Restricted Access Barrier Systems
As people are the greatest source of contamination during aseptic manufacturing of drugs, reducing personnel interventions into the process zone has significant impact on the quality of the final product.
From small to large batch production systems our proficiency extends to all fields that require particular attention to asepsis during filling processes for both non-toxic sterile and cytotoxic products which require totally enclosed environments.
Tema Sinergie develops custom-designed barrier systems by directly managing the integration activities with a party machine manufacturer and the end user.
Specific equipment can be also supplied along with the barrier system, such as Preparation Isolator Systems, Unidirectional Airflow carts, Active Bio-decon Pass Through Chambers, Sterility Testing Isolators to perform all the process steps.
The RABS assures the highest air quality of the isolated environment thanks to:
– an engineered filtration system composed of High-Efficiency Particulate Air (HEPA H14) filters;
– HYPER, Tema Sinergie’s integrated Vapour Phase Hydrogen Peroxide (VPHP) bio-decontamination system for very fast bio-decon cycle (applicable to Closed RABS);
– inflatable seals made of FDA-approved White Silicon Bio-Guardian®, with anti bacteria inhibitors (applicable to Closed RABS).
Maximizing operators’ effectiveness is essential to minimize the risks of accidents, eliminate unscheduled downtime and boost production quality. Operators are assured the most comfortable working conditions by the outstanding ergonomics of the RABS. We can offer mock-up activities to guarantee ergonomics for the operator.
The RABS can be equipped with an integrated Automatic Glove Leak Testing System (AGLTS) which performs an independent leak test cycle for each glove mounted on the isolator system according to the Positive Pressure Decay Method described in the international standard ISO 14644-7 Annex E.5. Wireless Wi-Fi data transmission based on a TCP/IP protocol. Recognition of the glove to be tested by means of Radio Frequency IDentification (RFID) Technology. Detection of holes down to 100μm diameter.
Thanks to the new sustainable low voltage ventilation fans, the isolator has a very low energy consumption throughout its life.
Our equipment are designed to meet all existing requirements for aseptic processing. A RABS provides protection by delivering a physical and aerodynamic barrier over a critical process zone with easier access to the process in the event a human intervention is required.
Tema Sinergie can develop different kinds of RABS.