Hvac Validation

Transcript

HVAC Validation Introduction Heating, Ventilation and Air Conditioning System (HVAC)  HVA HVAC systems can have an impact on product pro duct quality  It can provide comfortable conditions for operators  The impact on premises and prevention of contamination and cross-contamination to be considered at the design stage  Temperature, relative humidity control where appropriate  upplement to basic !"# Introduction Heating, Ventilation and Air Conditioning System (HVAC)  HVA HVAC systems can have an impact on product pro duct quality  It can provide comfortable conditions for operators  The impact on premises and prevention of contamination and cross-contamination to be considered at the design stage  Temperature, relative humidity control where appropriate  upplement to basic !"# HVAC system consists of/  Air conditioner   AH$s  %ehumidifier %ehumidifier & Heater   'ilters (#re ) H*# H* #A+  %ust *tractors  %ucting ('or delivery of controlled air+  upply 'ans  moe %etector   %ampers  Humidity & Temperature & #ressure sensors  .ag 'ilters  Heating & Cooling Coils Area 0 'resh Air  Area 1 HVAC Impure air  #ure air  Area 2 Area 3 4eturn Air  *haust air  I " # $ 4  * A I 4   !&AC Component# E'hau#t Air (rille Silencer Weather louvre Flo rate controller Fan Filter Control damper !eater + $reflter !umidifer   Coolin" coil !eatin"   ith coil droplet #eparator Secondar) Filter %ecirculated %ecir culated air  Terminal  T erminal flter $roduction %oom Validation of HVAC systems It includes: Commissioning  5ualification  "aintenance Commissioning  #recursor to qualification  Includes setting up, balancing, ad6ustment and testing of entire HVAC system to ensure it meets requirements in $47  Acceptable tolerances for parameters  Training of personnel Conti: Records and data maintained include: Installation records 8 documented evidence of measure capacities of the system  %ata/ design and measurement for, e7g7 air flow, system  pressures  9)" manuals, schematic drawings, protocols, reports 5ualification  To ensure that equipment is designed as per requirement, installed properly7  Action of proving that any equipment wors correctly and leads to the epected results7 HVAC 5ualification Validation "aster #lan 5$A;I'ICATI9< $ser 4equirement pecification %esign 5ualification Installation 5ualification 9peration 5ualification #erformance 5ualification 4e- 5ualification7 Conti:  "anufacturers should qualify HVAC systems using a ris based approach7  The qualification of the HVAC system should be described in a validation master plan (V"#+7  The validation master plan should define the nature and etent of testing and the test procedures and protocols to be followed7  A change control procedure should be followed Conti:  4is analysis to determine critical and non-critical parameters, components, subsystems and controls  Critical parameters should be included  7 %etails safety requirements7 ?7 'ull details of the intended construction prior to implementation7 @7 %etails all equipment that must be ordered7 Installation 5ualification (I5+ I# should include:  Instrumentation checed against current engineering drawings and specifications  #roperly served by the required utilities  Verification of materials of construction  Installation of equipment and with piping  Calibration of measuring instruments  9peration manuals and spare parts lists to assure the proper and continuous operation of the system  Components are installed at specified location Conti I# $ocument should contain Instrument name, model, I7%7 #a between classified area ) unclassified area o Action • H*#A filter blocage • Increase fan speed • Increase air flow to specific area by altering dampers Conti: A27 AI4';9 V*;9CIT  *quipment/ Anemometer   4eading should be taen 0Ecm from the surface of filter7  4ecord velocity reading from all the four corners and the Centre of the filter surface7  4epeat twice at each location  'or !rade A laminar flow worstations, the air flow rates shall be E72 meter per second J 1EK (for vertical flows+ and E73> J 1EK (for Hori=ontal flows+   7 Temperature and 4elative Humidity/  $se a sling psycrometer to measure the dry bulb and wet  bulb temperature of the air7  Chec the wic of the sling psycrometer, it should be always in wet conditions in order to record correct wet  bulb temperature7  ling the psycrometer in air for about a minuteDs time and record the dry bulb and wet bulb temperature7  Chec the wet bulb depression i7e7 difference between dry  bulb and wet bulb temperature7 Conti:  Acceptance criteria/ Temperature/ 1@oC Humidity/ 3> N >>K  'requency / %aily Conti:  A*Air chan"e rate7 • "easurement of the air supply volume and determination of the air change rate (AC4+ is a measure of the frequency of air turnover in the clean room7 • This gives some idea as to how quicly contamination may  be removed from the clean room provided there is acceptable miing of air in the room7 • The AC4 can be determined by measuring the mean air velocity at the supply H*#As or grilles and calculating the air change rate based on the mean air supply volume7 Conti:  *quipment/  ample Anemometer  locations At least four positions are tested across the filter or face to obtain the mean supply air velocity7  'requency of sampling ch " - ? "onthly !"# compliance 8 5uarterly grille Conti: A@7 "IC49.I9;9!ICA; T*T  olid growth media (e7g7 settle and contact plates+ oybean Casein %igest Agar medium can be used for both .acteria ) 'ungi tested7  The recommended si=e of solid media is ME mm in diameter (for settle plates+  >> mm for contact plates7 Conti: • ampling condition/ • ampling in the at rest condition may be continued at an agreed frequency to monitor baseline contamination levels • The operational conditions and the activities being  performed at the time of testing should be recorded • Incubation condition/ • Incubation of samples, inverted, at 1E 8 1> o C for at least > days is suitable for the growth of mould and fungi7 • Incubation of samples, inverted, at 2E - 2> EC for at least 1 days is suitable for the growth of bacteria7 Conti:  Acceptance criteria for Airborne .ioburden test/ Critical *nvironment/ no more than 0 C'$&m 2, or E7E2 C'$&ft2($# monograph+  Acceptance criteria for urface .ioburden test/ Critical *nvironment/ no more than 0 C'$&017Mcm 1, or 1 in1 ('%A Aseptic #rocessing !uidelines+ 4eferences • upplementary guidelines on good manufacturing practices for HVAC systems for non-sterile pharmaceutical dosage forms7 (H9 Technical 4eport- eries, ?7