GE AKTAprocess, Operating Instructions Manual

Page: 140 / 180

Function Part
CIP distribution manifold, provided by customer. 1
CIP connection hoses, provided by customer. 2
CIP-manifold, provided by GE Healthcare. 3
Specific manifolds are available as optional
equipment for each system battery limit.
For a detailed description of the process components, see Section 3.5 Flowchart, on
page 72.
Refer to the Section 6.2.3 General procedure for CIP and sanitization, on page 141 for
comprehensive instructions regarding the sanitizing/CIP procedure.
CIP methods in UNICORN
It is recommended that specific CIP-protocols are developed to standardize the
CIP-procedure in a repeatable and reliable manner depending on the applied user appli-
cation.
A routine cleaning method can be set up in UNICORN for regular cleaning and sanitizing
of the system and connected components.
Refer to UNICORN Method manual for comprehensive instructions on how to create a
sanitizing/CIP method in UNICORN.
Extended cleaning performance
If ÄKTAprocess has been heavily contaminated and the normal CIP procedure is not
sufficient, cleaning performance can be improved by:
•
Extending the CIP time period.
•
Changing to an alternative CIP-agent.
•
Filling ÄKTAprocess and attached components with cleaning agent to redissolve
contaminants for an extended time period before applying CIP.
Rinsing
After completed CIP, rinse the interior and all cleaned components of ÄKTAprocess
thoroughly with water of desired quality, for example Water For Injection (WFI), to remove
all traces of the cleaning agent.
140 ÄKTAprocess Operating Instructions 29-0252-49 AA
6 Maintenance
6.2 Cleaning
6.2.2 Cleaning-in-place (CIP)