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Closed Loop Contained Granulation Line commissioned by Fabtech

The Granulation system is a complete wall flush unit with a common SCADA operation system and single screen operation. It comprises a High Shear Mixer with a charging and sampling Isolator, and a positioning system with Alpha Beta Split butterfly valves manufactured by Fabtech. A Wet Milling Comill leads granules to the Fluid Bed Dryer with a tangential flow sieve thereby enabling spiral motion of fluidisation while ensuring uniform drying. Dried products are discharged into a Vacuum transfer device and the product is milled and sieved within the Isolator and fed to the Blender Bin with passive Split Butterfly Valves. The Blender Bin comes with a manual lifting trolley (worm wheel type) that makes for easy docking in the Blender. The complete system is flame-proof.

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The entire system adheres to 21 CFR part 11 as well as cGMP guidelines. Sensors measure process endpoints but also endpoints for cleaning and validation.

System highlights:

  1. Spiral Tangential Flow Sieve for Fluid Bed discharge into Vacuum Transfer System.
  2. Leak-proof High Shear mixer and Fluid Bed dryer to maintain the highest levels of containment.
  3. Specially designed sampling valves as well as cleaning nozzles to ensure the validation of system is perfect.
  4. All containment equipment filters incorporate the BIBO system for hassle-free filter changing procedures.

We also provided a multi-purpose washing station for bin washing bottles, blender bins and other equipment. The station is designed to incorporate manual half suit entry for flexibility of use. This also helps clean parts that are tough from a validation perspective.

We designed the API section with reactors (with contained charging Isolator), Agitated Nutsche filter dryer, 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.

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Tell us what you are building and where. An engineer will read your message and answer it. We reply within 24 hours.

What helps us reply faster
  • The process. What you will make, in what dosage form, and at about what scale. For example: tablets, capsules, liquids, sterile injectables, API or biologics. Your answer changes almost every later step of the project.
  • The containment requirement. If the material is potent, tell us its OEB band. OEB (occupational exposure band) is a grade that shows how little of a material a worker can safely be exposed to. This one figure decides if you need a booth, an isolator or a contained suite. Their costs differ by an order of magnitude, which means about ten times.
  • The market. Tell us which regulator will inspect the facility. Also tell us the electrical supply at the site: 50 Hz or 60 Hz. The format of the documents and the specification of the equipment both depend on this.
  • The state of the site. Greenfield (an empty plot), brownfield (a site used before), an extension, or a retrofit into a running plant. A retrofit means new work inside a plant that is still in production. It is a different engineering problem from an empty plot, and usually a harder one.
  • Your timeline. Include any regulatory or commercial date the project has to meet.

For a single piece of equipment rather than a facility, tell us four things: the machine, the material, the throughput and the destination market. Throughput is how much material the machine must process in a set time.

Telephone: +91 22 6554 0300