GMP Washing Systems

Validation:

To meet strict industry requirements, LANCER offers a validation package that is provided standard with every PCM and PRO washer. LANCER has established a rigorous system for checking that manufactured machines conform to the specifications indicated on the order. The FAT (Factory Acceptance Test - conducted at the factory) and SAT (Site Acceptance Test - conducted at the customer site) enable the installation and operation of the washer to be qualified (IQ/OQ). IQ/OQ protocols guarantee high quality compliance with the machine's specifications and the customer's requirements.

Features to aid in validation on the PCM and PRO models include built in conductivity meters (optional) that allow you to check and validate water quality in the final rinse cycle as well as monitor chemical concentration and create hard-copy evidence of each batch processed. DOP ports and differential pressure transmitters are standard features for validation of the HEPA filtered dual drying system. Microprocessors or PLCs and printers ensure and provide validation of efficient, reproducible washing cycles.

Every component in the washer bears identification labels. On PCM models, welds are numbered producing a weld map and supplied with a certificate.