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modernmicroscopy
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articles
Microscopical Evaluation of Glass Delamination In Pharmaceutical Vials: A Look at Three Different Vial Manufacturers
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Kristie J. Diebold, McCrone Associates, Westmont, IL |
Company C’s vials again were sent in for research
purposes only. Pitting was found at every temperature, but only at
the base of the vial. Pitting was found at 4˚C. Delamination
was common ~3/4 inch from the bottom at 40˚, 30˚, and 25˚C.
Company C’s vials were larger than the other companies; we could then
assume that this is still common to the fill line. There is some minor
delamination over the pitting at the base of the vial at 40˚C.
Apparently, as these results show, as temperature increases, delamination
increases.
Figures 18, 19, and 20 respectively,
show how delamination increases when temperature increases from Company
A’s vials.
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FIGURE
18 |
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FIGURE
19 |
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FIGURE
20 |
The increase of delamination with an increase in
temperature from Company C’s vials is shown in Figures 21, 22,
and 23. A thinner brownish color “delamination” is seen in 25˚C
(Figure 21). There are more colors seen in 30˚C
(Figure 22) and a blast of color in 40˚C (Figure 23).
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FIGURE
21 |
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FIGURE
22 |
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FIGURE
23 |
A third study involved four more vials from Company
B which had been kept at 40˚C, 30˚C, 25˚C, 4˚C respectively
for an eight week period. Further analysis was requested by the client.
To recap, the four week period had pitting at every temperature except
4˚C. There was no delamination, but there were striations with the
discoloration in between. At the eight week time period pitting was seen
at the base of all vials except at 25˚C, where no pitting was seen.
The only temperature with pitting at the neck of the vial was at 40˚C.
Delamination was seen only at 40˚C and 30˚C. Discoloration
and striations were seen on every vial. There was no discoloration found
on 25˚C, which corresponds to the four week period where there is
some discoloration and faint striations. Results show again as temperature
and now as the time period increases (from 4 weeks to 8 weeks), the more
prevalent delamination becomes.
Figures 24, 25, 26, and 27 show the striations
and discoloration from Company B’s vials; the eight week period shows
more developed striations and discoloration than the four week period.
Figure 25 shows an area with a clear space between the
striations; it is possible this area was common to where the fill-line
would be.
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FIGURE
24 |
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FIGURE
25 |
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FIGURE
26 |
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FIGURE
27 |
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