To lay down procedure for cleaning and operation of RLAF unit in Sampling Room at Raw Material Store.
This SOP shall be applicable for operation and cleaning of RLAF unit in Sampling Room at Stores Department.
Stores Assistant/QC Pharmacist
Head of Department
5.1 CLEANING AT THE BEGINNING OF THE SHIFT
5.1.1 Store person shall ensure that the RLAF power supply is switched off before starting cleaning activity.
5.1.2 Clean the external surface of the RLAF with vacuum cleaner.
5.1.3 Mop the external surfaces with clean dry lint free cloth damped with potable water.
5.1.4 Finally wipe with clean dry lint free cloth dampened with 70% IPA solution and allow it to dry.
5.1.5 Affix the status label as ‘cleaned’ with duly sign it.
5.2 CLEANING DURING ACTIVE MATERIAL SAMPLING
5.2.1 Switch off the RLAF and clean the outer surface of pre filter frame and side panel with vacuum cleaner.
5.2.2 Mop the entire surface of pre filter frames and side panel with clean dry lint free cloth dampened with 70% IPA solution.
5.2.3 Ensure that surface is visually clean.
5.2.4 Affix the status label ‘cleaned’ with duly sign it.
5.3 CLEANING DURING EXCIPIENT MATERIAL SAMPLING
5.3.1 Clean the area under RLAF, SS Table and Balances with clean dry lint free cloth and mopped with 70% IPA solution.
5.4 WEEKLY CLEANING
5.4.1 Store person shall ensure that the RLAF power supply is switched off before starting cleaning activity.
5.4.2 Remove the pre filter, cover it in intact polythene bags and transfer it on to washing area.
5.4.3 Clean the pre filter as per SOP for cleaning of RLAF filters.
5.4.4 Transfer the cleaned pre filter to respective area duly covered in clean polythene bags.
5.4.5 Clean the inner area of RLAF with vacuum cleaner. Wipe with clean dry lint free cloth.
5.4.6 Refix the clean pre filter by screwing the fixtures.
5.4.7 Clean the RLAF as per procedure described under point number 5.1.1 to 5.1.4
5.4.8 Record the cleaning activity.
5.5 OPERATION OF RLAF
5.5.1 QC person shall check and ensure for the ‘Zero’ reading in all three magnehelic gauges of RLAF unit, when the RLAF unit is switched off.
5.5.2 Check for the “CLEANED” status label.
5.5.3 Switch on the Blower.
5.5.4 Switch on the light.
5.5.5 Allow the RLAF to run for at least 15 minutes before start of observation & recording.
PRESSURE DROP ACROSS FINAL (HEPA) FILTER
Limit : 8 mm – 16 mm
Observe the reading and record the pressure on HEPA filter.
Incase reading is out of limit, Stop the operation & intimate Head-Store and Maintenance for rectification.
PRESSURE DROP ACROSS INTERMEDIATE FILTER
Limit : 3 mm – 6 mm
Observe the reading and record.
Incase reading is out of limit, clean /replace the intermediate filter.
PRESSURE DROP ACROSS PREFILTER FILTER
Limit : 1 mm – 6 mm
Observe the reading and record.
Incase reading is out of limit, clean /replace the pre filter.
5.5.6 On completion of operation, allow RLAF to run for 15 minutes. Then switch off the light and Blower.
5.5.7 Affix status label “TO BE CLEANED”
Pressure differential - Daily (In house)
Air velocity - Twice in a year. (Outside Agency)
DOP test - Twice in a year. (Outside Agency)
Particle count - Twice in a year. (Outside Agency)
Viable microbial test - Twice in month. (In house)
6.1 SOP – Standard operating procedure
6.2 RLAF – Reverse laminar air flow
6.3 IPA – Isopropyle alcohol
6.4 SS – Stainless steel
6.5 SOP – Standard operating procedure
6.6 mm – Millimeter
6.7 QC – Quality control
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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