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 Isolators that are fully compliant with the strictest cGMP and international regulations.
The Aseptic Containment Isolators 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.
Key characteristics and features that allow aseptic and contained processing include:
• 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)
