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Tuesday, August 11, 2009

MICROSCOPE PARTICLE SIZE DETERMINATION RAW MATERIAL FINISHED PRODUCTS

OBJECTIVE :- To determine the particle size of the raw material that is used as the active ingredients in pharmaceutical product and also the finished product microscopically


UNIT OF RESPONSIBILITY :- QA Executive and trained QA Assistants

IMPORTANT POINT/ NOTE/ PRECAUTIONS : -

1 Ensure the complete cleanliness of the microscope eyepiece and the objective before its use

2 Handle the Instruement carefully

PROCEDURE :-

1 Calibrate the eye piece micrometer scale by aligning with the stage micrometer (graduated in 10 u increment) under 10 X magnification so that they are parellel

2 Spread evenly over the cleaned microscopic slide, the material or the powder to be tested for particle size

Add a drop of liquid paraffin over it in case of powder to be tested and prepare the smear In case of finished product spread the material over the microscopic slide and cover with cover slip to prepare the smear

3 Adjust the microscope in such a way that the particles are clearly visible

4 Count about 100 particles

5 Record the count as per the limits specified in the individual monograph

6 Record the count as per the observations in the attachment No 1


OTHER RELEVANT DETAILS :

1 Limits as specified in the individual monograph


PERSONNEL TO BE REPORTED IN CASE OF NON COMPLIANCE :- Department Head


FREQUENCY OF OPERATION :- For every lot of raw material as well as finished product
NO OF ATTACHMENTS :- NOs

RETENTION OF RECORDS :- 5 Years
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