· Aseptic Media fill Validation is a sterile process validation which require for the Area, Equipment suitability & Process simulation.
Materials Required:
|
S.No |
Ingredients |
Quantity |
|
1 |
Dehydrated Soybean Casein Digest |
30 mg/mL (0.3%) |
|
2 |
Hydrochloric Acid |
q.s. to adjust pH |
|
3 |
Sodium Hydroxide |
q.s. to adjust pH |
|
4 |
Water for injection USP/Ph.Eur/IH |
q.s to 1 mL |
Interventions
during Vial/Ampoule filling as follows:
|
ROUTINE INTERVENTIONS |
||
|
S.No |
Interventions |
Type of Intervention |
|
1 |
Aseptic setup of filling parts, including
connections. |
Routine |
|
2 |
Removal of fallen vials/Ampoules from in feed turn
table. |
Routine |
|
3 |
Removal of empty
vials/Ampoules jammed on the feed warm or conveyor |
Routine |
|
4 |
Adjustment of feed warm |
Routine |
|
5 |
Aseptic set up of rubber stopper bowl |
Routine |
|
6 |
Addition of
stoppers in stopper bowl by operator |
Routine |
|
7 |
Removal of
fallen filled and stoppered vials from the conveyor. |
Routine |
|
8 |
Removal of fallen filled and stoppered vials from the out feed
turn table. |
Routine |
|
9 |
Removal of
filled vials without rubber stopper from the rejection conveyor. |
Routine |
|
10 |
Adjustment of
rubber stopper hopper/chute |
Routine |
|
11 |
Centering/ adjustment of filling needles |
Routine |
|
12 |
Adjustment of star wheel |
Routine |
|
13 |
Change of operating
personnel (crew) between the shifts. |
Routine |
|
14 |
Mimic the Collection of
vials/Ampoules from the conveyor to simulate fill volume check. |
Routine |
|
15 |
Sampling of primary
packing material, at initial and end of the filling. |
Routine |
|
16 |
Opening of swing conveyor |
Routine |
|
17 |
Setup/ removal of settle
plates in the aseptic filling area for microbiological monitoring. |
Routine |
|
18 |
Volumetric air sampling in
the aseptic filling line for microbiological monitoring. |
Routine |
|
19 |
Opening of filling doors |
Routine |
Interventions during Pre Fill Syringes filling as
follows:
|
ROUTINE INTERVENTIONS |
||
|
S. No. |
Interventions |
Type of
intervention |
|
1 |
Aseptic setup of filling parts, including connections |
Routine |
|
2 |
Aseptic setup of plunger stopper bowl and feeder |
Routine |
|
3 |
Addition of plunger stopper to hopper by operator |
Routine |
|
4 |
Adjustment of plunger stoppers in stopper bowl. |
Routine |
|
5 |
Clearing of
plunger stopper jams on track or chute. |
Routine |
|
6 |
Mimic collection of syringes from first tub for fill volume check |
Routine |
|
7 |
Centering /adjustment of filling needles. |
Routine |
|
8 |
Adjustment of centering frame. |
Routine |
|
9 |
Change of operating personnel (crew) between shifts. |
Routine |
|
10 |
Sampling of
primary packing materials from aseptic line (Syringe & Plunger). |
Routine |
|
11 |
Setup/Removal of settle plate in filling zone |
Routine |
|
12 |
Volumetric air sampling in aseptic filling zone |
Routine |
|
13 |
Opening of filling door. |
Routine |
Interventions
during Blow Fill Syringes filling as follows:
|
ROUTINE INTERVENTIONS |
||
|
S.No |
Interventions |
Type of Intervention |
|
1 |
Removal of Steam cup after
integrity of the product filter. |
Routine |
|
2 |
Parison setting. |
Routine |
|
3 |
Thickness adjustment of
parison |
Routine |
|
4 |
Removal of defective
filled card from the conveyor. |
Routine |
|
5 |
Removal of strucked card
from the mould. |
Routine |
|
6 |
Opening of guard doors of
filling machine. |
Routine |
|
7 |
Change of operating
personnel (crew) between the shifts. |
Routine |
|
8 |
Setup/ removal
of settle plates in the aseptic filling area for microbiological monitoring |
Routine |
|
9 |
Volumetric air
sampling in the filling line for microbiological monitoring. |
Routine |
Non - Routine Interventions for any filling
activity:
|
NON – ROUTINE
INTERVENTIONS |
||
|
S.No |
Interventions |
Type of Intervention |
|
1 |
Turn off the power, supplying to all the machines
& HVAC, of filling area to simulate power failure for 3 min., followed by
filling for minimum 10 min. |
Non –
Routine |
|
2 |
Run the filling machine at maximum speed
( vials/ min.) and carry out the filling
for minimum 10 min. |
Non – Routine |
|
3 |
Send 2 excess personnel (total 5 persons in
filling room) and carry out the filling for minimum 10 min. |
Non – Routine |
|
4 |
Perform the filling with only one person in the
filling room for 10 min. The person shall be in dynamic action, simulating
various operations, during this time. |
Non –
Routine |
|
5 |
Turn off the filling machine and simulate the
maintenance work by engineers on pumps, conveyor etc., in filling room for 60
min. Followed by filling for minimum 10 minutes. |
Non – Routine |
NOTE:
Minimum
batch size of media fill is 5000 containers, if below 5000 containers then
exact batch size is the minimum size ex. 1000, 2000….
No
single container shows growth for minimum batch size if found batch discard
Maximum
batch size of media fill is 1,00,000/more as per requirement should be run for
3shifts (24hrs) Mostly no single container shows growth, if 1found
investigations if more discard & revalidation.
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