EMCM has implemented an FDA compliant ampoule filling manufacturing process. The project is a finish-fill project for a US based company. The to-be handled bulk is a volatile liquid. Due to EMCM’s experience in the handling of volatile liquids, we have been able to adapt this into a safe process in our qualified production areas. To implement the manufacturing we have carried out a pilot batch and this is subsequently transferred into a GMP batch. The scope of the project also includes the validation of analytical test methods that are required for the release of the product.
