Biomedical Engineering Reference
In-Depth Information
SOP No. QAS-010.00 Effective date: mm/dd/yyyy
Approved by:
Laboratory procedure and action limits
Collect the samples from the portion compressed in that period and measure the thickness of 20
tablets. Record the mean thickness and range. If the mean thickness differs from the specification
limits, reject and discard that portion.
29.3.5.4 disintegration test
During the tablet compression process, check the disintegration time twice per shift and note down
the reading on a control chart. Note down any deviation observed in the remarks column of the
control chart.
Action limits
1. If one or two tablets fail to disintegrate completely within the limit given on the finished
product specification, repeat the test on 12 additional tablets. Not less than 16 out of 18
tablets should disintegrate completely within the finished products specification limits.
2. If less than 16 tablets out of 18 tablets disintegrate completely within the given time, then
inform the operator to adjust the machine and reject and discard that portion.
29.3.5.5
friability
a. Check whether the friability apparatus is clean and tidy.
b. Collect two samples for friability A and B each having 20 tablets.
c. Remove any loose dust with the aid of air pressure or a soft brush on the tablet.
d. Weigh samples A and B separately, record the weights.
e. Place them separately in the drums of the friabilator and subject them to 100 rotations (25
rotations/min for 4 min) or as per specification.
f. Remove the tablet.
g. Weigh samples A and B separately.
h. Find out the % loss which should be within the limits as given in the corresponding
specifications.
i. Note down the reading on the control chart.
j. During compressor process check friability testing at least twice per shift.
29.3.5.6 attribute characteristics
Collect the sample (per sampling plan) ejected from the compression machine and check for attri-
bute characteristics such as:
Critical defect:
a. Foreign matter:
Any thing other than the product.
Major defect:
a. Capping:
Any tablet showing separation of part of the tablet partially or through-
out its horizontal axis. Such tablets may or may not break into two parts.
b. Broken:
Any tablet broken into two or more pieces.
c. Picking:
Any tablet having depression of 2 mm or more on the surface.
d. Dirty:
Any tablet with a spot of a different color (not due to entrapped specks)
or oil from the machine.
e. Large specks:
Any tablet with entrapped specks or foreign material or 2 mm or more in
size.
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