Lock Touch Screen PC Inspection uses to provide key

Pharmaceutical manufacturers requiring metal detection solutions that comply with FDA 21 CFR Part 11 can now turn to Lock Inspection Systems for an effective solution. Lock has collaborated with industry experts to develop software that enables metal detection systems to deliver highly accurate inspection of tablets, capsules and granules whilst meeting the electronic records and electronic signature requirements of the FDA. The software can be accessed from either a machine-mounted Touch Screen PC panel or a remote PC.

Developed according to GMP guidelines, the specially developed Windows-based software allows pharmaceutical companies to comply fully with 21 CFR Part 11. The software implements all security access controls, user identification, audit trails, electronic records and electronic signatures, so in the event of contamination, batches can be fully traced and accounted for.

Lock has utilised an easy-to-use Advantech PC panel supplied by SolutionsPT Ltd. to run the “Part 11” software which is integrated to its MET 30+ Pharmaceutical unit. The panel PC is a ¼ VGA unit with a 5.7” LCD screen and runs Windows CE. It replaces the detector’s conventional user interface, allowing product set-ups, tests and diagnostics to be run from the machine itself. The panel is fully configured, inspected and QA tested by Pantek prior to being shipped to Lock Inspection.

Companies with restricted line space or with a number of metal detectors can operate the software from a remote PC which is permanently networked to all the detectors. In this way, reports are transmitted to the PC instantly rather than being stored in the detector. Diagnostics, set-up and interrogation routines are performed via the remote PC.

“Given that the onus to comply to Part 11 validation falls with machinery suppliers as well as pharmaceutical manufacturers, we’ve invested considerable time and resources into evaluating all the possible options for compliance;” explains Mike Randall, Chairman at Lock. “One option was to configure our detectors to fall outside the remit of Part 11, but that would have resulted in a retrospective approach, whereas we wanted to find a forward-looking solution that assisted our customers with FDA validation. Extensive R&D has proved worthwhile and with our key suppliers we’ve reached a solution that allows the unit to be operated in a compliant manner without compromising on the performance or communications capabilities of our machines.”

Every Lock machine comes with full operating and framework validation documents, facilitating the installation process and maintenance of the machines, as well as satisfying GMP requirements. This means Lock’s customers can rest assured in the knowledge that their machines are operating consistently to the highest standard, and are capable of validation at any time.

The use of an on-machine touch panel PC is a novel and effective solution to the requirements of enhanced local operation and compliance with the FDA guidelines whilst maintaining a high level of usability for the end user.