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Qualification is a crucial aspect of ensuring that the passivation process and the entire water treatment system in pharmaceutical facilities meet the required regulatory standards, such as GMP (Good Manufacturing Practice) and ISPE (International Society for Pharmaceutical Engineering) guidelines. Qualification involves a series of structured tests and procedures that validate the system’s performance, safety and compliance.
In the context of passivation, qualification serves to verify that the passivation process has been carried out correctly and that the water system will consistently produce water that meets the required quality standards.
The Pressure Test Certificate by the foreman and countersigned by the Customer.
The Pressure Test Certificate serves as a key document to confirm that the water treatment system, after the passivation or installation, is safe to operate under pressure and free of leaks. It ensures that the system can handle its operational conditions and meets the required safety and performance standards. The foreman’s signature and the customer’s countersignature both play a critical role in validating the test results and formalizing the completion of the qualification process.
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