Mechanical Evaluation

Freeze drying mechanical evaluation is useful when considering purchase of used freeze dryers, when malfunctions occur in existing systems, during FAT and SAT and IQ/OQ performance, during process validation, and anytime the freeze dryer requires or has just undergone software or mechanical system modifications.   Mechanical evaluation can be used to confirm that modifications such as component replacement, pump repair, upgrades to performance have been completed and the system incorporates the change in the expected manner.  Applewood Scientific can help create your team’s awareness concerning the need for implementation of GMP documentation of the impact of changes to the mechanical system, after adjustments are made. Applewood Scientific will manage and provide leadership to allow cGMP compliance.  Finding and repairing vacuum leaks, correcting pump rotation, sensor functionality, signal transmission, and heater performance, determining the origin and repair of shelf cold spots or hot spots are some examples where mechanical evaluation can be provided.  Applewood Scientific is able to assist you in house, help train technicians, or complete the work independently and issue a report. We will work with your team to develop the forms, and SOP’s necessary for GMP compliance, and good maintenance practices. This service is particularly important if you are evaluating a pre-owned system, where professional assessment of the mechanical status of the system may point out what is missing the replacement of which will require funds expenditure, and help you to have data to negotiate with the owner and most importantly, reduce down time.

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