Polyethylene plastics as injection water containers and as material for disposable medical devices sterilized by radiation

Investigation on polyethylene plastic manufactured in Indonesia has been carried out to study the possibilities of using it as pharmaceutical product container and as material for medical devices sterilized by irradiation. The investigation covers biological experiments such as systematic toxicity test, skin irritation test, pyrogene test, hemolysis test, and contamination prior to sterilization; physico chemical experiments such as determination of hydrogen peroxide, oxidazable matter, absorption of U.V. spectra, non volatile residue, pH determination, heavy metals determination, and weight lost during storage. Biologically the results of the experiments can be accepted, but physico chemically no conclusion can be drawn, due to the non existence of regulation for maximum limit of hydrogen peroxide, oxygen, and also the possible problem of radicals in water for injection. (author)