Menu

Spheronizer

Home / Products / Spheronizer

Overview


Spheronizers is the new pelletization range that builds on the proven Umang technology and its benefits. The design of the plate and the gap between the bowl and the chequered plate ensures that process and validation wise there is no difference to thepelletization process. This unique design of chequered plate, the chequered design of the plate cuts the extrudes in round pharma pellets making it an ideal Spheronizers machine.

The outstanding feature of the Spheronizers 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 Spheronizers is highly flexible, quick product changeover increases productivity and cost effectiveness.

The Spheronizers ranges from 100 gms / batch capacity to 100 Kgs./ batch featuring through the wall design and completely cleanable designs, allowing operation with platform and dust-free discharging via a linked mill directly into an IBC. The Spheronizers can be stand-alone or linked to a extrurder like a die roller extruder, screw extruder, basket extruder or a mixer extruder giving a highly dense and uniform pellet. A Fluid Bed Wurster can also be a part an integrated system.

Standard Features for Spheronizers :

  • Variaous designs of chequered plate starting from 1mm chequered size.
  • Plate and shaft seals not in direct contact with the product
  • 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 spheronization or pellet line / pelletization process

Standard Features for Spheronizers :

  • 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 bowl
  • 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
  • Product feeding both by gravity or vacuum loading system directly from the containers

Validation documentation and assistance based on GAMP:

More info

Technical Specifications for Spheronizer:

Model Spheronizers 250 Spheronizers 380 Spheronizers 500 Spheronizers 700 Spheronizers 900
Batch Cap./Kgs. 0.2 -1 kg / hr 1-3 kgs/ hr 3-7 kgs/hr 5-15 kgs/ hr 20-40 kgs / hr

 

  • Spheronizer with 3.2mm chequered plate and acrylic cover over drum.
  • Plate and shaft seals not in direct contact with the product.
  • Perfect GMP- design: smooth covering, no external tubing and piping allowing easy cleaning.
  • Completely integrated full opening side discharge: perfect discharge of difficult products.
  • Controls by touch screen 12.1” IPC by a touch panel control with trends (21 CFR Part 11).
  • Recording of critical parameters and process data in software.
  • Jacketed drums for processing temperature sensitive materials.
  • Various sizes of Chequered plate (1 / 2 / 3.2 / 6.5mm / special sizes).

  • 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

FormulationDevelopment

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.

AnalyticalDevelopment

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 is the lowest particle size which can be processed in a Spheronizer?
    200-300 microns

    What is the gap between the drum and chequered plate?
    0.2 mm .

    Can we minimize heat generation during spheronization?
    Yes, by a water jacket.

    Will the Spheronizer contaminate by product change over ?
    The Spheronizer is built completely CGMP which reduces risk of contamination.

    What is the rotational speed of a Spheronizer?
    Large Spheronizer run at a lesser speed of 300-750 RPM and small batch machine at 1500-3000 RPM .

    Can the Spheronizer make porous pellets?
    Yes

    Can a Spheronizer be used to make micro pellets / MUPS ?
    Yes due to less gap.

    Can a Spheronizer be coupled with a twin screw extruder to give hot melt pellets ?
    Yes , a jacketed spheronizer.

    Will the process heat up my material excessively?
    Just for a flash time.

    Do you offer wash down for SS designs ?
    Yes

To Top