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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

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