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Appendix D: Maintenance and Spare Parts
1. Maintenance
There is no specific need for maintenance other than routine cleaning, as described under
‘Care’ below. The critical part of the chassis is the spindle surface. The spindle itself can
provide approximately 50,000 N of force. The torque limiter is designed to limit the applied
force to a maximum of approximately 7,500 N. If the spindle accumulates soiling and build-up
over time, the amount of force delivered to the filter capsule stack can decrease. This decrease
in force may fall below the approximate 2,500 N minimum that ensures a full seal. The spindle
is constructed such that it locks itself thereby keeping the force on the capsule stack.
Note that force alone does not guarantee a seal. O-rings, filter capsules, etc. must be properly
installed. This is much the same as when a clamp and gasket connection requires proper
installation of the gasket into
the fitting and not simply closure of the clamp and tightening.
The recommended flush with DI or WFI water (50 L/m
2
for single layer depth filters, 100 L/m
2
for double layer) prior to depth filter use also serves as a system leak check. Any incidental or
improper capsule installation or chassis fitment will be viewed during a water flush as improper
fitment is fully expected to be a visible, macroscopic event.
The frequency of cleaning the spindle will strongly depend on envir
onmental conditions and
specific application usage. However, a yearly preventative maintenance is expected to be
sufficient in most cases.
2. Care
Routine cleaning of the external surfaces of the chassis to prevent bioburden and other residue
built-up can be followed on the same schedule as other external non-product contact parts,
such as manufacturing suite walls, control boxes and tank exteriors.
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