Before the fermentation process can begin,
the area has to be prepared.
All unneeded materials are removed.
Equipment is cleaned and sterilized according
to the standard operating procedures.
All required materials and documentation should
be gathered and prepared.
And all Process Control software loaded and
verified.
The Fermentation batch process will be guided
and documented with the BPR – Batch Process
Record.
The Batch Record leads the operator through
the process, with each step requiring a sign-off
and separate verification.
This record also includes spaces for documenting
key times, activities and instrument readings.
Operators begin with a complete check of all
critical equipment.
Valves, caps and lines are checked, hoses
are tightened, probes are verified and calibrated,
and 10 kilograms of HPW – High Purity Water
- is added to the vessel.
The bioreactor is brought up to normal process
pressure and monitored for 30 minutes in order
to check for leaks.
If a leak is detected, the problem is corrected
and the test is run again.
Once the reactor passes the test, we’re
ready to mix the media in the vessel.
