Consequently, the big challenge is to unite contradictory requirements in an optimum manner.
- Safety of the system to ensure operator safety
- Process automation for consistent production results
- Ergonomical design of the isolator. This must be designed such that all the requisite work steps really are carried out properly by the user.
- Economic efficiency: e.g. flexibility of the system for different products, technical environment in the production shop, integration into existing production sequences
- Compliance with the prevailing regulatory requirements for quality and documentation as per cGMP
- Special system components tailored for operation with isolators
Every isolator is designed to meet the following technical aspects:
- Specific requirements of the pharmaceutical product
- Requisite manufacturing process steps
- Toxicity of the product
- Required batch sizes
- Existing technical environment in production shop
A complete system from one single supplier brings the advantage of clearly defined interfaces – an important factor in order to achieve the required OEL values.
The use of so-called multi-mill isolator systems makes it possible to produce a large variety of products whose requirements diverge from one another. The universal system concept means that after a mill exchange, the requisite safety level is restored immediately.
To permit integration of the isolator into an existing production process, the process steps both upstream and downstream of the system are taken into consideration and the corresponding interfaces integrated into the isolator. This can be carried out by means of a wide variety of technical solutions: dependent on the batch size or OEL value, there are double butterfly valves, rapid-transfer ports (RTPs) or continuous liner systems available.