R&D | Pilot Scale Solid Drug Layering

R&D | Pilot Scale Solid Drug Layering


Drug layering is the new pelletization range that builds on the proven Umang technology and its operational benefits. Similar design of loss in weighttwin screw feeder, rotating plate and spray gun for liquid ensures that process and validation wise there is no difference to the layering process from alaboratory scale to a production scale. This unique design of twin screw feeder, plate and spray nozzle makes the not only a perfect drug layering machine but also an ideal machine suited for fast pelletization.

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

The drug layering capacity ranges from 500 gms to 120 Kgs./batch 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 drug layering can be stand-alone or linked to a fluid bed coating system for further sustained release coating or enteric coating to form an integrated pelletization system.


Standard Features for Drug layering :

  • Twin screw feeder configuration.
  • CIP entry from top cover
  • 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.

Standard Features for Drug layering :

  • 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
  • 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 Solid Drug Layering:

Model Drug layering - 380 Drug layering - 500 Drug layering - 700 Drug layering - 900 Drug layering - 1100 Drug layering - 1300
Batch capacity (Ltrs.) 7 22 70 130 260 520

 


  • Various Mesh size from 300 microns – 8000 microns depending on the product and customer application.
  • Various configurations of chequered plate like 1mm / 2mm / 3.25 mm / 6.5 mm plate configurations.
  • 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

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

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.

How often should I clean the machine, are internal parts completely accessible?
Yes as per GMP design.

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

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

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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