Ampoule plant Sopharma - modern production that saves liveThe ampoule plant in Sofia is the only plant of its kind for the production of ampoule forms of humanitarian medicine in Bulgaria. It is licensed by the BDA and meets international standards of Good Manufacturing Practice (GMP).
In 2007, Sopharma undertook a complete reconstruction of the ampoule production, doubling its capacity. To ensure quality and safety according to European requirements for ampoule dosage forms, for the most part, life saving, Sopharma invested 6 million EUR in modernization and reconstruction of the plant.
A new production line for dosing was introduced with a capacity of 24 thousand ampoules / hour. The new equipment has RABS / Restricted Access Barrier System /, enabling to ensure a high level of sterility of the product.
The introduction of RABS allows to reduce the influence of human factor, which is guaranteed by the original design of the machine / "quality by design" /, produced and installed by Bosch - a leading producer of filling machines. Equipped with full electronic control of dosing and sealing of ampoules.
The three new autoclave machines from "Getinge" are fully automated and allow for storing all process parameters. The automated line for visual grading and testing for leaks of full ampules provide for 100% quality control and excludes any human intervention.
The new labeling machine for ampoules of graded readers have e-phar-codes for medicinal products, which provides additional protection against counterfeiting. The state-of-the-art air conditioning system maintains parameters of the environment as required by the production of sterile products. Product portfolio includes solutions for injection of the major pharmacotherapeutic groups - gastroenterology, cardiology, pulmology, allergic, analgesic and anti-pyretic.
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.
We offer suppository products of high quality at economical prices in bilayer PVC/PE packs.
The suppositories plant of Sopharma AD is another unique production for Bulgaria.
In the beginning of 2005 we opened the fully renovated plant specialized in the production of non-sterile suppositories and peccaries licensed by the Bulgarian National Drug Agency and running under GMP requirements.
The product portfolio includes suppositories and peccaries from all pharmaceutical therapeutic groups for rectal and vaginal application - gastroenterology, allergy, analgesics, anti-inflammatory, antifungal and antibacterial.
Main manufacturing equipment includes:
- Homogenizer Fryma VME-400
- Vessel 120 l
- Filling and packaging line Sarong SAAS 15/AP
For additional information, please contact us:
Ana Lichkova Manager Contract Manufacturing and New Products
Tel: (+359 2) 8134 732
The "Vrabevo" plant – The Bulgarian dream come true.
In 2003 the new plant of Sopharma Ad in Vrabevo was opened by the President of the Republic of Bulgaria Mr. George Parvanov. The investments made amount to 10 million EUR and every step of the construction of the plant are carried out according to GMP standards. The plant is situated in the ecological area of the Troyan mountain with a total production area of 6 000 sq. m. The plant is a proof of the high social responsibility of Sopharma and provides 350 working places – a real opportunity for the local population. The plant has a license by the Bulgarian National Drug Agency for production of solid forms, gels, syrups and unguents. The main medicinal products produced at the plant are in the following areas: gastroenterology, cardiology, pulmology, allergy, analgesics, antipyretic, psychopharmacological and chemotherapeutic.
The production capacity includes:
- Solid forms: 1 billion annually
- Syrups: 20 million annually
- Unguents: 30 million annually
The plant received the award for the best production building in the national competition Building of the Year 2003 and was licensed under the provisions of EU Directive 91/356.
Pharmaceutical substance plant
The new pharmaceutical substances plant for production of phyto substances was opened in 2008. The plant is a part of the production cycle of Bulgarian Rose Sevtopolis AD, Kazanlak and is a unique module for extracting the active ingredients from herbs.
As a result of a highly technological cycle of refining, drying, grinding, homogenization and packaging, annually more than 1500 tons of plants will produce 100 tons of pharmaceutical substances as dry and liquid extracts. The high quality substances will be used in the production of the original phyto products of Sopharma – Tabex®, Tribestan®, Carsil®, Nivalin®, Broncholitin® etc.
The capacity of the pharmaceutical production is 1 billion tablets annually. The project and the construction of the tablet plant correspond entirely to the rules and requirements of the Good Manufacturing Practices.
The newly constructed building of the plant has a usable area of 1600 sq. m., and the investment in the new project amounts to 2.5 million EUR. 280 people work at the Bulgarian Rose – Sevtopolis, including those in the highly technological new production facility that operates on a continuous 3 shift regime.
The laboratory for Pharmacokinetics and Clinical trials by the “Medical and Regulatory Affairs” Department has established its name throughout the years as one of the leading laboratories in the field of pharmacokinetic research and studies for bioavailability/ bioequivalence.
The laboratory is fully equipped, with extended capacity, with an implemented system according to Good Laboratory Practice (GLP) and complies with all current regulatory requirements.
Main activities and services:
- Time-critical development and validation of new methods in accordance with customer’s requirements:
- Medicines and Metabolites;
- Combined medicines;
- Assay of analytes in biological matrices;
- High volume sample analysis Study report writing
- As a part of the Medical and Regulatory Affairs Department at Sopharma, the laboratory offers:
- Complete BA/BE project management, pharmacokinetic studies;
- Regulatory submission and consultancy in compliance with the international standards.
- Our long-term partnership with leading Contract Research Organisations (CROs), scientific and research organisations and academic facilities enables us to provide a complete service for pharmacokinetic and bioavailability/ bioequivalence studies:
- Documents preparation;
- Study design;
- Clinical phase;
- Statistical analysis;
- Final study report.
The key advantages of the laboratory are:
- Highly qualified personnel
- Conduction of all studies in compliance with the principles of GLP
- Complex services with high quality and optimal prices.Нашата мисия : „Прецизна работа, надеждни резултати”.
Our mission: “Precise work, reliable results.”