תיאור
DeltaVita®
Grinding and Dispersing of Pharmaceuticals
General
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
Technique
DeltaVita® 2000 – 60000
- 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
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 ZrO2, 316 stainless steel or nylon grinding chamber designs
- Documentation required for validation supplied with the machine
- Training and seminars
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
