7.7
Manual cleaning with wipe disinfection
Phase
Step
I
Pre-cleaning
II
Cleaning with enzyme
solution
III
Intermediate rinse
IV
Drying
V
Wipe disinfection
VI
Final rinse
VII
Drying
DW:
Drinking water
FD–W:
Fully desalinated water (demineralized, low microbiological contamination: drinking water quality at least)
RT:
Room temperature
*
Suitable enzyme solution: Helizyme, Cidezyme (the latter being used for validation purposes)
►
Do not clean the product in a ultrasonic bath and do not immerse the
product in any fluids. Let any fluid incursions drain out immediately,
otherwise there is a danger of corrosion and loss of function.
Phase I
►
Move flexible components (such as sleeves) during cleaning.
►
Clean the product under running water, using a suitable plastic clean-
ing brush until all visible residues have been removed from the sur-
faces.
►
Brush cannulation with cleaning brush TA011944 and difficult to
access surfaces with a suitable plastic cleaning brush for at least 1 min.
Phase II
►
Follow the operating instructions of the enzyme cleaner with regard to
correct concentration, dilution, temperature and water quality.
►
Spray products with a pH neutral enzyme solution, let soak in for at
least 2 minutes and then wipe off.
Phase III
►
Move flexible components (such as sleeves) during cleaning.
►
Rinse product under running tap water for at least 5 minutes.
►
Follow the operating instructions of the enzyme cleaner with regard to
correct concentration, dilution, temperature and water quality.
►
Remove contamination with a lint-free cloth or soft brush moistened
with enzyme cleaner.
►
Rinse flexible components (such as sleeves) and cannulations for
20 seconds with the water pistol (cold water, at least 2.5 bar).
►
After manual cleaning, check visible surfaces and areas of flexible com-
ponents for residues.
►
If necessary, repeat the cleaning process (phase 1 to 3).
Phase IV
►
Dry the product in the drying phase with suitable equipment (such as
lint-free cloths, pressurized air).
Phase V
►
Wipe all surfaces of the product with a single-use disinfecting wipe.
Phase VI
►
Rinse disinfected surfaces after the prescribed reaction time for at least
1 minute under running demineralized water.
►
Drain any remaining water fully.
T
t
Conc.
Water quality
[°C/°F]
[min]
[%]
RT (cold) ≥2
-
D-W
RT (cold) ≥2
0.8
D–W
≥5
RT
-
D-W
RT
-
-
-
-
>1
-
-
RT (cold) 0.5
-
FD–W
RT
-
-
-
Chemicals
Until visually clean
pH-neutral*
–
-
Meliseptol HBV wipes 50 % Propan-1-ol
-
-
Stage VII
►
Dry the product in the drying phase with suitable equipment (such as
lint-free cloths, pressurized air).
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