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Completeness Check for Bulk Pharmaceuticals

publication date: Apr 11, 2014
author/source: Sartorius Group

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The Cubis Lab Balance from Sartorius Helps to Improve Quality Control at Contract Manufacturer hameln pharma 

The Customer

For more than 60 years hameln pharma has specialized on the contract manufacturing of parenteral solutions and suspensions. With more than 400 employees, hameln pharma produces liquid medicines that – aseptically produced or terminally sterilized – are filled into ampoules or vials for national and international pharmaceutical companies. hameln pharma has extensive expertise and a log track record, especially in the production of highly demanding pharmaceutical products such as anesthetics, flammable liquids, and cold chain products. For over 20 years, hameln pharma produces cGMP-compliant medicines that are used especially in hospitals and intensive care in all healthcare markets worldwide. 

The Challenge

As a contract manufacturer in this environment, it is essential for hameln pharma to deliver goods to their customers reliably in terms of quantity, delivery time and quality. Therefore, the topic of quality assurance plays a huge role – for both finally packed units as well as for bulk products. After a long-term analysis of the bulk product weighing process, hameln pharma pursued the objective to significantly streamline their previous time-consuming process of manual counting and visual inspection. Moreover, taking cGMP standards into account, they wanted to optimize their existing process in order to avoid incomplete packages that could potentially lead to customer complaints. "Within the scope of this analysis, we found that we repeatedly had to fight against weight fluctuations of the packages that could either be attributed to changes in humidity during production, to the use of different labels or to the actual number of items in the bulk carton“, explained Katrin Strasser, hameln pharma's operational excellence expert. For that reason, the company - together with Sartorius - sought ways to safely, easily and quickly check its drug packages for completeness. 

The Solution

After a joint analysis of the existing control process, both companies concluded that the problems could be solved by improved weighing systems, standardization and technological process support.  Cubis, the premium lab balance from Sartorius, was therefore implemented for check-weighing. Special weighing programs called Q-apps can be stored on the lab balance. These Q-apps are available for standard applications such as weighing components, counting, mixing, and determining maximum values/density, as well as for individually defined weighing processes. The programs guide the user through the selected weighing process step-by-step and ensure that every step is carried out 100% as described in the SOP (Standard Operating Procedure). In this case, the Q-app was precisely tailored to the needs of hameln pharma and stored as a "customized app" on the Sartorius Cubis balance. This implementation allowed hameln pharma to accelerate its control process and increase the efficiency and safety of the overall process. After this successful project, hameln pharma not only converted its control process for bulk products but also its control processes for manually packaged finished pharmaceuticals so that today, hameln pharma relies on four Cubis balances from Sartorius and the "customized app" specifically configured for them.

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