Acceptance Criteria

a. Visual inspection: The visible internal equipment surfaces and all critical and difficult-to-clean parts are optically free from residue and the color of the final rinse water is comparable to WFI.

b. Facility qualification: The floor and wall swabs results should be less than or equal to the MAC of the biological products.

c. pH Determination: The pH value of the final rinse should be comparable to the blank WFI sample kept under the same conditions (WFI pH limit 5-7).

d. Conductivity: The conductivity of the final rinse should be comparable to the blank WFI sample kept under the same conditions (WFI conductivity limit is 1.1 ]s/cm at 25°C).

e. Total organic carbon: The TOC of the final rinse should be comparable to the blank WFI sample kept under the same conditions (WFI TOC limit is NMT 500 ppb).

f. Active ingredient detection: The active ingredient in the final rinse/swabs should be either not detected or less than the limit of detection of the biological product, which is XX ]g/mL.

g. Bio-burden: The bio-burden should not be more than 10 cfu/100 mL for the rinses.

h. Endotoxin: The endotoxin should not be more than 0.25 EU/mL.

i. Swab recovery challenge test: The swab recovery challenge test should be 70% of the known concentration of standard spiked.

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