The Molto Mat is designed to be one of the most versatile machines on the market for processing aseptic and fully sterile liquids and semi – solids. It complies to current cGMP, FDA and HSE rules. Pressure vessel certification to PED, ASME and Chinese rules can be chosen from. The Molto Mat is certified for EX Proof till Zone 0 processes.
A full validation package with Software written to GAMP V
is available for each machine.
Features Molto Mat
All k- mix features with extra’s:
2 /3 Bar execution for sterilisation
Double mechanical seals on all shaft movements
Validated Cleaning in Place system
Validated Sterilisation in Place system
Cooling of MS by thermosyphon or presurized unit.
100% sterility assurance level
Handling of Hazardeous materials
Pressure vessel certifcation
Ex Proof executions
The Krieger processing system with extras
The Molto Mat uses the famous Krieger Mixing and Homogenising Process, equipped with our special fluid dynamics counter rotating agitators and the self cleaning CTF Homogeniser with balanced shear. It offers all features of the the K-Mix line, but the Molto Mat has in addition all extra features for manufacturing creams, gels and ointments under more protective, sterile and even hazardous (Toxic) conditions.
The Molto Mat can be upgraded to suit the most demanding processing needs.
100% Sterility Assurance
In the Sterile execution that integrates the Krieger’s sterile processing technology, we can guarantee a 100% sterility assurance level to mix and homogenise products under these highly demanding conditions. Our validated CIP/SIP system provides fast sterilisation times, fast drying and cleaning of the installation.
Handling of hazardous materials
Contained interfaces for loading Hazardous materials enable to load toxic powders or other hazardous materials automatically into the Molto Mat.
The Krieger powder injection system combined with a contained split valve allow to set specific values for different characteristics of hazardous powders (Weight, flowability,...) for a fully automatic loading of toxic and hazardous powders through a bottom valve.
Secure quick vessel opening system
The quick action clamp allows to open and close the vessel in only one second
Before the clamp can be opened, the security bolt on the clamp needs to be unscrewed, eventual residual pressure inside the vessel will be released by this action to secure the operator that the vessel is pressure less when opening the clamp.
Pressure vessel certification
The Molto Mat comes standard with a 2 Bar execution.
Higher pressure ratings up to 4 Bar can be provided.
Pressure Vessel certification to meet the teritory standards is done according to PED, ASME or Chinese pressure regulations.
EX Proof Executions
The Molto Mat is certified for processing semi - solids in an Ex Proof zone 0 environment. For lower EX proof classes. Zone 1 & 2 are avaialble.
The Zone 0 Ex Proof equipment will be certified for each machine by an independent notified body.
For each machine a full validation package with IQ/OQ documents,
SS 316L material certifcates, FDA certified materials, Software GAMP 5 documentation
is provided. On demand our validation engineers will perform the IQ and OQ at your site.