This document details the procedure for the Operation of the Air Handling Unit. It is the policy of XYZ Pharmaceuticals Limited that a written procedure shall be followed for the Operation and Cleaning of Air Handling Unit and its use monitored in order to ensure smooth operation and its use monitored to obtain consistent and reproducible results and to minimize downtime and to meet regulatory requirements.
This procedure is to be applied at the time of Operation of the Air Handling Unit
Responsibility and Accountability
Persons along with their responsibilities and accountability are
given below:
Executive – Corporate Quality Assurance
Section - In Charge
Manager - Technical
Manager - Corporate Quality Assurance
PROCEDURE
PRELIMINARY CHECK
5.1.1 Clean the apparatus externally with a clean cloth with 70% IPA.
5.1.2 Clean the unit surface, filter with wiping
cloth.
5.1.3 The pre-filters are cleaned once a week.
5.2 PRECAUTION
5.2.1 Switch OFF the AHU after work. Adjust the temperature with the environment of a lab. Fill the red oil in the manometer properly from time to time.
5.3 OPERATION OF AHU
Switch ON the Air Handling Unit from the main switch. The AHU in the microbiology area should be switched “ON” one hour before the start-up of the work.
5.3.3 The AHU should be given time for its establishment so as to attain the designed room conditions. The maintenance of temperature and RH is determined every four hours once a day by using calibrated thermometers and manometers. Check the reading on the manometer before and after switching ON the AHU.
It shows the pressure in Pascal. The pressure difference between the two locations of the microbiology section is always 5 Pa or more than 5 Pa. Calibration shall be done from an Outside party.
Figure 1
AHU working principle with Diagram
5.0.6 Report
any discrepancy observed during operation and calibration of instrument to
Section
In charge of his representative for corrective and preventative action as per Sop No. XYZ/CQA/SOP-030, CAPA.
5.0.7 Section In-charge or his representative will take the necessary action and report the same to Manager-Quality Assurance.
5.0.8 Affix the “Out of Order” label on the instrument as per SOP No. XYZ/CQA/SOP-006, Labelling Policy.
Procedure for cleaning of AHU and ventilation filters
This SOP is applicable to the Air handing unit in production dept and the quality control department and ventilation filters of service floor.
Before opening AHU push starter button in
off condition Open the filter door of AHU.
Remove filter from inside.
Take the filter to washing room in service
floor.
Spray raw water and soap water on filters.
Rub it with nylon brush.
Spray raw water again to remove soap.
Pass compressed air on both the sides of
filter.
Allow it to dry.
Fix the filter in AHU.
Close the door of AHU.
Clean the cabin of AHU from inside by wet
cloth using soap and water. Check ‘V’ belt, motor pulley and fan pulley of AHU
unit.
6.0 ABBREVIATION
XYZ XYZ Limited
SOP Standard Operating Procedure
CQA Corporate
Quality Assurance
A.H.U. Air Handling Unit
CAPA Corrective And Preventative Action