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Containment Level Evaluation

Highly Reliable Containment Level Evaluation Technology for Chemical Hazards

JGC offers suggestions for structural methods to containment hazards at pharmaceutical production plants. We have applied these facilities-structural methods to numerous projects, earning high marks from our clients. In addition, when we deliver the hazard containment facilities on site, we also conduct an evaluation of the effectiveness of the containment. To help with such evaluations, ISPE (International Society for Pharmaceutical Engineering) publishes a guideline, “Assessing the Particulate Containment Performance of Pharmaceutical Equipment.” However, conducting practical evaluations based on this manual requires a great deal of labor in creation of the necessary measurement parameters. Furthermore, when performing measurements and evaluations, prior experience is a hugely important factor. JGC has a great deal of experience in this field, as detailed below, and we are able to provide highly reliable measurement parameters and evaluations of effectiveness.

Furthermore, by employing our patented chemical hazard powder airborne evaluation technology, we can provide containment level evaluation that will closely mirror conditions during actual production.

Containment Ability Measurement Record

Company Facility Type Classification Product Applicable Major Components OEL
µg/m3
Measured value*1
µg/m3
Company A solid non-aseptic surrogate drug isolator, mixer, others 1 ND(< 1)
Company A injection aseptic surrogate drug isolator 1 ND(< 1)
Company B injection aseptic active drug isolator, vial filling 1 ND(< 0.1)
Company C injection aseptic active drug A isolator, split valve, freeze-dryer 10 ND(< 1)
Company C injection aseptic active drug B isolator, split valve, freeze-dryer 10 ND~20*1
Company D solid non-aseptic surrogate drug isolator, mixer, others 10 ND~10
Company D solid non-aseptic active drug safety cabinet, mixer, others 10 ND~10
Company D solid non-aseptic active drug open-type sifter, mixer, others - 0.1~500
Company E bulk non-aseptic surrogate drug isolator 1 ND(< 1)
Company F bulk non-aseptic active drug isolator 1 ND(< 1)
Company G bulk non-aseptic active drug isolator 1 < 1
Company G bulk non-aseptic active drug
(raw materials)
downflow booth, split valve 100 0.1~20
Company H bulk non-aseptic active drug isolator, push-bull booth 100 20~110*1
Company J bulk aseptic active drug C aseptic positive pressure isolator 1000 ND(< 10)
Company J bulk aseptic active drug D aseptic positive pressure isolator 1000 ND(< 10)

*1: measured values are operational average, not eight-hour average

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