應用實例:

實際安裝

奈米製藥 實驗/量產型設備

Grinding and Dispersing of Pharmaceuticals

NETZSCH DeltaVita

     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 ZrO2, stainless steel 316 or nylon grinding chamber designs are available
  • Splash-proof machine stand
  • Comprehensive testing and qualification documentation, FAT, IQ, OQ, process validation
  • Production of GMP compliant machines in the USA
  • Trainings and seminars

 

DELTAVITA Technology

 

DeltaVita® 15 – 300 (Lab scale)

  • Zeta® grinding system with improved centrifugalseparation 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 ZrO2, 316 stainless steel or nylon grindingchamber designs
  • Documentation required for validation supplied with the machine
  • Training and seminars

DeltaVita® 600 (Trial production)

  • 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® 2000 – 60000 (Production units)

  • 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

DV 10000 mill appearance

 

Product out let and plate

 

 

Grinding chamber bottom

 

Sterilization In Place (SIP)


DELTAVITA Technology


Mill Appearnace / 機台及相關閥門外觀

Various Valves / 閥門做動狀況

System Overview (On Contril Panel) / 系統配置圖

SIP Sequence / SIP 流程

Parameter settings (Changeable)/各項系統參數設定

Pressure Hold Test for Sealing Liquid Loop / 軸封液管路壓力維持測試

Pressure Hold Test for the Milling Circuit / 物料管路壓力維持測試

 



Draining the Selaing Liquid / 洩除軸封液

 

Sterilizing the Seal Loop in Forward Direction / 軸封液管路正向滅菌



Sterilizing the Seal Loop in Reverse Direction /
軸封液管路反向滅菌


Filling the Seal Loop / 軸封液管路填充

Sterilizing the Milling Chamber and the Piping / 研磨室及物料管路滅菌

Sterilizing Inlrt/Outlet Valves / 進出料閥門滅菌

Milling Process / 物料研磨



Blow Down /
物料洩除

Netzsch Pharmaceutical mills

Grinding and Dispersing of Pharmaceuticals

NETZSCH DeltaVita systems

DeltaVita DV15-300 (Lab scale)

Grinding chamber bottom with screen                                      Agitator shaft with chamber extension kit

 

Grinding chamber seat                                                                Mech seal face seal

 

Guide rail for seal tank for easy cleaning                                  Polished seal tank interior for easy cleaning

 

DeltaVita DV600 with SIP (Trial production scale)

Appearance


Grinding chamberPALL filtration

Seal fluid tank

DeltaVita DV10000 (Production scale)

Switch cabinet ventilation system

Seal reservoir level transmitter

Integrated switch cabinet

Integrated graphic control system

Integrated pump