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在线式BFS类产品全自动检漏机Annex 1 of the EU GMP guidance requires a 99% CCIT of fusion sealed sterile pharmaceutical containers. This includes blow-fill-seal ampoules and bottles. Besides that, USP <1207> provides guidance for sterile drug product packaging for small and large volume parenterals including BFS and FFS containers. Our integrity testing solutions for BFS containers allow to fully meet those requirements.
Our 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.
One advantage is that the entire sample is tested at once while for instance, the HVLD methods allow only a partial measurement and therefore do not provide fully accountable test results.
Wide range BFS sizes and shapesThe test method can be applied for non-conductive contents as well as for different shapes and sizes of the packaging on the same system. Therefore, the versatile use of the equipment helps CMOs to run multiple presentations on one line therefore reducing investment costs for multiple systems.
Up to 60.000/h
Sensitivity of down to 5 microns
Testing of entire BFS container at once
Applicable for various shapes and sizes of BFS containers
Applicable for oily and non-conductive liquids in BFS containers
Applicable for BFS with low filling volume
Non-destructive test method
Deterministic test method preferred acc. USP1207
Test method according ASTM – F 2338
Design according GMP guidelines
Data Handling in compliance with 21 CFR part 11
Reliable product handling
Easy and tool-less format changeover
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摘要:CCIT测试腔体定制/样品支架
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