Case Study

Pharmaceutical Manufacturer Utilizes Checkweighers To Identify Inaccurately Filled Product

Sanofi Aventis

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 core medical areas, such as diabetes/metabolism, the cardiovascular system, thrombosis, the central nervous system, internal medicine, oncology and prevention through progressive vaccines. METTLER TOLEDO checkweighers check vital insulin: in the Injectables Division, where liquid drugs such as different types of insulin or drugs for emergency medicine are produced, the packaged medical compounds are subjected to final checks using a dynamic checkweigher.

The in-line checkweigher separates packages with missing or empty vials. The smallest vial has a net capacity of just 1 ml with a fill weight of just 1 g. Over 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 g. Defective product packages which have been under or overfilled, as well as packages that are not correctly aligned i.e. askew, are sorted by two separate air jets into separate collection containers.

The photo-electric detection of askew packages prevents jams and costly downtimes in downstream production areas

"Gliding limits" (mean value tracking) compensate for long-term tare fluctuations thus minimizing false rejections

Standard checkweigher components add to process reliability
A good product countercheck (in line with "good philosophy") is performed by a downstream light barrier to ensure that all bad products have been successfully ejected. 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 so doing, all products located on the checkweigher are removed from the transport path and any incomplete drug packages are thus 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 check. The checkweigher is operated via the userfriendly touchscreen terminal. Here an individual user profile can be set up for each operator.

Extensive product tracking between the checkweigher's infeed and outfeed conveyors is one of the checkweigher's standard features.

This allows the active, continuous tracking of products which is required in the pharmaceutical industry. "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. It is essential, therefore, that the availability of our products is always guaranteed", says Stephan Koll, responsible for production in the Injectables Division. "We opted for this checkweigher because it meets our standard component requirements in full" continues Koll.

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" (also referred to as "mean value tracking") function is used to take these fluctuations in weight 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. Long-term tare fluctuations can therefore be compensated for, 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 IPC (in-process check) facilitates the required spot-checks
The highly accurate checkweigher also supports the IPC check required in the pharmaceutical industry. Quality control spotchecks must be performed on a regular basis for documentation reasons. These "sample products" are ejected by the checkweigher at the touch of a button.

Through the use of many standard components METTLER TOLEDO can always guarantee the availability of spare parts. Furthermore, the stringent service demands of a modern and critical pharmaceutical company are fulfilled thanks to the efficient global METTLER TOLEDO service network.

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