The entire granulation system adheres to FDA, 21 CFR part 11 as well as cGMP guidelines. Sensors measure process endpoints but also endpoints for cleaning and validation.
OEL 5 Compliant Contained Granulation Line – Granulation line is the most important equipment in pharmaceutical manufacturing process. There are many ways of classification such as: intermittent lines (independent machines), integrated line (synchronised machines), non-Atex line (water/aqueous based), Atex line (solvents based), containment line (for toxic / anti-cancer drugs),…
Closed Granulation line Wall-mounted – Granulation process starts from material loading to high-speed Mixer & Granulator. Wet granules after mixing go through Inline Milling are discharged to product container of Fluid bed Dryer & Granulator. Once drying stage finishes, operator pushes product container to lifting & tilting device. With support of the lifter, dry granules freely fall down to IBC and ready for final blending.
We designed the Pharmaceuticals API section with reactors (with contained charging Isolator), Agitated Nutsche filter dryers, Micronizing Mill with complete containment OEL 4. An IPQC Isolator with instruments like weigh balance, disintegration apparatus, oven friability tester, hardness tester and Karl Fisher apparatus (moisture analysis) completes the system.