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BP A456 Appendx XIX (D. Containers for Blood and Blood Components)

QSYSTEM 2009. 11. 13. 09:39

BP A456 Appendx XIX

 

D. Containers for Blood and Blood Components

 

Leakage

Place the contaner which has been submitted to the stretch test between two plates covered with absorbent paper impregnated with a 1 in 5 dilution of bromophenol blue solution R1 or other suitable indicator and then dried.

Progressively apply force to the plates to press the container so that its internal pressure (i.e the difference between the applied pressure and atmospheric pressure) reaches 67 kPa within 1 min. Maintain the pressure for 10 min. No signs of leakage are detecrable on the indicator paper or at any point of attacnment (seals, joints, erc)