Blending | Effective Sampling During Process Validation | Optimize Sampling Location

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Important of sampling during blending:

Sampling plays a great role in achieving the accurate results of analysis. Sampling must and procedure must be defined in validation protocols and training should be provided to the concerned staff before the validation activities start.


Samples are representative of the whole batch. So it should be handled and weight carefully because segregation may occur during weighing and transpiration. Sample quantity should not be more than the required and whole mass sample should be used in the analysis.


Fig: Blending Machine



Sampling for blend:


Blends are tested for their homogeneity. Homogeneity of the blend is critical for the quality of the final product. The sample should be taken from at least 10 locations in the blender. The sampling location should be selected according to the difficulty of the blending. Ares of poor blending must be covered in sampling. Corners and discharged point must have sampling location. Blender geometry should be taken consideration during the sampling of the blender.

Fig: Sampling Plan of Blending during process validation

Sampling Plan:

Top (left, middle, right)
Middle (left, middle, right)
Bottom (left, middle, right)

Discharge port.


Fig: Critical sampling zone

Blend uniformity samples should be taken directly from the blender just before unloading the blend. If it is not possible to perform sampling from blender then the sample may be taken from the container after unloading. Three samples should be taken from each sampling location. 


Acceptance criteria for blend uniformity = RSD ≤ 5%





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