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