May 4, 2022
ALKALOID OPENS NEW, €1.8 MILLION MANUFACTURING FACILITY
The new plant for manufacturing dialysis concentrates, including a raw materials, packaging, and finished products warehouse occupies 2.600 m2. It complies with the strict good manufacturing practice standards, medical device manufacturing regulations, and quality assurance directives.
Following the newest industry trends in the production of affordable, quality, effective, and safe products is a principle deeply rooted in Alkaloid’s corporate policy and its brand guarantees high quality and safety. In the past 15 years, the company has invested nearly €200 million in manufacturing facilities, laboratories, new technologies, research and development, and continuous employee education. Investments continued throughout the crisis caused by the Covid-19 pandemic.
"Nowadays, Alkaloid sells over 65% of its products in about 40 countries worldwide, incorporating the global pharmacy, chemistry, phytotherapy, and cosmetology trends into its daily operations. Haemodialysis solutions have been part of the company's medical portfolio since 1990, and now, three decades later, we are launching state-of-the-art manufacturing facilities for this type of product. With an annual production output of nearly 15 million litres, we will be able to meet the market demand in the region and beyond," said Zhivko Mukaetov, Alkaloid’s Chief Executive Officer and President of the Management Board.
The new production facilities consist of 3 units - preparation of haemodialysis concentrates, production of purified water, and packaging of solutions. The process equipment consisting of three mixer-reactors and a preparatory container has a total volume of 25.000 litres. Designed to ensure state-of-the-art, fully automated manufacturing, it allows for fast, accurate, and reliable operation. The special robotic line can fill and package 7.500 litres of ready-to-use haemodialysis concentrates per hour. This manufacturing plant is largely powered by Alkaloid’s own renewable electricity sources.
The Alkaloid’s Chemistry Department, established in 1957, started producing haemodialysis solutions at the beginning of the 90s, where the solutions were developed and controlled for quality. It begun with manufacturing solutions for acetate dialysis and then for bicarbonate dialysis. Today, products range from concentrated solutions with various dilution ratios to dry bicarbonate cartridges and solid and liquid sets, suitable for all modern haemodialysis machines.
In 2010, Alkaloid’s solutions for haemodialysis were CE-certified for compliance with the European Medical Devices Directive.