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CAQ-Software at Sartorius: Quality without Risks or Side Effects

When the college-educated mechanic Florenz Sartorius from Göttingen founded his company in1870, no one imagined that it would go on to become an international supplier of laboratory and process technology. Even though the city of Göttingen was already known at this time for its superior mechanical and optical industry, it wasn’t yet conceivable that, including the areas biotechnology and mechatronics, the company would grow to have a business volume of over 600 Million Euro and employ 4,500 people.

High Tech in Göttingen – Fast Growth in Bio-Pharmaceuticals with the Help of New Ideas

Even Thomas Hackel, when founding his company Toha Plast in 1973 and subsequently entering product development for Sartorius 3 years later, surely didn’t imagine future production lots in the tens of millions. But after merging his company with Sartorius, the shared company’s success story merged as well and both experience continual annual growth.

Medical Die-Casting for Over 20 Years

Since January 2007 Toha’s 100 employees have become part of the Sartorius team and have, in the division Stedim Plastics GmbH, strengthened the company’s position as a technology leader in plastics technology for biopharmaceutical throw-away products.

In order to heed brand recognition of TOHAMED products produced by the Toha plastics die-casting company, which has established itself as a leader over 20 years in the medical technology branch, these established products continue to be produced, sold, and supported by Sartorius, in addition to company-internal utilized plastics components which are used to process products in the biopharmaceutical industry. The TOHAMED skin clamp, developed through ingenious die casting techniques, is just as ergonomic as are the numerous tube segment openers, used in the medical industry to ensure superior protection against infections and to ensure hygienically immaculate conditions. Annually, over 50 million plastics components are produced under clean room conditions to satisfy the high demands of bio technology and medicine and varying in weight from 0.1 to 400 grams per individual piece.

Highest Quality Demands

DIN ISO 9001, ISO 13485 and CE certifications and standards as well as FDA regulations and registrations guarantee the highest quality criteria. And adhering to these criteria, in turn, defines the basis of success of Sartorius’ product manufacturing. In order to achieve and maintain quality regulations imposed by the bio-technology and medical industry, Sartorius Stedim Plastics GmbH trusts in CAQ AG Factory Systems software support and performance.

Up until 2006 – and therefore shortly prior to the company merger – the quality assurance support team led by Norbert Böttcher collected all data manually in meaningful Excel tables. Meticulously arranged, an immensely large database was created which increased drastically adding 40,000 new entries annually.

In order to be able to utilize singular details for future calculations, it was necessary to apply meticulous effort before the result could be published. “If we wanted to evaluate the interconnection of inspection measurements and the melt index of a granulated material, for example, we had to spend at least one whole day on copying and connecting singular data and lists,” Mr. Böttcher reports. “Today, we manufacture approximately 400 different products. This adds up to 300 million plastic components for internal production at Sartorius alone. In order to collect all data particularities and distinctiveness, it was more than necessary for us to switch to computer-aided quality control (CAQ = computer aided quality).”

Choosing a Software System in a Systematic Manner

In order to approach this step with a partner one can trust and, in the future, to have the desired evaluations appear at the push of a button on the computer monitor, the person in charge of quality assurance at Sartorius decided on a detailed inspection of the quality assurance software providers that existed.

After an initial examinations of all of the candidates, Mr. Böttcher reduced the prospective providers and arrived at two finalists. Mr. Böttcher explains how he was able to reduce so drastically the initially broad field of software providers: “We were looking for a partner who was experienced and knowledgeable about our industry as well as a company who would be able to provide 100% customization, but in a standard software package.”

Due to the fact that one of the providers offered even more than the Sartorius company demanded, the decision was made fairly quickly and after only one presentation in Göttingen: “CAQ AG was able to provide an impressive list of references in the plastics die-casting industry without much effort. Moreover, CAQ AG provided us with a number of reports covering the implementation of the software in clean room conditions of the medical and pharmacological industry,” Mr. Böttcher of Sartorius explains.

Quality with CAQ AG

Sartorius, with its, in 2007, newly acquired branch Toha in mind, ordered a customized version of the standard quality assurance software from CAQ AG. A lean system for initial implementation was defined and has been refined and expanded continuously up to the present day. Initially, Sartorius decided on a minimal software package consisting of Compact.Net (Inspection Planning / Quality Inspection) coupled with the supplementary module EMP.Net (Initial Sample Inspection), and the module PMM.Net (Gauge Management). Within one year, other expansions followed: QBD.Net (Document Management), REM.Net (Complaint Management / CAPA), Process.Net (Process Management), Risk.Net (Risk Management), QAM.Net (Audit Management), PMS.Net (Preventative Maintenance), and QDrive.Net (Quality Center).

Whereas the modular design of the software addressed the potential cost and usage ratio, the company also recognized immediately the savings resulting from the much reduced time usage compared to evaluations that had been done manually up until then. Even in the first test evaluation all relevant data from individual lots or specific components could be collected and evaluated. The software system delivers comprehensive and complete transparency and offers information related to values of first sample inspections, gauge measurements from random samples, or details related to deliveries and further processing in a matter of seconds.

Service and Exchange

Mr. Böttcher of Sartorius Stedim Plastics GmbH also found it only self-evident to order the software maintenance plan (TSP-Top Service Pack), equipped with expansive attributes of short-term amortization, as an assurance for the smooth initial implementation of the software system. In addition to included training sessions and software updates, Mr. Böttcher appreciates the built-in user workshops in which he and his team regularly participate in order to find out about new software features and possibilities and to confer with users from similar or ancillary industrial sectors: “Being so close to other users with similar needs and concerns is invaluable,” says Mr. Böttcher. “Conducting conversations with colleagues and software users in the industry, but also outside of one’s own field offers interesting starting points with which we can optimize our quality management. Moreover, these discussions and suggestions also find fertile ground in continual software development which will eventually benefit us all in the shape of updates. This closeness between user and software developer is a rare feature which only few software providers offer. To this end, we are also happy to answer questions of other users as to specific implementation strategies and situations. Who knows, maybe the quality management crew of other companies will provide input, which will, in turn, benefit our company as well and may appear included in an update provided by CAQ AG ...”

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