Clean From the Outset
Thanks to a new production line, the requirements of the pharmaceutical industry regarding POM can be met successfully. Impurities in raw materials and product are eliminated; a computer-aided quality management system assures complete documentation.
The requirements to be met by active ingredients in medications, packaging and related applications are becoming increasingly stringent. The guidelines require rethinking even in terms of production. In the current issue of Kunststoffe, Tilo Vaahs, Manager of Market Development for Industrial Applications at Ticona, reports on a new production line in Kelsterbach that is at present the only such operation in the world.
In Kelsterbach production of medical-grade POM (Hostaform MT) is separated completely from the other industrial grades. The separate production line presents considerably improved production conditions. These result in greater purity and traceability of all raw materials and additives. The walls and floors of the production areas can be cleaned easily, thus assuring a high level of cleanliness. Impurities and contamimants in the raw materials and final product are excluded, because there is no direct contact with the surroundings during the entire production process. The extruders have adequate sources of ventilation and are shielded appropriately. With these measures, the production conditions satisfy the requirements of the pharmaceutical industrial.
A high degree of purity and long-term traceability
In addition, the new production line is equipped with a computer-aided quality management system that permits monitoring of the entire production process from receipt of incoming goods through blending and compounding to warehousing and shipping.
All components are identified by a bar code, registered electronically and documented completely. These data are retained permanently in a formulation database. Regular quality control inspections are also performed during production and prior to shipment. In addition, samples are taken from each batch and analyzed – using methods commonly employed in the pharmaceutical industry, among others.