Includes three ISO 8 cleanrooms
Gerresheimer Medical Plastic Systems has completed a pharmaceutical packaging and assembly area at its facility in Pfreimd, Germany.
The area has a modern, flexible zone design and comprises three Class D (ISO 8) cleanrooms ranging in size between 70 and 90m2.
The modular production cells are separated from each other by pressure cascades and the rooms are equipped with assembly, filling, and test equipment that complies with the German Pharmaceuticals Act. A Qualified Person supervises the pharmaceutical filling process.
Gerresheimer Medical Plastic Systems has 10 years of experience in the filling and packaging of active ingredients in various application systems.
In 2001, clinical test samples and stability batches of a dry powder inhaler were being filled, but the filling permit was limited to the handling of clinical test samples. It included the production of powder mixtures as well as the assembling, packaging, and labelling of dosing devices that came with the powder mixtures.
In 2007, this filling permit was expanded to include the loading and packaging of applicators with implants. Last year, Gerresheimer Medical Plastic Systems obtained a manufacturing permit, which entitles the company to package and assemble in accordance with the German Pharmaceuticals Act.