Merck EMD Millipore NovAseptic, Installation And User Manual

Cleaning and Sterilizing 

Procedures

Cleaning in Place (CIP)

GMP mixers are designed for CIP using any 

of the following processes: sprayball, rotary 

jethead, or submerged. 

Sprayball and Rotary Jethead Cleaning

!

Start the liquid circulation through 

the sprayball or jethead before 

starting the mixer to ensure 

lubrication of the bearing.
Ensure that the bearings are 

continuously lubricated.
Stop the mixer before turning off 

the sprayball/jethead function.
Add liquid before running the 

mixer after cleaning to ensure 

lubrication of the bearings.

NOTE  

Recommended maximum speed of 

the mixing head is 100 rpm.

Submerged Cleaning

Introduce enough cleaning or rinsing liquid into 

the vessel to cover the mixing head and the 

male bearing.

NOTE: 

Avoid vortex.

Add liquid before running the mixer 

after cleaning to ensure lubrication of 

the bearings.

Magnetic Particles: 

If presence of magnetic particles is 

suspected, remove the mixing head. 

Remove the particles and reinstall the 

mixing head. (Refer to Male Bearing 

Installation, Mixing Head Installation, 

and Drive Unit Installation in this 

manual.) 

 
Magnetic particles are not removed 
from the mixing head during CIP; 
they must be removed manually or by 
alternative cleaning. Magnetic particles 
can cause corrosion and damage. They 
can also cause a higher torque, which 
may cause the mixing head to decouple 
and severely damage the vessel.

Sterilizing in Place (SIP)

GMP mixers are designed for SIP. 

Sterilization by Pressurized Steam

The mixer can be intermittently operated 

during the initial condensate phase of the 

sterilization sequence up to 100 °C (212 °F). 

Recommended maximum speed of the mixing 

head is 50 rpm for no longer than 30 seconds.

NOTE 

Ensure that condensate lubricates the 

bearing surfaces.

Recommended maximum speed of the 

mixing head during sterilization is 50 rpm.

Turn the mixer off when the 

temperature reaches 100 °C (212 °F).

Add liquid before restarting the mixer 

after sterilization to secure lubrication 

of the bearings.

Magnetic Particles 

If presence of magnetic particles is 

suspected, remove the mixing head. 

Remove the particles and reinstall the 

mixing head. (Refer to Male Bearing 

Installation, Mixing Head Installation, 

and Drive Head Installation in this 

manual.) 

Magnetic particles are not removed 

NovAseptic

®

 GMP ATEX Mixer 

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