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

1.0 Objective

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

2.0 Scope

This procedure is applicable for monitoring the physical parameter of the clean area and of equipment 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.
PRECAUTION: The filters of all LAF & the terminal filters of clean area should be cleaned before monitoring.

5.0 Procedure

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

A HEPA filter integrity i.e. DOP test

FREQUENCY: 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.

B AIR VELOCITY:

FREQUENCY: 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:

FREQUENCY: 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.
3. 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.
4. 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.
5. 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.
ACCEPTANCE CRITERIA (At rest):

Location	Area condition / 209E	Maximum permitted nos. of particle/m3
		At Rest		In Operation
		0.5µ	5µ	0.5µ	5µ
LAF Bench	Grade A (M 3.5)	3500 (class 100)	Nil	3500 (class 100)	Nil
Sterility Room Cooling zone Inoculation Room Air lock-III	Grade B (M 5.5)	3500 (class 100)	Nil	350000 (class 10000)	2000
Air lock-II	Grade C  (M 6.5)	350000    (class 10,000)	2000	3500000  (class 100000)	20000

Ref. EUGMP 1997

6.0 ABBREVIATION

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.

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