Pharma

Integrated turn-key solutions for aseptic filling and containment, developed to ensure contamination control, operator safety, and production efficiency, in 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.

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 are required to evolve: from simple protective devices to integrated elements of the contamination control strategy.

From aseptic filling systems and isolators to RABS, Passboxes, and inspection systems, our technologies ensure the integrity of pharmaceutical manufacturing processes and help reduce the risk of contamination, serving as a fundamental tool for contamination control within Contamination Control Strategies (CCS).

Tema Sinergie systems are designed to simplify and enhance the safety of pharmaceutical manufacturing processes, supporting contamination control as a key element of an effective CCS.

Integration of Control Systems

Isolation, monitoring, and decontamination are integrated into a single solution to support contamination control as a cornerstone 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 increasing process control and repeatability.

Optimized VPHP Decontamination

The VPHP system is designed based on the architecture of the barrier 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 Meet 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 the production layout 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.