The setup for Gerresheimer’s small batch production (SBP) for glass products has made good headway to move into its plant by 2020.
With the set up of an ultra-pure water system, an important component of SBP has now successfully passed its test run. In accordance with the European Pharmacopoeia PhEur, water for injection (WFI) is produced in three steps. In the first step, hardening ions such as calcium and magnesium are bound by means of hardness stabilisation.
In the second step, reverse osmosis is used to filter out sodium ions and other impurities, resulting in clean purified water (PW). During the third step, the PW is distilled to produce ultra-pure sterile WFI. The site acceptance test (SAT) that verifies function in line with specifications was passed in week five, allowed Gerresheimer to begin with performance qualification in March 2019.
The test will take until the first quarter of 2020, and ensures that the system maintains the required quality criteria even with changing supply water qualities. This test will also make sure climatic influences varying due to the season and changing production environments are looked at.
At the end of 2019, Gx InnoSafe is scheduled to be the first ready to fill product manufactured in SBP.