Pilot Plant modernization
POLPHARMA has developed the necessary in-house expertise to design and realize modern and cGMP compliant API development facilities.
One of the latest investments was the modernization of SMALL SCALE PRODUCTION AND DEVELOPMENT GMP FACILITY that was finalized in January 2006.
Investments resulted in the design of an outstanding Pilot Plant Crystallization, Drying, and Isolation (CD&I) area.
State-of-the-art engineering techniques, such as 3D-modelling and the use of best design practices, such as Design Review, HSE review, HAZOP, and cGMP review enabled us to develop a modern, ergonomic, and safe working environment meeting the highest standards for occupational safety and product protection.
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After finalizing the modernization the plant has the required flexibility to scale-up the processes. It is equipped with three processing lines with solution preparation vessels and reactors capacity of 100L, 250L, and 500L.
The equipment is designed and installed with the intention of minimizing the environment impact. In the critical points, where powders are handled, a dedusting system with local exhaust hoods provides the required level of containment and cross contamination control.
The HVAC system and the critical parameters of the process are controlled through 200 I/O points of DCS system supplied, and integrated by one of the most qualified industry monitoring systems with paper print-outs to be used with the batch manufacturing record.
Carefully selected and qualified materials and cleaning agents assure the highest level of cleaning effectiveness without compromising the quality of the end product.
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