1. OBJECTIVE
To lay down the procedure for operation, cleaning and calibration of LFC.
2. SCOPE
This procedure is applicable to Microbiological Laboratory
3. RESPONSIBILITY
• Microbiologist
• Manager QC
4. SAFETY INSTRUCTIONS
• Do not work when UV light is on as it may cause eye damage
• Take care to prevent any damage to the integrity of filter during cleaning. In case of observation of any damage to filters, immediately inform to your superior for further action.
5. PROCEDURE
5.1 OPERATION
5.1.1 Switch “OFF” the UV light.
5.1.2 Clean the equipment with clean lint-free cloth duster and spray 70% IPA solution to LAF unit and entire Area of LAF room.
5.1.3 Switch “ON” the “AIR” and Visible Light switch situated on the control panel on the right-hand side of the instrument.
5.1.4 Now check the LAF Manometer pressure, it should be within 10 – 20 mm of Water Gauge.
5.1.5 Check the log record for burning hour of UV light, it should not exceed more than 2000 hours. UV tube should be replaced after a specified burning period.
5.1.6 Start the gas burner with the help of gas lighter and carry out the routine works.
5.1.7 After completion of work, switch OFF the Airflow and gas burner.
5.1.8 Clean any remaining water or waste liquid material spilled on the laminar airflow platform properly with a dry cloth.
5.1.9 Clean properly the working chamber from the ceiling, followed by side glass and then the platform of the chamber with sterile 70% IPA.
5.1.10 Spray sterile 70% IPA and switch OFF the Visible light and then Switch ON the UV light till to start the next operation.
5.1.11 If the LAF is used for Aseptic filtration, clean the receiver pipe tank with hot WFI.
5.1.12 Open the outlet of Solution Collection Tank and collect the solution in a plastic crate. Close the valve and transfer the crate for solution disposal.
5.2 Cleaning of Pre filters
5.2.1 Ensure that the LAF is switch off. Affix the tag on Instrument “UNDER MAINTENANCE”.
5.2.2 Pre-filter is situated on the backside of the LAF, unscrew and then remove the pre-filter from LAF.
5.2.3 Transfer the pre-filter to washing area and blow the compressed air from reverse side to blow out all the dust particles.
5.2.4 Wash the pre-filter with DM water and then with liquid detergent solution. Finally wash again with DM water to remove the detergent solution.
5.2.5 Remove the trapped water from the pre-filter by jerking and finally rinse with 70% IPA solution.
5.2.6 Allow drying the pre-filter at room temperature.
5.2.7 Assemble the pre-filter at their original place and tighten the screw properly.
5.3 Frequencies
5.3.1 Daily for operation
5.3.2 Fortnightly for Pre-filter cleaning
5.3.3 Calibration: Yearly by an External agency
5.3.4 And internal calibration will be done once in every 15 days according to Annex-III
6. RELATED DOCUMENTS
Operational Log Book Format – Annex I
Cleaning Log Book Format – Annex II
Calibration Report Format – Annex III
7. DISTRIBUTION INDEX
Original Copy will be retained by Quality Assurance Department.
| DISTRIBUTION INDEX | ||
|---|---|---|
| Distributed To | Copy No. | Received By/Date |
| Quality Control Department | 01 | , |
| Microbiological Lab | 01 | , |
8. ABBREVIATIONS
Q.C Quality Control Department
LFC Laminar Flow Cabinet
LAF Laminar Air Flow
DM Demineralized
IPA Isopropyl Alcohol
9. REVISION HISTORY
| Revision No. | Issue Date | Supersedes | Reason of Change / Description |
| Revision No. Dated | |||
| 00 | 20/08/2022 | 00 N/A | First Version |