SOP for RLAF Unit in Sampling Room

1.0 OBJECTIVE

To lay down the procedure for cleaning and operation of RLAF unit in Sampling Room at Raw Material Store.

2.0 SCOPE

This SOP shall be applicable for operation and cleaning of RLAF unit in Sampling Room at Stores Department.

3.0 RESPONSIBILITY

Stores Assistant/QC Pharmacist

4.0 ACCOUNTABILITY

Head of Department

5.0 PROCEDURE

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 a vacuum cleaner.
5.1.3 Mop the external surfaces with a clean dry lint-free cloth damped with potable water.
5.1.4 Finally wipe with a 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 a vacuum cleaner.
5.2.2 Mop the entire surface of pre-filter frames and side panel with a 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 polyethylene bags.
5.4.5 Clean the inner area of RLAF with a vacuum cleaner. Wipe with a 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 the 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 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 the 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.
In case 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.
In case 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.
In case reading is out of limit, clean /replace the pre-filter.
5.5.6 On completion of the operation, allow RLAF to run for 15 minutes. Then switch off the light and Blower.
5.5.7 Affix status label “TO BE CLEANED”

5.6 FREQUENCIES

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)

6.0 ABBREVIATIONS

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 mm – Millimeter
6.6 QC – Quality control

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