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Annex 1 of the EU GMP guidance requires a 99% CCIT of fusion sealed sterile pharmaceutical containers. This includes fusion sealed bags for injections. Our automated bag testing platform can test up to 150 bags per minute.
High throughput (150/min)
Multiple bag sizes (250ml, 500ml, 1000ml)
Full integration in MES
Applicable for non-conductive products
Applicable for products after thermal sterilization
Non-destructive test method
Deterministic test method preferred acc. USP1207
Reliable product handling
Easy format changeover