Barrier/Isolation Technology in Pharmaceutical Containment Systems

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- Containment Level Assessment Systems in potent compound handling -

JGC has proposed pharmaceutical facility design criteria to contain active pharmaceutical ingredients, which have already been reflected in various facility designs and construction. On the other hand, JGC provides containment level assessment services to quantify the design criteria incorporated into actual facilities. The assessment is carried out in a method pursuant to the ISPE (International Society for Pharmaceutical Engineering) containment determination, combined with some of JGC's self-developed, unique practices, thus making the method internationally applicable.

Containment level assessment in a simulated laboratory test
(Weighing process assessment in an open booth)

Features

Self-developed practices drawing on accumulated performance assessment experience
Application of optimum assessments based on international standards and latest information available
Containment assessment covering an entire hazard area in a plant, without being limited to airborne dust assessment and containment assessment of individual equipment/systems.

Applications

Bulk manufacturing plants and pharmaceutical plants handling substances having high physiological activities.

Airborne dust assessment
Short-term particulate airborne concentrations (STPAC)
Time weighted average (TWA)
Peak concentrations (Real time monitoring)
Occupational exposure limit (OEL)
Contamination assessment for surfaces of equipment/facilities
Swab tests
Property assessment for particulates
Airborne particle size distribution
Total powder size distribution

Experience

Open isolation system for non-aseptic bulk manufacturing facilities
Closed isolation system for non-aseptic bulk manufacturing facilities
Open isolation system for aseptic dosage from manufacturing facilities


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