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