Production of Helicobacter Test INFAI
Quality assured production
Equipped with the most modern automated production line, and supervised by experienced and highly qualified staff, INFAI provides a registered 13C-breath test which is of highest pharmaceutical quality and reliability. A Quality Manager has been appointed to ensure full compliance with our internal operating procedures and to manage a program of objective audits.
Production process
In January 1998 a new automated production line was installed at our factory in Bochum, Germany. With an annual capacity of more than 3 million breath tests, the INFAI production line is the largest in the world with a manufacturing process designed to exceed all pharmaceutical quality guidelines.
13C-urea is precision dispensed into small vials in a specially designed filling station and the vials inserted automatically into the test pack. The other components of the kit are added to the pack by computer controlled robotic systems, ensuring the highest degree of quality control and error free assembly. In the final stage of assembly the pack is wrapped in a tamper evident cellophane film to ensure cleanliness and pack integrity until the test kit is used.
Kits are manufactured specially for each country with a maximum output of 15,000 units per day. Modern warehousing and distribution systems guarantee minimum delivery times throughout the world.
Quality Management and Certification
In May 1999 INFAI GmbH successfully achieved EN ISO 9001 certification. The quality management system introduced at INFAI GmbH encompasses all sections of the company including manufacturing, research and development, sales and service. The objective of the quality policy, which provides a basis for the quality management system, is the production and marketing of products and services of the highest value. Customer satisfaction and good employee, distributor and supplier relations in addition to a culture of innovation and flexibility are at the centre of all our activities.