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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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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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