Containment Solutions
Process highly potent/highly effective active ingredients in a safe production environment
Process highly potent/highly effective active ingredients in a safe production environment
The development and use of highly active pharmaceutical ingredients, both biotechnical APIs and chemical APIs, is constantly increasing. This is associated with increased demands on containment when handling and processing the substances.
We support you in your responsibility for people, products and the environment and work with you to find the suitable combination of the right level of containment and efficient production. Containment considerations and an appropriate containment strategy already play a central role in the early project phases.
Ensuring product quality, such as avoiding cross-contamination, and guaranteeing occupational safety and environmental protection are in the focus of our considerations. Thereby, the required safety measures for production are based on a risk assessment developed by the customer. Right from the beginning we take the approach of developing and evaluating concepts together with you, the customer, and working out the most suitable concept for your specific project.
The exposure level of the substances (Occupational Exposure Limit) and the procedural and process-related risks determine the necessary containment measures. Our specialists will support you by analyzing the risks in your process environment and determining the hazard potential within your risk assessment.
Factors such as substance quantity, duration and frequency of exposure play a key role in deriving the necessary containment measures.
Following the (S)TOP method, we first concentrate on developing a suitable primary containment solution. Of course, we also have the expertise to support your needs for secondary containment, such as suitable room and airlock concepts or pressurized zone and HVAC concepts.
Containment of a solid drugs production is incomplete where the production environment is neglected. Closed process equipment and the production environment need to be considered as an integral solution. There should however be a reasonable balance between protective effects and plant productivity. Glatt Process & Plant Engineering develops and provides integrated system solutions for high containment processes.
Further information on this topic and related topics can also be found in the following publications:
Published article: ‘Outsourcing – Trust in competent partners’ PDF, English
Published article: ‘New Challenges for Material Handling in Pharmaceutical Production’ PDF, English
Published article: ‘Containment solutions only cost-effective when adapted’ PDF, English
Published article: ‘Success Factor Containment – Safe contract manufacturing with zero contamination’ PDF, English