Polpharma began production at its Dry Forms II plant in Starogard Gdanski, Poland, in February 2001.
The plant is a secondary manufacturing facility for the production of tablets, capsules and effervescent tablets. It complements the company’s synthesis plant at the same site, which produces active pharmaceutical ingredients (API).
Both plants are US Food and Drug Administration (FDA) validated and regulated. The synthesis plant carries out contract synthesis, while the Dry Forms II plant deals with finished forms manufacturing.
Since opening in Q3 2001, the Dry Forms II plant has been running at full capacity. It was instigated as the next stage of Polpharma’s development, with new manufacturing concepts and techniques.
The plant conforms to global pharmaceutical manufacturing standards, current good manufacturing practices (cGMP) and FDA validation requirements.
Polpharma is a leading domestic provider of pharmaceuticals in Poland, producing cost-effective generic drugs. It is also equipped to carry out contract synthesis and forms manufacture for the international market.
The output of the Dry Forms II facility between 2001 and 2002 was 5bn tablets, capsules and effervescent tablets per year. By 2003, the production output had risen to 8bn.
A construction contract for the plant was awarded to M+W Zander Facility Engineering, a subsidiary of technology group Jenoptik.
The order had a contractual value of approximately $14.3m and covered the planning, delivery and installation of the new facility.
Planning for the project was carried out by Life Science M+W in Stuttgart, a 50:50 joint venture (JV) of M+W Zander with the Day & Zimmermann Group of the US. Planning work was completed by May 1999, allowing construction to begin.
The construction of the buildings and all the civil engineering work on the site was carried out by Hydrobudowa.
In addition to providing air conditioning and building supply services, M+W Zander equipped the new production site with cleanrooms for sterile production.
The plant was also fitted with clean-in-place (CIP) systems to allow the process equipment to be maintained and cleaned to a satisfactory standard between production batches without major disassembly.
The Dry Forms II facility has a floor space of 25,000m². Of this, 3,500m² is designated as a clean zone to prevent API on manufacturing lines from affecting staff. To enter these zones, employees are required to pass through regulated positive pressure air-locks and wear special shoes and coveralls.
There are six floors in the 115m-long building, which are each divided into functional zones. These include a production zone on the second, fourth, fifth and sixth floors, a storage zone for APIs and finished products on the second and third floors, mechanical workshops on the first floor, employee areas on the second floor, and administration and quality control laboratories on the third floor.
Validation for the new market
In order to produce drugs as a contract manufacturer after its privatisation, Polpharm improved its manufacturing processes to comply with good manufacturing practice (GMP) regulations, including a new manufacturing execution system (MES).
The contract for the MES was awarded in September 1999 to the Warsaw-based company ATM for delivery, installation and validation of a POMS MES system from the POMS Corporation of the US (which was taken over in the same year by Honeywell).
Implementation of the MES system involved 70 POMS MES system workstations and more than 40 machines and production lines, including packaging lines, wet granulation lines and a tabletting and effervescent tablet packaging line. All of these systems were integrated to improve the production efficiency of the plant.
A provision was also made for future expansion of the Dry Forms II facility. The system was installed and validated in compliance with the methodology and concepts of the good automated manufacturing practice guide (GAMP 4). The system integrated ordering of raw materials, production, packaging, warehousing and movement of stock to wholesalers.
Polpharma is a pharmaceutical company in Poland that produces a wide range of ready-to-use drugs in more than 80 different forms and dosages.
The company is also one of Poland’s largest producers of pharmaceutical intermediates and one of the largest manufacturers of cardiology drugs in the country, offering a wide range of therapeutic standard drugs for patients with ischaemic heart disease and Type 2 diabetes mellitus.
Polpharma was privatised in December 1995. In July 2000 a consortium of investors led by Spectra Management purchased a 52% stake and the company became privately owned. This led directly to a new capital investment in the synthesis plant and Dry Forms II’s facilities.
Plans were also made to invest in a multipurpose plant to expand the company’s operational range to allow special reaction conditions such as low-temperature reactions.
Polpharma manufactured 1,800t of APIs in 2002. The company holds 25 drug master files (DMF) for APIs.
In late 2006, Polpharma was awarded a certificate of GMP for the production of 30 active ingredients. In the first half of 2006, the company also launched seven new products to expand its active portfolio, including Glibetic (glimepiryd), Trioxal (itrakonazol), Epilactal (lamotrygina), Ryspolit (risperidon) (as trong dopamine blocker used as antipsychotic medication), Zotral (sertralina), Acidolac (Lactobacillus acidophilus) and Meloxic (meloksikam).
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