Strict product and personal safety requirements apply to the development and processing of highly active substances. On the one hand, the substances allow only minimal contamination of the environment due to their high active concentration. On the other hand, it is necessary to effectively and safely protect the people involved in product handling from contact with the highly active and, in this concentration, partly toxic products.
High-containment tasks are implemented with the help of isolators. Practice has shown that each isolator has to be adapted to the specific requirements of a pharmaceutical product and its manufacturing process, to the batch sizes as well as to the technical environment in the production building. To meet the requirements of a completely closed process control with a guaranteed OEL value, the Hosokawa Micron Group has further developed the isolator containment systems.
These are process plants that are highly optimised for operation in isolators. The isolators are operated in negative pressure in order to be able to safely serve the critical points of the process throughout all process phases. Manual work steps can be carried out using gloves, e.g. filling or transferring containers, changing tools on process machines, as well as inspection or cleaning.
For products such as antibiotics, aseptic production in a sterile system is also required. Depending on the design, the isolator is designed for negative and/or positive pressure and is SIP-capable.
Depending on the requirements, different isolator concepts can be realised:
- High-end stainless steel isolators with safety-glass windows, safe-change filters, alpha-beta transfer systems, WIP/CIP cleaning capability and much more
- Acrylic glove boxes with simple filter and transfer systems
- Flexible isolators with elastic plastic skin (insulator tent) and endless hose transfer system
Many customers source their systems or components (isolator system, process system, etc.) from different suppliers. This leads to problems with interface definition and coordination. Frequently, the design of the available pharma-grade process components is also only suitable for containment to a limited extent. To avoid these problems, we offer you solutions from a single source. We can supply you with machines and components for subtasks such as:
This is where we benefit from the combined expertise of the Hosokawa Micron Group: Together with the technology specialists from Hosokawa Micron Ltd. (UK) and Hosokawa Micron Powder Systems (USA), we cover the entire range of process technology, cleanroom and isolator technology and implement them in integrated concepts. This way we can offer you a perfectly coordinated complete solution for your process engineering containment tasks.
- No interface between process or machine supplier and insulator manufacturer
- Optimal adaptation of system components and isolator
- Process safety
- Well thought-out concept starting from the process, to the containment concept, to cleaning and automation.
- Turnkey systems with the necessary pharmaceutical qualification