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.
GUARANTEED ASEPSIS
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).
ERGONOMIC DESIGN
Maximizing operators’ effectiveness is essential to minimize the risk 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.