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On my homepage services are described related to the pharmaceutical machines manufactured for the aseptic production of drug product.

Aseptic Pharmaceutical Processes

Several machine manufacturers for the packaging of pharmaceutical products and a lot of suppliers have been settled in Crailsheim and environment.This companies provide their products to pharmaceutical manufacturers in the whole world.
The term Packaging Valley has firmly established itself and the region is known from pharmaceutical companies as a center for the production of high quality packaging equipment.
The portfolio of system manufacturers is constantly expanding (keyword one stop shopping), so that not only filling and sealing machines are delivered, but also facilities for the adjacent processes. Such processes are e.g.
  • Sterilization with clean steam.
  • Dry Heat Sterilization.
  • Depyrogenization of primary packaging materials.
  • Decontamination of surfaces with Vaporized Hydrogen Peroxide.
  • Freeze Drying.

These processes must be validated according to the applicable pharmaceutical regulations. The qualification of equipment is offered often and in different ways by the equipment manufacturers as a service.

The validation of the processes is running in most cases under the direction of the pharmaceutical companies.

Interface to Engineering

During the validation it is demonstrated that the process meets the requirements for preparation of a drug. This requires a good knowledge of the system functions as well as a detailed knowledge of the pharmaceutical regulations.

At this interface often interdisciplinary teams are working on the qualification / validation of the systems. The services presented on this pages provide the necessary professional knowledge and experience for the work at this interfaces. The experiences gained during this collaboration promote the understanding for the overall pharmaceutical process (PAT).

Process Analytical Technology - PAT

The innovative approach - PAT - demands a risk assessment and minimization for the manufacturing processes to ensure the quality of pharmaceutical products. For this, a detailed understanding of the relevant processes is necessary. Quality should arise already during the manufacturing process and not afterwards determined by test. - „The goal of PAT is to enhance understanding and control the manufacturing process, which is consistent with our current drug quality system: quality cannot be tested into products; it should be built-in or should be by design.” 1. (FDA, Guidance for Industry: PAT – A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance, September 2004, S. 4)

 

Bibliography:

1. FDA, Guidance for Industry: PAT – A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance

September 2004, http://www.fda.gov 

Picture:

k8442331 / www.fotosearch.de