In pharmaceutical manufacturing, production performance and efficiency meet the challenges of occupational safety, health and environmental protection. Tensions can arise, especially in areas where risks are not immediately apparent and contact with hazardous substances is not permanently visible. In this technical article, we shed light on the questions of which protective measures are appropriate for containment in the pharmaceutical industry and why temporary measures are not sufficient.
Containment strategy in pharmaceutical production: Indispensable and interwoven with GMP
Pharmaceutical manufacturing processes require the development of a well thought-out containment strategy. Processed substances and processes are closely examined with regard to exposure and contact with humans. This strategy is inextricably linked to the application of Good Manufacturing Practice (GMP) and has become indispensable, especially since the emergence of the term “cross-contamination”.
Relevant regulations, standards and guidelines are followed for new projects and production planning. The continuous development of active substances requires adaptation to ever stricter Occupational Exposure Limit (OEL) values. The further development of protection systems and technical solutions is in line with these increasing requirements.
Challenges for existing systems and processes: Upgrade or new development?
Existing plants and manufacturing processes are facing challenges in order to meet the increasing requirements for containment levels. Operators must decide whether to retrofit or convert or implement new solutions that meet current standards. These challenges affect not only the manufacturing process itself, but also peripheral processes such as ventilation, dust extraction, material transportation and cleaning.
The adaptation to the new requirements affects not only the direct manufacturing areas, but also all areas in which the processed substances occur. This includes technical areas with outdated equipment that process highly potent substances but do not meet current standards.
Conclusion: Containment in the pharmaceutical industry – a holistic view
The question of the appropriate level of containment requires a comprehensive approach. While new projects can comply with current standards, existing systems face the challenge of keeping pace with increasing requirements. Operators must choose between retrofitting or implementing new solutions to meet current technological standards. The practice of containment requires not only an adaptation of the manufacturing process, but also a comprehensive retooling of peripheral processes to ensure the protection of employees and the environment.
