Cognex Vision Ensures Compliance for Pharmaceutical Products
Global pharmaceutical company Sanofi-aventis offers a broad pharmaceutical product portfolio including prescription medicines, generics, and consumer healthcare.
Responding to new regulations affecting readability of GS1 codes, Sanofi-aventis was also keen to implement a product verification solution to ensure zero operator errors caused by data input, a reduction of waste products, and improved product coding quality across a range of products at their factory in Poland.
In order to achieve these objectives and ensure FDA CFR Part 11 compliance, Sanofi-aventis worked with Cognex Partner Systems Integrator (PSI) Wedzony, a specialist in industrial automation, to design and implement a print and code verification solution. Wedzony was selected both on its ability to provide a complete solution incorporating scanner, camera and verifier and on its previous experience developing a successful prototype system.
The solution is designed as a mobile system, which can be adapted for packing lines and installed along the production process, as required. The system consists of a band conveyor with a regulated slide for boxes, Wolke double head printer, Cognex In-Sight® 5400 camera with track and trace software, a panel PC, and a set of pneumatic air nozzles to reject defective products. The database within the PC stores the required product settings and various camera functions as well as information required for the audit trail.
The PC program provides a graphical user interface for the Cognex In-Sight camera which eliminates operator errors by providing a list of products to choose from based on product name, lot number and expiry date required. The CIP code for global track and trace relates to the product name and following selection, a GS1 Datamatrix code is automatically generated and sent to both printer and camera. As the products pass along the line, the required codes are printed onto the packaging.
Each unit then passes immediately beneath the Cognex In-Sight camera at a speed of 300 parts per minute, and the camera reads the printed data and verifies against the selected information. The In-Sight camera has integrated track & trace software which delivers a ready-to-deploy data capture and verification solution designed to help pharmaceutical manufacturers achieve unit-level product traceability. Using Cognex’s advanced software, any incorrect codes are identified immediately and the offending product is removed from the line via a reject shoot. After batch completion, a production report is created to ensure complete product traceability and maintain operational efficiency.
Dariusz Piotrowski, Technical and Investment Department Manager commented, “We have been delighted with the robust and reliable solution provided by Wedzony. Production efficiency has improved with impressive levels of accuracy and we are looking at opportunities to utilize this technology within other factory sites.”
Due to the success of the system, five complete solutions have been installed, with four placed at Sanofi’s factory in Rzeszów, Poland. In addition, Sanofi’s personal recommendation has led to the system being installed at an independent manufacturing firm in Poland.
David Hinchliffe, District Sales Manager for Cognex Eastern Europe commented, “We are seeing tremendous growth for our products from the pharmaceutical industry, driven by the need for regulation fulfilment. European Parliament ratified serialization guidelines earlier this year, the guidelines are expected to be in place as soon as 2016. To reach this milestone, we anticipate vision systems will play a fundamental role in the serialization of pharmaceutical products over the next few years.”