תיאור
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
• Production of GMP compliant machines in the USA
• Trainings and seminars
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
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
