Plastic Containers For Intravenous Injections

Jul 20, 2012

By M.Turner

ISO 15747 details the required physical, chemical and biological testing for parenterals and other infusion systems which are stored and/or dispensed from plastic containers. MET provides a full suite of particulate analysis, physical tests and chemical analyses for these products.

The service is complimented by testing to food migration and pharmacopeia monographs including:

Migration testing EN 1186-1 Materials and articles in contact with foodstuffs. Plastics. Guide to the selection of conditions and test methods for overall migration

And

Testing of extractables and leachables and based on Ph Eur Monograph 3.2.2 PLASTIC CONTAINERS AND CLOSURE FOR PHARMACEUTICAL USE.

The methods in the standards can be supplemented by very sensitive organic and elemental analysis.

Related test methods from MET are:

ISO 1135 Transfusion equipment for medical use

ISO 8362 Injection containers and accessories

ISO 8536 Infusion equipment for medical use

ISO 8871-1 Elastomeric parts for parenterals and for devices for pharmaceutical use -- Part 1: Extractables in aqueous autoclaves

ISO 8871-2 Elastomeric parts for parenterals and for devices for pharmaceutical use -- Part 2: Identification and characterization

ISO 8871-3 Elastomeric parts for parenterals and for devices for pharmaceutical use -- Part 3: Determination of released-particle count.

ISO 8871-4 Elastomeric parts for parenterals and for devices for pharmaceutical use -- Part 4: Biological requirements and test methods

ISO 8871-5 Elastomeric parts for parenterals and for devices for pharmaceutical use -- Part 5: Functional requirements and testing

ISO 8872 Aluminium caps for transfusion, infusion and injection bottles -- General requirements and test methods

ISO 9187 Injection equipment for medical use

ISO 10985 Caps made of aluminium-plastics combinations for infusion bottles and injection vials -- Requirements and test methods

ISO 11418 Containers and accessories for pharmaceutical preparations

ISO 15010 Disposable hanging devices for transfusion and infusion bottles -- Requirements and test methods

ISO 15137 Self-adhesive hanging devices for infusion bottles and injection vials -- Requirements and test methods

ISO 15375 Medical infusion bottles -- Suspension devices for multiple use -- Requirements and test methods

ISO 15747 Plastic containers for intravenous injections

ISO 15759 Medical infusion equipment

ISO 21649 Needle-free injectors for medical use -- Requirements and test methods

ISO 22413 Transfer sets for pharmaceutical preparations -- Requirements and test methods

ISO 15759 Medical infusion equipment

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