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14/12/14 18:21Pharma Treasures: Air Flow Visualization (smoke test) and contamination control - FDA's inspectional observations (483's)
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Pharma treasures is an informatory site, which shares pharma related articles. The ultimate goal of this site is to become a knowledge hub
by gathering all pharma related technical information under one roof...... This blog mainly talks about QMS,cGMP,Regulatory Filings &
Guidelines,Validation & Qualifications,Drug Stability,FDA 483s &Media Fill. Hope this blog will cater the needs of both freshers and
experienced professionals.
Monday, 7 October 2013
Air Flow Visualization (smoke test) and contamination control - FDA's inspectional observations (483's)
SMOKE TEST
AIR FLOW VISUALIZATION STUDIES IN CLEAN
ROOMS
Air flow visualization studies are intended to demonstrate
visual evidence of air flow direction. The test helps to identify
stagnant areas within a clean room; these areas can further
act as a channel or reservoir of contaminants. The test can
also be used to demonstrate the effects on airflow caused by
equipment.
The predominant sources of contaminants within a clean room are people
and machinery. Air flow patterns in the clean zones can be easily
disturbed by the factors such as machine guarding, equipment design,
inappropriate component specifications or necessary interventions. These
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factors can altogether contributes to a higher potential risk of air borne
contamination.
FDA and regulatory agencies in the EU ask for documented studies about
air flows in critical zones under dynamic conditions. Turbulence and
stagnant air can act as a channel or reservoir for the accumulation of air
borne contaminants.
Smoke studies provides visual evidence of air flow direction. If a particle
or air born contaminant enters a clean room, the smoke test will
demonstrate where the particle will likelymove.
Desired airflow characteristics in clean room are
1.Air flow move toward potential sources of contamination and away from
the product path. Ex:HEPA filtered air should not flow over clean room
personnel and then over the product path.
2.Air should be flowing smoothly in one direction with no turbulence or
eddies.
3. For movement within the air stream, such as a person manipulating
materials or product, air disruption should recover quickly to regain
unidirectional flow.
CLEAN ROOM AIRFLOW VISUALIZATION AND REGULATORY
REQUIREMENTS
WHO GMP For Sterile Pharmaceutical Products Working document
QAS/09.295 Rev.1
Grade A: The uniformity and effectiveness of the unidirectional flow
shall be demonstrated by undertaking airflow visualization tests
EU GMP Annex 1It should be demonstrated that air-flow patterns do not present acontamination risk, e.g. care should be taken to ensure that air flows do
not distribute particles from a particle generating person, operation ormachine to a zone of higher product risk.
Pharmaceutical Inspection Convention (PIC/S)GMP Annex 1 Revision
2008 Interpretation Of Most Important Changes For The
Manufacture Of Sterile Medicinal Products -Recommendation January
2010
Non-viable particles should be measured and are expected to meet grade
A requirements. Smoke studies should be performed.
FDA Guidance Document Sterile Drug Products Produced by AsepticProcessing Current Good Manufacturing Practice (September 2004)
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14/12/14 18:21Pharma Treasures: Air Flow Visualization (smoke test) and contamination control - FDA's inspectional observations (483's)
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Posted by Don at 09:43
determine that the personnel activities do not negatively
affect air flow patterns within ISO 5 hoods.
7. The smoke study does not demonstrate critical aseptic
connections performed during the assembly of ISO 5 hoods
used to fill sterile pharmaceuticals.
In any environment where human operators are involved ,microbial
contamination is inevitable .Carefully designed ventilating system and
operating practices can protect the product from contamination risks to
some extent. Airflow visualization helps to diagnose problems such as
excess contamination build up in clean room.
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