R&D | Scale Fluid Bed Coating | Granulation

R&D | Scale Fluid Bed Coating | Granulation


Fluid Bed Coating | Granulation is the new coating and granulation range that builds on the proven Umang technology and its benefits. Similar design of distribution plate, nozzles and continuous working filter bags ensures that process and validation wise there is no difference to the granulation / coating process. This unique design of plates, nozzles and filters makes the not only a perfect granulation system but also an ideal machine for fluid bed coating applications.

The outstanding feature of the Fluid Bed Coating | Granulation range is the integrated and CIP optimized design. Connections, cabling and supplies are completely integrated, covered and sealed so the outside of the machine is smooth and very easy to clean. The innovative discharge valve design and optimized seals inside the bowl allow for CIP. As a result of this the our Fluid Bed Coating | Granulation is highly flexible, quick product changeover increases productivity and cost effectiveness./p>

The Fluid Bed Coating | Granulation ranges from 1 to 1500 liters featuring through the wall design and movable head, allowing operation with platform and dust-free discharging via a linked mill directly into an IBC. The Fluid Bed Coating | Granulation can be stand-alone or linked to a high shear mixer for granulation or a extrusion and spheronization system to form an integrated system.


Standard Features for Fluid Bed Coating | Granulation :

  • Distribution plate available in plain uniform perforations.
  • Swirl design of plates possible as a option.
  • Perfect cGMP-design: smooth covering, no external tubing and piping allowing easy cleaning
  • Completely integrated full opening side discharge: perfect discharge of difficult products
  • Through the wall installation: minimum space required in GMP area
  • User-friendly operator-machine interaction via graphical operator panel 12" Industrial PC software with PROCESS + range of software which helps interlinking all plant equipments to a single system.
  • Flexibility (processes and products) for wet granulation.
  • Different up plate and down plate configurations for fluid bed coating applications.

Optional Features for Fluid Bed Coating | Granulation :

  • Explosion proof design
  • Automatic cleaning (WIP/CIP) of entire system
  • 21 CFR part 11 certified controls.
  • ADVANCE PROCESS + for easy and automated granulation control
  • Jacketed / insulated liquid tank
  • Total containment through up- and downstream split valves and flexible isolation systems.
  • Integration with mill and/or fluid bed possible: perfect closed link for dust-free operation
  • Video monitoring of the process
  • Liquid addition system (peristaltic pump / pressure vessel)
  • Product feeding both by gravity or vacuum loading system directly from the containers
  • Validation documentation and assistance based on GAMP


Technical Specifications for Fluid Bed Coating | Granulation:

MODEL Fluid Bed Coating | Granulation - 50 Fluid Bed Coating | Granulation - 125 Fluid Bed Coating | Granulation - 250 Fluid Bed Coating | Granulation - 500 Fluid Bed Coating | Granulation - 750 Fluid Bed Coating | Granulation - 1000 Fluid Bed Coating | Granulation - 1500
Batch Capacity (Ltrs.) 56 125 265 525 800 1100 1640

  • Various Mesh size from 300 microns – 8000 microns depending on the product and customer application.
  • Various mesh sizes possible depending on the design of extrusion starting from 300 microns upto 7500 microns.
  • Jacketed / insulated bowl and extrusion chamber.
  • Total containment through up- and downstream split valves and flexible isolation systems.
  • Integration with a high shear mixer is also possible for uniform mixing of blends for further Extrusion and spheroinization operations.
  • Through the wall installation: minimum space required in GMP area
  • User-friendly operator-machine interaction via graphical operator panel 12" Industrial PC software with PROCESS + range of software which helps interlinking all plant equipments to a single system.
  • Explosion proof design
  • Automatic cleaning (WIP/CIP) of entire system
  • 21 CFR part 11 certified controls.

  • Agricultural chemicals
  • Fertilizers
  • Agrochemicals
  • Carbon black
  • Ceramics
  • Atomic tablets
  • Soya and food processing
  • Home and Personal care.
  • Cosmetics
  • Agglomeration
  • Particle size build up
  • Heat Sensitive materials
  • Pressure sensitive materials
  • Pharmaceuticals
  • Pigment
  • Toner, etc.

Umang Pharmatech : Pharmaceutical Test Station

The Umang Pharmaceutech Test Station is located in Vasai, THane, conveniently located very close to Mumbai airport, only forty five minutes from Mumbai International Airport. The Test Station's purpose is to assist our Pharmaceutical and Biopharmaceutical Industry customers with feasibility testing of their products on our equipment, and to be a partner with them in the process development as they move forward from the Research and Development stages to clinical production, and eventually into full-scale Manufacturing.

The station combines decades of design and development know-how in the pharmaceutical industry with the very latest in processing equipment to provide you with a unique opportunity for feasibility, development, and small-scale manufacturing of pharmaceutical products.

Your needs are critical and individual. The UMANG Pharmaceutical Test Station has been designed to meet those needs.

  • Product evaluation & testing
  • Demonstration
  • Training
  • Formulation development
  • Process optimization
  • Small-scale manufacturing

We offer the following process options:

  • Spray drying
  • High shear mixer
  • Extrusion and spheronization
  • Fluid bed coating and granulation.
  • Fluid bed rotor
  • Cone extrusion.
  • Die roller extrusion.
  • Continuous vibratory fluid bed dryer.
  • fluid-bed granulator - dryer

  • Analytical Capabilities

    • Specification development
    • Method development
    • In-process controls
    • Impurity profiling
    • Method validation
    • Stability testing and Degradation studies
    • Release of Intermediates and final product
    • Technology transfer to manufacturing sites
    • Support to regulatory filings
    • Pre-Fo HPLC (Shimadzu) AGilent, RI, Fluoresence Detectors
    • UV-Vis Spectrophotometer
    • Thereo Gravimetric Analyzer (TGA) (Shimadzu)
    • Moisture Analyzer
    • Granulators (Fluid Bed or High Shear)
    • Comminution Mill
    • Diffusion Blenders - V, Octagonal, Double Cone types
    • Multi-purpose equipment - Planetary Mixer, Granulator, Blender attachments
    • Tablet Coating - solid pan of various sizes
    • Pilot Plant for Dermatologicals
    • USP dissolution Apparatus with auto sampler
    • Vertical Cell Diffusion (Franz) Apparatus
    • Tablet: USP Hardness Tester, USP Disintegration Tester & USP Friability Tester
    • Stability Chambers (set to ICH Guidelines)
    • UV-Vis Spectrophotometer
    • FTIR
    • Brookefield Viscometer

    Formulation Development

    Our expertise in formulation development extends to the development of all conventional dosage forms. Our strategic alliances broaden the scope to consider many Novel Drug Delivery Systems (NDDS), including transdermal & liposomal delivery systems. We consider multiple approaches to improve the bioavailability of drugs. We have expertise in improving delivery of poorly soluble/ permeable drugs and the capability to screen potentially innovative drugs based on pharmacokinetic properties. We possess pelletization, drug-layering, particle-coating and other technologies to achieve extended release profiles for tablets or capsules.

    Analytical Development

    Our analytical development services include assay and RS method development and validation, dissolution method development and validation, stability studies as per ICH guidelines, polymorphic form characterization (DSC/TGA/XRD/Microscopy), cleaning validation studies and HPLC to UPLC method conversions.

    Generics and NCEs

    • Pre-formulation
    • Proof of Concept studies
    • Phase Appropriate CT Formulations
    • Formulation and Process Development
    • Scale-up and Technology Transfer
    • Life cycle management
    • Differentiated generics, 505 (b) (2)

    Dosage Forms

    • Pellets - Immediate Release, Modified Release
    • Granules - Immediate Release, Modified Release
    • MDF - Mouth Dissolving Film
    • Physico chemical evaluation

    Solubility studies:

    • pH dependent aqueous solubility
    • solubility in co-solvents
    • surfactant assisted solubility
    • equilibrium solubility
    • Intrinsic dissolution study in various pH conditions
    • Salt design/screening and selection
    • Dissociation constant redetermination
    • Partition coefficient and log P determination
    • Polymorphism studies
    • Particle size, surface area, bulk / tapped density determination
    • Particle size distribution
    • Bulk/tapped density determination
    • Binding constant determination
    • Drug-excipient compatibility studies

    Containers:

    • Closure integrity testing
    • Filter compatibility
    • Stress stability
    • Photo stability
    • Hold-time study

  • Integration with fluid bed possible: perfect closed link for dust-free operation
  • Video monitoring of the process
  • Liquid addition system (peristaltic pump / pressure vessel)
  • Product feeding both by gravity or vacuum loading system directly from the containers

What type of material is suitable to process in a dome extruder ?
Non-sticky , powdered

What are the particle size constraints of a dome extruder?
There are no constraints we design the machine as per your product requirements .

Will the process in a dome extruder heat up my material excessively ?
No there is a uniform air distribution in the machine.

How often should I clean the machine dome extruder? Are the parts easily available ?
Yes the parts are easily accessible for product change over.

Do you offer the machine dome extruder in mild steel construction for industrial application ?
Yes we do offer the same for procie sensitive products / segments .

How quick can we get the delivery of the machie dome extruder ?
3-4 weeks depending on the size.

Do you provide a complete processing line ?
Yes we do give machine from high shear mixing to extrusion , spheronization to fluid bed drying/coating as per product / process needs.

Is the Extruder and powder feeder controlled by a inverter?
Yes.

Content

Contact me