 Pharmatronic AG www.pharmatronic.ch |
Automation, calibration and validation of manufacturing equipment.
Pharmatronic Services
Pharmatronic AG, Pratteln (CH) offers its services for the pharmaceutical industries and presently employs 40 engineers and technicians.
As a member of the Glatt Group we are involved in international projects, but also offer direct services to the pharmaceutical companies based in and around Basel.
Qualification
We qualify GMP conform laboratory and production equipment, incl. all required documents, for the project phases design (DQ), installation (IQ), function (OQ) and performance (PQ).
We also affect the relevant tests and documentation of all test results. Our experienced staff only selects the essential qualification tests, as such reducing costs to a minimum.
Validation
We validate computer systems (CSV), as well as process and cleaning procedures. Computer systems are specified by means of the V-model and validated as per “Tick it” in accordance to 21-CFR 11 and GAMP 5.
For the cleaning validation we take samples from the critical areas, which are then analyzed in the laboratory by means of defined test methods, as such avoiding cross-contamination as required by the international regulations.
For process validation of solid and liquid dosage forms we have qualified staff, who suggest product specific solutions.
Calibration
By means of our more than 150 certified test instruments we calibrate all usual sensors in the pharmaceutical industry. All calibrators comply with SCS or DKD standards and can therefore be related to the basic physical units.
Our instruments data base simplifies the logistical data administration, whereas our automated customers data base allows us to notify our customers regarding due calibrations.
Monitoring
We detect critical areas in your stores (incl. cooled stores) via strategically placed data loggers. Evaluating the data received, we analyze trends and suggest preventive action
Automation
Our software experts design all kinds of control systems and visualizations for pharmaceutical production lines. We only use proven and renowned hardware and develop customized solutions.