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Optimum competence networking

, Gerresheimer AG

Integrated quality management at Gerresheimer Tubular Glass

The partnership between the pharmaceutical and packaging industries facilitates the continuous improvement of medical technology solutions. Consequently, each sector has to keep pace with the other‘s innovations. New testing and diagnostics processes are constantly raising the benchmark, and the packaging industry often assumes a pioneering role in the development of innovative packaging technology for new medications.

Innovative solutions and a robust quality management concept are essential prerequisites for coping with these increasing requirements. In this knowledge, Gerresheimer Tubular Glass has established a new, integrated process concept. Tubular glass production, forming and pharmaceutical filling traditionally follow each other in linear succession. Each sector has extensive know-how in its own field. For example, the tubular glass manufacturer knows the chemical and physical properties of glass and its behavior in all environmental conditions.

Complex interactions

In the next step, know-how focuses on the effects of the forming process and potential changes to the surface of the glass. The pharmaceutical industry has a detailed knowledge of the chemical properties of its medications and medication filling operations. Usually, too little know-how is transferred along the linear process chain, especially to the next but one stage and, as a result, the complex relationships between all quality factors are not taken into account.

To effectively meet new challenges in the production of primary packaging products it is necessary to optimally network competencies along the entire value chain. Once they are networked, for example, it is possible to align the tube dimensions in the glass production process with the forming parameters and the pharma manufacturer’s filling process requirements in a specific packaging project. Gerresheimer Tubular Glass is optimally geared to this approach. The company’s production facilities in Germany, Italy, Poland, Mexico, China and the USA have both tubular glass and forming operations. Knowhow acquired over a 30-year period is continuously transferred between the 40 countries on all continents to which it supplies its products.

Automated in-line inspections have replaced random sampling

Decisive quality assurance improvements in tubular glass production are achieved by substantially increasing the number of automated in-line inspections. Manual random sampling is no longer performed because subjective factors can never be ruled out in this type of inspection process. Gerresheimer has doubled the former 4 automated in-line inspections now to 8. In the near future, there are plans to introduce 14 automated inspections covering all key production process parameters.

A SCADA (Supervisor Control and Data Acquisition) System will guarantee the thorough and comprehensive acquisition of the most important measurement data. A new traceability process has also been introduced which can trace tubular glass right back to the individual tube bundle.

Tekion process and clean-to-clean environment

Cosmetic defects caused by glass particles are considerably reduced by the proprietary Gerresheimer Tekion process, both in tubular glass production and in the forming process. The tubular glass dimensions are tested in-line on four axes with the assistance of the Thickometer process, which permits a level of precision of 0.5 microns.

The introduction of a clean-to-clean environment also considerably enhances quality. This involves cooling and packaging operations being performed in a different room to the one where the tubular glass furnace is located, which means that processing and packaging take place in a controlled environment. The objective is to pack products in the same kind of clean room that the customer uses to unpack them.

, Gerresheimer AG

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