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.
Was this article helpful?
Thousands Have Used Chemicals To Improve Their Medical Condition. This Book Is one Of The Most Valuable Resources In The World When It Comes To Chemicals. Not All Chemicals Are Harmful For Your Body – Find Out Those That Helps To Maintain Your Health.