On site TQM at Rhône-Poulenc Rorer Weighing with complete confidence Rhône-Poulenc Rorer’s Le Trait works has ISO 9002 certification and complies with GMP. It also meets the extremely rigorous standard laid down by the American Food and Drug Administration (FDA). We went along to ask how weighing was helping them to achieve this Total Quality objective. Rhône-Poulenc Rorer’s Le Trait works are situated near Rouen 10 the magazine “We received advice from METTLER TOLEDO on everything from the purchase of the weights used for inspection work...” In the Metrology laboratory, René Ferquin showed us a full set of calibration weights. “We received advice from METTLER TOLEDO on everything from the purchase of the weights used for inspection work to the methods employed in carrying out that work. Procedures for verifying and validating the models had to be put in place and the company did, obviously, offer us guidance on the choice of equipment. Our relationship developed into a partnership, in the true sense of the word, and we are still very pleased about the way this relationship has progressed.” “The formulations that are going for manufacture are made up at the Weighing Centre” The Weighing Centre is a clean area which bears a striking resemblance to a strong room. It is here that the starting materials, either in powder or liquid form, are unpacked and weighed, after which staff get to work on making up the formulation prior to re-packing. In the Metrology Laboratory, there is a whole range of METTLER TOLEDO Class E 2, F1 and M1 weights and masses. There are several balances that are used to carry out checks on the masses used in our work. René Ferquin Metrology Manager Rhône-Poulenc Rorer Jean-Baptiste Brisson, the Manager in charge of preparation work and of the LOVENOX line, explained to us that “weighing takes place twice: first in the clean room then outside to check the weight after re-packing.” The METTLER TOLEDO balances are connected to a terminal which ensures that the formula can be traced back to its source. The Weighing Centre is in a controlled-atmosphere area and is equipped with a balance that can weigh items of up to 60kg x 1g and one of 400g x 0,01g balance. The same equipment is used outside, but with the addition of a 4kg balance. All this weighing equipment is linked to the METTLER TOLEDO terminal. “Soon, we will have software that we will be able to use for computer-aided formulation” As part of its PRIZEM Project, the RhônePoulenc Rorer Group has developed new software that will safeguard the formulation and provide a real-time total stock overview. The METTLER TOLEDO balances with which the Le Trait works has already been validated with these arrangements in mind. Jean-Baptiste Brisson added: “METTLER TOLEDO balances can be wired up even to the most highly-specialised dataprocessing systems.” On site tinuously on a GARVENS checkweigher. (GARVENS is a METTLER TOLEDO subsidiary specialising in dynamic weighing). This machine checks that the two syringes are, in fact, present in the box, along with the accompanying leaflet. If the balance detects a problem, the box is rejected from the production line so that it can be checked manually. The weighing assists in three stages in the fabrication line of Lovenox “We inspect the bottles every 10 minutes” Inspection procedures are exactly the same, whether it is the clean production area used for the manufacture of nasal solutions or a sterile area used to prepare collyria? “An operator takes samples every 10 minutes. He then carries out two checks. First, he verifies the amount of torque required to unlock the caps, then he weighs the liquid. For the latter operation, the bottle is weighed whilst full, then again once it has been emptied, using a METTLER TOLEDO balance, accurate to the nearest milligramme. The results are then entered into batch records.” “We are really looking forward to the arrival of the SQC 14, which will enable us to achieve optimum reliability in recording the results and will allow us to dispense with paper altogether,” says Lionel Quinton, the Pharmacist in charge of aseptic allocation. “The new LOVENOX production lines consists of two sections, each 38 metres long!” In technological terms, the production line for LOVENOX (an anti-thrombotic product) really does break new ground, since it allows syringes to be sterilised, filled and sealed in a continuous operation, under insulated conditions in a sterile environment. The packing line, which features an integral three-stage weighing facility, covers everything from clarity inspection to palletisation. Quantitative verification Finally, the palleting machine packs the boxes into cartons. The balance stores the weight of the filled carton and the check is carried out by means of differential verification, based on this nominal weight. 11 the magazine Monitoring of filling Once the syringes have been filled, the METTLER TOLEDO SQC 15, which is linked up to a balance offering accuracy to the nearest milligram, is used to carry out a statistical check. The self-calibrating PR303M balance was chosen for the excellent reliability and reproducibility it offers. Sorting and rejection of ‘non-standard’ product Once packing and labelling have been completed, the cases are weighed con- Equipped with a METTLER TOLEDO load cell, this tank has been converted into a scale The operator carries out two checks, the amount of torque required to unlock the caps and the weight of the liquid The checkweigher secures a continuous flow of 6000 packages/hour METTLER TOLEDO Reader Service No. 5