R&D | Pilot Scale Hot Melt Extruder

R&D | Pilot Scale Hot Melt Extruder


Melt extruder is the new mixer extrusion range that builds on the proven Umang technology and its benefits. Similar design of the twin screws, extrusion die and cutting mechanism in the process and validation, so that there is no difference to the extrusion process. This unique design of segmented twin screws, mixing attachments and cutting makes the not only a perfect hot melt extrusion granulator but also an ideal machine for performing one stop operations.

The outstanding feature of the Melt extruder range is the the twin screw segmented barrel and twin screw feeders attached to it for uniform and continuous product feeding. Connections, cabling and supplies are completely integrated, covered and sealed so the outside of the machine is smooth and very easy to clean. Our system Melt extruder is a result of high level of engineering expertise and product technology knowledge, quick product changeover increases productivity and cost effectiveness.

The Melt extruder capacity ranges from few 100 gms. to 150 kgs. / hr. 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 Melt extruder can be stand-alone or linked to a Cone Mill or Multi Mill to form an integrated system.

With its special versions of the twin-screw extruder suitable for the production of pharmaceutical compounds, Umang is one of the pioneers in the development of Pharmaceutical Hot Melt Extrusion. In this continuous production process, polymers are mixed with binding materials, carrier materials and active pharmaceutical ingredients (API’s). This innovative, flexibly applicable process has recently become increasingly important.


Standard Features for Melt Extruder:

  • Twin segmented screws and barrels.
  • No seals 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 wet granulation.
  • Machine with variety of processing screws like mixing, kneading, processing, cooling and extrusion.
  • Various size of dies possible.
  • Cutting assembly for strands.
  • Precise temperature control including both water cooling and heating to the individual process zones.
  • Different L/D ration from 1 : 20 to 1 : 60 possible as per product and process requirements.
  • Hinged processing barrel ensuring faster processing.

Optional Features for Melt Extruder:

  • Explosion proof design
  • 21 CFR part 11 certified controls.
  • ADVANCE PROCESS + for easy and automated granulation control
  • 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 Hot Melt Extruder:

MODEL UHME-16 UHME-25 UHME-40 UHME-50 UHME-60
Batch Cap./Kgs. 0.05-2 KGs/HR 1-5 KG/HR 10-40KG/HR 80-100 kgs/HR 150-200 kgs/HR


  • Twin segmented screws and barrels with heating and cooling arrangement till 145 deg. cen.
  • No seals in direct contact with the product / materials.
  • Perfect GMP- design: smooth covering, no external tubing and piping allowing easy cleaning.
  • Twin screw feeder (variable speed), Twin segmented screws (split barrel) with variable speed.
  • Controls by touch screen 12.1” IPC by a touch panel control with trends (21 CFR Part 11).
  • Down stream equipments like cutter and underwater are supplied as per project needs.
  • Hot and chilled water equipments as per product / customer needs.
  • Down stream equipments as per customer / project needs.

  • 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

Can we encapsulate drugs by Hot Melt Twin Screw Extrusion ?
Yes around 60 C - 80 C the wax / polymer melts.

Do we need a Twin Screw Extruder or a single screw extrusion can deliver the same product quality?
Single screw gives a lesser product performance than a twin screw extrusion.

Will the twin screw extruder contaminate my powder ?
No, the extrusion chamber is on hinges completely dismantlable and cleanable.

Are the screws of segmented design?
Yes the screws can be arranged in a design best suited for the customer products, the segmented screw is completely configurable.
drying/coating as per product / process needs.

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

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

Does the machine have vent ?
Yes

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

Do you offer wash down for SS designs ?
Yes

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