Difference between calibration and validation… biological indicator strip is used for autoclave calibration or validation…reply me all microbiologist
Difference : Calibration- Qualification- Validation is as follows,
- The set of operations that establish, under speciﬁed conditions, the relationship between values indicated by an instrument or system for measuring (for example, weight, temperature and pH), recording, and controlling, or the values represented by a material measure, and the corresponding known values of a reference standard.
- Limits for acceptance of the results of measuring should be established.
For example: Analytical balance, pH meter, FTIR, HPLC, Pressure gauge, Flow meter, Conductivity meter, TOC Analyser, Thermo-hygrometer etc.
Action of proving and documenting that any premises, systems and equipment are properly installed, and / or work correctly and lead to the expected results. Qualiﬁcation is often a part (the initial stage) of validation, but the individual qualiﬁcation steps alone do not constitute process validation.
For example: IQ/OQ/PQ of Manufactruing equipent, Analytical instruments (UV Spectrophotometer, HPLC, GC, FTIR etc.)
Action of proving and documenting that any process, procedure or method actually and consistently leads to the expected results.
For example: Analytical Method Validation, Manuf. Process Validation, Cleaning Validation
Purified water generation system etc.
Biological indicator is used to conduct Performance Qualification of autoclave.
Biological qualification of the sterilisation cycle is to demonstrate that the delivered lethality measured by the actual kill of micro-organisms on a Biological Indicator system results in a PNSU ≤ 10-6 or as per the sterilization cycle requirement.
• A device consisting of a known number of microorganisms, of a known resistance to a particular sterilization process in or on a carrier and enclosed in a protective package.
Micro-organisms are in the form of endospores (not vegetative state) as these are most resistant to sterilization.
• All instruments must be calibrated before conducting autoclave validation e.g.
– temperature recorders and sensors
– pressure sensors for jacket and chamber
– conductivity monitors for cooling water
– flow metres for water/steam
– water level indicators when cooling water is used
– thermometers including those for thermocouple reference, chamber monitoring and laboratory testing
• Indicators should be calibrated
– physical and chemcial indicators should be tested to demonstrate acceptable response to time and
– biological indicators should be tested for count and time / temperature exposure response
• for commercial indicators - test certificate with count and D-value and exposure response should be
available. Results are acceptable if verified “in house” periodically.
• In house indicators must be fully characterized (Dvalue, identification) and appropriate for sterilization
All indicators should be appropriately stored and within expiry date (shelf life).