Biotech

Integrated solutions for biotech processes and advanced therapies, designed to preserve the integrity of biological products and sensitive organic materials while ensuring contamination control, operator safety, and compliance with GMP requirements and Annex 1.

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NEEDS AND SOLUTIONS

cGMP Annex 1 has redefined the requirements for the pharmaceutical industry at the international level. New approaches such as the Contamination Control Strategy (CCS) and Quality Risk Management (QRM) have brought about a significant evolution in controls and procedures, placing greater emphasis on sterile manufacturing, the adoption of advanced containment and decontamination technologies, and the reduction of human intervention in favor of greater automation and process control.

In this context, barrier systems must evolve: from simple devices designed to protect both the product and the operator to integrated and fundamental elements of the contamination control strategy. From aseptic filling systems to isolators, from RABS to passboxes, and on to verification systems, our technologies ensure the integrity of pharmaceutical manufacturing processes and provide concrete support in defining and implementing Contamination Control Strategy (CCS) procedures. For this reason, Tema Sinergie systems are designed not only to optimize sterility control but also to simplify and make the pharmaceutical manufacturing process safer, within a CCS-driven approach.

Integration of Control Systems

Isolation, monitoring, and decontamination are integrated into a single solution to support contamination control and the implementation of an effective Contamination Control Strategy (CCS).

Automation and Instrumentation

The integration of process instrumentation eliminates the risk of sterility breaches and centralizes process data into a single digital reporting system.
Automation reduces the need for human intervention, thereby improving process control and repeatability.

Optimized VPHP Decontamination

The VPHP system is designed based on the architecture of the containment system to eliminate any aerodynamic blind spots and ensure uniform distribution of the decontaminant.
This ensures repeatable decontamination cycles, optimized ventilation times, and rapid restoration of Grade A conditions.

Data Integrity and Traceability

Systems compliant with 21 CFR Part 11 ensure data integrity and complete traceability.
Simplified process management enables the generation of clear, tamper-proof batch records, facilitating audits and accelerating batch release.

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Method

How We Address the Needs of Modern Pharmaceutical Manufacturing

An integrated approach that combines experience, clinically oriented design, and ongoing support for the implementation of solutions.

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Proven experience

Tema Sinergie is the leading global partner for the design of advanced isolation systems, ensuring the highest standards of protection for both the product and the operator in the pharmaceutical industry.

Modular Architecture

Scalable solutions that optimize production layouts and reduce installation and qualification (IQ/OQ) times.

Integrated Solutions

A turnkey system that includes hardware, software, and qualification and validation documentation to support the entire project lifecycle.

System Integration

Native connection between the isolator, VHP decontamination systems, and cleanroom infrastructure, to support the maintenance of Grade A.

Support During the Start-up Phase

Technical support during the installation, qualification, and operational commissioning phases of the system.

Specialized Training

Structured training programs for operational and technical staff, designed to ensure the proper use of systems and to maintain quality and safety standards.