The highly technological process for development and production of Sopharma’s medicinal
products is licensed according to the Good Production Practices. For only a few months
the main production facilities were modernized and new factories and plants were
In 2010 another highly technological plant for solid forms will be fully operational. It is
designed as a small compact complex of buildings – for main production, for packaging,
warehouse, administrative building and central laboratory – buildings of 8 966 sq. m. and
a total area for utilization of 13 502 sq.m.
All activities related to the project - construction and validation - are carried out according to the European Standards for pharmaceutical production and are coordinated with the Bulgarian National Drug Agency.
BULGAMMA is a facility for gamma radiation and is the only large-scale facility of this type in Bulgaria. The source of the gamma rays is the radioactive isotope Cobalt-60. This is the most popular isotope used in radiation technology.
The radiation facility BULGAMMA is operational since 1990 which allowed us to gain substantial experience in the radiation technology for sterilization of a wide range of products and materials.
The gamma-ray radiation is the most modern method for cold sterilization preferred over the usage of highly cancerogenic and mutagenic toxic gases.
Due to its competitiveness, the gamma-ray method for sterilization is preferred by most businesses.
The facility is validated by its producer NORDION, Ottawa, Canada, which is a leading producer of radiation facilities.
The processes are carried out according to the requirements of GMP.
The qualification of the personnel corresponds to the strictest requirements of the International Agency for Atomic Energy.
The radiation apparatus in BULGAMMA is licensed and controlled by the Agency for Atomic Regulation of the Republic of Bulgaria.
The technology is applied for a variety of purposes:
THE MAIN ACTIVITIES PERFORMED AT BULGAMMA ARE:
1. Sterilization of disposable medical materials (syringes, needles, catheters, chirurgical gloves etc.).
2. Disinfection of different products: cosmetics, pharmaceutical substances, dry food additives, teas, raw materials etc.
At BULGAMMA we have a microbiological laboratory with extensive experience in the determination of suitable radiation doses for different products according to their contamination and the quality requirements for the end product.
Pharmaceutical contract manufacturing