Operation and Calibration Procedure for Pass Box SOP

	STANDARD OPERATING PROCEDURE
	Department: Quality Control	SOP No.: QC/MB/
Operation and Calibration Procedure for Pass Box	Effective Date:
	Review Date:
	Page No.: 1 of 5

1.0            OBJECTIVE:

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

2.0            SCOPE:

2.1                   This SOP is applicable to all Pass Boxes located in the Microbiology Laboratory of   Pharma Private Limited

               Make: Klenz flow

               Equipment .ID.No:                                                                                      

3.0            RESPONSIBILITY:

3.1                 Microbiologist – Responsible for operating.

3.2                 Section In-charge – Responsible for review the procedure.

3.3                 QC Head – Responsible for implementing the procedure.

3.4                 QA Head – Overall compliance.

4.0            PROCEDURE:

4.1                 Operating procedure of pass box ;

4.1.1             Disinfect the outer and inner surface of pass box with 70% IPA.

4.1.2             Switch on the main supply.

4.1.3             Switch ON the blower 30 minutes prior to the operation.

4.1.4             Switch ON the UV light for 30 minutes prior to operation.

4.1.5             Load the sterilized items i.e., microbial media flasks, sampling bottles, etc.

4.1.6             Ensure that the pass box doors are in closed condition, after loading.

4.1.7             Switch on the UV for 20 minutes to ensure the surface sterilization of loaded sterilized    items.

4.1.8             Record the pressure gauge reading and UV lamp burning hours in Annexure I.

4.1.9             Operation of pass box shall be followed carefully, precautions like opening of both the doors at the same time shall be avoided.

4.1.10         Every day after completion of work pass box shall be cleaned using 70% Isopropyl alcohol.

4.1.11         If any spillage occurs during transferring or unloading of material it shall be     immediately wiped off with 70% IPA.

4.2                 Operating procedure of pass box :

4.2.1             Disinfect the outer and inner surface of pass box with 70% IPA.

4.2.2             Switch on the main supply.

4.2.3             Open the door by pressing the “Open” button.

4.2.4             Load the pass box with tested plates, flasks, tubes etc.

4.2.5             Ensure that the pass box doors are in closed condition, after loading.

4.2.6             The UV light of Pass box will always in ON condition when pass box in closed condition.

4.2.7             The blower and normal light will ON when the pass box in open condition.

4.2.8             Operation of pass box shall be followed carefully, precautions like opening of both the doors at the same time shall be avoided.

4.2.9             Every day after completion of work pass box shall be cleaned using 70% Isopropyl alcohol.

4.2.10         If any spillage occurs during transferring or unloading of material it shall be immediately wiped off with 70% IPA.

4.3                 Operating procedure of pass box (   ):

4.3.1             Disinfect the outer and inner surface of pass box with 70% IPA.

4.3.2             Switch on the main supply.

4.3.3             Open the door by pressing the “Open” button.

4.3.4             Load the pass box with destructed media.

4.3.5             Ensure that the pass box doors are in closed condition, after loading.

4.3.6             The blower and normal light will be in ON condition when the pass box in open condition.

4.3.7             Operation of pass box shall be followed carefully, precautions like opening of both the doors at the same time shall be avoided.

4.3.8             Every day after completion of work pass box shall be cleaned using 70% Isopropyl alcohol.

4.3.9             If any spillage occurs during transferring or unloading of material it shall be     immediately wiped off with 70% IPA.

4.4                   Sanitize all Pass boxes with disinfectant as per current version of SOP Sanitization     procedure for microbiology equipments (QC/MB/xx) and record the sanitization details in respective log.

4.5                 Calibration: Calibration of Pass box shall be carried out by external agency once in a year ± 30days or after maintenance job.

4.6              UV lamps shall be replaced once in year or after 9000 thousand burning hours which is earlier.

5.0            ABBREVIATIONS:

QA: Quality Assurance	QC: Quality Control
SOP: Standard Operating Procedure	%: Percentage
IPA: Iso Propyl Alcohol	UV: Ultra Violet

7.0            REFERENCES: NA

8.0            DOCUMENT HISTORY:

Version No.	Reference Change control No.	Changes made	Reason for change
00	NA	New	NA