Biomedical Engineering Reference
In-Depth Information
SOP No. QAS-024.00 Effective date: mm/dd/yyyy
Approved by:
table 43.1
Pack size (ml)
Preset limit (ml)
in-Process limit (ml)
10
10.3-10.5
10.0-10.5
15
15.0-16.0
14.0-16.0
15 (susp.)
15.0-17.0
15.0-16.0
30 (drops)
30.0-31.0
30.0-32.0
3. If the volume of individual bottle or average crosses the laboratory limits ask the con-
cerned operator to adjust the machine and separate the portion filled before. Inform the
packaging supervisor and manager.
4. Enter the findings on a control chart for liquid filling.
5. Also confirm the readings taken by the line boss as per the written procedure. If any devia-
tion is observed, then enter in the remarks column of the control chart.
Note
: For fill checks limits and range limits refer to Table 43.1.
43.3.2 c
olor
and
P
articulate
m
atter
c
hecking
After conducting the volume variation check, carry out the color and particulate matter check on the
same sample.
Stopper the measuring cylinder and check the solution in optical checking hood divided into two
portions, one should have a white background and the other black. The illumination should be from
a shielded 100 W bulb day light/quality light source, at a point 25.4 cm (10 in.) from its source.
Inspect the solution with a shaking motion invert the measuring cylinder and retain it to the
upright position under an optical checking hood for 10-12 s in front of a white background and then
in black background to inspect the following:
• Fiber
• Particles (black or white)
• Any other foreign matter
Note any fine flocculent material in the solution that tends to float, hang, or slowly settle down-
wards. Check the clarity of the solution, there should be no haze, the solution must be sparkling
clear. The color should be as specified. Enter your findings in the control chart for liquid filling.
43.4 reason for revision
First time issued for the ABC Pharmaceutical Company.
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