Biomedical Engineering Reference
In-Depth Information
SOP No. QAS-032.00 Effective date: mm/dd/yyyy
Approved by:
3. Volume check is done only during machine setting.
4. During filling all major and minor interventions will be performed as defined in approved
MFM and recorded.
5. Power shutdown to be simulated by stopping the laminar flow unit and the main AHU's
for 30 s.
6. The containers are sealed and the media-filled units are collected in sequentially num-
bered trays or boxes (to correlate to the filling time).
7. The filled units should be briefly inverted and swirled after filling to assure closure contact
with the medium.
8. Increase the size of the filling crew to more than the number necessary to fill the batch
(maximum three people).
9. All routine activities which take place on the filling line should be a part of the test, that is,
weight adjustments (only initial machine setting allowed), stoppers loading, and so on.
51.7.2
l
yoPhilized
P
roductS
51.7.2.1 compounding and filling operations: as above
Compounding as described in Section 51.7.1.
Filling operations will also be carried out as mentioned above but the containers are to be par-
tially stoppered, which will be transferred through the dedicated conveyors to the automatic load-
ing/unloading systems (ALUS).
The filling operation of lyophilized products shall be accomplished as indicated in Table 51.2.
51.7.2.2 lyophilization simulation
Media fill test should simulate the normal production environmental condition and process flow,
including filling of product, loose capping, covering, transport to a freeze dryer, uncovering, filling
of freeze dryer vacuum process, and seating of stoppers.
During the process, manual intervention may occur, including removal of tray tops or bottoms in
the chamber, when loading vials, connections of thermocouples or thermoprobe junctions and
unloading the chamber. All manual intervention should be included during scheduled media fill.
The freeze dryer media fill should be duplicated as much of the freeze drying process except
freezing, as practical, including partial vacuum and duration as appropriate for the media. The
methods employed for the lyophilization process simulation testing generally is similar to those
used for solution fills with the addition of the transport and freeze-drying steps.
However, it should be focused on loading and sealing activities, which are presumed to be the
greatest source of potential contamination. The test will be conducted according to the process
details and description in the MFM.
table 51.2
lyophilized Products
runs
filling and loading
unloading
Run I
Day 1/Shift 1 with interval
On day 3
Day 2/Shift 1 with interval
Run II
Day 1/Shift 1 with interval
On day 3
Day 2/Shift 1 with interval
Run III
Day 1/Shift 1 with interval
On day 3
Day 2/Shift 1 with interval
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