Biomedical Engineering Reference
In-Depth Information
SOP No. QCS-014.00 Effective date: mm/dd/yyyy
Approved by:
14.4.4 S
torage
t
eSt
c
onditionS
/f
reQuency
The length of the studies and the storage conditions should be sufficient to cover storage, shipment,
and subsequent use (e.g., reconstitution or dilution as recommended in the labeling). See Table 14.1
for accelerated and long-term storage conditions and minimum times. An assurance that long-term
testing will continue to cover the expected shelf life should be provided.
table 14.1
accelerated and long-term storage conditions and minimum times
for solid sample
months
temperature and
relative humidity
type of stability study
b. no.
till complete shelf lives
(a)
30°C ± 2°C
1st year
2nd year
3rd year
4th year
5th year
Long term
(b)
(60% RH)
(c)
0 3 6 9 12
18 24
36
48
60
(d)
Two
40°C ± 2°C
Accelerated or short
term (I)
(e)
(75 ± 5% RH)
3
6
(f)
(II)
(g)
One
50°C ± 2°C
(h)
3M
(i)
Two
For products to be kept
refrigerated for long
term
(j)
20°C ± 2°C
3
6
(k)
25°C ± 2°C
(l)
for liquid sample
months
temperature and
relative humidity
type of stability study
b. no.
till complete shelf lives
(a)
1st year
2nd year
3rd year
4th year
5th year
30°C ± 2°C with
Long term
(b)
(c)
0 3 6 9 12
18 24
36
48
60
(d)
40°C ± 2°C with
Two
Accelerated or short
term (I)
(e)
3
6
(f)
(II)
(g)
One
50°C ± 2°C
(h)
3
(i)
Two
For products to be kept
refrigerated for long
term
(j)
20°C ± 2°C
3
6
(k)
25°C ± 2°C
(l)
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