COMPONENT TYPE |
SOLVENT |
TIME (IN DAYS) |
||||||
|
50% Ethanol |
pH3 0.1M phosphoric acid |
pH10 0.5 NaOH |
WFI |
1 |
7 |
21 |
70 |
Containers |
X |
X |
X |
X |
X |
|
X |
X |
Tubing attached to
containers |
X |
X |
X |
X |
X |
|
X |
X |
Bag ports |
X |
X |
X |
X |
X |
|
X |
X |
Closures |
X |
X |
X |
X |
X |
|
X |
X |
Containers |
X |
X |
X |
X |
X |
|
X |
|
Bag ports |
X |
X |
X |
X |
X |
|
X |
|
Impellers & moulded parts for bioreactors / mixers |
X |
X |
X |
X |
X |
|
X |
|
Tangential flow modules
for perfusion or continuous processing |
X |
X |
X |
X |
X |
|
X |
|
Tubing attached to
containers |
X |
X |
X |
X |
X |
|
X |
|
Tubing connectors and
disconnectors, fittings, over-moulded junctions |
X |
X |
X |
X |
X |
|
X |
|
Filtration cassettes |
X |
X |
X |
X |
X |
|
|
|
Aseptic connectors and
disconnectors |
X |
X |
X |
X |
X |
X |
|
|
Filters |
X |
X |
X |
X |
X |
X |
|
|
Filling needles |
X |
X |
X |
|
X |
|
|
|
Chromatography column
housing |
X |
|
|
|
X |
|
|
|
Small components
(O-rings, gaskets, etc) |
X |
|
|
|
X |
|
|
|