PQ Methodology and Validation Matrix for Compression Machine

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4035

VALIDATION PLAN AND METHODOLOGY

Performance of the Double Rotary Tablet Compression Machine shall be tested at extreme and optimum operation conditions, which are identified as Critical Process Variables:-

Critical Process Variables are:

  • Machine Speed (RPM)
  • Percentage Occupancy of powder level in hopper
  • Pre Compression force

Equipment Performance Qualification shall be carried out, simulating actual production conditions and varying minimum and maximum critical process variable conditions. No Pharmaceutical Active Ingredients shall be used for the qualification purpose. Excipients used for manufacturing of routine products using Compression method shall be used for the study.

Dispensing, sifting and blending of the raw material and finally compression of the blended powder shall be done. Physical characters of the powder blend (i.e. Bulk Density, tap Density, Compressibility ratio and particle size analysis) are to be recorded from three different layers of blend, unloaded from blender to ensure the physical uniformity.

VALIDATION MATRIX

Validation Plan is described in the following Matrix:

Process Variable Parameter selected for qualification Number of trials Number of tablets to be compressed Quality Parameters to be tested Sampling frequency
Effect of Machine Speed

(RPM of the Machine)

16 01 5000 a.   Weight variation

b.   Hardness

c.   Thickness

d.  Friability

3 set of sample containing 50 tablets in each trial (Total: 50´3=150 Tablets)
32 01 5000
48 01 5000
Effect of powder level in hopper

(% Occupancy

of powder in the hopper)

20% 01 5000 a.   Weight variation 3 set of sample containing 50 tablets in each trial (Total: 50´3=150 Tablets)
50% 01 5000
80% 01 5000
Effect of Pre-Compression Pressure Nil 01 5000 a.   Hardness

b.   Thickness

3 set of sample containing 50 tablets in each trial (Total: 50´3=150 Tablets)
Optimum 01 5000
Maximum 01 5000

ACCEPTANCE CRITERIA  

  • Average weight variation of tablets should not be more than ±2% of target weight and individual weight variation should not be more than ±5% of target weight.
  • Hardness of tablets should not be less as per prior fixed specification
  • .
  • Friability should not be more than 1%.
  • Relative Standard Deviation between the results of any test parameters should not be more than 5%.

RE-VALIDATION CRITERIA

Performance Qualification of Double Rotary Tablet Compression Machine to be Re-validated on:

  • Substitution of existing Tablet Compression Machine with a new Tablet Compression Machine.
  • Replacement of existing instrument / component with a new one, which can have a direct impact on the performance of the Tablet Compression Machine.
  • Any major modification to the existing Tablet Compression Machine which can affect the performance of the equipment.
  • If the Tablet Compression Machine is found to be malfunctioning during performance qualification.

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