An internationally renowned outsourcing partner in the medical and pharmaceutical industry specializes in order development and manufacture of parenteral drugs in vials and ampules at a location in Germany. Since the middle of last year, the company has been an official partner for industrial scale filling and packaging of a COVID-19 vaccine.
Due to the current challenging situation regarding rapid global vaccine supply, it is essential for companies to meet the strict quality requirements of not only the vaccines, but also their filling and packaging.
For in-process control during the filling process, the force with which the rubber plug is gripped between the crimp cap and the vial opening plays an extremely important role. The sealing system itself as well as process control guarantee the ultimate integrity of the drug.
For determination of the residual seal force, a closed vial is placed on a retainer plate and aligned via the adjustable centering aid so that the specimen is optimally centered. A compression die mounted by means of a spherical cap is attached to the crosshead. This compression die is then applied in a compression test to determine the residual seal force. All test relevant parameters and data are entered in the testXpert III testing software. The values determined during the test are directly transfered to testXpert III and evaluated.
The residual seal force (RSF) is determined with a zwickiLine table-top testing machine. The testing machine can be quickly adapted to various vial shapes through the flexible interchangeable test tool.
With the zwickiLine, in addition to their own GMP quality requirements, the company also ensures compliance with the demands of their customers, which include renowned international pharmaceutical companies.
The customer’s decision to opt for the zwickiLine from ZwickRoell was an easy one. Several of their partners are already using this table-top testing machine for RSF determination. Many years of positive experiences and the reliability of the test results spoke for themselves. Not only did these factors convince the customer, but also the qualification to DQ/IQ/OQ as well as quick delivery of the testing machine.