Biomedical Engineering Reference
In-Depth Information
Sampling Stage and Sample Amount for Different Products
after visual
inspection
for liquid-
borne
Particulate
matter
f. chemical
bulk after leak
test autoclave
lyophilization
micro f. bulk
after leak test
autoclave
lyophilization
chemical
bulk
(g/ml)
s.
no.
contai-
ner
contai-
ner
contai-
ner
contai-
ner
contai-
ner
Product name
micro bulk (g/ml)
Physical
injections
1.
Diclofenac
75 mg/3 mL
50 mL
(C-19/2)
ACB
100 mL
(C-19/2 and C-31)
SPFB
20 Ampoules
PB
40 Ampoules
PB
Pack size 50s
1 box
Pack size 5s
4 boxes
Pack size 3s
3 boxes
FP
10 Ampoules
2.
SWFI 10 mL
SWFI 5 mL
SWFI 4 mL
SWFI 2 mL
400 mL
(C-19/2)
400 mL
(C-19/2)
400 mL
(C-19/2)
400 mL
(C-19/2)
ACB
200 mL + 100 mL
(C-19/2 and C-31)
200 mL + 100 mL
(C-19/2 and C-31)
200 mL + 100 mL
(C-19/2 and C-31)
200 mL + 100 mL
(C-19/2 and C-31)
SPFB
40 Ampoules
PB
40 Ampoules
PB
Pack size 50s 1
box
Pack size 50s 1
box
Pack size 50s 1
box
Pack size 50s 1
box
FP
10 Vials
ACB
SPFB
80 Ampoules
PB
40 Ampoules
PB
ACB
SPFB
100 Ampoules
PB
40 Ampoules
PB
ACB
SPFB
200 Ampoules
PB
40 Ampoules
PB
3.
Vancomycin HCl
0.5 g
50 mL
(C-19/2)
ACB
100 mL
(C-19/2 and C-31)
SPFB
20 Vials
PB
40 Vials
PB
Pack size 10s 1
box
Pack size 1s 20
boxes
FP
10 Vials
4.
Metaclopromide
10 mg/2 mL
50 mL
(C-19/2)
ACB
100 mL
(C-19/2 and C-31)
SPFB
20 Ampoules
PB
40 Ampoules
PB
Pack size 50s 1
box
Pack size 5s
4 boxes
Pack size 3s
3 boxes
FP
10 Ampoules
 
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