1.0 OBJECTIVE
To lay down a standard procedure for operation, cleaning and maintenance of Dynamic Pass box.
2.0 SCOPE
This Standard Operating Procedure is applicable to the Pass box located in the Incubation room of Microbiology laboratory.
3.0 RESPONSIBILITY
Microbiologist shall be responsible to follow the procedure mention in this SOP.
4.0 ACCOUNTABILITY
Department Head & QA Head shall be accountable for effective implementation of this SOP.
5.0 ATTACHMENTS
Format for the record of U.V. lamp burning hours of Dynamic Pass box. – Attachment-I
Format for the record of daily monitoring performance of Dynamic Pass box. – Attachment-II
6.0 PROCEDURE
6.1 Precautions:
6.1.1 Ensure that the pass box is well cleaned.
6.2.2 Do not open the pass box doors immediately after switch OFF the UV light.
6.2.3 Both the doors of the pass box should not be opened simultaneously.
6.2 Operation
6.2.1 Switch ON the main power supply.
6.2.2 Ensure that the equipment is in clean state.
6.2.3 Clean the working area of pass box with 71% of I.P.A.
6.2.4 Close the both doors of pass box and switch ON the UV light for 15 minutes before transferring the
material.
6.2.5 After 15 minutes switch OFF the UV light and start the blower.
6.2.6 After 15 minutes of starting the blower, transfer the material to the pass box.
6.2.7 Ensure that one door should be closed while transferring the material.
6.2.8 After material transfer close the door carefully.
6.2.9 Transferred material is to be removed from opposite side of the pass box.
6.2.10 Carefully remove all the material from the pass box and close the door.
6.2.11 After completion of work, Disconnect all utilities and clean the entire area with 70% IPA.
6.3 Cleaning of Pass box
6.3.1 Keep the pass box interior and exterior free from dust.
6.3.2 Before starting the operation, clean the pass box with 70% IPA using a lint free cloth.
6.4 Monitoring performance
6.4.1 Prepare the plates of Soybean casein digest agar (for bacteria) and Sabouraud Dextrose Agar (for
fungus) as per SOP Media preparation and sterilization.
6.4.2 Pre-incubate the plates before exposure at 30-35°C for 24 hours.
6.4.3 After incubation of 24 hours transfer the SCDA & SDA petriplates into pass box.
6.4.4 Decontaminate the external surface of the petriplates with the help of a sterile mop soaked in 70%
IPA solution.
6.4.5 Ensure that the dynamic pass box is ON for 30 minutes before exposing the plates.
6.4.6 Expose the plates for 4 hours during working activity.
6.4.7 After 4 hours exposure incubate the exposed plates in inverted position at 30-35°C for 3-5 days for
bacterial growth and at 20-25°C for 5-7 days for fungal growth.
6.4.8 After incubation observe and count the number of colonies on the colony counter or in the source of
light with the help of marker.
6.4.9 Keep negative control plate without exposure and positive control plate by exposing the plate in the
outside environment.
6.4.10 Note down the observation in the format no. SOP/ML/027/F02-02.
6.4.11 If the count obtained are above the limit specified below investigate the results and take necessary
actions.
6.4.12 Frequency of monitoring
Class A: Once in a day whenever there is activity.
6.4.12 Acceptance criteria
- Action limit: Class A: 1 CFU/plate
- The positive control should show growth and negative control should not show any growth.
7.0 REFERENCES
In-house
8.0 ABBREVIATIONS
SOP: Standard operating procedure
°C : Degree Celsius
Psi : Pound per square inch
IPA : Isopropyl Alcohol
QA : Quality Assurance
QC : Quality Control
9.0 DISTRIBUTION LIST
Quality Assurance Department
Quality Control Department
10.0 HISTORY OF REVISION
| Version Number | Effective Date | Reason for Revision |
Format for the record of daily monitoring performance of Dynamic Pass box. – Attachment-II
| Frequency: Once in a day whenever there is activity.
Acceptance criteria: Action limit: Class A: 1 CFU/plate |
||||||
| Date of plate exposure | plate exposure start time | plate exposure end time | Plates exposed by | Total bacterial count (CFU/plate/4 hrs.) | Total fungal count (CFU/plate/4 hrs.) | Checked by |
Format for the record of U.V. lamp burning hours of Dynamic Pass box. – Attachment-I
| Instrument ID No.: | |||||
| Date
|
UV Lamp | Done By | Checked By | ||
| From | To | Total Min. | |||
