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Pharma Extruders

First-class twin screw extruders for continuous mixing of pharmaceutical active ingredients

Coperion is pioneer in the development of high-end closely intermeshing, co-rotating twin screw extruders. We possess a unique know-how and an extraordinary wealth of experience in this continuous production process. Since the beginning of pharmaceutical extrusion we have continuously set new standards in the continuous manufacturing of pharmaceutical products with our special ZSK pharma extruders. This begins with special applications on a laboratory scale and extends right through to continuous pharmaceutical production systems.


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Description

Special Features of Coperion's ZSK Pharma Extruders

  • Modular barrel design with customized process length L/D to each individual product
  • Modular screw design with broad selection of screw elements for high process flexibility
  • Intensive mixing and dispersion of the twin screws for supreme product quality
  • Specific torque up to 18 Nm/cm³ allowing low ratios of throughput/rpm resulting in minimized product temperatures and API degradation
  • Manufactured in GMP design
  • All parts coming in contact with the product made of stainless steel with minimized surface roughness
  • Use of FDA-conformant oils/lubricants
  • Complete documentation of all process parameters (V-lifecycle) based on URS (User requirement specification)
  • Compact design and therefore low space requirement
  • Self-cleaning of the twin screws avoids dead spaces and results in short residence times
  • Clear arrangement of the extruder with easy operation, easy access for cleaning and maintenance
  • Simple handling and quick dismantling using quick release couplings
  • PLC and visualisation system conform to CFR Part 11
  • FAT (factory acceptance test) and SAT (site acceptance test)
  • Reliable scale-up due to geometrical constancy within the ZSK series
  • Professional process engineering support with know-how from over 30 years of experience in pharmaceutical applications
  • Comprehensive after-sales services by worldwide Coperion service network

Typical areas of application of Coperion's Pharma Extruders

  • Pharmaceutical Hot Melt Extrusion
    • Solvent-free production of solid dispersions or solids solutions of APIs ( also BCS class 2 & 4), thus enhancing their bioavailability
    • Hot Melt extrudates as basis for solid dosage forms with controlled / sustained release of APIs
    • Degassing of water to counteract API re-crystallisation
    • Encapsulation and taste masking
  • Wet Extrusion of APIs as basis for granules for capsule filling
  • Extrusion of adhesives with APIs for transdermal plasters
  • Extrusion of adhesives for medical applications such as stoma
  • Extrusion of compounds for implants/biodegradable implants or contraceptive rings
  • Extrusion of medical plastics (wound plasters/butterfly closures)

Technical Data

ZSK Max. torque per shaft [Nm] Specific torque Md/a³
[Nm/cm³]
Max. screw speed
[min-1]
Max. motor power N
[kW]
Screw diameter
[mm]
18 MEGAlab* 38 11.3 1,200 10 18
26 140 15 1,200 37 25
32 315 18 1,200 83 32
40 510 13.6 1,200 135 40
70 3,500 18 1,200 924 70

* Laboratory extruder

Laboratory extruder ZSK 18 MEGAlab

Highest performance even for smallest batch sizes. Modular construction, GMP design, maximum speed, highest power density, safe scale-up, tailor-made controls – the ZSK 18 MEGAlab laboratory extruder is the smallest member of the ZSK family. This targeted and further development of proven ZSK technology extends the performance range of the series for R&D and production of pharmaceutical materials in a minimum quantity range.

  • Md / a3 = 11.3 Nm/cm³
  • Do / Di = 1.55
  • Maximum speed = 1,200 rpm
  • Maximum length of process section = 15 barrels (60 D)
  • Throughput rates between 1 and 10 kg/h
  • Quick plug & play commissioning
  • Reliable, low noise drive concept
  • Modular construction with exchangeable 4D barrels and all standard screw elements
  • Flight depth of 3.2 mm enables pellet feeding
  • Simple to operate via PLC control and touch screen
  • Compact size – mobile stainless steel base frame with integrated controls and water cooling system with option for direct mounting of a Coperion K-tron solid feeder
  • Proven scale-up due to geometrical constancy within the ZSK series

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