Flexible packaging of disposable medical devices—A review

Abstract

AbstractThe rapid increase in number of elderly persons with greater needs for medical care in future years will influence considerably the growth of medical packaging. A growing importance of disposable medical devices produced, packed and sterilized in manufacturers plants using various form‐fill‐seal (FFS) packaging systems has been observed during several recent years.The present predominance of flexible package thermoformed by a FFS system results from the considerably lower costs of these packages in comparison with rigid packaging. The role of packaging in this area is still not properly appreciated and analyses that were carried out showed that the major part of claims connected with sterility problems resulted for faulty packaging (mainly defective seals, pinholes and holes).The results of the assessment of heat‐seal strength are presented for thermoformed flexible packages processed on a Multivac machine and made of various laminates (mainly polyamide/polyolefine laminates) sealed with different types of sterilizable paper and used for packing disposable syringes and blood transfusion sets.A large scatter of results was found in both the individual packagings and the various packages processed on the same machine and made of the same materials. This spread of results occurred not only when packages were sealed using uncoated paper but also when paper with a grid pattern coating was used. A distinct advantage of the latter is the peelable opening of packages even when maximum seal strength is recorded. The reduction in the seal strength, which is very difficult to avoid, stresses the importance of selecting such combinations of materials giving distinctly higher average seal values while simultaneously maintaining the requirement for a peelable separation of the sealed layers during opening. An assessment of thickness distribution in the laminate and the PA layer shows that, because of the presence of areas of drastic thinning, the saving achieved by using a PA layer, increases the risk of package puncture, and therefore, may not be worthwhile.The substitution of polyproplyene for polyamide in laminate destined for thermoformed packages for medical devices must take account of the greater local thinning with simultaneous lower puncture resistance of polypropylene.