DeltaVita 600 - NETZSCH Измельчение и Диспергирование

NETZSCH DeltaVita® 600

Grinding and Dispersing of Pharmaceuticals

Общее описание

The comminution or desagglomeration of active pharmaceutical ingredients (API) is called micronization and brings about several advantages. The increase of the particle surface caused by the comminution results in a considerably better dissolution rate and bioavailability of the agents and therefore the APIs act faster. Due to the increased bioavailability a lower amount of APIs is required which in turn leads to a more cost-efficient product with less risks and side effects for the patient.

Based on comprehensive experience with the production of GMP-compliant pharmaceutical products, all sizes of NETZSCH DeltaVita® machines ranging from small laboratory- to production-size machines excel by the following specific features:

  • All product wetted parts are designed and manufactured according to the latest GMP standards
  • Material, production and calibration certificates are supplied together with the machine
  • Optional cleaning in place (CIP) and sterilization in place (SIP)
  • All indirectly product-wetted surfaces are made of stainless steel
  • Optional data recording and formulation management
  • Operator management with password protection for different levels of security
  • Laboratory mills can be used with variable grinding chamber sizes
  • Various materials like NETZSCH-Ceram Z, stainless steel 316 or nylon grinding chamber designs are available
  • Splash-proof machine stand
  • Comprehensive testing and qualification documentation, FAT, IQ, OQ, process validation
  • Trainings and seminars
NETZSCH DeltaVita - Grinding and Dispersing of Pharmaceuticals

Технические характеристики

DeltaVita® 600

  • Interchangeable agitating systems
  • Optional explosion-proof design for installation in hazardous areas
  • PLC control with optional interface for data acquisition
  • Optional CIP and SIP ready

 

DeltaVita® 15 - 300

  • Zeta® grinding system with improved centrifugal separation system using small grinding media
  • The smallest grinding media from 0.05 mm – 2 mm for reduction to the nanometer range
  • Scalability
  • Double-acting mechanical seal
  • Safe, simple and clean operation
  • Variable-speed drive via frequency inverter
  • Flexible mode of operation suitable for continuous-pass and circulation operation
  • Available in two confi gurations – mobile or bench top
  • A selection of four grinding chamber volumes – 15, 50, 150 and 300 ml
  • Operator management with password protection on different levels
  • Optional data acquisition available
  • IP 65 machine stand for complete wash down
  • Optional NETZSCH-Ceram Z, 316 stainless steel or nylon grinding chamber designs
  • Documentation required for validation supplied with the machine
  • Training and seminars
  • Fully CIP and SIP capable
  • PLC control
  • Optional data recording and process formulation management
  • Double acting mechanical seal
  • Choice of wetted components and grinding tools
  • Batch sizes from 4 liters to 4000 liters

Применения

Videos

NETZSCH at the P Mec2013 in Frankfurt, Germany

Литература

Брошюра

Брошюра

As the global leader in particle-reduction machinery, NETZSCH offers the technology and machinery to provide true drug development solutions.

Прикладная литература

Прикладная литература

The pharmaceutical field has long been a model for industry, creating best practices in R&D, manufacturing, marketing and other disciplines. As such it also has recorded historic levels of profitability. But an evolving marketplace, changing regulatory standards, increased manufacturing costs and a number of other factors have begun exerting pressure on pharmaceutical producers.

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