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ISO 22413-2010 pdf free download
ISO 22413-2010 pdf free download.Transfer sets for pharmaceutical preparations — Requirements and test methods
Ensemble de fransfert pour preparations pharmaceutiques — Exigences et méthodes dessai.
Piercing devices are manufactured from appropriate materials, e.g. metal and/or plastic. 5 Physical requirements
5.1 Particulate contamination
Transfer sets shall be manufactured under such conditions that minimize particulate contamination. All parts shall be smooth and clean, When tested in accordance with 8.1 the evaluation number of the particulate contamination shall not exceed 90.
5.2 Tensile strength
5.2.1 When tested as specified in 8.2 the transfer set shall withstand a static tensile force of not less than
15 N for 15 s.
5.2.2 When using metal piercing devices the steadiness under tensile or compressible force without breaking shall comply with the values listed in Table 2 of ISO 7864:1993.
The transfer set shall be air-tight, no leaks of air or liquid shall occur when tested in accordance with 8.3. Sterility shall be maintained.
5.4 Free flow
When tested in accordance with 8.4 a free flow of air and/or liquid shall be ensured.
5.5 PIercing device
The piercing devices shall be suitable for penetration of the intended closure system for injection and/or infusion containers made of glass or plastic. After puncture, a free flow shall be ensured. When tested in accordance with 8.5 the surface of the piercing devices shall be smooth and free of burrs.
The maximum diameter of the piercing device shall be 6,5 mm.
5.6 Penetration force
When tested in accordance with 8.6 the penetration forces determined in Table ‘1 shall not be exceeded.
5.7.1 The design of the piercing devices should avoid fragments being emitted during piercing.
5.7.2 If plastic piercing devices are tested in accordance with Annex A, a maximum of two fragments per ten penetrations may occur.
5.7.3 If metal piercing devices are tested in accordance with Annex B, a maximum of three fragments per
100 penetrations may occur.
5.8 Air inlet and air outlet
For transfer sets containing an air inlet device with air filter, the device shall allow venting and maintain sterility. Testing shall be effected in accordance with 8.8.
The air filter should be hydrophobic.
5.9 Protective caps
The protective caps at the end of the transfer sets shall maintain the sterility of the dosure-piercing device. Protective caps should be secure but easily removable.
The protective caps shall be appropriate for the intended sterilization process.
5.10 Transfer sets with a housing
5.10.1 Transfer sets with a housing shall be designed in order to compiy with the series of International
Standards ISO 8362 and ISO 8536 as well as to comply with the International Standards ISO 15747 and
5.10.2 The transfer sets with a housing should be designed in a manner that injury or contact with cannulae is prohibited by the housing, the protective caps or by suitable packaging.
5.11 Luer connector
Transfer sets with Luer connectors shall be designed in compliance to ISO 594-1 and ISO 594-2.
5.12 Filter for particles
Particle filter, if integrated, shall retain particles that might plug or become lodged in capillaries.ISO 22413-2010 pdf free download.
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