Semi automatic torque meter

Validation
1

Hi

  • how can I do the performance qualification for semi automatic torque meter ?
  • I cannot fine any reference for (value of maximum torque to opining the bottles) so kindly provide me by reference or data sheet to guide me to find the torque limits for opining bottles.
    BR
2

Ref general chapter 671 opening and closing torque value for qualification as well as in process test.

1 Like
3

You can conduct PQ by selecting the products with respect to cap or insert sise.
You can take three batches better with different speed min and max, also it must be supported by leak test integrity test for non destructive product sample.
you can define the limits with reference to general chapter 671.

Thanks

4

Dear Mr. dushyant,
sometime it has been observed that there is somewhat different value as per the machine than the std USP 671,
in that what shall be done?
In this case machine need to adjust or need to define inhouse limit??
Thanks