CALIBRATION OF DIES REQUIRED FOR BLEND SAMPLING

CALIBRATION OF DIES REQUIRED FOR BLEND SAMPLING

The objective of this procedure is to establish the guideline for the calibration of dies required for blend sampling.

This SOP is applicable to dies required for a sampling of the blend for validation batches manufactured in the Pharma Industry.

Procedure

Take a die to be calibrated for the volume mentioned on it.

Keep it on weighing balance and record the weight of empty die.

Add water of 25°C by means of a syringe or micropipette in the cavity till it is fully filled. Then record the weight of the filled die.

To calculate the volume of the die cavity, the following formula shall be used

Volume of die (in ml)  = (A – B) X 1.0040

Where

A = Weight of die with a cavity filled with water

B = Weight of die with an empty cavity

1.0040 = Volume of 1.0 gm water at 25°C

Acceptance criteria

Mentioned volume ± 2%

Procedure for calibration of die shall be documented on the raw datasheet