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In microbiology labs, a biological safety cabinet (BSC) is an essential part of the apparatus. Experts can safely handle harmful biological agents and carry out procedures that safeguard the person conducting the study and the surrounding environment within its ventilated, enclosed workplace.

The biological safety cabinet protects against product, personnel, and cross-contamination by using directional airflow and high-efficiency particulate air (HEPA) filtration. The front grille of the cabinet draws in unfiltered room air, shielding the user from the materials within. After passing through HEPA filters and collecting particulates, the air is vented back into the space. Furthermore, pollutants are moved away from the work surface by HEPA-filtered laminar airflow within the workplace.

SOP – Cleaning & Qualification of Biological Safety Cabinet

1.0   Purpose:

• • To lay down the procedure for cleaning and qualification of Biological safety cabinet.

2.0   Scope:

• • This Standard Operating Procedure is applicable at Microbiology Department.

3.0   References:

• • User manual of Biological safety cabinet.

• • SOP for Laboratory Instrument Qualification

4.0   Responsibility:

• • Officer or Executive of Microbiology department shall be responsible for preparation of new or revision of existing SOPs.

• • Head of the department / designee of respective areas & QA shall be responsible for reviewing the SOPs.

• • Plant Head and Head-Quality shall be responsible for approval of SOP.

• • QA shall be responsible for distribution and control of SOPs to various departments.

5.0   Abbreviations:

• • CC : Change Control
  • Fpm  : Feet Per Minute
  • IPA : Isopropyl alcohol

• • LCD : Liquid Crystal Display

• • m/s : Meter per second

• • SOP : Standard Operating Procedure

• • UV : Ultra violet

6.0   Procedure for Qualification of Biological safety cabinet

• • Precaution during handling of Biological safety cabinet

• • Do not put any object on the air grill.

• • Do not use toxic, explosive or flammable substance in Biological safety cabinet.

• • Avoid UV exposure to eyes and skin.

• • Do not block front side or back air grill.

• • Qualification of Biological safety cabinet

• • Frequency: Once in six months ±15 days. OR

• • The qualification of Biological safety cabinet required:

• • If any failure observed during routine monitoring.

• • In case of breakdown, maintenance, preventive maintenance.

• • In case of change in installation location.

• • As per schedule

• • Parameters of Biological safety cabinet Qualification:

• • Following tests are performed during qualification and results are within acceptance criteria.

• • Down flow velocity test.

• • The down flow velocity test is primarily performed in class II biological safety cabinets to establish the average air descent speed and confirm laminar flow within the work area. The down flow velocity test is specific to class II safety cabinets because it uses direct HEPA filtration to keep the air uniform.

• • PAO test.

• • DOP/PAO testing is a rapid technique that uses DOP or PAO solutions to assess the HEPA (High Efficiency Particulate Air) filter’s integrity under operational conditions.

• • These solutions produce a gaseous particles, which then produces gas particles greater than.03 microns. The test will ensure that the HEPA filter is properly operational and that there are no leaks or damage.

• • Particle count test.

• • Viable particles are made up of living pollutants like bacteria and mold. Historically, viables were sampled using a settling plate near the aseptic process, then incubated and CFUs were analysed.

• • Non-viable particles include dust and other non-living items that may convey viable particles into the aseptic space. Maximum counts of non-viable particles are recorded.

• • Smoke pattern test

• • Airflow smoke pattern tests are performed on a class II biosafety cabinet to ensure that air flows smoothly in the work area with no dead spots and does not escape from the cabinet.

• • Procedure of Down flow Velocity Test:

• • Remove the U.V lamp, make a grid of 5 test points on the work zone.

• • Place the anemometer at a height of 10cm from the lower end of the sash, and take the 5 readings and report in Annexure-2
  • Acceptance criteria: 0.30±0.02 m/s

• • PAO (Poly alpha olefin) Test/ filter integrity test:

• • Ensure that the filter integrity test of the ULPA (Ultra-low particulate air )filter done by using PAO (Poly Alfa Olefin).

• • Acceptance criteria: The penetration level should be less than 0.01%.

• • Particle count test:

• • Ensure that particle count of the work station is done by using a calibrated air borne particulate matter counter.

• • • Acceptance criteria: As per ISO Class 5

• • • ≥ 0.5µ  particles: NMT 3520 particles per m³

• • • ≥ 5.0µ  particles : NMT 20 particles per m³

• • Smoke pattern test:

• • Using the Smoke Generator generate the smoke behind the sash, in the center of the working zone to demonstrate the laminarity of the air flow in the work zone.

• • Acceptance criteria: The smoke must gradually come down being sucked by the front and back grilles.

• • Generate the smoke just behind the sash to demonstrate that the inner air does leak to the exterior.

• • Acceptance criteria: The smoke generated must not leak to the exterior of the cabinet.

• • Generate the smoke by placing the smoke generator at the level of the armrest, to demonstrate that the air does not enter into the work zone.

• • Acceptance criteria: The front grilles must suck in the smoke generated, without entering the work zone.

• • Qualification shall be done by external agency if facility not available at location.

• • After Completion of Qualification write the details and pest as per Annexure-3.

7.0   Annexures for Biosafety cabinet Qualification :

Annexure- 1: Operation Record of Biological safety cabinet 

Annexure-2 : Qualification Protocol of Biological Safety Cabinet

Instrument Id:                              Date of Qualification:                                  Next Due Date:

1.0   Down flow Velocity Test:

INSTRUMENT :                                                MAKE/Model :                                        INSTRUMENT I.D :

Calibration Done:                                              Next Due Date:

Result: The average reading obtained is within acceptance criteria.

2.0   PAO (Poly alpha olefin) Test/ filter integrity test:

Filter Leak Acceptance: Maximum Particle penetration of 0.01%. No filter leaks present

3.0   Particle count test.

INSTRSUMENT DETAILS:              INSTRUMENT :              MAKE/Model :

INSTRUMENT I.D :       Calibration Done:                                 Next Due Date:

Remarks:

4.0   Smoke pattern test.

The airflow pattern test in the cabinet found to be pass/Fail.

Performed By:                                                  Checked by:

Annexure-3 : Qualification Status Label of Biological Safety Cabinet