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We are proud to announce that a fully modernized facility for the production of active pharmaceutical ingredients (API) has been put into operation to meet our customers’ continuously growing requirements as regards quality and quantity.

News   |   01.09.2017

A completely rebuilt and modernized production facility for the production of API was put into operation in February 2017 as Polpharma Pharmaceutical Works’ response to our customers’ continuously growing requirements as regards quality and quantity. The hall is equipped with 11 enamelled reactors and 5 stainless steel reactors with working capacity from 350L to 4,000L, providing for total capacity of approximately 40,000 litres. One of the technological lines is made entirely of Hastelloy C22 steel, which allows for the production of very sensitive yet also very aggressive substances. Thanks to the use of so-called “Flow Plate”, all devices (reactors, filters, etc.) can work in virtually any configuration.

In the synthesis zone it is possible to carry out the following, among others: Amidation, Ginard's reaction, Esterification, Methylation, Metho- / Ethoxylation, Acetylation, Coupling, Cyclization, Dehydrogenation, Hydrogenation and Lithiation.

In order to protect the air, VOC (Volatile Organic Compounds) emission sources are connected to an RTO (Regenerative Thermal Oxidizer), which guarantees full utilization.

In the finishing area, the so called “clean zone: has been designed to comprise two lines consisting of automatic centrifuges and vacuum dryers (conical and double cone ones). Other units in this area (micronizer, homogenizer, vacuum paddle dryers, granulator, sieve and packaging head) further increase the whole facility’s versatility.

Employee safety is ensured by means of fire, explosion and dosimetry systems integrated with the Company's Monitoring Centre to detect any hazardous conditions and objects (e.g. fire, increase in hazardous substances, oxygen levels).

The hall has also been equipped with DCS and BMS / EMS computer control and monitoring systems. Siemens DCS PCS7-type system allows for automatic control of heating and cooling parameters in the reactors, for process parameters archiving and control of the processes carried out in machines equipped with their own autonomous control based on Siemens S7-300 PLCs (centrifuges, dryers, etc.). Meanwhile, the BMS / EMS system, integrated with PlantX by Rockwell Automation, is responsible for regulating and monitoring environmental parameters in production areas in the clean zone and in storage areas.

A production hall configured in the above manner creates the potential to produce up to 500MT of product per year. However, keep in mind that the facility is not dedicated to one product only. Two independent lines for the production of technical products and two lines for the production of pharmacopoeial products allow for simultaneous production of even several different products under “full GMP” conditions.