Visit the Stowlin Croftshaw web site
Click on the advert above to visit the company web site

Product category: Pharmaceutical manufacturing: handling and packaging equipment
News Release from: Schneider Electric | Subject: Bespoke packaging line
Edited by the Manufacturingtalk Editorial Team on 28 February 2005

Pharmaceuticals company gets a packaged
solution

Request your FREE weekly copy of the Manufacturingtalk email newsletter. News about Pharmaceutical manufacturing: handling and packaging equipment and more every issue. Click here for details.

A bespoke packaging line for a hazardous and time-critical pharmaceuticals process includes a fully integrated system comprising drives, automation controllers, HMIs and software.

Schneider Electric has partnered automated handling company PES Technology in developing a bespoke packaging line for a hazardous and time-critical pharmaceuticals process The system developed for GBP 3 million project includes a fully integrated system comprising drives, motion control, automation controllers, HMIs, software from Telemecanique, a brand of Schneider Electric, and Schneider Electric's new web-based Transparent Ready control solution

In the pharmaceutical manufacturing environment, there are constraints encountered nowhere else.

The US Federal regulation 21CFR Part11, 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 as one pharma company has discovered, judicious design and integrated controls can alleviate some of the burden.

The packaging line handles diagnostic treatments 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 a guaranteed 36 hours and thereafter they must be used within a further 72 hours.

If a production delay occurred, it is essential for the customer to scrap each order that was in process.

To describe the manufacturing and packaging system as mission critical is no exaggeration.

Schneider Electric also partnered PES Technology in identifying other machine builders to provide the check weighers, strappers and shrink wrappers in the line.

Those OEMs also used Schneider Electric equipment and system, thereby ensuring compatibility, seamless integration and ease of validation.

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.

The readings from the bar codes are fed via a multiplexing unit into the Modicon Premium programmable logic controllers (PLCs), from Telemecanique and presented via an operator interface.

Quality is of paramount importance in the process; the data that is used and generated in the automation controllers (PLCs) to run the packaging line is accessed through the manufacturing information system (MIS).

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.

These bar codes once read into the MIS contain the data that tells 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.

The final pre-despatch inspection checks that the weight corresponds with the set weight for the package specification.

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.

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.

Final word comes from Terry of PES: "The key to this project", he explained, "was to minimise both development time and costs, while delivering a failsafe and reliable system that was easy to install and simple to use.

It was no mean challenge, but the ease with which we were able to integrate the automation played a major part in the success of the project".

The complex bespoke packaging line has now been running for 1 year, 24/7 without a single intervention in its current pharmaceutical manufacturing environment.

Schneider Electric: contact details and other news
Email this article to a colleague
Register for the free Manufacturingtalk email newsletter
Manufacturingtalk Home Page

Search the Pro-Talk network of sites

Visit the Stowlin Croftshaw web site