Biomedical Engineering Reference
In-Depth Information
SOP No. QAS-032.00 Effective date: mm/dd/yyyy
Approved by:
51.7.2.7.1 Media-Fill Runs Exceeding Alert Levels and Corrective Actions
Perform investigation as follows:
When media-fill action levels are exceeded, an investigation shall be conducted and docu-
mented regarding the cause.
If action levels are exceeded, there shall be a prompt review of all appropriate rec-
ords relating to aseptic production between the current media fill and the last success-
ful one.
The investigation should include, but not be limited to, consideration of the following:
a. Microbial environmental monitoring data.
b. Particulate monitoring data.
c. Personnel monitoring data (finger impressions, etc.).
d. Sterilization cycles for media, commodities, and equipment.
e. HEPA filter evaluation (airborne particulate levels, smoke-challenge testing, velocity mea-
surements, etc.).
f. Room air flow patterns and pressures.
g. Operator technique and training.
h. Unusual events that occurred during the media fill.
i. Storage conditions of sterile commodities.
j. Identification of contaminants as a clue to the source of the contamination.
k. Housekeeping procedures and training.
l. Calibration of sterilization equipment.
m. Pre- and postfilter integrity test data, and/or filter housing assembly.
n. Product and/or process defects, and/or limitation of inspectional processes.
o. Documented disqualification of samples for obvious reasons prior to final reading.
p. Critical systems (HVAC, compressed air, gas, water, and steam) should be reviewed for
documented changes.
q. Calibration records should be checked.
r. All HEPA filters in the filling area should be inspected and rectified, if warranted.
s. Training records for all individuals (production, maintenance, cleaning) involved in the fill
should be reviewed to assure that proper training was provided.
t. If the root cause is assignable, corrective action needs to be taken and documented.
51.7.2.8 corrective actions
• Media-ill tests which exceed alert levels shall require action as described in Table 51.3.
• Decisions on whether or not to take action against the product being held and/or distributed
shall be based upon an evaluation of all the information available and shall be
documented.
• All product(s) that has been produced on a line following the media ill shall be quaran-
tined until a successful resolution of the media fill has occurred.
Note : A review of production batches in association with an unsuccessful media fill should include
appropriate environment monitoring data the record of sterility test results over this period, possible
assignable causes for current media fill results, and any other information that would bear upon the
sterility of the product involved.
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