Haupt Pharma: New Separate Production Area for Sex Hormone-Containing Solids Sets Standards for EHS and GMP - Pharmaceutical Technology
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Haupt Pharma: New Separate Production Area for Sex Hormone-Containing Solids Sets Standards for EHS and GMP

Handling of sex hormones as highly potent, pharmacologically active substances requires increasingly complex facilities and machinery to protect the product, the workforce and the environment. Haupt Pharma meets these demands by continuously investing in modern technologies. The provided services will be further optimised by a new production department for sexual hormone-containing solids, such as oral contraceptives, that will go into operation at the Münster plant.

Haupt Pharma will use the new production facilities to manufacture film- and sugar-coated tablets that will be packed in blisters in a second production step. The new facility follows 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.

With respect to the handling of highly potent active substances, the greatest hazard is working with powders. This risk is considerably reduced by processing in closed systems. The new production 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.

This investment underlines the competitiveness of Haupt Pharma in the manufacture of solids with highly potent active substances at the highest technical level.

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