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SCR’17

June 8th-10th 2017, Bern - Switzerland

XIV Turku PET Symposium

May 27th-30th, Turku - Finland

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GMP/NBP Validation

 

According to GMP and Italian NBP specifications, Tema Sinergie recommends the customer to undertake

equipments validation processes through an independent third party: the validation is actually the evidence by documents of the committee's acceptance parameters consistent with the equipment use and its related regulations.The correspondence between the system design class and its microbial and microbiological classification is the heart of the validation process. This is the only way to ascertain that the sterile product manipulations take place with the necessary protections, through the verification of the absolute filters proper installation, of the air-tight gaskets and of the laminar flow proper consistency.

Hence, Tema Sinergie is supporting the customer through all of the validation processes performed by independent third parties, speeding up the activities required to obtain GMP and NBP authorizations. Tema Sinergie is also suggesting the customer the most suitable cleaning and sterilizing processes, by pointing out the most consistent routines and supplies which need to be approved by the relevant figures and then validated through MEDIA FILL for the process to be confirmed. All of the equipments are already supplied with the required presets for validation test performance.