modernmicroscopy
:
articles
Microscopical Evaluation of Glass Delamination In Pharmaceutical Vials: A Look at Three Different Vial Manufacturers
| by |
Kristie J. Diebold, McCrone Associates, Westmont, IL |
Figure 11 shows large pitting at
the base of Company C’s vials and Figure 12 shows finer
pitting at the neck.
click image to enlarge (353K) 
FIGURE
11 |
click image to enlarge (376K) 
FIGURE
12 |
SEM images were also taken to show tapering
of pitting and the enlargement of pitting (Figures 13, 14, and
15).
click image to enlarge (282K) 
FIGURE
13
|
click image to enlarge (107K) 
FIGURE
14 |
click image to enlarge (92K) 
FIGURE
15 |
Delamination is shown in Figure 16. If
the whitish line is focused on, the SEM images shown in Figure
17 provide detail on a close up of the delamination and the flakes
starting to slough off. Again, an IR spectrum was obtained to show a
~1100λ band which is a characteristic of silica; again, suggesting
glass.
click image to enlarge (320K) 
FIGURE
16 |
click image to enlarge (393K) 
FIGURE
17 |
The second study consisted of four vials having been
kept at 40˚C, 30˚C, 25˚C, and 4˚C respectively for
a four-week period. Company B’s vials were sent by the client for further
analysis. Company A and C’s vials were sent for research purposes.
Company A’s vials resulted in pitting at the base
of the vial at all temperatures and finer pitting was in the neck area,
as seen in Figure 12. Delamination was found ~1/2
inch from the top of the vial; this area is common to the fill line.
The pinkish residue is seen but only at 40˚C. Again, this residue
is believed to be thin delamination.
Company B’s vials, which were sent in per client
request, contained pitting at all temperatures except 4˚C.
There was no delamination found. The strange vertical striations were
visible again at all temperatures along with the residue/discoloration
between the striations, similar to the first study. A reference vial
was sent in which only showed very faint striations.
|
