Influence of filtering on the effective concentration and sterility of a 2% cyclosporine ophthalmic solution: a quality improvement perspective

Table 2 Detection results of aerobic and anaerobic microorganisms in 2% cyclosporine ophthalmic solutions

Preparer	Detection time of aerobic microorganisms (hours:minutes)	Detection time of anaerobic microorganisms (hours:minutes)
Positive control	78:33	9:48
A	Not detected	Not detected
B	Not detected	Not detected
C	Not detected	Not detected
D	Not detected	Not detected
E	Not detected	Not detected

Note: Positive control test was performed with the addition of Staphylococcus aureus ATCC^® 29,213™, regulated to 1.0 McFarland, equal to 3.0 × 10⁸ colony-forming unit (CFU)/mL. 1 mL of regulated S. aureus ATCC^® 29,213™ and 5 mL of the prepared 2% CyA ophthalmic solution were mixed; Bacterial culture tests were performed for up to 336 h; 5 mL of 2% cyclosporine ophthalmic solution was injected into each resin bottle

ISSN: 2055-0294