In‐process pharma metal detection system secures API integrity

Published: 6-Jul-2012

Enables reduction of product waste and manufacturing downtime earlier in the production process

The new INSIGHT PH Gravity Fall metal detection system from Lock Inspection enables pharmaceutical manufacturers to achieve improved product integrity during the production process.

The in‐process system does not negate the need for end‐of‐line product inspection, which remains a Critical Control Point (CCP) for pharmaceutical manufacturers, but enables customers to reduce product waste and manufacturing downtime earlier in the production process.

The INSIGHT PH Gravity Fall system inspects raw materials in powder or granular form for contaminants at a flow rate of up to 3000kg/hr prior to the tableting process. Specifically developed to deliver the assurance of product integrity to the growing number of manufacturers adopting a fragmented supply chain model, it can be used both to review the API leaving one site and then again when it enters the next stage of the process at the tableting site.

Not only is the inspection of materials before tableting/packing increasingly important to maintain product integrity, it also protects expensive machinery components such as tablet press tooling from damage by foreign objects hidden in the ingredients.

Contaminated material is automatically removed using a fully integrated sealed flap or cowbell type reject, and Lock’s innovative OPTIX detector management software and DDS (Direct Digital Signal) creates vector diagrams to help manufacturers achieve quick automated product set‐ups and a high level of traceability.

Importantly, the PH system is very compact and can be retrofitted with minimal disruption to the production line. ‘When completing any plant modifications, it is essential that disruption is kept to a minimum,’ said Lock’s head of sales and marketing, Simon Taylor. ‘Where required,the new INSIGHT PH Gravity Fall system can be installed in a space of less than 72cm or alternatively it can be used as a standalone unit, making it a useful process enhancement in new or existing production lines.’

The fully validatable system, with four level protected security, is constructed and designed to comply with 21 CFr Pts 210 and 211, and includes a comprehensive range of communication options to enable users to extract and report inspection data in a variety of ways, including a USB portal, via wired or wireless ethernet or directly feed data into the onsite SCADA system for monitoring purposes as required by the FDA.

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