sop for Cleaning and Operation of Reverse Laminar Air Flow

Cleaning and Operation of Reverse Laminar Air Flow

1.0 Objective
To lay down a procedure for cleaning and operation of reverse laminar air flow.
2.0 Scope
This Standard Operating Procedure is applicable for cleaning and operation of reverse laminar air flow to be followed at formulation plants of abc company.
3.0 Responsibility
3.1 Officer/Executive warehouse shall be responsible for operation and cleaning of this SOP.
3.2 Engineering Officer/ Executive shall be responsible for filter cleaning of RLAF.
3.3 Head Warehouse is responsible for implementation of this SOP.
3.4 Head QA or his designee shall be responsible for compliance of this SOP.
4.0 Abbreviations and Definitions
SOP : Standard Operating Procedure
i.e. : That is
No : Number
QA : Quality Assurance
WH : Warehouse
HOD : Head of Depatment
5.0 Procedure
5.1 Cleaning procedure of RLAF
5.1.1 Ensure that the RLAF filter cleaning done by engineering department as per respective filter cleaning SOP.
5.1.2 Mop the external surface of the RLAF with the help of lint free cloth.
5.1.3 Finally mopping done with 70% IPA Solution with the help of lint free cloth.
5.1.4 Ensure the proper cleaning in RLAF area.
5.2 Operation procedure of RLAF
5.2.1 The required entries are made in the dispensing log record.
5.2.2 Switch “On” the main power supply and the lights of RLAF.
5.2.3 Then press the key to start the blower motor.
5.2.4 Ensure that the RLAF is started half an hour before dispensing activity.
5.2.5 Ensure the Magnehelic gauge / Manometer readings are within the limit before start up of the dispensing activity.
5.2.6 The limit for the Magnehelic gauge / Manometer readings should be within range i.e.
5.2.6.1 Limit of pre-filter – 1 to 3 ± 1mm of water
5.2.6.2 Limit of Microvee filter – 1.5 to 5 ± 1mm of water
5.2.6.3 Limit of HEPA Filter – 8 to 14 ± 1 mm of water
5.2.7 Working area i.e. “Safe Zone” shall be marked with red line.
5.2.8 Always ensure the dispensing activity is carried out in safe zone of working station.
5.2.9 Switch “Off” the machine after all the utensils and containers are transferred out of the workstation.
5.2.10 Consider precautionary measures when the Gauge 1 pressure reading decreases indicates the clogging of filter and the Gauge 2 and 3 pressure-reading increases as the filter clogs, reading drop indicates malfunctioning of Motor Blowers or leakage of filters.
5.3 GENERAL CONDITIONS:
5.3.1 Magnehelic gauges / Manometer reading should be within the specified limits.
5.3.2 Filters should be cleaned as per their schedule / requirement.

5.4 PRECAUTION
5.4.1 Avoid excessive movements while performing Dispensing activity in RLAF.
6.0 Forms and Records
6.1 RLAF Operation record – Annexure-1
7.0 Distribution
7.1 Master Copy – Documentation Cell (Quality Assurance)
7.2 Controlled Copy – Warehouse Department.
8.0 History