
Settle Plate Changer SPC 1000
Submitted by: Syntegon Technology GmbH, Crailsheim
Type and intended use: Automation of the change of sedimentation plates for passive bacterial count monitoring in pharmaceutical filling machines.
Status: The submission is ready for the market but has not yet been introduced (prototype).
Material: Machine
Country: Germany
What the jury said
The latest version of the EU GMP Annex 1 Directive stipulates that continuous microbiological monitoring must be ensured in pharmaceutical production. Sedimentation plates are used for this purpose, which are placed at predetermined test points in the machine and must be changed after a maximum exposure time of four hours.
Until now, this has needed manual intervention with an increased risk of contamination and significant interruption to production time. The intervals for manual intervention in pharmaceutical production can be increased to at least 24 hours by automatically replacing the plates and then having a robot subsequently seal and collect the samples in the process room. This equates to a reduction of 80% in manual interventions and saves a considerable amount of unproductive downtime.