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Ekstruderji

Ekstruderji

Ekstruderji se uporabljajo za natančno in kvalitetno mešanje, stiskanje in procesiranje viskozne snovi. Tako jih v laboratorijih uporabljamo za simuliranje in optimizacijo proizvodnega procesa, medtem ko pri farmacevtskih raziskavah, razvoju in produkciji uporabljamo ekstruderje z dvojnim vijakom (Twin-Screw Extruders) za visoko-temperaturno ekstrudiranje ter granulatorje z dvojnim vijakom za ponavljajočo granuliranje.

Ekstruderji za farmacevtske aplikacije

Farmacevtski kompounderji od Thermo Scientific za ekstrudiranje z vročim taljenjem in za neprekinjeno granuliranje ponujajo zanesljive rešitve za odkrivanje in razvoj zdravil. Naši farmacevtski ekstruderji ustrezajo široki paleti aplikacij za razvoj zdravil in so idealni za razvoj ter testiranje receptov z dragimi API in povezanimi spojinami.

Linija izdelkov Pharma ekstrudorjev:

  • Pharma 11 Twin-screw Extruder
  • Pharma 16 Twin-Screw Extruder
  • Pharma 24 Twin-Screw Extruder 
  • Pharma 24 Twin-Screw Granulator
  • Pharma mini HME Micro Compounder
  • Pharma mini Implant Line

Pharma 11 Twin-screw Extruder

Ekstruder z dvojnim vijačenjem Thermo Scientific™ Pharma 11 potrebuje le majhne količine aktivne farmacetvske surovine (deluje pri 20 g / h) za materialno in delovno učinkovito ekstrudiranje. Uporabite ga lahko za pridobivanje informacij o delovnem procesu kot tudi za proizvodnjo majših količin. Na voljo je široka paleta dodatkov za  ekstruder Pharma 11, vklučno z volumetričnimi in gravimetričnimi podajalniki, tekočim trakom in peletizatorjem.

The Pharma 11 Twin-screw Extruder Features:

  • Uses smaller material quantities for faster, cost-effective development
  • Converts easily from hot melt extrusion (HME) to twin screw granulation (TSG) applications
  • Operates at throughput ranges from 20g/h up to 2.5kg/h
  • Processing length: L/D ratio 40:1
  • Screw elements and barrel design scale geometrically across the all Thermo Scientific Pharma Extruders and allow easy process scale-up
  • Easy-to-operate with user-friendly, intuitive touch screen with integrated feeder control
  • Maximize lab space with small footprint machine
  • Perfect for glove box or isolator applications with removable touch screen
  • All material contact parts are easily removable
  • Documentation of extrusion parameters and suitable for process analytical technology (PAT)
  • GMP-compliant, full validation available: FAT, SAT, IQ/OQ

Pharma 16 Twin-Screw Extruder

Dvovijačni ekstruder Pharma 16 je namenjen hitremu razvijanju farmacevtskih pripravkov in sprejemanju procesnih metod. Ekstruder lahko enostavno preklaplja med ekstrudiranjem z vročim taljenjem (HME) in mokro granulacijo (TSG). Hitreje in enostavneje optimizirajte parametre razvoja zdravil in jih enostavno razširite na večje ekstruderje Thermo Scientific™ z minimalno količino dragih API-jev in pomožnih snovi.

Ekstruder Pharma 16 je idealen za pilotne in neprekinjene HME in TSG procese, ki se uporabljajo za raziskave, razvoj in proizvodnjo v farmacevtski industriji. Svoje izdelke boste lahko hitreje pripeljali na trg v primerjavi s serijskimi postopki. Z uporabo ekstrudorja Pharma 16 boste lahko enostavno preučili pogoje za pripravo zdravil.

 Pharma 16 Twin-Screw Extruder highlights:

  • 2-in-1 process design – quickly disassemble parts for easy cleaning and process switching from HME to TSG.
  • Simple continuous process integration - plug-and-play functionality with upstream and downstream process equipment (e.g., feeders, chill rolls, pelletizers, dryers, etc) simplifies production line design.
  • Less optimization time, cost and effort – extruder process parameters are scaleable to larger Thermo Scientific extruders due to geometric similarity with minimal use of expensive ingredients.

Pharma 24 Twin-Screw Extruder

Dvovijačni ekstruder Pharma 24 je idealen za neprekinjeno proizvodnjo delovanje za raziskave, razvoj ali proizvodnjo v farmacevtski industriji. Možnost dveh konfiguracij: HME in TSG (dvovijačna granulacija). Z inštrumentom Phrma 24 boste 

The Thermo Scientific™ Pharma 24 Twin-Screw Extruder, with avaialble HME and Twin-Screw Granulation (TSG) Application Sets, is ideal for continuous processing in research, development or production in the pharmaceutical industry. The Pharma 24 extruder drives reduced clean room area, consistent and controllable processing, reduced product changeover time, on-demand production, minimized scale-up risk and reliable cleaning. It is suitable for process analytical technology (PAT).

 

The Pharma 24 Twin-Screw Extruder features:

  • A small footprint to take up less space in clean rooms
  • Continuous operation which consumes fewer utilities than traditional batch processes
  • High free volume screw design
  • A small process inventory
  • Lower ingredient consumption which reduces handling and operator exposure
  • Segmented screws and barrel
  • Removable screws and liners

PAT Compatibility: PAT can be applied to your process to monitor parts of theprocess such as homogeneity of mixing or moisture content to assure required product quality. The Pharma 24 Extruder can be used with a range of PAT instruments such as Thermo Scientific™ FT-NIR system.

Options: We offer a full range of GMP compliant ancillaries which are matched to the extruder performance. This downstream equipment can be integrated into the extruder control system.

For TSG configurations: available ancillaries include volumetric or gravimetric dosing feeders and liquid injection pumps.

In addition, self-contained units of either configuration can be operated with recirculating chillers to reduce water consumption.

TSG configuration recommended for:

  • Wet granulation
  • Dry/melt granulation

For HME configurations: available ancillaries include volumetric or gravimetric dosing feeders, air cooled conveyors for product cooling, strand and face-cut pelletizers to make pellets, or chill roll/flaker units for rapid product cooling and flaking.

HME configuration recommended for:

  • Solubility enhancement
  • Modified release
  • Co-extrusion
  • Drug delivery systems
  • Biomedical products

 

Pharma 24 Twin-Screw Granulator

The Thermo Scientific™ Pharma 24 Twin-Screw Granulator (TSG) is a dedicated system for wet and dry granulation processes. It can be used as a stand-alone instrument or integrated into a modular, continuous manufacturing line that spans from raw materials to final tableting. Such flexibility minimizes scale-up risks.


The Pharma 24 TSG provides consistent and controllable processing, on-demand production, and reduced clean room space and ATEX risk. It is also suitable for process analytical technology (PAT).

Pharma mini HME Micro Compounder

The Thermo Scientific™ Pharma mini HME is a GMP compliant conical micro compounder for Hot Melt Extrusion in research and development in the pharmaceutical industry. When developing new drugs, shortening time-to-market and reducing waste of expensive API's and overall development costs provide a distinct competitive advantage. Hence, quick and early assessment of new API/excipient formulations is critical. Hot melt extrusion and continuous processing can lead to speedier formulation development and cost efficient production. The Thermo Scientific Pharma mini HME allows users to identify the right drug candidates for hot melt extrusion by compounding as little as three grams of material.

With the Pharma mini HME, we offer a micro twin-screw compounder which requires as little as three grams of total material to identify the right drug candidates for hot melt extrusion. The compounder with conical co- or counter-rotating screws is designed to minimize waste and reduce downtime necessary for cleaning.

  • Requires only 3g (4mL) of material for compounding
  • Small footprint, fanless design with separate, touch-screen control for operation in fume cabinet or glovebox applications
  • Removable and exchangeable product contact parts for quick and easy cleaning
  • IP 54 for protection against dust and water allows the Pharma mini HME to be spray-washed
  • Useable as small-scale production unit for throughputs of 100g/h
  • Touch screen control with user levels and password protection
  • Data logging software as option to record temperatures, torque, and screw speed
  • Optional batch conversion kit to use the Pharma mini HME as small batch mixer
  • Complementary workflow solution when coupled with the Thermo Scientific™ HAAKE™ MiniJet injection molder

Recommended for:

Materials:

  • Pharmaceutical ingredients (API's)
  • Excipients
  • Medical polymers
  • Drug delivery systems
  • Soft gels

Applications:

  • Hot melt extrusion
  • Medical devices
  • Implants
  • Controlled drug release
  • Handling and processing of highly potent API's in a glovebox

A small footprint reduces clean room volumes, and lower ingredient consumption reduces handling and operator exposure.

Dodatki za Pharma mini HME Micro Compounder

Pharma mini Implant Line

Produce high-quality, injectable drug delivery systems with the Thermo Scientific™ Pharma mini Implant Line. This automated end-to-end solution meets cGMP and FDA requirements. Accurate dosing of pre-blended material enters the extruder, which moves material through a die to produce a filament. A closed-loop filament control system ensures that the implant strand has minimal diameter variability. The strand is cut to the required implant diameter and length. Out-of-specification implants are automatically discarded, assuring 100% quality.

The Pharma mini Implant Line offers a complete solution for developing and producing injectable drug delivery systems. High-quality components and precise automation with integrated Quality Control and documentation assures consistent drug implant manufacturing.

Pharma mini Implant Line advantages

  • Hermetically sealed material container for maximum operator and product safety
  • High accuracy gravimetric feeding (± 0.5%, depending on material)
  • Reproducible and stable extrusion process up to 100 g/h
  • Accurate diameter control adjustable in the range of 0.5mm and 2.0mm; precision of final product is ± 0.005% to 0.05% (depending on physical parameters of the compound used)
  • Exact cutting of implant strand into specified length
  • Automated sorting of in-spec and out-of-spec product for 100% quality assurance
  • Integrated software control system for process monitoring, documentation and displaying all relevant system and process data
  • 21 CFR part 11 compliant Batch Report and Audit Trail

Pharma mini Implant Line components

  • Container with containment valve 
  • Gravimetric feeder with feeder screws and feeder stand
  • Pharma mini HME micro compounder  with co- or counter-rotating screws
  • Filament diameter control and cutting unit with sorting unit
  • PLC with integration of all Pharma mini implant line instruments
  • Chiller unit

Brošura

 

 

 


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