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Gerresheimer Medical Plastic Systems is expanding its range of services to offer more complete solutions. In addition to injection molding, assembly, packaging and finishing, the service portfolio now includes pharmaceutical product assembly and packaging. Gerresheimer Regensburg GmbH facility in Germany now has a pharmaceutical packaging and assembly area. The area is comprised of three clean rooms classified and validated in accordance with GMP Class D (ISO 8), ranging in size between 70 and 90 square meters.
“When producing different products, the production areas must be physically separate,” said Armin Henning, director of production sites in Europe. “The packaging and assembly area therefore consists of modular production cells, which are separated from each other through pressure cascades. The rooms are equipped with assembly, filling, and test equipment that complies with the guidelines of the German Pharmaceuticals Act. Compliance with the quality standards is guaranteed through regular audits by the government of Upper Bavaria. The pharmaceutical filling process is supervised by a ‘qualified person,’ a pharmacist with 25 years of experience in the area of the production of pharmaceutical products.”
“When producing different products, the production areas must be physically separate,” said Armin Henning, director of production sites in Europe. “The packaging and assembly area therefore consists of modular production cells, which are separated from each other through pressure cascades. The rooms are equipped with assembly, filling, and test equipment that complies with the guidelines of the German Pharmaceuticals Act. Compliance with the quality standards is guaranteed through regular audits by the government of Upper Bavaria. The pharmaceutical filling process is supervised by a ‘qualified person,’ a pharmacist with 25 years of experience in the area of the production of pharmaceutical products.”
