Aseptic Containment

By combining the vast experience gained through many years in the design and production of aseptic and containment systems, Tema Sinergie can offer a comprehensive range of hybrid Aseptic Containment Isolator Systems that are fully compliant with the strictest cGMP and international regulations.


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The systems have been designed for the Sterile processing of High Potent Active Pharmaceutical Ingredients (HPAPIs, including cytotoxics, and may be customized to permit various processing tasks such as:

  • Aseptic Product Transfer
  • Manual Sampling, Weighing & Dispensing
  • Synthesis & Final Formulation

Cost-effective upgradable standard systems are available, as well as process specific fully customized solutions. The systems may be configured and used in both R&D laboratories and production suites.

Product protection – Asepsis:

  • Processing in a controlled and reliable GMP Class A / ISO 5 environment
  • Recirculating unidirectional airflow system through multi-stage filtration units
  • Integrated Vapor Phase Hydrogen Peroxide (VPHP) bio-decontamination system
  • Full integration of process equipment ensures barrier continuity

Operator protection – Containment:

  • Class 2 leakage certification according to ISO 10648-2
  • To OEL5 (≤50 ng /m3)
  • Multi-stage H14 air filtration units in Safe Change – Bag In/Bag Out (BI-BO) canisters and isolation valves
  • Integrated Wash-In-Place (WIP) system to neutralize residual HPAPI prior to open door interventions
  • Explosive proof (ATEX) compliant applications available

A vast range of available process equipment for complete system integration:

  • Vacuum dryers
  • Reactors
  • Weighing scales
  • Autoclaves
  • Pump heads
  • Technical gas/fluid and electrical power utility pass through connections
  • Aseptic transfer devices for both solids and liquids
  • High Containment Split Butterfly Valves (HCSBV)
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