Where is my inhaler? : A simulation and optimization study of the Quality Control on Symbicort Turbuhaler at AstraZeneca

Sammanfattning: Symbicort Turbuhaler is a medical device produced by the pharmaceutical company AstraZeneca for the treatment of asthma and symptoms of chronic obstructive pulmonary disease. The delivery reliability of the product is dependent on the performance of the whole supply chain and as part of the chain the results from the department, Quality Control (QC), are mandatory to release the produced batches to the market. The performance of QC is thus an important part of the supply chain. In order to reduce the risk of supply problems and market shortage, it is very important to investigate whether the performance of QC can be improved. The purpose of the thesis is to provide AstraZeneca with scientifically based data to identify sensitive parameters and readjust work procedures in order to improve the performance of QC. The goal of this thesis is to map out the flow of the QC Symbicort Turbuhaler operation and construct a model of it. The model is intended to be used to simulate and optimize different parameters, such as the inflow of batch samples, the utilization of the instrumentation and staff workload. QC is modelled in a simulation software. The model is used to simulate and optimize different scenarios following a discrete event simulation and an optimization technique based on evolution strategies. By reducing the number of analytical robots from 14 to 10, it is possible to maintain existing average lead time. Through a reduction, the utilization of the robots increases, simultaneously the workload decreases for some of the staff. However, it is not possible to extend the durability of the system suitability test (SST), and still achieve existing average lead time. From the investigation of different parameters, it is found that, an added laboratory engineer at the high-performance liquid chromatography (HPLC) station has the best outcome on lead time and overall equipment effectiveness. However, a reduced laboratory engineer at the Minispice robots has the worst outcome. With the resources available today the lead times cannot be maintained in the long run, if the inflow is of 35 batch samples a week or more. By adding a laboratory engineer at the HPLC station and by using a SST with durability of 48 hours, the best outcome in terms of average lead time and number of batch samples with a lead time less than 10 days is received.