BS EN ISO 8362-2-2015 pdf download.Injection containers and accessories.
7 Performance requirements
7.1 General
The requirrnlcnta specified In 2.2 to 2.4 represent minimum requirements which refer to the cundllion of the s-lastoaneric dosures on receipt by the user,
7.2 Physical requirements
7.2.1 Hardness
The hardness agreed between manufacturer and user shall not differ from the nominal value by more than aS Shore A when tested in accordance with ISO 7619-1 on a special leSt specimen. Alternatively, the hardness car, be tested on the dosures in accordance with ISO 48. II tested in accordance with ISO 48. the microhardness shaLl riot differ by more than ±5 IRHI) from the type sample.
7.2.2 Penetrability
The requirements of ISO 8871-5:2005.41 shall apply.
71.3 Fragmentation
The requirements of ISO 8871.5:2005. 4.2, shall apply.
7.2,4 Self-sealing and aqueous solution tiiJttness test The requirements of ISO 8871-5:2005.43, shall apply.
7.2.5 Dye solution tightness test
The requirements of ISO 8871-5:2005. 4.4. shall apply. If the test specimen complies with 2.2.4. the requirements of this subclause have also been met and separate testing according to this subclause Is not needed
7.2,6 Resistance to aeing
The maximum time between the date of manufacture and pharmaceutical use should be agreed upon between the nhanulacturer 01’ the closures and the user.
The dosures shall maintain their performance characteristics throughout the entire shell-life of the medicinal produti. which Is tested as part of the stability test by the user.
NOTI Agein depends upon the storage and handI,n condition; Gaida-lines for stora5e of vulcanized rubber are given in 150 2230.
7.3 ChemIcal requirements
the requirements of ISO 8871-1 shall apply.
7.4 Biological requirements
The rquiiiauaits oF 1St) 8871-4 Slid11 apply.BS EN ISO 8362 pdf download.