Bespoke answer to tough packaging challenge

Related tags Title 21 cfr part 11

Schneider Electric has teamed up with automated handling company
PES Technology to develop a bespoke packaging line for a hazardous
and time-critical pharmaceuticals process.

The packaging line handles diagnostics for individual patients and the flasks containing the treatments can be despatched to anywhere in the world. Crucially, from the time the flasks leave the processing line, they must be at the hospital within 36 hours and must be used within a further 72 hours. If a production delay occurred, it is necessary for the customer to scrap each order that was in process.

"To describe the manufacturing and packaging system as mission critical is no exaggeration,"​ said Scheider in a statement.

The system - developed in a £3 million project - comprises drives, motion control, automation controllers, interfaces, and software. Schneider also partnered with PES to identify other machine builders to provide the check weighers, strappers and shrink wrappers in the line.

The packaging system is complicated. Apart from the mechanical considerations of how to handle the pallets, products and cartons, the controls required were extensive. For instance, for traceability, there are 16 discrete bar code readers that record the content and details for each order.

Individual flasks when packaged and labelled are each designed to have a unique set of characteristics - stored in the bar codes. This is compared against actual measured characteristics and in the event of any discrepancies an alarm is raised and the offending batch is automatically rejected.

The bar codes tell the system which accessories to pack with each carton. After every process, the system inspects the package to check that the right goods are in the right box. A final pre-despatch inspection checks that the weight corresponds with the set weight for the package specification.

In the pharmaceutical manufacturing environment, there are constraints encountered nowhere else. The US Federal regulation 21 CFR Part 11, enforced by the Food and Drug Administration, is a stringent regulation that requires every part of a pharmaceutical manufacturing process to be validated.

"That validation is rigorous, time consuming and costly. But … judicious design and integrated controls can alleviate some of the burden,"​ according to Schneider.

Traditionally, packaging systems such as this one would require the end user to source a variety of machines, conveying systems and controls from up to 10 different manufacturers, then organise validation themselves, said the company. Instead, the end user received a proven and integrated turnkey system that was already validated in accordance with 21 CFR Part 11, with PES acting as a central point of accountability for the entire process line.

The bespoke packaging line has now been running full time for 1 year, without a single intervention in its current pharmaceutical manufacturing environment.

Related topics Drug Delivery Processing equipment

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