ISO 15747:2018 download.Plastic containers for intravenous Injections.
Plastic containers for intravenous injections
1 Scope
ISO 15747 specifies requirements to the safe handling and the physical, chemical and biological testing of plastic containers tar parenterals.
ISO 15747 is applicable to plastic containers for parenterals having one or more chambers and having a total nominal capacity in the range of 50 ml to 5 000 ml such as film bags or blow-moulded plastic bottles for direct administration of infusion (in)ection) solutions.
NOTE In some countries, national or regional pharmacopocias or other overnmcnt regulations are legally binding and these requirements take precedence over this document.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
iSO 2768-1, General tolerances — Part 1: Tolerances for linear ond angular dimensions without individual w?erortce indications
ISO 2768-2, General tolerances — Part 2: Geometrical tolerances for features without individual tolerance indications
ISO 8536-4, lnfusron equipment for medical use — Part 4: Infusion sets for single use, gravity feed
ISO 10993-1. BiologIcal evaluation of medical devices — Part 1: Evaluation and testing with?n a risk management process
ISO 10993-S. Biological evaluation of medical devices — PortS: Test.s for in vitro cytotoxicity
4.1.1 Manufacturing process compatibility
The infusion container shall be in accordance with the requirements given in 4.1.2 to 4.1.5 and 417 to 4J.J.2 after the manufacturing process (such as sterilization).
4.12 Resistance to temperature, pressure and leakage
The Infusion Container shall withstand alternating thermal stress, shall be resistant to pressure and shall be leak-free when tested as specified in A3,
4.1.3 Resistance to dropping
The infusion Container shall sustain no damage after being dropped when tested as specified in 4.
4.1.4 Transparency
The infusion container shall be sufficiently transparent so that suspended particles, turbidity and discoloration can be recognised when tested as specified in L. Alternative procedures may be used.
Blockrng of UV radiation should be considered depending on the content of the container.
4.1.5 Water vapour permeability
Unless otherwise defined for specific applications or uses, the packed lnfusHm solution shall not lose more than 5% of Its mass during the period of usability. when tested as specified In Lb.
Permeability ci other gases (e.g. oxygen) should be taken into account depending on the content of the container.
4.1.6 Particulate contamination
Infusion containers shall be manufactured so that contamination with particles is avoided.
When empty Infusion containers are tested as specified in A.7. no more than 25 partIcles with a diameter alO pm and no more than 3 particles with a diameter 25 pm shall be found per millilitre of nominal capacity. Finished parenteral solutions in the Infusion containers shall be in accordance with relevant pharmacopoeial requirements for particulate matter in finished products,
4.1.7 Cover
The access port shall be protected by a cover. Its Intactness is determined by visual inspection. It shall be possible to remove the cover without using mechanical aids.
4,1.8 Access port — Penetration ability of the Insertion point
It shall be posstble to pierce the insertion point with the insertion part clan infusion device as specified In ISO 8536-4 or of a reference spike as described in Annex D. The force shall not exceed 200 N at an insertion rate of 500 mm-mm-1. when tested as specified in &ff.
4.1.9 Access port — Adhesion strength of the infusion device and Impermeability of the insertion point
The material and design olthe access port shall be suitable foraccepting the insertion part ofan infusion device in accordance with ISO 115364 or of a reference spike as described in Annex I). for sealing oil the Insertion point and for holding the insertion part firmly when subject to tensile load. When tested as specified in &9. no leakage shall occur and the insertion part shall not slide out from the insertion point The removal force shall be greater than IS N.
4.3 Biological requirements
The biological tests shall be carried out according to Annex C.
4.3.1 ImpermeabilIty ror microorganisms
The infusion container shall be impermeable to microorganisms when tested as specified in Cl.
4.3.2 MigratIon
The materials used for the manulacture or infusion containers (eg. turns, wrappings, adhesives, adhesion promoters, printing inks) shall not release any substances into the infusion solLition in such quantities that they have a pyrogenic or toxic effect when tested as speci fled in C.i CA and ISO 10993-1.
5 Application of tests
A distinction Is made between type testing and batch testing. All tests specified In Annexes A to Care type testing, They shall be repeated if one or more of the following conditions is changed significantly so that the requirements as specified in Clause 4 might be affected:
— the design;
— the plastic composition;
— the process of manufacturing the Infusion container;
— the sterilization process.