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Freeze dryers and Freeze drying

Freeze dryers and freeze drying

Progress-PME has the knowledge and experience to install and validate complex pharmaceutical installations, such as freeze dryers, in your company. We have already proved our ability to successfully manage the whole process from concept to transfer of the validated installation to the end user.

Replacing a freeze-drier for a drug manufacturer
Progress-PME replaced an existing freeze dryer with a new freeze dryer with three times as much plate surface. We implemented this project for a manufacturer of parenteral (intravenous) drugs which are freeze-dried in bottles. Progress-PME was responsible for the project management, consisting of:

  • removal of the existing freeze dryer
  • installation of the new freeze dryer
  • implementation of the required architectural and grade A/B air-technical modifications

Minimum production downtime
An important condition for this project was that the replacement should be completed with minimum production downtime. In order to achieve this goal, the project was implemented in phases. Short periods of production downtime alternated with longer periods when production could continue as normal. After each production downtime, the validated cleanrooms were transferred to the production department.

Validation work
In this project, most of the validation work for the freeze dryer and the cleanrooms (class A/B) was performed by our personnel. Besides the usual tests for the installation qualification, operational qualification, performance qualification and process validation (conformance runs), more specific tests were also carried out, including product temperature measurements during the freeze drying process.

The result
Progress-PME successfully installed and validated the freeze dryer. 

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