Table 2

Surface bioburden expressed as mean cfu count per ampoule or vial before disinfection and after one-step TT and two-step TT disinfection

Plastic ampoulesGlass ampoulesInjection vials
Contact plateTotal immersionContact plateContact plateTotal immersion
Mean cfuSDMean cfuSDMean cfuSDMean cfuSDMean cfuSD
Before disinfection0.67 (n=30)1.642.45 (n=20)2.500.93 (n=30)1.820.57 (n=30)1.047.35 (n=20)17.26
After one-step TT0.03 (n=30)0.180.10 (n=20)0.460.2 (n=30)0.410.13 (n=30)0.431.35 (n=20)3.67
After two-step TT0.03 (n=30)0.180.00* (n=20)0.00*0.00* (n=30)0.000.03 (n=30)0.80.30 (n=20)0.56
p1 0.010<0.0010.0070.0220.003
p2 0.010<0.0010.0020.008<0.001
p3 1.0000.6790.2180.3040.423
  • *For the Wald test the mean (x̅) of zero cfu was replaced by a pseudo-count of 1 (the lowest possible contamination: x̅=0.05 in 20 samples and x̅=0.03 in 30 samples).

  • cfu, colony-forming unit; n, number of samples examined; p1, p value; one-step TT disinfection compared with before disinfection;p2, p value; two-step TT disinfection compared with before disinfection; p3, p value; two-step TT disinfection compared with one-step TT disinfection.