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Table 4 Microbiological results after one simulated use

From: Multiple use applicator for vaginal tablets/vaginal inserts: compliance verification and suitability studies

Option no

Cleaning method

Result after single simulated use

1

Clean with cold water

Out of specification (OOS)

TAMC: 1.6 × 103 CFU/Applicator

TYMC: 4.17 × 102 CFU/Applicator

(Bacteria: 4.15 × 102 CFU/Applicator,

molds 2.00 × 100 CFU/Applicator)

S. aureus: conforms

P. aeruginosa: conforms

C. albicans: conforms

2

Clean with warm water

OOS

TAMC: 1.04 × 102 CFU/Applicator

TYMC: 4.90 × 101 CFU/Applicator

S. aureus: does not conform

P. aeruginosa: conforms

C. albicans: conforms

3

Clean with cold water with soap

TAMC: 7.90 × 101 CFU/Applicator

TYMC: 1.00 × 101 CFU/Applicator

S. aureus: conforms

P. aeruginosa: conforms

C. albicans: conforms

4

Clean with warm water with soap

TAMC: 7.00 × 100 CFU/Applicator

TYMC: < 2.00 × 100 CFU/Applicator

S. aureus: conforms

P. aeruginosa: conforms

C. albicans: conforms

  1. Tests were performed with n = 5 applicators per option