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Concentrates for hemodialysis

The company is the major manufacturer of concentrates for hemodialysis in Bulgaria. New types of concentrates are under development, which are expected to offer additional therapeutic solutions for the treatment of renal insufficiency.

The company is the major manufacturer of concentrates for hemodialysis in Bulgaria, by manufacturing and qualifying the products in compliance with the European normative requirements.
In 2006 the facilities were partially reconstructed which led to process optimization and production capacity increase.

Beginning
On May 22th, 1981 a scientific production laboratory was established for the manufacture of hemodialysis concentrates.

Reconstructions
In 1992-1994 a new workshop was established for the manufacture of concentrates for haemodialysis at Unipharm JSC. In 1999-2000 a second major reconstruction was performed of the technological production line for concentrates for haemodialysis where a total of BGN 5.1 million were invested.

Today
The concentrates for hemodialysis of Unipharm JSC, which is a part of Sopharma Pharmaceuticals, are high quality medical products, manufactured while observing both the strict regulatory requirements in the country and the international production standards, such as GMP, ISO 9001 and ISO 13485.

• The technological premises are fully provided for class of cleanliness (Class D) with controlled temperature, humidity and air purity ;
• Up-to-date equipped warehouses are provided for raw materials, immediate and outer packaging materials, which are input in manufacture after a compulsory incoming control;
• Only pharmacopoeial raw materials from validated suppliers are used for the manufacture;
• The company disposes with its own water handling facilities, and the purified water produced, conforming to the requirements of European Pharmacopoeia, is used in all technological operations;
• A closed cycle is ensured for the production of concentrates for haemodialysis using high class technological equipment (reactors, membrane filtration).
• The concentrates for haemodialysis are automatically dosed, sealed and labeled in disposable primary packages of polyethylene-teraphtalate by the machine on the production site.
• Each production batch of concentrates for haemodialysis has a strictly kept batch documentation;
• Unipharm AD ensures the continuous improvement of its staff’s qualifications through various forms of education;
• The leading pharmacists of this manufacture have a long-time production experience and excellent theoretical training.

Control

Since its establishment till today the Company relies on the excellent quality of the concentrates for hemodialysis. Control is performed at all stages of the technological process in the Company's own chemical-analytical and microbiological laboratories, which are an integral part of the Analytical Block of Unipharm AD, conforming to GLP.

The requirements for the chemical, microbiological and biological control methods of the concentrates for haemodialysis are also being currently increased.

• Incoming control – compulsory for all raw and auxiliary materials, the purified water, immediate and outer packaging materials;
• Repeated in-process control (IPC) both of the temperature, рН, clarity, conductivity, and of the ion composition of solutions;
• Control of each batch of the finished product – Concentrates for haemodialysis with constant parameters – continuous increase of the requirements to the precision of the chemical analyses performed on up-to-date apparatuses, harmonized with the newest requirements of European Pharmacopoeia (atom absorption apparatus, automatic titrators, conductometers, etc.);
• Compulsory microbiological control to determine the total count of microorganisms and the pathogenic microorganisms restricted in the concentrates for haemodialysis by using Crystal automated system (Becton and Dickinson,USA)

• Since as early as 2001 at Unipharm JSC the method for determination of endoxines (LAL test) for biological control of concentrates for haemodialysis, purified water and some raw materials has been used;

According to the requirements of GMP, ISO 9001 and ISO 13485 each production batch of concentrate for haemodialysis has strictly kept batch documentation.
The concentrate for hemodialysis dispatched to the hospital Haemodialysis Center must be accompanied by Release for Sale and Batch Certificate.
It ensures the reliability of the delivered pharmaceutical product and the precision of adjustment of the hemodialysis apparatuses to provide quality dialysis.
Stretch foil-wrapped, palletized and reliably stacked products are delivered to the hospitals with the Company's own transport.

The company produces 56 types of concentrates for haemodialysis:

- 4 types of Acetate concentrates with dilution 1:35

- 3 groups of Acid bicarbonate concentrates with dilution 1:35

- 1 group of Acid bicarbonate concentrates with dilution 1:45

- 2 Basic bicarbonate solutions 8,4% and 8,4% Plus.

Unipharm includes in its production list also dry bicarbonate for haemodialysis in two types of packaging „cart” and „bag”.

Certificates

Since 2008 Unipharm is certified according to the international standards ISO 9001, ISO 13485, and the manufactured concentrates for hemodialysis have a CE-marking in accordance with the requirements of Directive 93/42/EEC.

Concentrates for hemodialysis Concentrates for hemodialysis Concentrates for hemodialysis