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
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Technique
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
- Zeta® grinding system with improved centrifugal separation system using small grinding media
- The smallest grinding media from 0.05 mm – 0.8 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® 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
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