Blending Validation

GOOD VALIDATION PRACTICE (cGVP) PROCESS VALIDATION
1

I request to give your valuable input,

  1. Batch size selection of blend batch i.e. % minimum and maximum capacity, looking at to blender volume.
  2. Selection of sampling location in blender.
  3. Type of sampling tools recommended collecting sample from blender.
  4. Selection of test performed to establish homogeneity.
  5. How to fix acceptable range.

Note: I have octagonal type of blender in my manufacturing facility.

Please suggest approach/technique/methodology/reference guideline to perform blending validation of approved API batches effectively.

2

The following points are to be considered during the blending validation:

  1. Minimum & maximum working volume based on the equipment capacity
  2. Mixing time
  3. Rotation per minute (RPM) of the blender
  4. Number of individual batches are to be blended per single blend batch
  5. Quality parameters to be monitored like water content/LOD, residual solvents, particle size distribution, bulk density (Tapped /untapped)
  6. Sampling locations and frequency of sampling

[quote=snagabiru]I request to give your valuable input,

  1. Batch size selection of blend batch i.e. % minimum and maximum capacity, looking at to blender volume.
  2. Selection of sampling location in blender.
  3. Type of sampling tools recommended collecting sample from blender.
  4. Selection of test performed to establish homogeneity.
  5. How to fix acceptable range.

Note: I have octagonal type of blender in my manufacturing facility.

Please suggest approach/technique/methodology/reference guideline to perform blending validation of approved API batches effectively.[/quote]

3

[quote=snagabiru]I request to give your valuable input,

  1. Batch size selection of blend batch i.e. % minimum and maximum capacity, looking at to blender volume.
  2. Selection of sampling location in blender.
  3. Type of sampling tools recommended collecting sample from blender.
  4. Selection of test performed to establish homogeneity.
  5. How to fix acceptable range.

Note: I have octagonal type of blender in my manufacturing facility.

Please suggest approach/technique/methodology/reference guideline to perform blending validation of approved API batches effectively.[/quote]

Mixing or blending technique:[COLOR="#0000FF"] Diffusion (tumble), convection (planetary or high intensity), or pneumatic (fluid bed) techniques can be used to mix or blend materials.[/color]

Mixing or blending speed: Determine the intensity (low/high shear) and/or speed (rpm) of the mixing or blending.
[COLOR="#FF0000"]
Mixing or blending time: [/color]How much mixing or blending is required toobtain a uniform mixture? The mixing or blending time will be dependent on the mixing or blending technique and speed.

[COLOR="#FF0000"]Equipment capacity/load:[/color]

Test different-sized loads in the mixer/blender (e.g., 30, 50, and 70% of working volume) for optimal mixing or blending.

4

Hi,

Thanks shiva

5

It can be able this FDA Guide “Guidance for Industry - Powder Blending and Finished Dosage - Stratified In-Process Dosage / Unit Sampling and Assessment”.
I know the strategy adopted for some companies that use 10 sampling points (4 surface / 4 intermediate / 1 center / 1 bottom) in triplicate. Some tests are considered (Bulk and Tapped Density, Moisture, Particle Size Distribution, Uniformity Content). To uniformity content is considerede the follow spec (90 - 110% to individual / 95 - 105% to average / RSD <5%).

1 Like
6

can you give us any more examples