Title: Standard operating procedure of
Blister Sealing test for tablet strips.
1.0
OBJECTIVE:
To lay down a procedure of Blister
Sealing test for strips/blister packing.
2.0
SCOPE:
This SOP shall be applicable to Q.C
Dept.
3.0
RESPONSIBILITY:
3.1
Doing: Q.C Analyst.
3.2
Checking: Q.C-Manager.
4.0
ACCOUNTABILITY:
4.1
Head of the Q.C Department.
5.0
MATERIAL AND EQUIPMENT:
5.1
Vacuum desiccator.
5.2
Strips/ blisters.
5.3
Rubber band.
5.4
Methylene blue.
5.5
Water.
5.6
Lint free duster.
5.7
Scissors.
6.0
PROCEDURE:
6.1
Take the required number of strips/ blister. Check the
quality of strips/ blisters for any damages.
6.2
Tie the collected strips/ blisters with a rubber band.
6.3
Add few drops of methylene blue in water and mix it to give
a light blue colour.
6.4
Ensure that all strips/ blisters are completely immersed in
water and close the lid.
6.5
Connect opening of the desiccator to the vacuum pump.
6.6
Apply a vacuum of 300mmHg and close the knob of the
desiccator.
6.7
Keep the vacuum for 30 sec.
6.8
Release the vacuum by opening the knob of the desiccator
slowly and open the lid remove the strips/ blisters.
6.9
Wipe out the traces of water from the strips/ blisters by
using lint free duster.
6.10
Open the pocket of strips by using scissors to remove the dosage
units.
6.11
Open the blisters manually.
6.12
Check for any traces of water inside the strips/ blisters.
6.13
Calculate the %age of strips leaked by using formula:
%age of strips leaked = No. of
strips leaked x 100
Total No. of strips
6.14
Number of samples (dosage-units), which have become wet, should
not be more than 1%. If the leakage is more than the above percentage repeat
the leak test.
7.0
REVISION LOG:
|
Revision No. |
Effective Date |
Reason |
|
00 |
|
New
SOP |
8.0
REFERENCES:
8.1
Not Applicable.
9.0
ANNEXURES:
Annexure
1: Observations and calculations.
Annexure: 1
Observations and calculations.
Date:
______________
Product
name: __________________________
Pressure:
________________mmHg.
Time:
__________________min.
Total
No. of strips: _______________________
No.
of strips leaked: ______________________
Calculation:
%age of strips leaked = No. of
strips leaked x 100
Total No. of strips
Result:
___________________________________________
Remarks:
_________________________________________