2. Modified (0.2 u) Filter Design &
Change Control System
Ref: Richard. L. Friedman,
US-FDAApril 2005 (PDA)
3. Assumption Changed geometrical design of
outer cage of 0.2 u sterilizing grade
cartridge
Just an aesthetic minor change &
no impact on reliability or
effectiveness
4. Assumption Who will assess that the modified
filter is continued to be suitable for
its intended use
?
5. What
happened
Increased rigidity of the cage that
afforded inadequate expansion
room to accommodate filter
medium swelling during some
manufacturing operation …
6. What
happened
… the lack of adequate expansion
room resulted in the rupture of
some filter during processing
depending on the liquid being
filtered & processing conditions
7. Equipment failure caused major
product loss
Several integrity failures (post-processing)
because product specific studies not being
conducted
8. The change control program within an effective
Quality System was not accurately assessed
Facilities & Equipment system was the most
deficient in this case
