General

Nuclear medicine hot cells provides the highest level of protection for the operator and offers clean working conditions and protects the environment from contamination. 

Advantages

  • More than 25 years of experience in isolation technology
  • Innovative equipment integration solutions
  • Tested and validated subsystems used, provide the certainty of achieving the necessary level of protection
  • Solutions for details that significantly affect the ability to provide clean conditions

Working principle

Operator’s and environment safety is assured by

  • Physical barrier and 50 mm lead shield between operator and process
  • Controlled negative pressure inside the isolator and transfer systems
  • System and procedures for safe material transfer into/out of isolator
  • HEPA filtration of exhaust air.
  • Tight construction
  • System for safe changing of gloves
  • System for safe filter exchange
  • Clean version of the isolator chamber

Product protection is assured by:

  • Cleanable design of isolator chamber
  • Laminar air flow of H14 HEPA filtrated clean air (ISO 5)
  • Controlled conditions and pressure cascades in isolator chambers
  • HEPA filtration of inlet air
  • Bio-decontamination system - Optional

Control

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.

Specifications

The design and configuration of the isolator is adapted to the process that takes place in the isolator. 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 ensure the necessary level of protection.

Material:

  • 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 ...)

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