|Contract manufacturing of solid dosage forms|
|Contract manufacturing of solid dosage forms|
ABOUT THE PROJECT
The project for the new technology factory for solid dosage forms is built in accordance with European requirements for Good Manufacturing Practice and ensures control and easy traceability of the manufacturing process at every stage.
The value of the project amounts 75 million BGN, of which 3.9 million BGN were provided by an European project on competitiveness.
The new plant for solid dosage forms will produce over 80 products from major pharmaceutical groups: cardio-metabolic, neurological, psychiatric, respiratory products and OTC products - analgesics and antipyretics. Sopharma is a well-established company in the pharmaceutical industry with 80 years of experience in the production of sterile (injectable, infusion, and lyophilic) forms, liquids, suppositories and semi-solid dosage forms.
In order to create pure product one must ensure a clean environment. Without using the specific terminology, we can say that it is created in order to protect the product, to protect the people and to protect the product from the people.
The plant consists of two main buildings. The first unit is the manufacturing workshop, which for the most part has two floors. On the first floor is located the manufacturing and on the second floor – the technological equipment, which serves the production processes taking place underneath. The second unit is the laboratory and office complex.
At project level the management of processes that consume energy takes into consideration the subsequent costs depending on the workload of production. Practically, the
BMS regulates the system so that the workshop consumes only as much energy as is needed to maintain optimal settings at any time. Furthermore, the BMS manages all the parameters and backs up the data, so that the parameters in any room can be checked against any moment in the past.
The technological process requires certain parameters for the production of the product at different stages, for example a constant temperature of 22 + / -1 ° C, a pressure differential between the premises and the corridors, different humidity below 30%, or between 30 and 60% depending on the product. The BMS manages the various systems, so as to maintain the parameters set by the technologists. For example, the requirements for a clean environment are 100 000 particles with a size of 0.05 microns in 1 cubic meter, whereas in the environment are between three and five million. Around 200,000 cubic meters of air are processed per hour. They do not simply pass, but are also filtered, cooled or heated, depending on the temperature and season.
The movement of materials and products takes place by using special dedusting systems which are for loading and transferring. Here the objective is to produce large volumes, to have absolute consistency in each subsequent step, an absolute uniformity of the product, while protecting the environment.
The new plant uses both purified and drinking and industrial water. Since the process that requires the use of the largest amount of water is washing the machines, through the facilities it is executed by a WIP (purified water) system, which, compared to manual hand washing, saves a lot of water and ensures a quality washing of the equipment.
We are proud that our new plant will have a minimal environmental footprint. Perhaps the most important step in this direction is the repeated reduction of organic solvents used in the granulation process and filming. These organic solvents will be replaced with water ones in our new production process and thus the annual consumption of isopropanol will decrease by up to 20,000 kg and the consumption of the acetone by up to 9,200 kg. We might add also the fact that we have installed 8,000 m2 photovoltaic units which will ensure the reduction of carbon dioxide emissions by up to 900 tons per year. The air coming out of the processes first goes through HEPA filter and is then discharged into the environment.
THE PLANT IN NUMBERS
• Investment – 75 million BGN
• Capacity – 4 billion tablets yearly in a two-shift mode
• 400 jobs, of which 80% are occupied by people with higher education
• Plant for solid dosage forms – built-up area – 22 000 м²
• Laboratory and administrative complex – built-up area – 5000 м²
• High-shelves warehouse with 4200 pallet places with an electronic systems for material management
• The air conditioning system processes around 200 000 м³ of air per hour and has 18 000 м² air pipelines. Provides a controlled working environment for the pharmaceutical production.
• The construction took 2.5 years with a full-time employment of 150 people and over 100 000 workday.
• The materials, equipment and services were contracted with over 200 Bulgarian and foreign suppliers.
• Over 120 km. of cables were used.