Containment isolators are designed to protect the operator, the environment and the product when working with highly active substances.
- More than 25 years of experience in insulation technology
- Innovative equipment for integration solutions
- Tested and validated subsystems used, provide the certainty of achieving the necessary level of protection up to the level of OEL ng / m3
- Detail solutions that have a significant impact on the ability to provide safety at all steps of use and maintenance of the insulator and subsystems
- Possibility of protocol preparation and OEL test
The protection of the operator is provided by
- Physical barrier between operator and process
- Tight construction
- Supervised underpressure in the isolator
- System for safe material transfer
- System for safe changing of gloves
- System for safe filter exchange
- Dual HEPA filtration of exhaust air
- Clean version of the isolator chamber
The protection of the product is provided by
- HEPA filtration of the supply air
- Controlled laminar air flow in the working chamber
- Clean version of the isolator chamber
Environmental protection is ensured by dual HEPA filtration of exhaust air.
The solutions of the monitoring systems follow the GMP recommendations and the GAMP 5 guidelines. If necessary they allow compliance with 21 CFR Part 11 and adapt to the specific requirements of the customer.
The core of the control system is the SIEMENS controller, which, with its I / O, ensures controlled and safe operation of the system. The user interface is implemented through the touch screen, where the user chooses the modes of operation or gives the PLC system commands, and controls them executively. The system can be connected via the ethernet connection to the subscriber's network. Through this connection, the system obtains access data, access to the disk for storing reports and events (Audit Trail), remote access to the panel is also possible. If the system is not connected to the customer's network, the data is stored on the internal medium and the approach is limited by local users.
For more demanding equipment, the management and control of GMP parameters is provided through the iFIX SCADA control system. In this case, the customer may control data individually. With the parallel use of the touch screen, all parameters and functions can be monitored and controlled on the panel, of course, with the appropriate access restriction.
For the needs of the periphery, communication of the device with a higher control system of the customer can be planned.
The design and configuration of the isolator is adapted to the process that takes place in the isolator (sampling, weighing, packing, grinding, sowing, capsulation, tabletting, IPC, washing ...). For the design of the system we use standard subsystems (material transfer, ventilation, filtration, sealing, cleaning ...), which we have developed and tested to the extent to guarantee the necessary level of protection.
In the DQ phase of the project, together with the end user, we perform the MOCK UP test on a model made of steel, where we determine the optimal distribution of elements and dimensions according to the intended process and user.
- Material in contact with the product
- AISI 316L, polished
- FDA suitable materials
- Seals - silicone
- The front lifting glass is made of tempered safety glass with a thickness of 12 mm
- Details manufactured according to GMP norms for pharmaceutical production (cleaning corners, treatment, welding, sealing ...)
- Automatic tightness test
- Automatic washing
- ATEX version
- Version for sterile work with highly active substances (Aseptic-toxic)
- Bio-decontamination system with hydrogen peroxide
- Inert atmosphere
- System with laminar air flow
- Temperature and humidity control system in the isolator
- Integration of equipment (scale, sieve, mill, HSM, FBD, container mixer, tablet press, capsule filler, capsule polisher, reactor, mixing container, rotavapor, vacuum dryer, lyophilizer, welding tongs...)
- Police filter
- Iskra PIO isolator scales
- Glove tester
- Iskra PIO welding tongs for primary packaging installed in the isolator (possibility to wash with water)
- Iskra PIO welding tongs for endless bag with triple sealing and automatic cutting of the bag
- Customize the system according to customer needs