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Calibration of processing equipment - 21 CFR 820.70 Production and process controls

R

RLKESTER

#1
Recently been involved in conversations regarding the need for calibration of processing equipment - specifically injection molding of medical products.

The careful reading of 21 CFR 820 Sec. 820.70 Production and process controls. Specifically Sec. 820.72 "Inspection, measuring, and test equipment" sub section (b) is where calibration is listed.

Specific reading of the section could indicate only items used for acceptance activities require calibration. The extension of the concept to processing equipment therefore results in the interpretation that calibration of process parameters are unnecessary.

Considering Process Validation; ref (Sec. 820.75 Process validation)
The implication is that the process variables must be controlled "....monitoring and control of process parameters for validated processes to ensure that the specified requirements continue to be met. "
creating a product that meets specification requires knowledge of process parameters and associated controls (e.g. time, temperatures, pressures, chemical, etc.)

Can anyone provide more specific citation of the requirements for process controls to be calibrated?

Thanks
 
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Mark Meer

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#3
Re: Calibration of processing equipment - 21 CFR 820.70 Production and process contro

Specific reading of the section could indicate only items used for acceptance activities require calibration.
Can you elaborate on how you arrived at this interpretation?

820.72 is under Subpart G—Production and Process Controls, and not Subpart H—Acceptance Activities.

Also, 820.72 only says "is suitable for its intended purposes and is capable of producing valid results", which can cover just about any quality system process, not just acceptance activities.

Finally, remember that process validation is intended "where the results of a process cannot be fully verified by subsequent inspection and test" (820.75(a)).

So, in the case of injection molding, is the output product checked? I imagine they are (e.g. dimensions, durability, any other requirements you've specified...), in which case I think it can be argued that the results of the injection molding are verified by subsequent inspection and test, and hence outside the scope of 820.75.
 
R

RLKESTER

#4
Re: Calibration of processing equipment - 21 CFR 820.70 Production and process contro

Process control elements such as time, temperature pressures, contamination (O2, %RH, etc.) can affect the output of a product in ways that cannot be verified. Consider heat treating, sterilization, chemical processes, etc.

Many injection molded products have contact with patient, medication or drugs. Chemical leechables, biocompatibility, toxicology, stability/aging, material physical properties and sterilization processing can all impact the intended use and approved use of the device.

Processing parameters ( eg. Temperature, material dryness, etc) are known to impact the material physical characteristics.
 
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