41
6.4.2
Cleaning
The cleaning should be performed no later than 24 hours after the
procedure.
The cleaning can be divided into automated cleaning and manual
cleaning. Automated cleaning is preferred if possible
6.4.2.1
Automated cleaning
•The cleaner must be approved by CE certification in accordance
with EN ISO 15883.
▪
There should be a flushing connector connected to the inner cavity
of the product.
▪The cleaning procedure is suitable for the product, and the irrigating
period is sufficient.
It is recommended to use a washer-disinfector in accordance with EN
ISO 15883. For the specific procedure, please refer to the automated
disinfection section in the next section "Disinfection".
Notes:
a)
The cleaning agent does not have to be pure water. It can be
distilled water, deionized water or multi-enzyme. But please ensure that
the selected cleaning agent is compatible with the product.
b)
In the washing stage, the water temperature should not exceed 45 °C,
otherwise, the protein will solidify, and it would be difficult to remove.
c)
After cleaning, the chemical residue should be less than 10mg / L.
6.4.3
Disinfection
Disinfection must be performed no later than 2 hours after the cleaning
phase. Automated disinfection is preferred if possible.
6.4.3.1
Automated disinfection-Washer-disinfector
·
The washer-disinfector use should be approved by CE certification
in
accordance with EN ISO 15883.
·Use high temperature disinfection function. The temperature should
not exceed 134 ° C, and the disinfection under the temperature cannot be
more than 20 minutes.
·The disinfection cycle must be in accordance with the disinfection
cycle in EN ISO 15883.
Cleaning and disinfecting steps by using Washer-disinfector
1.
Carefully place the product into the disinfection basket. The product
needs to be fixed only when the product is moving in the device. The
products are not allowed to contact each other.
2.
Use a suitable rinsing adaptor, and connect the internal water lines
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