USER MANUAL
TD069-O&M-001
REVISION 6
Page 49 of 80
The manufacturer recommends that re-calibration of the Active Air Sampler is
performed every 6–12 months and also if the air sampler has potentially been
damaged or the flow rate has been compromised.
4.8 Aseptic Hold
The Aseptic Hold period is the validated time that aseptic conditions can be
maintained after a decontamination cycle of the complete system has been run.
This period must be validated for each installation, and Bioquell can assist in this
process.
The display shows the user the time elapsed since the aseptic hold was
established by the completion of a successful decontamination cycle.
The timer starts when a complete system decontamination has finished and ends
when there has been a system breach: a pressure or airflow alarm, the front
door has been opened or the timer ends (which is set in the Administration
screen). The aseptic hold period is only applicable to QEXT modules.
Aseptic hold period displayed here
(days and hours).
In case of power failure the QUBE system has been designed to ensure that the
seals remain inflated, to maintain containment, but aseptic hold will end as
pressure and airflow will be out of specification.
The amber coloured surround to
the modules means the aseptic
hold has been breached.
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