Barrier Isolation Technology Profile
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CUSTOMIZED BARRIER SYSTEMS FOR CONTAINMENT AND ASEPTIC PROCESSES PROVIDING HIGH QUALITY SOLUTIONS TO MAXIMIZE OPERATOR AND PRODUCT PROTECTION

THE CUTTING EDGE TECHNOLOGY THAT MEETS YOUR NEEDS QUALITY-BY-DESIGN Tema Sinergie utilizes a remarkably experienced staff composed of technical sales engineers, designers, technicians, fitters for all projects. Client expectations are met or exceeded through the continuous improvement of manufacturing methods and superior design. ENGINEERING The Barrier Isolation Technology Technical Team considers all engineering aspects of a project, from concept design (preliminary study) to detailed design, mechanical, hardware, and software, plus Piping & Instrumentation Diagram (P&ID). TECHNOLOGY...

CUSTOMIZED ISOLATORS FOR CONTAINMENT AND ASEPTIC PROCESSES PHARMACEUTICAL PRIMARY PRODUCTION Tema Sinergie can provide customized equipment to cover a wide range of processes, from HPAPI synthesis to final formulation for both R&D and production. Customized solutions for chemical synthesis and manufacturing processes that comply with user requirements, such as standard and custom-designed Multi-stages Containment Isolator Systems that guarantee the lowest Operator Exposure Levels (OEL). Class 2 leakage testing according to ISO 10648-2. Explosive proof (ATEX) compliant applications. Full...

PHARMACEUTICAL FILLING PROCESSES 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 the...

Aseptic Processing Isolator Systems Aseptic Processing Isolator Systems designed for QC Labs and pharmaceutical production. The high level of aseptic conditions achievable makes these isolators the perfect flexible equipment for different applications, such as Sterility Testing, Aseptic Dispensing & Sampling, and Aseptic Product Transfer. Specific applications for Beta emitters available. Recirculating Unidirectional Air Flow with return filters, and integrated Bio-decontamination system to allow 6-log bacterial reduction. Rapid Gas Chamber (RGC) with integrated VPHP technology for a...

OTHER APPLICATIONS GMP compliant manipulation of Advanced Cell Therapy for medical treatments or research purposes into CGMP Class A/ISO 5 isolated environments equipped with Unidirectional Air Flow, and Integrated bio-decontamination system to allow 6-log bacterial reduction. Full integration of specific process equipment, such as incubator, digital microscope, and centrifuge. Aseptic Containment Isolator Systems suitable for a safe handling of hazardous compounds (Chemotherapy, Oncological Applications). Increased operator safety with better ergonomics into CGMP Class A/ISO 5 isolated...

BARRIER ISOLATION TECHNOLOGY A BARRIER ISOLATOR SYSTEM PROVIDES A PHYSICAL BARRIER BETWEEN OPERATORS AND WORK PROCESSES. THIS TYPE OF EQUIPMENT IS COMMONLY USED FOR A WIDE RANGE OF PROCESSES IN VARIOUS INDUSTRIES; FROM FRUIT JUICE FILLING LINES IN THE ALIMENTARY INDUSTRY, TO THE PREPARATION OF CYTOTOXIC COMPOUNDS IN THE PHARMACEUTICAL INDUSTRY, TO CRITICAL MANUFACTURING PROCESSES IN THE ELECTRONICS INDUSTRY. WITH OUR EQUIPMENT IT IS POSSIBLE TO: - securely weigh and dispense HPAPIs - fill vials or syringes under aseptic conditions - perform reliable sterility testing - manipulate cell...

Tema Sinergie, established in 1985, has become a world leader in the design and manufacture of shielded isolators for the nuclear medicine market. Presently the focus of the company is customized high-quality stainless steel barrier isolator systems for aseptic and containment processes for the pharmaceutical and chemical sectors as an additional business unit. Tema Sinergie enhances its position in the pharmaceutical equipment market and promotes internal growth by anticipating industry demands with innovative ideas. The company is certified according to international standards ISO 9001...