SOP for Instrument for Macroscopical Examination

1.0 OBJECTIVE

To clearly define the operation of the instrument for better and error free use of the same.

2.0 SCOPE

This procedure is applicable for visual inspection of vial only for insulin.

3.0 RESPONSIBILITY

3.1 Doing: Technical Assistant/Executive
3.2 Checking: Executive/Manager

4.0 ACCOUNTABILITY

Head of the Department

5.0 PROCEDURE

5.1 Clean the instrument with a clean cotton cloth.
5.2 Switch “ON” the mains.
5.3 The lamp having 1000 lux intensity will be “ON”.
5.4 Examine the vials in both black and white background.
5.5 For soluble insulin
5.5.1 Examine the vials for turbidity and foreign matter.
5.5.2 Interpretation of results: The sample should be colorless liquid free from turbidity & particles.
5.6 For Protamine containing insulin product and zinc drug product.
5.6.1 Shake the sample gently while it is cold. Roll the vial between the hands 20 times, roll the penfil Cartridges between the hands 10 times and turned up and down 10 times.
5.6.2 Examine the sample whether it is white homogeneous suspension
5.6.3 Interpretation of results: The sample should remain white homogeneous suspension when kept at room temp. at 45° to horizontal. After 24 hours the sediment should be white & the supernatant should be clear colorless liquid.
5.7 Switch off the mains and records the results in the insulin finish product datasheet.

6.0 ABBREVIATION

      Nil

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