Lyophilizer Qualification: Some Practical Advice
Lyophilizer Qualification: Some Practical Advice
September/October 2004
Thorsten Fischer, ZLB Behring GmbH (formerly Aventis Behring GmbH), Department Facility Qualification
Key words: Control system; Computer and Software Validation (CSV); Empty Chamber Temperature Distribution Study; Installation Qualification (IQ), Lyophilizer; Shelf Temperature Distribution Study; Operational Qualification (OQ), Performance Qualification (PQ); System Qualification Procedure (SQP).
This article describes the commissioning and qualification of a technically upgraded lyophilizer after performance of defined changes. The article assumes that the reader is passingly familiar with the basic theoretical development of lyophilization, computer and software validation and equipment qualification. It gives a practical report of the qualification activities (IQ/OQ/PQ) performed on the upgraded equipment.
From experience of several recent FDA-inspections, lyophilizer qualification is one of the most discussed topics. Lyophilizers are amongst the most complex equipment used for production. Qualification requires knowledge in many diverse fields including computer and software validation, mechanical and electrical engineering, refrigeration engineering and steam sterilization.
This article presents the results of a hands-on approach, by a report of experiences, to the efficient and reliable qualification of lyophilizers.
The project was initiated by a change control request one year before starting commissioning. The change request identified that an existing lyophilizer required equipping with a new control system, an automatic filter integrity test system and associated new pipe work.
Before starting the project, the contributing departments of Engineering, Production, Qualification and Quality Assurance, analyzed the qualification status of the system. It was found that the implementation of the defined changes would have continued into a major change of the whole system. In this start-up meeting, it was determined that a new qualification with the steps IQ, OQ and PQ was required. Each protocol was to be pre and post approved by all the involved departments.
The Qualification exercise included parts of computer and software validation as well as the equipment qualification. To assure a coherent qualification, it was determined that portions of the computer and software validation would be subject to an interim approval. This would allow specified computerized systems validation (CSV) tasks to be completed prior to starting equipment operations, and subsequently performance qualification
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