Standard Operating Procedure Operation and Validation of Laminar Air Flow Hood
1.0 Objective: To provide a written procedure for the operation and validation of Laminar Air Flow Hood.
2.0 Scope: This SOP covers the operation and validation (in-house) of Laminar Air Flow Hood.
3.0 Responsibility: Microbiologist: To perform or implementation of this SOP
QA Officer/QAM: For overall compliance with this SOP.
4.0 Procedure:
4.1 Operation:
4.1.1 Switch on the mains.
4.1.2 Activate the Ultra Violet (UV) light for 30 minutes before beginning work.
4.1.3 Turn on the Laminar flow at least 15 minutes before starting work.
4.1.4 Ensure the Ultra Violet light is off during the working period.
4.1.5 Check the pressure of the Nanometer, indicated by the red liquid level. It should be between 5 – 15 mm.
4.1.6 Record the usage of the Ultra Violet lamp and Nanometer pressure in the Ultra Violet Lamp Usage Log Book.
4.1.7 Switch off the instrument once the work is completed.
4.1.8 Clean the interior surface of the Laminar with 70% Isopropyl Alcohol (IPA) before and after analysis.
5.0 Validation:
5.1 HEPA Filter Performance Check:
5.1.1 DOP Test: To be performed by an external agency.
5.1.2 Particulate Count: To be performed by an external agency.
5.1.3 Velocity Measurement: To be performed by an external agency.
5.1.4 Frequency: Once in a year.
5.1.5 Plate Count Method:
5.1.6 Expose Soya Bean Casein Digest Agar and Sabouraud Chloramphenicol Agar plates (duplicates) to airflow for 2 hours.
5.1.7 Incubate Soya Bean Casein Digest Agar plate at 35 to 37°C for 24 hours and Sabouraud Chloramphenicol Agar plate at 20 to 25°C for 72 to 120 hours.
5.1.8 Observe and count the number of colonies on the plates. Record the observations in the Laminar Flow Validation Log Book.
Acceptance Criteria: Not more than 1 colony-forming unit (cfu) per plate/2 hours.
Frequency: Once a month.
Related: SOP for Colony Counter
6.0 Routine Maintenance:
6.1 Cleaning and Maintenance:
6.1.1 Clean the instrument with a dry cloth and the Laminar Air Flow (LAF) bench with Isopropyl alcohol.
6.1.2 Check the level of the red liquid in the Nanometer.
6.1.3 Clean the tube of the ultraviolet light with a dry cloth.
7.0 Abbreviations:
SOP: Standard Operating Procedure
UV: Ultra Violet
QA: Quality Assurance
QAM: Quality Assurance Manager
IPA: Isopropyl Alcohol
cfu: Colony-Forming Unit
LAF: Laminar Air Flow
Related: Operation of Laminar airflow
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