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4 Good manufacturing requirements -- Part 2: 4WHO/VSQ/9!"2

HVAC PQ

Objective

To determine that the HVAC systems model # perform as intended by running thesys- tem as-built, at rest, and operational, for 20 consecutive or!ing days each and monitoring

and re- cording all relevant information and data" esults must demonstrate that performanceconsistently meets pre-determined specifications under normal conditions, and here appropriatefor orst case situations"

Scope

To be performed after the $% has been completed and approved" Any e&uipment or systemserving this HVAC system must be fully validated before HVAC validation begins"

a' (or ne installation, modification, replacement, or relocation of any component of the

HVACsystem"

b' Annual re-validation

c' )f there is a contaminationproblem"

Responsibility

(acility engineer is responsible for riting the protocol, supervising the performance of the *%,verify- ing the data and riting the *% report"

%A is responsible for approving the protocol and revieing and approving the data and

conclusions and for scheduling re-validations

Materials, Equipment an!ocuments

+aterials re&uired are all the items hich ill be routinely used to test air &uality for particulatesand microbial counts, the manual operations or computer-programme controlling the facilitytemperature, humidity, airflo, ma!e-up air, etc"

ocumented calibration is re&uired before using the folloing to measure the facility

air +icromanometer or ifferential *ressure .augeThermal Anemometer 

Vane-type Anemometer +icro-ohmmeter ith AirfloHood

*article Counter 

+icrobiological Air /ampler and +ediaplates

Charts for the time, temperature and pressurerecording"

/$*s for each test method, for the operation and calibrations of the e&uipment used, the data to

be recorded, and the criteria for acceptance must be prepared and approved before beginning the

perfor- mance &ualification"

Re"erence !ocuments#

)/ Contamination Control ivision ecommended *ractice 001"2 Testing Cleanrooms"

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4 Good manufacturing requirements -- Part 2: 4WHO/VSQ/9!"2

)/ Contamination Control ivision ecommended *ractice 02"3 +icroorganisms inCleanrooms"

4H$ .ood +anufacturing *ractices for *harmaceutical *roducts" T/ 52 Anne6 3, 3772"

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Proceure

)n this third part of the HVAC validation, tests are performed to sho that the air &uality meets the

specifications for particulates, temperature, humidity, microbial counts, lighting levels, etc" for thespecification and classification of each room"

*% is performed on the facility in three different

stages 8As-built9 :no e&uipment, no personnel'

8At-rest9 :e&uipped but no operations and no

personnel' 8$perational9 :ith personnel, e&uipment

operations'

The folloing list of tests :e6cept microbial counts' for Air %uality Validation is e6tracted from the

)nstitute of nvironmental /ciences ocument Contamination Control ivision ecommended

*rac- tice 001"2 Testing Cleanrooms" This document also describes the methods for each test"

+icrobial counting methods are described in the )nstitute of nvironmental /ciences ocumentCon- tamination Control ivision ecommended *ractice 02"3 +icroorganisms in Cleanrooms"+icro- bial counts are performed at the 8at-rest9 and 8operational9 stages of performancevalidation"

The re&uirements for particulates and microbial counts in air in cleanrooms is e6tracted from4H$ .+* .uidelines T/ 52"

 All data is to be recorded on data record forms prepared for the /$*s for each testperformed"

 A successful performance &ualification re&uires consistent results ithin specifications for 20con- secutive or!ing days for each of the three stages :as-built, at rest, operational'"

Reportin$

esponsible person verifies that the information is complete, prepares the deviation report andthe*erformance %ualification eport and submits to %A for revie andapproval"

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%able o" air cleanliness classi"ications "rom &HO %RS '()* +Re"#)-

(pasted in, not available in electronic format)

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%able o" Propose Air classi"ications an Air an Sur"ace Microbial.imits*

P!A .etter +Re"# ()-/

(pasted in, not available in electronic format)

;/ource egulatory and )ndustry anuary 3771"

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%able o" Recommene %ests by Cleanroom %ype +0ES-* +Re"#12-

(pasted in, not available in electronic format)