SOP for Operation and Calibration of Pass Box

OBJECTIVE

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

SCOPE

This SOP is applicable to all Pass Boxes located in the Microbiology Laboratory of PharmaSky Limited

RESPONSIBILITY

Microbiologist – Responsible for operating.

Section In-charge – Responsible for review the procedure.

QC Head – Responsible for implementing the procedure.

QA Head – Overall compliance.

PROCEDURE

Operation

Disinfect the outer and inner surface of the pass box with 70% IPA.
Switch on the main supply.
Switch ON the blower 30 minutes prior to the operation.
Switch ON the UV light for 30 minutes prior to operation.
Load the sterilized items i.e., microbial media flasks, sampling bottles, etc.
Ensure that the pass box doors are in the 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 pass box shall be followed carefully, precautions like the opening of both the 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 surface 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 the 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 pass box shall be followed carefully, precautions like the opening of both the 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 surface 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 the closed condition, after loading.
The blower and normal light will be in ON condition when the pass box is in open condition.
Operation of pass box shall be followed carefully, precautions like the opening of both the 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 current version of SOP Sanitization procedure for microbiology equipment and record the sanitization details in the respective log.

Calibration

Calibration of Pass box shall be carried out by an external agency once in a year ± 30days or after maintenance job.
UV lamps shall be replaced once in 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