilization.
HISTORICAL PERSPECTIVE
The selection of a plastic resin for a pharmaceutical or medical device package has largely been a matter of marketing or transportation requirements, or for bonding to a material which will allow the free passage of a sterilantgas into and out of the package without allowing bacteria or viruses to enter. In addition, the matter of costs is aconstant focal point. The need for increasingly large amounts of product information on the label is anotherchallenge. It is almost to the point where a magnifying glass is needed to read it. Last but probably most important,is the maintenance of seal integrity to preserve function and sterility. With the development of gamma radiationprocessing, and resins which will withstand gamma radiation processing, more packaging options are open to themanufacturer today than ever before. Breathable materials are no longer required as there is no sterilant gas to get inor out of the package. Barrier materials to control humidity are possible as there is no need to change theatmospheric environment for gamma radiation processing. This is a feature, unique to gamma radiation processing.It can provide opportunities to reduce the volume of packaging materials while providing greater visual recognitionof contents. It will also provide greater assurance of the maintenance of sterility throughout transportation, storageand subsequent use.However, the development of newer gamma radiation stabilized resins requires a knowledge of the additives used toachieve these properties (1-3). This in turn will provide better understanding of how the components of the resinswill respond to radiation. There is a saying at Nordion that runs along these lines:"You will have better products after gamma radiation processing than you would have if you didn’t use theprocess."The reason for this, of course, is that the investigation of this technology forces you to understand more about yourproduct(s) and manufacturing process than you ever thought you needed. For example, are you aware that standardinjection molding techniques can rob a polymer resin of 80 to 90% of its elongation properties. A resin with 600%elongation (according to the manufacturer), ends up after molding with only 50% elongation. No wonder it reactspoorly to gamma radiation processing, or results in an unreasonable number of product failures under normalconditions. This can be attested to by the number of product recalls listed in the "Gray Sheets" for loss of sterilitydue to package failure. This is a very costly failure in more ways than one!
ATTRIBUTES OF PACKAGING FOR CONSIDERATION
The attributes that need to be considered for all types of packaging have been grouped for discussion under thefollowing topics: Materials, Seals, Adhesives, Rigors of Use/Shipment and Marketing Materials. Some are listed forthe sake of completeness and thus there is only a brief discussion; others warrant more discussion.
 
 MDS Nordion Gamma Radiation Processing: www.mds.nordion.com Effects on Packaging Materials
Page 2 of 7
Materials
Medical Devices
Materials for medical device packaging need to have the following properties.
 
easy to handle
 
provide good visibility
 
be easily manufactured
 
provide moisture/climate barriers
 
be bondable to themselves or other materials
Pharmaceuticals
In addition to all of the above considerations, the pharmaceutical manufacturer is primarily concerned with theimpact of additives and their breakdown products on the active drug in the package. These are not new (4-7). Themigration of free radicals, from a plastic, to the surface and their reaction with a pharmaceutical is a major concern(8). While technologies exist to coat the surfaces of plastics with a thin film of glass (as silicon), to reduce thepotential for product/package interaction (9) this process is not widely used on a commercial basis. It is important tohave available plastics, whose surfaces will not interact with the pharmaceutical. This is important not only fortradition pharmaceuticals, but also for the vast majority of new classes of pharmaceuticals such as monoclonalantibodies, liposomes and other biotechnology-derived products. These products are very sensitive to their externalenvironment.New techniques for irradiating pharmaceuticals are also emerging. They include treating the pharmaceutical in thefrozen state (14), or as a lyophilized powder (15). This sterilization step puts additional stress on a plastic. If theproduct can be safely frozen and thawed, or lyophilized, the potential exists to provide a much greater range of terminally sterilized pharmaceuticals.
Seals
Packaging seals, in addition to all of the specific requirements for each type of product as detailed below, must alsoprovide evidence of tampering, i.e., evidence of intactness from time of manufacture to point-of-use.
Pharmaceuticals
There are two good sources of information for pharmaceutical septa. The first is a very good study published by thePDA (16). The second is a technical brochure published by Stelmi (17). Both deal with the effects of gammaradiation on various elastomeric formulae. The work done by the PDA was at higher doses than are normally usedfor parental products.
Medical Devices
Seals should not shed fibers onto the operating field due to separation at the wrong junction. The package must notbe sealed so tightly it cannot be opened except with a crowbar, because the adhesive has formed a strong cross-linked bond. The package must not have gaps in the seal where contamination can enter thus compromising thesterility of the product.These packages may need to be able to withstand not only gamma radiation but also the rigors of EtO sterilizationwhich include high humidity and high vacuum. Too often package integrity becomes compromised with this lasttechnology. However, there are products which cannot commercially be sterilized in any other way at the moment.I would like to draw your attention to two articles by Don Barcan. In the first article (18), he describes a very simpleyet elegant test for seal strength, which measures the stress strain curve. It is a variation on the tensile tester whichmeasures only the maximum force generated during separation of the seal. Barcan states: "Because ¼peak values of seal strength can be misleading and do not provide complete information about the seal separation,.¼an alternativetechnique that measures seal strength in terms of stress/strain curves has been developed". This equipment uses adigital force gauge with output connected to either an x-y plotter or a computer programmed to calculate average
 
 MDS Nordion Gamma Radiation Processing: www.mds.nordion.com Effects on Packaging Materials
Page 3 of 7seal force. Samples are shown in the following figures. Figure 1 shows the three main features of the stress/straincurve; the Preliminary area (normally called the peak seal strength), the Sustaining area and the Concluding area.In Figure 2, the materials’ peel characteristics remained virtually unchanged through 50 kGy . After 100 kGy thepeak value dropped but the sustaining value was higher, apparently caused by minor cross-linking -- an example of avery stable and consistent heat-sealing system. Figure 3 shows that the seal strength improved up to 25 kGy (similarshape, higher values), but above 50 kGy the concluding seal strength dropped off. This indicates an initial cross-linking followed by chain scission. Figure 4 presents curves for a very poorly performing combination of materials.Figure 5 takes a little more interpretation, but if one looks closely at the width of the peak, it becomes obvious thatthe seal is failing with increasing radiation dose. Lastly, Figure 6 provides an example of increasing strength towardsthe Concluding area of the seal. However, the performance with increasing radiation dose is again rather poor. Onemight reasonably accept 25 kGy, and perhaps even 50 kGy (note the effect of cross-linking in the increase inpreliminary (peak) strength). However, by 100 kGy the preliminary strength is poor.These five examples show that "there is more to understanding seal strength than peak values" (18). The design of asterile medical package should include stress/strain analysis. This will help in selecting the right materials, the rightvendor and the right process conditions. The second article (19)covers many of the same areas we are addressinghere, but with greater detail.
Adhesives
The most difficult area to address is the area of adhesives. They must have the right degree of tack, holding andrelease for the package to provide the degree of functionality and protection required for the product. The choice of adhesive is also dependent upon the type of sealing equipment in use.
Pharmaceuticals
This application encompasses what is best termed the ‘gray area’. It involves the intimate coupling of bothpharmaceutical and device. Examples would be the ‘patch’-type drug delivery system used for hormone replacementtherapy or for providing a substitute for nicotine. Here the device is both the drug package and to some degree thedelivery system. The package must have a special type of adhesive which protects the drug during routine handling,yet will stick to the skin without causing dermal reactions. Now this is one tough adhesive problem. In addition,while these drugs/devices are meant to be applied to the intact dermal surface, this may not always be the case.Therefore they must also have some degree of sterility. Because the drug is contained in a viscous base for timing of delivery, gamma radiation is the method of choice for sterilizing these products. Gamma radiation has the potentialto adversely affect the adhesive if care is not taken in selecting the appropriate adhesive formulation.
Medical Devices
Both curing and polymerization of pressure sensitive and other types of adhesives involves intentional exposure toionizing radiation. The impact of this exposure on adhesives, while incidental, must be anticipated to ensuresatisfactory performance. There are four main areas where adhesives are used namely, Packaging, Assembly,Delivery and Labeling.When the cross-linking process is controlled, it leads to a useful increase in the cohesive force. Excessive cross-linking can lead to embrittlement and loss of tack. Simple chain scission will lead to loss of cohesive strength. Foradditional information, the reader is referred to the article by Fries, presented at Radtech’88 (20).According to Fries adhesives can be functionally classified as follows:
 
Laminating
 
Heat Seal
 
Cold Seal
 
Pressure SensitivePressure Sensitive adhesives are further divided into the Hot Melt PSAs where hold falls off with increasingradiation dose and the Acrylic Solution PSAs where the hold increases with increasing radiation dose). It is to benoted that these observations are for gamma irradiation only. Fries refers also to electron beam effects on varioustypes of adhesives.

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