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.
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.
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.
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:
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.