Sanofi-Aventis ensures product quality with METTLER TOLEDO Checkweighers

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In no other industry is the need for product quality and process reliability as critical as in the pharmaceutical industry. Sanofi-Aventis is the global leader in key medical areas, including treatment of diabetes, metabolic disorders, cardiovascular problems, thrombosis, and central nervous system difficulties. The company is equally strong in providing solutions in the fields of internal medicine, oncology and disease prevention through progressive vaccines.

Hi-Speed’s checkweighers, a member of the METTLER TOLEDO Group, check vital insulin for Sanofi-Aventis’ Injectables Division, where liquid drugs for diabetes or emergency medicine are produced. The packaged medical compounds are subjected to final checks using a dynamic checkweigher from Hi-Speed.

“Process reliability plays an extremely important role in the production of pharmaceutical products. Our medicines save lives. Insulin is a vital substance and market demand must be met,” says Stephan Koll, production manager, Injectables Division, for Sanofi-Aventis. “It is essential, therefore, that the availability of our products is always guaranteed.”

The company’s XS2 checkweigher separates packages with missing or empty vials. The smallest vial’s capacity is just 1ml, with a fill weight of just 1g. More than 20 different drugs in a variety of package sizes are packed on this production line with a throughput of up to 400 packages per minute with an accuracy of 0.3 grams.

Defective product packages are generally those that have been under or overfilled, as well as packages that are not correctly aligned or askew, and are sorted by two separate air jets into separate collection containers.

Standard checkweigher components add to process reliability
A good product countercheck (“good philosophy”) is performed by a downstream light barrier to ensure that all bad products have been successfully sorted.
At this point, the downstream drop-down conveyor is lowered to guarantee that only good products are sent down the line for further packing.

In this fashion all products located on the checkweigher are removed from the transport path and any incomplete drug packages are safely removed from the production process. The checkweigher then triggers the conveyor belt to stop by means of a time delay, thus enabling operating staff to perform an additional quality-control check.

The checkweigher is operated via the user-friendly touch screen terminal, with individual user profiles programmed for separate operators.

Gliding limits are based on the nominal weight of the pharmaceutical products
As the weight of all the individual package components can vary from batch to batch, the “gliding limits” function is used to take these weight fluctuations into account by defining variable upper and lower limits. This enables medium- and long-term fluctuations against the mean value to be recorded and remedied which in turn enables compensating for long-term fluctuations by using these newly calculated tolerance limits. The removal of the defective products under the “gliding limits” option is based solely on the nominal weight of the pharmaceutical product.

Optional Automatic In-Process Check (IPC)

The Hi-Speed checkweigher also supports the IPC check required in the pharmaceutical industry. Quality control spot-checks must be performed on a regular basis for documentation reasons. These “spot check products” are sorted by the checkweigher with the simple touch of a button.

Extensive product tracking between the checkweigher’s in and out feed conveyors is an X-Series standard feature. This allows the active, continuous tracking of products required by pharmaceutical industry safety guidelines.

“We opted for the Hi-Speed checkweigher because it meets our standard component requirements in full,” continues Koll.
Through the use of many standard components METTLER TOLEDO Hi-Speed can always guarantee the availability of spare parts. Furthermore, the stringent service demands of a modern and critical pharmaceutical company are fulfilled with METTLER TOLEDO’S 24-hour service network.

About METTLER TOLEDO
METTLER TOLEDO is a leading global supplier of precision instruments and services. The Company is the world’s largest manufacturer and marketer of weighing instruments for use in laboratory, industrial and food retailing applications. METTLER TOLEDO also holds top-three market positions in several related analytical instruments and is a leading provider of automated chemistry systems used in drug and chemical compound discovery and development. In addition, the Company is the world’s largest manufacturer and marketer of metal detection and other end-of-line inspection systems used in production and packaging and holds a leading position in certain process analytics applications. Additional information about METTLER TOLEDO can be found at www.mt.com.