ISO 22413:2010 pdf free download – Transfer sets for pharmaceutical preparations – – Requirements and test methods.
B.1 General
Many medical disposables are equipped with piercing devices. These piercing devices are intended to be used to pierce closure systems, which may result in fragmentation. Fragments are particles — unintentionally generated while puncturing the closure system by means of the piercing device — which block the channel of the piercing device or may fall into the pharmaceutical preparation.
The test described below is to be used as a reference method for closure systems intended to be pierced with metal piercing devices.
This test does not apply to piercing devices for infusion stoppers.
Transfer sets have, in general, multiple piercing devices. During testing and evaluation each piercing device is to be considered separately.
B.2 Principle
The closure system of the containers for infusion or injection is punctured with a piercing device; the remaining fragments are collected and counted.
B.3 Apparatus
B.3.1 25 injection bottles, half-filled with filtered water, sealed with closure systems.
B.3.2 Device for rinsing the particles out of the cannulae, e.g. disposable syringes.
c) Sterilization serves as a simulation of the normal pre-treatment. In case of deviation due to a different method of application (e.g. sterilization by irradiation), it shall be stated in the test record.
d) Drying of the autoclaved injection stoppers is done at a temperature of 60 °C for 60 mm in a drying cabinet.
e) The injection bottles (B.3.1) are cleaned so that they contain no particles that would falsify the test result.
B.6 Procedure
The injection stoppers are placed on injection bottles, half-filled with filtered water and sealed with a crimp cap. Afterwards, each injection stopper is punctured four times with the metal piercing device at different places of the piercing area. After the fourth puncture any fragment is removed from the piercing device by rinsing or puncturing. After a total of 100 punctures the crimp caps of the bottles are removed and the content is filtered through a membrane filter (0,8 pm).
Testing is performed in accordance with ISO 7864:
— four punctures per piercing device x 25 piercing devices result in 100 punctures;
— four punctures per stopper x 25 stoppers result in 100 punctures.
Due to statistical reasons or because of technical facts (e.g. for transfer sets with a housing) the number of test samples may be increased up to 100 and the numbers of punctures for each test sample may be decreased to 1. That means that one puncture per piercing device x 100 punctures result in 100 punctures.
B..7 Evaluation
Fragments that are visible on the membrane filter from a viewing distance of 25 cm are evaluated. The nature of the fragments is assessed using a six-fold magnifying glass.
The number of the discovered fragments for every 100 punctures shall be stated.