SOP for Validation of Clean Area and Equipment Lying in Clean Area : Pharmaceutical Guidelines

SOP for Validation of Clean Area and Equipment Lying in Clean Area

Standard operating procedure of monitoring the HEPA filter integrity and air velocity of clean area and of equipments situated in clean area viz. LAF unit, sterile dress cabinet & culture cabinet, by outside agency

1.0  Objective

       To describe the procedure for monitoring of clean area and equipment lying  in clean area.

2.0  SCOPE

       This procedure is applicable for monitoring the physical parameter of clean area and of equipments situated in clean area viz. LAF unit, sterile dress cabinet & culture cabinet, by outside agency.

3.0  Responsibility

3.1  Doing      :   Outside agency/Eng. Dept.
3.2  Checking :   Executive / Manager/Eng. Dept.

4.0  AccountAbility

       Head of the Department/Eng. Dept.


       The filters of all LAF & the terminal filters of clean area should be cleaned before monitoring.


      TPL Representative has to remain present & ensure the methodology followed and results correctness.

A  HEPA filter integrity i.e. DOP test


Every six month
1. The test is performed using DOP aerosol generator, which genereates dioctyl pthalate (DOP) monodisperse aerosol with air pressure not less than 1.2 kg/cm2.
2. Allow DOP aerosol smoke from upstream of HEPA filter and directed down stream through HEPA filter.
3. Ensure that upstream flow have 100% concentration, by using a photometer.
4. Ensure any leakage in HEPA filter by the photometer probe transverse through out the filter surface at a distance not more than 3 inches from filter surface or the protective grill over the filter at a transverse rate of probe not more than 3 mtr/min (10 ft/min).
5. In case of any leakage observed, identity the location of leakage and do the necessary action or inform the engineering department.

Acceptance  Criteria  :

There should be at least 99.99% retention of particles above 0.3 µ size.



     Every six month.
1.  Measure air velocity through supply diffuser in all LAF unit and at each terminal HEPA in clean area with mechanical vane type or orifice type anemometer in mtr/min. or ft/min.
2.  The average of 3 readings at different points should be considered if orifice type anemometer is used.
3.  Collect the print out of results and attach it with report.

     Acceptance Criteria :

     For LAF: 90 to 110 feet/min.

C  Airborne particulate matter :


Every six month
1. The monitoring of airborne particulate matter(Air particulate matter) is performed using a volumetric electronic air particle counter.
2. Three sample reading are to be taken for each location.
Ø The test is performed “At rest condition” i.e allow the AHU & LAF “ON” for at least 30min before performing the test and after completion & cleaning of last operation carried out.
Ø Take sample of at least 1 cubic foot of air per minute and select particle size of 0.5µ and 5.0µ, on the instrument.
Ø Read the particulate number directly from digital display for 0.5µ and 5µ.
Repeat the process for at least three times at each location and collect the all print out of results and attach it with report.



Maximum permitted nos. of particle/m3
At Rest
In Operation
LAF Bench
Grade A
(M 3.5)
(class 100)
(class 100)
Sterility Room
Cooling zone
Inoculation Room
Air lock-III
Grade B
(M 5.5)
(class 100)
(class 10000)
Air lock-II
Grade C
 (M 6.5)
   (class 10,000)
 (class 100000)

Ref. EUGMP 1997


6.1  LAF       =  Laminar Air Flow
6.2  HEPA    = High Efficiency Particulate Air
6.3  DOP      =  Dioctyl Pthalate
6.4  µ            =   Micron
6.5  CUFT   =   Cubic feet
6.6  CU MTR = Cubic Meter.   

Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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2 comments: Post Yours! Read Comment Policy ▼

  1. In case of Environment Monitoring of clean room please tell us the location of settle plate and the height of petriplate stand.

  2. Locate the plates at critical locations and at hight of return risers.



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