R DPBFS
Product Descriptions
Annex 1 of the EU GMP guidance requires a 100% 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.
Advantages of the LFC method® for BFS
Vacuum decay and in specific the LFC method® provide several advantages for 100% high speed integrity testing of fusion sealed containers such as BFS and FFS containers
Testing of entire BFS product
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 a fully accountable result on the test result.
Wide range BFS sizes and shapes
The 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.
Specifications and highlights
– Up to 60.000/min
– Integrated LFC method ®
– 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 2339
– Design according GMP guidelines
