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)