SOP for Calibration and Operation of Pass Box

OBJECTIVE

To lay down a procedure for the operation of pass boxes.

SCOPE

This SOP applies to all Pass Boxes located in the Microbiology Laboratory of PharmaInfo Limited

RESPONSIBILITY

Microbiologist – Responsible for operating.

Section In-charge – Responsible for reviewing the procedure.

QC Head – Responsible for implementing the procedure.

QA Head – Overall compliance.

PROCEDURE

Operation

• Disinfect the outer and inner surfaces of the pass box with 70% IPA.
• Switch on the main supply.
• Switch ON the blower 30 minutes before the operation.
• Switch ON the UV light for 30 minutes before operation.
• Load the sterilized items i.e., microbial media flasks, sampling bottles, etc.

• Ensure that the pass box doors are in closed condition, after loading.
• Switch on the UV for 20 minutes to ensure the surface sterilization of loaded sterilized items.
• Record the pressure gauge reading and UV lamp burning hours in Annexure I.
• Operation of the pass box shall be followed carefully, and precautions like the opening of both doors at the same time shall be avoided.
• Every day after the completion of work pass box shall be cleaned using 70% Isopropyl alcohol.
• If any spillage occurs during transferring or unloading of material it shall be immediately wiped off with 70% IPA.

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• Disinfect the outer and inner surfaces of the pass box with 70% IPA.
• Switch on the main supply.
• Open the door by pressing the “Open” button.
• Load the pass box with tested plates, flasks, tubes etc.
• Ensure that the pass box doors are in closed condition, after loading.
• The UV light of the Pass box will always be in ON condition when the pass box is in closed condition.

• The blower and normal light will ON when the pass box is in open condition.
• Operation of the pass box shall be followed carefully, and precautions like opening both doors at the same time shall be avoided.
• Every day after the completion of work pass box shall be cleaned using 70% Isopropyl alcohol.
• If any spillage occurs during transferring or unloading of material it shall be immediately wiped off with 70% IPA.
• Disinfect the outer and inner surfaces of the pass box with 70% IPA.
• Switch on the main supply.
• Open the door by pressing the “Open” button.
• Load the pass box with destructed media.
• Ensure that the pass box doors are in closed condition, after loading.
• The blower and normal light will be in ON condition when the pass box is in open condition.
• Operation of the pass box shall be followed carefully, and precautions like the opening of both doors at the same time shall be avoided.
• Every day after the completion of work pass box shall be cleaned using 70% Isopropyl alcohol.
• If any spillage occurs during transferring or unloading of material it shall be immediately wiped off with 70% IPA.
• Sanitize all Pass boxes with disinfectant as per the current version of the SOP Sanitization procedure for microbiology equipment and record the sanitization details in the respective log.

Calibration

• Calibration of the Pass box shall be carried out by an external agency once in year ± 30 days or after the maintenance job.
• UV lamps shall be replaced once in a year or after 9000 thousand burning hours which is earlier.

ABBREVIATIONS

QA: Quality Assurance

QC: Quality Control

SOP: Standard Operating Procedure

%: Percentage

IPA: Iso Propyl Alcohol

UV: Ultra Violet

REVISION HISTORY

Nil

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