Economic cleanroom manufacturing despite high standards

Cleancert_160x127

In the pharmaceutical and biotech industry, technological trends or increasing quality requirements are changing production in cleanrooms. At the CleanRoom Village of TechnoPharm 2013, TÜV SÜD presents comprehensive services for safe and economical cleanroom and process technology (Hall 9, Stand 9-215). The international trade fair for life science process technologies will take place from April 23 to 25, 2013, in Nuremberg.

"To ensure a smooth manufacturing process under consistent conditions, quality assurance plays a key role in the planning and execution of production technical facilities and the environment," says Dipl.-Ing. Walter Ritz, cleanroom expert and GMP compliance auditor at TÜV SÜD Industrie Service GmbH in Munich. "Sterilization technology and cleaning systems must filter out airborne molecular contaminants that could compromise the safety and economic efficiency of the products."

A cleanroom or controlled environment is a designated area where the number of airborne particles is kept as low as necessary. Critical factors include airflow, humidity, air pressure, and room temperature. Cleanrooms, cleanroom products, and clean media are among others certified according to VDI 2083 and EN ISO 14644, and must be periodically re-certified. In the pharmaceutical, food, or cosmetics industries, additional guidelines for quality assurance of production processes and environments must be considered. For the manufacturing of medicines and active pharmaceutical ingredients, as well as cosmetics, food, and feed, the requirements of GMP (Good Manufacturing Practice) apply.

The Center of Competence for Cleanroom Technology at TÜV SÜD Industrie Service supports manufacturers, operators, and suppliers in planning, construction, and certification of cleanroom systems and machinery. Other services include GMP-compliant project support, construction control, acceptance testing of new and renovated facilities, and employee qualification.

TÜV SÜD technical presentations within the CleanRoom Village (Hall 9):
- Applied Cleanroom Technology: Basics and Influencing Factors (April 23, 11:00-11:30 a.m.)
- GMP Risk Analyses in Planning and Acceptance of Pharmaceutical Process Systems (April 24, 1:30-2:00 p.m.)
- GMP Qualification: Regulatory Requirements and Quality Deviations in Process and Pharmaceutical Systems (April 25, 11:00-11:30 a.m.)