Company Data

Technical Bulletin
Alsoft A : Surgical handrub – in vivo test-
BCL No.11946

Alsoft A : Surgical handrub

－in vivo test－
EN 12791 ( CEN standard, phase 2 / step 2 )

【Purpose】
The efficacy of Alsoft A as a surgical hand antiseptic should be evaluated by a test simulating practical
conditions in accordance with the European Standard EN 12791 (2005), as well as in accordance with
the Standard Methods of German Society for Hygiene and Microbiology (DGHM).

【Independent Laboratory】
Hygiene Nord GmbH, BioTechnikum,Walther-Rathenau- Strasse 49a D-17489 Greifswald

【Test Date】
March 09, 2009 to March 25, 2009

【Methodology】
The number of resident skin flora released from fingertips of hands was assessed before and after a
surgical hand disinfection procedure. A cross over design was used for testing the activity of the test
product.

Test product Alsoft A

Reference product propan-1-ol (60 % v/v)
Test organism Resident skin flora from hands；means of the log counts ≧ 3.5
Total No. of subjects 20
Application Keep the hand moist for 3 minutes using 3 mL applications as needed
Sampling Immediate and 3 hours after disinfection
Neutralizer 4% polysorbate 80 + 0.5% SDS + 0.4% lecithin + 0.5% Na-thiosulfate +
3% saponin
Incubation 37±1℃ for 24 hours, reincubated for a further 24 h to detect any
slow-growing colonies
Significance test Wilcoxon matched-pairs signed-ranks test

1
 Company Data
Technical Bulletin
Alsoft A : Surgical handrub – in vivo test-
BCL No.11946

【Results】
The mean log reduction of the test product Alsoft A was smaller than the reduction factor of the
reference product propan-1-ol 60% v/v for the immediate and 3-hours effect. This difference was not
considered significant (P = 0.215 > 0.1 and P = 0.382 > 0.01, respectively).

3
n.s.
1) Alsoft A
60% Propan-1-ol
2.5 2)
n.s.
Log reduction factor

1.5

0.5

0
0h 3h

Wilcoxon matched-pairs signed-ranks test

n.s. : not significant
1): level of significance: P = 0.215; required: P = 0.1
2): level of significance: P = 0.382; required: P = 0.01

Figure 1. Mean log reduction factor (n = 20) of Alsoft A in comparison to

the reference product (60% v/v Propan-1-ol), 3 min

【Conclusions】
The test product Alsoft A is suitable for surgical hand disinfection when hands are kept moist for 3 min
– the product Alsoft A does correspond to the requirements of the EN 12791 (2005) for surgical hand
disinfection.