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Biopharmaceutical manufacturing instrument classification


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Classification of Instruments

Published in: Health & Medicine
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Biopharmaceutical manufacturing instrument classification

  1. 1. Biopharmaceutical Manufacturing Instrument Classification
  2. 2. Instrument Classification And Identification
  3. 3. For biopharmaceutical applications, instruments are generally classified as critical or non-critical, with some organizations allowing for a third classification, diagnostic or reference.
  4. 4. Please note: The author does not advocate the use of the diagnostic or reference designations. The concept of an instrument that is not ever calibrated, violates any concept of good engineering or maintenance practices.
  5. 5. Every instrument in a facility should be identified as one of these classifications. Generally, instruments classified as critical are calibrated typically on a quarterly schedule, those classified as non-critical are typically calibrated annually. The diagnostic instruments are not calibrated regularly.
  6. 6. The definitions of the various classifications are not totally objective. They usually have to allow for some judgment in assigning the criticality of the device. For example, following are typical definitions used to distinguish between critical and non-critical instruments.
  7. 7. Critical Instrument: A process instrument, the failure or incorrect calibration of which can create an immediate negative impact on product quality.
  8. 8. Non-Critical Instrument: A process instrument, the failure or incorrect calibration of which may impact a secondary processing system or a non-quality related parameter of the process.
  9. 9. Note that there is a lot of room for maneuvering. Since these definitions have to apply to many different systems, they cannot be exact. Judgment is required, and wisdom to err on the conservative side.
  10. 10. Examples of critical instruments would be temperature recorders on hot Water-For-Injection (WFI) or steam sanitized USP Purified Water systems.
  11. 11. Examples of non-critical instruments could be a pressure gauge on a compressed air line for a line supplying air to a pressure reducer.
  12. 12. Identification means each instrument must have a unique identifying designation. This identification will remain with the instrument throughout its life and allow for proper scheduling and repair record. The designation system is usually defined in the Standard Operating Procedure (SOP) for the Calibration System.