SOP for Operation and Cleaning of Pass box : Pharmaceutical Guidelines

SOP for Operation and Cleaning of Pass box

Standard operating procedure to operate and clean the Pass box used to transfer the material in sterile area.

1.0 PURPOSE

To lay down the procedure for Operation and Cleaning of Pass box.

2.0 SCOPE

It is applicable to operation and cleaning of pass boxes in Microbiology lab

3.0 RESPONSIBILITY

QC Microbiology officers and trained laboratory assistant is responsible for operation and cleaning of pass boxes.

4.0 ACCOUNTABILITY

Head of Department

5.0 PROCEDURE

5.1 Operation of Dynamic Pass Box

5.1.1 Switch on the main supply.
5.1.2 Ensure equipment is in a clean state
5.1.3 Mop the area with 70 % isopropyl alcohol/ disinfectant.
5.1.4 Start blowers 30 minutes prior to the operation.
5.1.5 Switch on the Ultra Violet (UV) light on for 30 minutes prior to use or when required.
5.1.6 Record the differential pressure across the High Efficiency Particulate Air (HEPA) filter (where applicable)
Note: Should be between 10 – 15 Pascal
5.1.7 Ensure that one door should be closed while transferring the material.
5.1.8 Keep the material in the pass box and wait for five minutes for stabilizing the pass box.

5.2 Operation of Static Pass Box

5.2.1 Switch on the main supply.
5.2.2 Ensure equipment is in a clean state
5.2.3 Mop the working area with 70 % isopropyl alcohol/ disinfectant.
5.2.4 Switch on the Ultra Violet (UV) light on for 30 minutes prior to use or when required.
5.2.5 Ensure that one door should be closed while transferring the material.

5.3 Monitoring of dynamic pass box (Passive air sampling)

5.3.1 Transfer the preincubated soybean casein digest agar Petri plate into pass box (LAL test room to Incubator).
5.3.2 Enter the respective area as per the SOP.
5.3.3 Decontaminate the external surface of the Petri plates with the help of a sterile mop soaked in a filtered sporicidal agent.
5.3.4 Mark the Petri plates at the base with the following details with a marker,
Media lot No.
Name of the location / ID
Date of exposure
Exposed by
5.3.5 Place the Petri plate inside the dynamic pass box and remove the upper lid of the Petri plate and keep it in inverted position.
5.3.6 Expose the media plate for 4 hours, after 4 hours of exposure, close the Petri plate with lid. Collect the Petri plate and transfer the plates into the incubator.
5.3.7 Incubate the exposed Petri plate in an inverted position in the incubator at 32.5 ± 2.5°C for 5 days.
5.3.8 After incubation observe the plates for a number of colonies on the colony counter or in the light source with the help of a marker.
5.3.9 Note down the observation.
5.3.10 If the counts obtained are above the limits specified below, investigatethe results and take necessary actions as per SOP.
5.3.11 Frequency of Monitoring
Class A: Daily.
5.3.12 Acceptance criteria
Action limit: Class A: 1 CFU / plate

5.4 Cleaning of Pass box

5.4.1 Keep the Pass box interior and exterior free from dust.
5.4.2 Before starting usage for the first time in a day, clean with 70% Isopropyl alcohol (IPA) / Disinfectant using a non-fiber shedding cloth.
5.4.3 Inside cleaning of the pass box is recommended in the following cases
5.4.3.1 Before starting any work in the pass box.
5.4.3.2 In the event of liquid spillage in the pass box or when required.

5.5 Shutting - down procedure

5.5.1 Disconnect all utilities.
5.5.2 Clean down the entire area with 70 % Isopropyl alcohol/ Disinfectant
5.6 Record the details of UV burning, Differential pressure.
5.7 Expose the plate in the dynamic pass on every working day and record.
5.8 Perform the revalidation of dynamic pass box on the yearly basis

6.0 ABBREVIATIONS

6.1 SOP - Standard Operating Procedure
6.2 UV - Ultra Violet
6.3 HEPA - High Efficiency Particulate Air Filter
6.4 % - Percent
6.5 CFU - Colony Forming Unit
6.6 °C - Degree Centigrade





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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