Polpharma began production at its new Dry Forms II plant (Oddzial Formy Suche II – FSII Solid Forms Branch) in Starogard Gdansk, Poland in February 2001. The Dry Forms II plant is a secondary manufacturing facility for the production of tablets, capsules and effervescent tablets.
The Dry Forms II facility complements the synthesis plant situated on the same site producing APIs and carrying out formulation. Both plants are FDA validated and regulated and can carry out contract synthesis and finished forms manufacture respectively.
“Polpharma is a leading domestic provider of pharmaceuticals in Poland, producing generic drugs.”
Since the third quarter of 2001, when it first opened, the Dry Forms II plant has been running at full capacity.
The Dry Forms II project was instigated as the next stage of Polpharma’s development with new manufacturing concepts and techniques. The plant conforms to global pharmaceutical manufacturing standards (cGMP and FDA validation requirements).
Polpharma is a leading domestic provider of pharmaceuticals in Poland, producing generic drugs which are then less expensive than importing the same drugs from the international market. However, it is also equipped to carry out contract synthesis and forms manufacture for the international market.
The output of the Dry Forms II facility in 2001–2002 was five billion tablets, capsules and effervescent tablets per year. By 2003 the production output had risen to eight billion tablets, capsules and effervescent tablets per year.
CONTRACTORS FOR THE DRY FORMS II PROJECT
The construction contract for the plant was awarded to M+W Zander Facility Engineering GmbH, a subsidiary of technology group Jenoptik AG. The order had a contractual value of approximately DM30m ($14.3m) and covered the planning, delivery and installation of the new facility.
Planning from the initial to final design stage of the project was carried out by Life Science M+W GmbH in Stuttgart, a 50:50 joint venture of M+W Zander with the Day & Zimmermann Group of the US. Planning was completed by May 1999, allowing construction work to begin. The construction of the buildings and all the civil engineering work on the site was carried out by Hydrobudowa SA of Poland.
CONSTRUCTION AND INSTALLATIONS
In addition to providing air conditioning and building supply services (refrigeration, heat, vapour), M+W Zander equipped the new production site with clean rooms for the various process requirements (class 10,000 to 100,000).
The plant was also fitted with the latest 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. The manufacturing lines are protected by full containment to prevent APIs affecting the employees and to prevent contamination of the products. To these ends 3,500m² of the production areas are clean zones. To enter these zones staff 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 (volume of 140,000m³), 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
Polpharm was very interested in producing drugs as a contract manufacturer after the privatisation. To this end the company improved its manufacturing processes to comply with Good Manufacturing Practice (GMP) regulations. Part of the process for this involved a new Manufacturing Execution System (MES).
The contract for this was awarded in September 1999 to the Warsaw-based company ATM S.A. for delivery, installation and validation of a POMS MES system from the POMS Corporation of the US (taken over in the same year by Honeywell).
In the dry forms II plant the 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. Provision was also made for expansion of the dry forms II facility (space for 120 POMS MES work stations). The system was installed and validated in compliance with the methodology and concepts of the Good Automated Manufacturing Practice Guide (GAMP 4). The system has totally integrated ordering of raw materials, production, packaging, warehousing and movement of stock to wholesalers.
Polpharma is a leading pharmaceutical company in Poland. It produces a wide range of ready-to-use drugs in over 80 different forms and dosages. The company is also one of Poland’s largest producers of pharmaceutical intermediates.
“In late 2006 Polpharma was awarded a certificate of Good Manufacturing Practice (GMP) for the production of 30 active ingredients.”
Polpharma is the largest manufacturer 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 the Dry Forms II facilities.
Plans are also being made to invest in a new 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 (seven of which are approved by the FDA).
In late 2006 Polpharma was awarded a certificate of Good Manufacturing Practice (GMP) for the production of 30 active ingredients. In the first half of 2006 the company also launched seven new products to expand their 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).