Objectives: The purpose of this SOP is to provide guidelines for the operation of the Laminar Flow-Hood (LFH) in a safe and effective manner, ensuring the prevention of contamination of samples and reagents. This SOP outlines the procedures for the operation of the LFH, including the frequency of external validation for the High-Efficiency Particulate Air (HEPA) filter, standard UV light life hours, and acceptance limits for differential pressure.
Scope: This SOP is applicable to all personnel who operate the LFH for handling samples and reagents that require a sterile environment. This includes laboratory technicians, research assistants, and other personnel who may come into contact with the LFH.
Responsibility: The Principal Investigator (PI) of the laboratory is responsible for ensuring that all personnel who operate the LFH are adequately trained in the procedures outlined in this SOP. The PI is also responsible for ensuring that the LFH is maintained in good working order, including performing regular external validation for the HEPA filter and replacing the UV light as per standard life hours.
Accountability: All personnel who operate the LFH are responsible for adhering to the procedures outlined in this SOP. Any deviations from this SOP should be reported to the PI immediately.
Procedure:
Pre-Operational Checks: a. Ensure that the LFH is clean and free from any debris or contamination. b. Check the differential pressure gauge on the LFH to ensure that it is within the acceptable range. c. Check the HEPA filter indicator to ensure that it is not indicating a need for replacement. d. Check that the UV light is functional and within its standard life hours.
Operational Procedures: a. Wash hands thoroughly before entering the LFH and wear appropriate PPE, including gloves and lab coat. b. Place all samples and reagents within the LFH and close the door. c. Turn on the LFH and allow it to run for 15 minutes before beginning work. d. Work within the LFH without opening the door unless necessary. e. If the door is opened, turn off the LFH and allow it to run for 15 minutes before resuming work. f. When finished with work, turn off the LFH, remove all samples and reagents, and clean the LFH thoroughly.
External Validation for HEPA Filter: a. External validation for the HEPA filter should be performed annually by a qualified technician. b. The technician will perform particle count tests to verify the filter's efficiency. c. If the HEPA filter fails the validation test, it should be replaced immediately.
Standard UV Light Life Hours: a. The UV light in the LFH should be replaced after 12 months of continuous use, regardless of the number of hours used. b. If the UV light fails before the 12-month period, it should be replaced immediately.
Acceptance Limits for Differential Pressure: a. The differential pressure gauge on the LFH should be checked before and after each use to ensure that it is within the acceptable range. b. The acceptable range for differential pressure is between 0.45 and 0.75 inches of the water column. c. If the differential pressure falls outside of this range, the LFH should be inspected and repaired if necessary.
Frequency of Review: This SOP should be reviewed and updated annually or as necessary to ensure that it remains relevant and effective. Any changes to this SOP should be communicated to all personnel who operate the LFH.
Limits for Differential pressure:
According to ISO: 05-20 Pascal's between adjacent areas.
According to WHO: 10-15 Pascal's between the adjacent areas.
According to USP: 05-12.45 Pascal's between the adjacent areas.
According to USP: 05-12.45 Pascal's between the adjacent areas.
Standard UV Light life hours: 6000 hours.
END OF DOCUMENT
My Recent Gadgets purchased after great research:
Boya Microphone: https://amzn.to/3Sd1AhU
American Touristic Bag: https://amzn.to/3k9fXai
Mobile Phone: https://amzn.to/3SaBdJk
Laptop: https://amzn.to/3IvLMDA
Air Drops: https://amzn.to/3EhuOXc
Vega Trimmer: https://amzn.to/3S6BMUx
Camera: EOS 200D-II, (EF-S 18-55 IS STM) https://amzn.to/417hxKw
Dreaming to update for following
Camera EOS 50 Mark –II EF-M 15-45mm is STM https://amzn.to/417hxKw
Asus Notebook-14 : https://amzn.to/3YGZYzn
You may like to read these links:
Hi. I’m Writer of Researchsop.com. ’ ’ Please share these SOPs to all concern pharma people for their development. I like to fullfill the need of curious people. These things inspire me to make things looks better.
0 comments:
Post a Comment