Annex 1 of the EU GMP guidance requires a 100% 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.
Specifications and highlights
– 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
R DPX is an inspection platform for 100% leak testing of multiple types of primary packaging containers in production environments.
automated CCI testers for blow-fill-seal containers use the latest generation of vacuum decay testing procedures allowing a highly sensitive and robust measurement for multiple product types.
