應用實例:

實際安裝


奈米製藥 實驗/量產型設備                 

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 DeltaVita® 10000