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