In 2007 ICROM opened a new GMP manufacturing unit with the purpose of carrying out niche APIs productions and chemical development studies under Custom Synthesis agreements with its clients.
It is the perfect GMP manufacturing unit to produce small volume of those API's which are New Chemical Entities devoted to Clinical Trials.
The GMP Kilo Lab is a self contained GMP manufacturing unit, fully independent from the other processing units, and is equipped with:
- 4 x 25 L glass reactors
- 2 x 10 L glass filters (30 cm diameter)
- 2 vacuum driers of 120 L each
The GMP Kilo lab is in class 100.000 (ISO 8) and can operate in ranges from 0.05 to 0,5 bar and from - 20 °C to 150 °C.
This GMP manufacturing unit has independent ancillary services (warehouses for starting materials and finished products, utilities, HVAC and USP purified water system) and enables ICROM to carry out small scale special GMP manufacturing and chemical development studies and new API development processes in full GMP compliance.
ICROM is therefore fully capable of providing full scale up operations and commercial production of high valued products with volumes ranging from few hundred grams to several kg.
The GMP manufacturing unit is supported by ICROM R&D and Quality Unit Staff.
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