German contract developer and manufacturer Haupt Pharma has set up a new separate production area for sex hormone-containing solids that it says sets standards for EHS and GMP. The new department for sexual hormone-containing solids, such as oral contraceptives, will go into operation at the company’s Münster plant next month.
The new area will be used for the manufacture of film- and sugar-coated tablets that will be packed in blisters in a second production step. The company will follow the closed and high-containment principle to prevent substances escaping from the machinery and contaminating the surroundings. This involves the use of a dispensing isolator, one-pot dry mixer and wet-granulating equipment, high-containment tablet presses as well as a film- and sugar-coater. Critical transfer processes will be carried out using containers that allow dust-free loading of the equipment by means of special valve systems and lifting columns.
The facility complies with the latest FDA requirements and can thus also be used for the corresponding US products.
Construction of the separate production area for sex hormone-containing solids began in October 2008 and will be handed over to the production department in November 2009.
The company says this investment underlines its competitiveness in the manufacture of solids with highly potent active substances at the highest technical level.
The handling of sex hormones as HPAPIs requires increasingly complex facilities and machinery to protect the product, the workforce and the environment and Haupt Pharma says it meets these demands by continuously investing in modern technologies.