Ampoule plant Sopharma - modern production that saves lives
The 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.