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Wednesday, October 22, 2008

Qualification Protocol of Heating, Ventilation and Air Conditioning (HVAC) System - overview

Purpose :
To provide the documentary evidences that the HVAC system of System No. even numbered...
· Designed as per XXXX requirement
· Installed as per design specification
· Operating as per set parameters and
· Performing as per its intended use.
Scope:
This qualification protocol is applicable to the HVAC system of XXX Drug Area designed by M/s. (Contracting company) and installed by them.
Intended Use :
· To supply the required air quantity to the Compression Room to provide product protection from air borne contamination.
· To maintain the temperature and humidity for process as required by the product specification.
· To provide room pressure gradient to prevent ingress of contaminant
Location :
Service floor, XXXX, (Place).
Reference :
NA
Attachments :
Ducting Layout As Attachment (User Should attach one layout)
G.A. Drawing for Air Handling Unit As Attachment (User Should attach one layout)
Air Flow Diagram As Attachment (User Should attach one layout)

Study for qualification :
IQ:
To check all parts of AHU are as per predefined specification
To review proper installation as per protocol.
OQ:
To operate the AHU system as per proposed procedure and record.
To challenge the operating parameters of AHU and record.
To challenge the safety operation and record.
PQ:
HEPA filters integrity leak test by cold DOP test and air velocity shall be checked during performance.
Temperature and Humidity for three consecutive days shall be checked.
Air pressure, Air pattern and Air movement shall be checked for three consecutive days.
Air changes for the room shall be calculated to meet predefined specification.
Responsibilities :
M/s. (Contracting company)
· To install the HVAC system as per approved designed specification and at designated
Place.
· To prepare qualification protocol.
· To submit qualification protocol to 'XXXX company' for approval.
· To record the observation alongwith 'XXXX company' as per predefined specification.
· To submit final qualification reports to 'XXXX company' for approval.
Quality Assurance
· To review qualification protocol and approval.
· To record the observation along with production and engineering as per designed protocol.
Engineering
· To prepare the Qualification protocol.
· To install the system as per the design specification.
· To provide utilities and supportive services for qualification.
· To arrange for the calibration of the instruments for qualification study.
· To assist QA/Production while qualification study.

2 comments:

ravi said...

No mention of non-viable & viable partculate count test & area recovery. Idealy this (at rest condition) may be the part of OQ. After system balancing,filter integrity test, air velocity, CFM & ACPH measurement, Air flow pattern test need to be performed.

dinesh said...

in design qualification other four important parameter which not described.please mention this things.