Pavla Sitková Email and Phone Number

Manufacturing of medical devices (ISO 13485) - radiofrequency ablation probes and HF-resection electrodes for minimally invasive electrosurgery.Qualification and monitoring of cleanrooms (ISO 14644, ISO 14698). Airborne particle concentration measuring. Microbiological monitoring of cleanrooms. Projects: cleanroom extension - involved in cleanroom layout definition, set-up of cleanroom parameters, coordination of DQ, IQ, OQ, PQ activities.Sterilization of medical devices with ethylene oxide (ISO 11135) - process validation and monitoring. Overkill method - Half cycle. Projects: introduction of new products in existing sterilization cycle, validation of process for new products.Biological evaluation of medical devices - ISO 10933-7: Ethylene oxide sterilization residuals.LAL test, endotoxine testing.Sterilization of medical devices by gamma irradiation (ISO 11137)- process validation and monitoring. VDmax25 dose substantiation, dose mapping (process qualification). Projects: introduction of new products in existing sterilization cycle, validation of process for new products.Microbiological methods used in cleanroom and product bioburden testing. Product bioburden and sterility tests performed on product - method definition/verification/validation. Communication with external sterilization providers and contract laboratories regarding sample testing and validation activities.Responsible for creation of SOP's related to cleanrooms and sterilization processes.Good Manufacturing Practices. Coordination of NC procedures.ISO 19011 Internal auditor certificate. Internal and external audits (sterilization service providers, contract laboratories).Software skills: Microsoft Office, Lotus Notes, SAP, Minitab

Manufacturing and development of light sources.

Green field project: picture tube line installation. 3 months training in Eindhoven, NL, Durham, UK and Aachen, GE. Responsible for lacquering and aluminizing processes. Start-up of production line. Process stabilization and improvement. Creation of work instructions for manufacturing and control. Operator training. FMEA, MSA, DOE.