Borth Salt Mine Produces Pharmaceutical Ingredient
High-purity Evaporated Salt for the Pharmaceutical Industry
This summer the Borth salt mine belonging to esco – european salt company commenced production of API sodium chloride. API stands for "active pharmaceutical ingredient" and designates substances, which meet the most stringent pharmaceutical purity requirements and are continuously monitored and documented in all process and processing stages. When she came to hand over the manufacturing authorisation on 20 October, Dr. Dorothea Prütting, Head of the Health Department at the Ministry for Work, Health and Social Affairs of the State of North Rhine-Westphalia, visited the Borth mine and saw the process for herself.
The basis for the new production line is a directive on the production of pharmaceutical ingredients, which has been valid since October 2005, and specifies in detail how substances must be produced, analysed and their composition permanently checked. Moreover, API products must fulfil all requirements of the relevant international regulations.
In order to be able to commence production of API sodium chloride in Borth in accordance with the new requirements, it was, in addition to implementing a comprehensive quality management system compliant with the rules of GMP (good manufacturing practice), necessary to adjust the existing production and further processing technology. The project, with which the plant has opened up a promising market segment for itself, was approved by the regional government in Düsseldorf as the approval authority. Altogether, 350.000 Euro have been invested in modifying the production facilities. The training of employees working in this area was especially important, since all operations have to be documented continuously. Modern process guidance and control systems have been installed for these varied process- management and monitoring tasks. After internal checks and an inspection by the regional government, production started this summer. Production itself is subject to strict internal checks and will also continue to be subject to external checks by customers and authorities. The production capacity of the plant has been adjusted so that it meets market requirements and can be expanded in a modular fashion.
Pharmaceutical sodium chloride is used primarily in infusion and dialysis solutions. esco is the leading manufacturer of pharmaceutical sodium chloride in Europe. The company’s most important market regions abroad are Asia, South America, the Middle East and Africa.
One of the world's leading suppliers of salt
The K+S Group offers its customers a complete range of high-quality salt products for industrial applications, commerce and household use, and has particularly advantageous and cost-effective production and logistics structures.
With its two subsidiaries esco – european salt company and the Chilean Sociedad Punta de Lobos,
acquired in June 2006, K+S is among the world’s top producers of salt. esco and SPL sell a total of
more than 10 million tons of salt products annually and furthermore possess considerable reserve
capacity, which is used chiefly to ensure especially reliable deliveries of winter road clearance
products to customers.
10/20/06 12:00 AM
