Takeda Italia Farmaceutici SpA manufactures a variety of pharmaceutical capsules and tablets at its plant in Cerano, Italy. As part of a rigorous quality assurance process, samples are routinely taken from production and inspected. In order to weight-sort any suspect batches and salvage good products, the company has recently invested in a SADE SP100 tablet/capsule weight sorter from CI Electronics of Salisbury.
Because the sorter is only used in the event of a problem with the capsule filling or tablet production processes and the fact that the value of salvaged products can vary considerably, it is difficult to predict the payback period. However, Dr Roberto Moroni, the Production Manager, states: "At the time when we decided to buy the SADE SP100, we estimated that we would reach break-even in two years." Although the sorter is only used when necessary, at those times it is required to operate 24 hours per day. Dr Moroni adds: "The sorter has been 100 per cent reliable, and the support from CI Electronics has always been excellent."
Five sizes of capsule and tablet are processed by the sorter: size 3 and size 1 capsules must have gross weights in the range 230-240mg and 440-450mg, respectively, round tablets must be 130 +/-4mg; and oblong tablets must be 130 +/-4 and 200 +/-5mg. All of these product types can be processed by the sorter with no need to change any components.
Takeda Italia Farmaceutici's decision to purchase the SADE SP100 was straightforward, as the company had previously rented a similar SADE P4 tablet/capsule weight sorter from CI Electronics. Dr Moroni says: "We had a positive experience with the SADE P4, as well as good customer service from CI Electronics. The Italian representative, Ing. Carlo Guazzoni of TECNOMAC Srl, was also very helpful, so these three strong points helped us to make our decision."
The SADE SP100 features a high-accuracy (+/-1mg), compact CI MK6 weigh head that gives fast response, together with a 60-litre hopper, an integral removable draught shield and a facility for generating statistical reports for viewing on the integral display or printing on an A4/Letter printer connected across a network. In Takeda Italia Farmaceutici's case, however, the sorter is connected to a local printer via a USB cable.
Cleaning is quick and easy thanks to all contact parts being manufactured from electropolished 316 stainless steel. The SADE SP100 sorter is designed for use in GMP environments and it is supported by comprehensive validation documentation and a full installation and maintenance service.
