Process qualification during compression stage ׀ Process validation sampling protocol during compression

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Process validation sampling plan during compression:
process validation a plan for sampling

Fig: Sampling during process validation

During compression following stages to be considered to collect samples-

  1. Initial hopper
  2. Full hopper
  3. Low RPM
  4. High RPM
  5. Medium RPM
  6. Low hardness
  7. High hardness
  8. Stoppage of machine
  9. Restart of machine
  10. Regular interval

Initial hopper:

compressed tablet collect from the hopper at the startup of the machine or initial stage. Put the collecting sample into zipper poly bag with proper leveling. 

Full hopper: 

compressed tablet collect from the hopper before the end of granules in the hopper. Put the collecting sample into zipper poly bag with proper leveling.

Low RPM:

Set the turret RPM at the lowest point then collect the sample into zipper poly bag with proper leveling.

High RPM:

Set the turret RPM at the highest point then collect the sample into zipper poly bag with proper leveling.

Medium RPM:

Set the turret RPM at the middle point then collect the sample into zipper poly bag with proper leveling.

Low hardness:

Set the turret RPM at the highest point then collect the sample into zipper poly bag with proper leveling. When setting the turret RPM at the highest point, that time low hardness of tablet produces from the machine.

High hardness:

Set the turret RPM at the lowest point then collect the sample into zipper poly bag with proper leveling. When setting the turret RPM at the lowest point, that time high hardness of tablet produces from the machine.

Stoppage of machine:

Collect the sample at every stoppage of the machine. For example- Lunch period, Tea break etc.

Restart of machine:

Collect the sample at every stoppage of the machine. For example- Lunch period, Tea break etc.

Regular interval: 

Collect the sample at the beginning of compression to before end up of compression.  

Example of a sample level-






Table 1: Standard sample level
Product Name
Batch No.
Batch Size
Sampling Location
Sampling Stage
Sample by

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