12
N*6ECVP#G Kleenpak Nova capsules are sterilizable by autoclaving and incorporate filter
cartridges directly comparable to AB1UECV7PH4 filter cartridges. Filters of this type are
therefore fully covered by the bacterial challenge testing of AB1UECV7PH4 filter cartridges,
which were also autoclaved prior to bacterial challenge testing. S-Grade Kleenpak Nova
capsules (part number N*6ECVP#S) are sterilized by gamma irradiation (max. dose: 50 kGy).
Representative sample of N*6ECVP#S filters were therefore sterilized by gamma irradiation
at a target dose of 50 kGy (variation of irradiation process: ± 5 kGy) and submitted to
bacterial challenge testing to verify their bacteria retention capabilities.
3.3 Results
The Forward Flow and Brevundimonas diminuta retention results for Supor EX grade ECV
filters tested are shown in Table 3.2. The Forward Flow value of the filter type NP6UECVP1S
presented is the result of the Forward Flow test out-of-box prior to challenge, after the filter
capsules have been flushed with DI water at a flow rate of minimum 4 L/min for 10 min with
a 2 bar (29 psi) back pressure.
All of the filter cartridges gave sterile effluent when challenged with > 1 x 107CFU per cm2of
filtration area using Brevundimonas diminuta.
Table 3.2
Results of Forward Flow and B. diminuta Retention for Typical Pre-Sterilized (Irradiated) Supor
EX Grade Filters in Kleenpak Nova Capsules
* Forward Flow values at 2760 mbar (40 psi) air test pressure, wet with water, at 20 °C ± 5 °C (68 °F ± 9 °F).
3.4 Conclusions
Supor EX grade ECV filters incorporated in Kleenpak Nova capsules and sterilized by gamma-
irradiation were found to provide sterile effluent when subjected to aqueous microbial challenge
tests using Brevundimonas diminuta at a challenge level of > 1 x 107CFU/cm2. The results
confirm that the Forward Flow limit value for 254 mm (10 inch) Supor EX grade ECV filters in
sanitary AB-style (21.0 mL/min) is also applicable to 254 mm (10 inch) Supor EX grade ECV
filters incorporated in Kleenpak Nova capsules (part number N*6UECVP#S).
Part Number
Irradiation Dose
(kGy)
Pall Filter
Serial Number
Forward Flow*
(mL/min) Sterile Effluent Titer Reduction
NP6UECVP1S 48.3 – 49.9 IR4931 69588 15.6 yes >2.29 x 1011
NP6UECVP1S 48.3 – 49.9 IR4931 69590 14.2 yes >3.34 x 1011
NP6UECVP1S 48.3 – 49.9 IR4931 69592 15.4 yes >2.0 x 1011
NP6UECVP1S 48.3 – 49.9 IR4931 69593 15.9 yes >1.76 x 1011
NP6UECVP1S 48.3 – 49.9 IR4931 69596 15.1 yes >2.53 x 1011
NP6UECVP1S 48.3 – 49.9 IR4931 69599 17.1 yes >1.94 x 1011
NP6UECVP1S 48.3 – 49.9 IR4931 69602 15.6 yes >1.95 x 1011
NP6UECVP1S 48.3 – 49.9 IR4931 69598 15.3 yes >2.11 x 1011
NP6UECVP1S 48.3 – 49.9 IR4931 69622 15.3 yes >2.65 x 1011
NP6UECVP1S 48.3 – 49.9 IR4932 69612 16.8 yes >2.45 x 1011
NP6UECVP1S 48.3 – 49.9 IR4932 69616 15.5 yes >2.33 x 1011
NP6UECVP1S 48.3 – 49.9 IR4932 69619 15.7 yes >3.00 x 1011
NP6UECVP1S 48.3 – 49.9 IR4932 69621 15.6 yes >3.25 x 1011
NP6UECVP1S 48.3 – 49.9 IR4932 69623 15.8 yes >2.27 x 1011
NP6UECVP1S 48.3 – 49.9 IR4932 69624 16.4 yes >3.62 x 1011
NP6UECVP1S 48.3 – 49.9 IR4932 69627 15.6 yes >2.69 x 1011
NP6UECVP1S 47.3 – 47.6 IS0534 005 11.8 yes >3.65 x 1011
NP6UECVP1S 47.3 – 47.6 IS0534 036 14.7 yes >2.48 x 1011
NP6UECVP1S 47.3 – 47.6 IS0534 042 17.0 yes >2.94 x 1011
NP6UECVP1S 47.3 – 47.6 IS0534 079 14.6 yes >3.82 x 1011
NP6UECVP1S 47.3 – 47.6 IS0534 114 15.7 yes >2.37 x 1011
NP6UECVP1S 47.3 – 47.6 IS0534 118 14.7 yes >2.24 x 1011
NP6UECVP1S 47.3 – 47.6 IS0534 128 17.1 yes >3.12 x 1011
NP6UECVP1S 47.3 – 47.6 IS0534 132 14.7 yes >2.27 x 1011