QAS-032 - Quality Operations Procedures for Pharmaceutical, API, and Biotechnology - page 517

SOP No. QAS-032.00 Effective date: mm/dd/yyyy
Approved by:
51.4 general reQuirements for all media fills
The following list details requirements for all aseptic process simulations:
a. A total of four people are to be present in the filling room (two operators, microbiologists,
and technicians or maintenance) during the filling of the entire fill. Any additional
personnel should be identified and documented (two operators during vial filling are
necessary).
b. All activity carried out during filling (or lyophilization) should be as per the related SOPs,
identified in the specified MFMs.
c. All personnel scheduled to work under aseptic conditions must participate in at least one
media fill.
d. New employee must participate in the next scheduled media fill after receiving pertinent
clean room training as per the appropriate SOPs.
e. Each semi-annual requalification run must be of a duration greater than/or equivalent to a
routine fill and is to occur using both first and second filling shifts. The duration of bian-
nual requalifications is a maximum of 24 hours.
f. The fill volume should not be less than approximately 50% of vials/ampoules.
g. Checking of the in-process fill is not allowed during media fill except during initial volume
adjustment.
h. During each media fill, all major and minor defined interventions will be performed once.
The time and the personnel performing the intervention will be documented as per the
approved MFM.
i. The media fill operations shall be monitored for the operator's behavior by the operations
manager and/or the manufacturing director (the usual and unusual intervention) through
fixed cameras.
j. If multiple sizes of the same container/closure configuration are aseptically filled, selective
sizes may be used for media fills. Containers with the widest diameter openings and slow-
est line speed should be included in the media-filling regimen and may be representative
of worst-case conditions. However, the small containers are representative of worst condi-
tions because of lack of container stability in the line operations.
k. Clear glass vials/ampoules should be used for media fill runs.
l. The duration of the run should be sufficient to cover all manipulations that are normally
performed in actual processing, and all production shifts for line/product/container
combinations.
51.4.1 e nvironmental m onitoring
Environmental monitoring is to be performed as per the current SOPs for the following:
A. Airborne bio-burden will be analyzed as per SOP, QCS-111.
B. Airborne particulate will be analyzed as per SOP, QAS-222.
C. Surface bio-burden will be analyzed as per SOP, QCS-333.
D. Personnel bio-burden will be analyzed as per SOP, QCS-444. In addition, QC/
microbiology will perform audit monitoring of all media fill participants including
themselves.