The summarize:
High contain is a new hot topic in pharmaceutical oral solid dosage area. According to recent research ,every one new medicine contains one high active API and request high contained processing and handing.We focused in past years of such technology and developed the TJB serious high contained granulation suit.
Principle:
TJB-G serious high contained granulation suit is integrated high shear mixer,cone will (wet & dry ),TJB into isolator with reliable sealing.The wighed material inside the contained container is transferred from weighing & dispensing isolator into the granulation suit, and loading through the high contained handing unit,e.g RTP, αβ
Valve, LEV, etc, into the high shear mixer (or integrated with wet mill) for wet granulation, FBD drying (or integrated with dry mill) and unloading the high contained handling unit, e.g αβ valve, quick liner, etc, into the high contained container. The whole granulation processing is working under the isolation sys with reliable AHU isolator handing unit. The take in air of isolator is cleaned from the H14 grade push-push filter with recycling loop ensure the safe and ensured negative pressure condition. According to specific project features, the high contained granulation could reach to OEB 3 to OEB 5 level.
Wip:
The high contained granulation suit is designed with WIP system ensure the safe changeover. All points with product remaining possibility are designed with specific washing ball /nozzles ensure the reliable washing gun is designed inside the isolator chamber to wash the isolator interior surface and machine exterior surface to ensure the operation safety.