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General things for Qualification and Validation
Remember: A change control is mandatory when equipment or any other new thing
happens at site.

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For IQ

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HVAC System
1. Supply line is always installed below Return line
2. Control valves are always installed in Return line
3. Strainer is always in supply line
4. Temp. / RH transmitter is always in Return duct.
Test aerosol source substances:
 poly-alpha olefin (PAO) oil
 dioctyl sebacate (DOS)
 di-2-ethyl hexyl sebacate (DEHS);
 dioctyl (2-ethyl hexyl) phthalate (DOP3))
 paraffin oil
 polystyrene latex
Relationship b/w Temperature and RH:
If temp increases = RH Increases.
How??: High temp air will have more water holding capacity.
How AHU reacts??: Temp incr – Hot water valve closes – temp decr.
As high temp air passes thru chilled water coil, then air will take up moisture and RH
will incr.
IQ of HVAC

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Physical verification:
 Magnehelic gauges
 HEPA filters Number/ Quality/Sr.
No. (cross check with Document)/
Size (cross check with GA
drawing)
 Fine filters Number/ Quality/Sr.
No. (cross check with Document)/
Size (cross check with GA
drawing)
 Pre filters Number/ Quality/Sr.
No. (cross check with Document)/
Size (cross check with GA
drawing)
 Chilled water line
 Valves i.e. Butterfly / Ball type
 Temp / RH sensors
 Fire damper
 Manual Volume dampers
 All the Supply and Return ducts
numbers
 Smoke detectors
 Hot water line
 Chilled water / Hot water lines
valves
 Control valves
 Testing port
 Tagging
 Limit switch
 Blower
 Strainer in supply line
 Perforated plate as a safety
parameter
 Insulation for water piping and
ducts
 Manual valves
Documentation:

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Drawings / Diagrams:
 GA Drawing
 AHU zoning diagram
 Pressure Zoning diagram
 Heat load sheet
 Air flow diagram

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OQ of HVAC
❶ Functional challenge of the components and pieces of equipment:
Check all the pieces of equipment / AHU are working or not, especially for Safety
aspects and Alarm verification.
E.g. limit switch: AHU fan should be turned off automatically when the door (for
AHU blower) is open. Temp /RH alarm: When RH/ Temp goes in Alert and Action
limits then alarm should be generated in BMS.
❷ Room balancing.
❸ Testing temperature and %RH monitoring and control systems
Verification that the values of the actual temperature/ %RH in the rooms are:
■ correctly measured.
■ correctly sent to and received by the control system (BMS).
■ correctly interpreted by the control system (i.e. control system sent back the
appropriate control signal to AHU, humidifiers and heaters.)
One person is checking temp/ RH in the room and second person is checking in
BMS. Both the values should be cross checked and matched.
Challenge test like increase or decrease in Temp. /RH should also be done and both
the sensor and system should show these changes. Person verifying system should
check the alarm generated during challenge test.
❹ Temperature and %RH mapping.
For every room. E.g. Sensors are kept at different places in one room like in the
middle/ center/ @ 3 ft height/ @ 8 ft height. Values should be within limits for all the
sensors present in the room.
❺ Testing differential pressure monitoring system.
■ correctly measured.
■ correctly sent to and received by the control system (BMS).
■ correctly interpreted by the control system
❻ Testing air quality.
NVPC and VPC tests are conducted to check air quality.

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PQ of HVAC
PERFORMANCE QUALIFICATION TEST:
 Temperature and % Relative humidity (RH) monitoring
By digital hygrometer
Freq.: every 4 hours for 3 days
 Differential pressure Measurments
By magnehgelic guage
Freq.: every 4 hours for 3 days
 Air Velocity and Air Change calculation
For Plenum HEPA (by using Fan type Anemometer): Instrument should be
kept 6 inches away from the HEPA. Locations: 5 (4 corner+center)
For Terminal HEPA (by using Hot wire type Anemometer).
5 locations per filter
Formula for Calculation:-
 Air quantity (CFM) = Average air velocity (FPM) * Area of grill
/ diffuser / terminal HEPA filter (sq. ft.)
 Total air quantity (CFM) = Sum of the air quantity of all grills /
diffusers / terminal HEPA filters
 ACPH= [Total air quantity (CFM) X60]/ Room Volume (cu. ft.)

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 Filter Integrity Test
By using PAO: Poly Alpha Olephin (conc.: 10-100 mg/m3
)
Conc < 20: Reduce the sensitivity for leak detection
Conc. > 80: Give rise to excessive filter fouling over an extended test period
Equipment: Aerosol Photometer + Aerosol generator + Scanning probe
Leakage must not be greater than 0.01% of the upstream concentration
Photometer will scan the surface of HEPA at the rate of NMT 10 feet/min or
NMT 5 cm/s.
Scanning probe should be keep 2 inches away from the HEPA surface.
Scan the HEPA surface + filter casing + joints.
 Air Flow Pattern test (Smoke Test)
By using videography
Smoke is made up of Glycerin + water. This solution when heated
generates Fog or Smoke.
 Non-Viable particle counting test (NVPC) (Air cleanliness test)
By using Optical Particle Counter
Volume of sample (for ISO5 - at rest and operation): 1 m3
equivalent to
35.31 ft3
.
Volume of sample (for ISO7 at operation & other grades at both
conditions): 1 ft3
Number of sampling point locations by using the equation: NL = √A
√A is the area of the room in square meter (m2
)
NL is the minimum number of sampling locations
Probe shall be positioned at ~ 1-3 m height/working height from the
floor.
Preferably sampling locations should be preferred under HEPA as well as
where air flow is not reaching.
Delay time b/w 2 continuous readings must be 5 seconds.
1 cu.meter = 35.31 cu.ft (1 m3
= 35.31 ft3
)

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 Microbiological Monitoring (Passive Air Sampling/Settle plate count (SPC)
method)
Done by settle plate (passive air sampling)
Plates are made up of SCDA: Soya-bean Casein Digest Agar for both
sampling techs.
Settle plate (passive air sampling) Settle plate count (SPC) method:
Expose the plates near the return air risers, filling locations on the SS stands
and other locations on the floor.
Raise lids to expose the surface of the medium and rest the lid on the very
edge of the plate so that the entire agar surface is completely exposed.
Precaution: Take care not to put fingers on plates. Avoid passing anything
over the top of plates being exposed, where possible.

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Time: Expose the plates for NLT 2 hrs for Class D & NLT 1 hrs in CNC areas
for three days.
Incubation conditions:
For Soybean casein digest agar: 20-25°C for 72 hrs (for Fungi) followed by
30-35°C for 48 hrs (for Bacteria).
Air sampler (active air sampling) VAS (Volumetric Air Sampling):
Use sterilized/Sanitized sieve.
Perform the air sampling at predetermined locations as per define location in
Grade D areas for three days.
Sample 1000 liters (1 m3
) of air at each location.
Incubation conditions:
For Soybean casein digest agar: 20-25°C for 72 hrs followed by 30-35°C for
48hrs.
Acceptance Criteria
Cleanliness Class
Allowable counts
Passive Air Sampling (CFU / plate)
RLAF (Installed in Class 8) NMT 50 CFU/ 2 hours of exposure
ISO Class 8(Grade D) NMT 100 CFU/ 1 hours of exposure
Cleanliness Class
Allowable counts
Active Air Sampling (CFU)/ m3
RLAF (Installed in Class 8) NMT 100 CFU / plate
ISO Class 8(Grade D) NMT 500 CFU / plate
 Recovery Test (For Classified Area):
For Temperature/ RH and for NVPC

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For NVPC:
Location: @ Centre of the room
• Take initial base line particle count which should meet the static condition
on viable air borne Particle count monitoring limits. Note down the time (T1).
• Set the particle counter with 1 minute sample time.
• Increase the particles by switching off the AHU and increasing man
movement / PAO.
• Increase the particles 10 times greater than initial base line particles of 0.5
micron particle sizes.
• Note down the time (T2) when the particles reach to 10 times and switch
off the generator.
• Let the particles to attain the cleanliness class limit & note the time (T3).
Result: T3-T2 = Recovery time
 Containment leak test
This test is performed to determine if there is intrusion of unfiltered air into the
clean room from outside the clean room through joints, seams, doorways and
pressurized ceilings.
Procedures for containment leak test
Discrete-particle counter (DPC) method
 Measure the particle concentration outside the cleanroom enclosure
immediately adjacent to the surface or doorway to be evaluated.
 This concentration should be greater than the cleanroom concentration by a
factor of 103
, and equal to at least 3.5 × 106
particles/m3
at the particle size to
be measured. If the concentration is less, generate an aerosol to increase the
concentration.
 To check for leakage through construction joints, cracks or service conduits,
scan inside the enclosure at a distance of NMT 5 cm from the joint, seal or
mating surfaces to be tested at a scan rate of approximately 5 cm/s (10 ft/min).
 To check for intrusion at open doorways, flow visualization methods are
recommended.
 Record and report all readings greater than 10−2
times the measured external
aerosol particle concentration at the appropriate particle size.
Photometer method
Same method but,
A reading on the photometer 0.1 % setting in excess of 0.01 % indicates a leak.

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Compressed Air System
Components:
CA Gen System:
 Oil free air compressor unit. This eliminates hydrocarbon content in the
compressed air and eliminates or reduces the need for coalescing type
filters.
 Air receiver. (Wet Receiver) In order to avoid contamination, acts as a
reservoir when CA demand is high, Pressure stabilization, pulsation
reduction.
 A dryer (Air dryer unit). Serves to remove as much water as possible,
decreasing the dew point.
 Copper piping network / Fitting/ valves. This network is oil free and has
been cleaned with alcohol. (Note that the use of galvanized piping,
which is porous, is avoided. Such pipe materials will retain moisture.)
CA Distribution System:
 0.5 µ filters (Cartridge filters) at each potential product-air contact point of
use.
 Pressure Gauge to check filter leakage
 Piping and fittings and valves (Manual)
CA is used:
 When air cleaning or dry cleaning is required
 For any instrument which has movementable parts
IQ of CAS
Important is to check Quick disconnects to create a sampling point at each POU or
monitoring point.
Other things are similar as per image shown in Classical IQ testing.

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OQ of CAS
 Functional qualification at component and systems- levels:
Functional qualification at component level:
 Verification that mechanical moving parts move freely.
 Verification that all necessary adjustments can be performed.
 Verification that normal operating adjustments are not at the minimum or
the maximum of the range.
 Low and high alarm testing.
 On/off sequences testing.
 Simulation of a power supply shut down and recovery.
Functional qualification at system level:
The CAS delivers the required cubic feet per minute (cfm) at the specified
working pressure, and is capable of achieving and maintaining the specified
dew point.
 Air quality testing.
Samples after dryer and @ each POU.
VPC:

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Remember: Take blind sample before and after compressed air sample to ensure that there is no
contaminated air in the area.

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NVPC:

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 Hydrocarbon content: ≤ 0.5 mg/m3
or < 1 ppm
 User Points Pressure Check Test
The pressure should be NLT 6.0 bar.
With a portable manometer, check the pressure @ each valve.
 User Points Dew Point Check Test
Should NLT -40o
C, check with portable dew point meter.
 Oil and Moisture content test
Oil content should be within 0.1-0.5 mg/m3
, preferably, 0.1 mg/m3
PQ of CAS
1st phase: VPC/ NVPC/ hydrocarbon content tests should be done after at least 1 week
after OQ completion. Sampling locations and tests reamins same as in OQ.
2nd phase: Less intensive but > routine.
NVPC and VPC tests are done for 3 months.

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Purified Water System
Backwash: Backwash is used where filters or membranes are used.
When water is filtered thru such filter or membranes then particles
will retain on the surface of filter or membranes. To remove these
particles water is flushed in reverse manner (unlike regualr) to
remove these particles.
Phases of Water System Validation
Phase 1
 For 2-4 weeks
 Operational parameters/ Cleaning-Sanitization method developement
 Dialy sampling from after each step / skid, @ each POU
 Water cannot be used for production
Phase 2
 For 2-4 weeks
 Shows consistency in water quality as per SOP
 Same sampling method
 Water can be used for production
Phase 3
 1 year
 Water quality checked over a long period of time
 Weekly samples of all POU
 Show that seasonal variations doesn‘t affect water quality i.e. system is
robust in worst condition as well.

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PWGS
Pre-treatment
Raw water Raw water from municipality. Check whether raw water is chlorinated
or not. If chlorinated sample it and verify its limits.
If not then Chloriantion is required.
Raw water chlorination by Sodium Hypochlorite.
ppm content of free chlorine should be within limits.
NMT 5 ppm of free chlorine should be present in water as it could foul or
damage the MGF.
Raw water coagulant dosing system by PolyAluminium Chloride. Which
coagulates impurities like suspended particles and iron impurities in water-forms
coagulates which are easy to remove.
Static mixers are provided here to mix dosing chemicals.
Raw water storage / recirculation / chlorination in UG tank RW is
continuously recirculated to aviod stagnant water which could be the cause of
Microbes growth.
In addition, sod. Hypochlorite dosing is also done and 4-5 ppm (mg/L) free
chlorine is maintained.
MGF Multi Grade Filter or Sand Filter All suspended particles of > 50 µ sized
are removed here. Resulting water has turbidity of < 1 NTU (Nephelometric
Turbidity Unit).
Auto backwash @ every 20 hrs or diff pressure exceeds 1.5 bar.
UF Ultra Filtration Main purpose of UF is to remove SDI (Slit Density Index)
causing particles. Hence resulting water will have SDI < 3 which incr. the
efficiency of RO.
Water is passed thru 40 µ bag type filter and then thru membrane filter
(Polysulphone material).
UF is required to save RO membranes. Replacing UF, 0.45 µ filter can be used.
But UF is more safe. Generally, SDI<5 is accptable but don’t take a risk and get
< 3 SDI water.
By SDI, we can measure fouling potential of particles. How much amt of flow
(SDI gives % drops per time in flow rate) is reduced while filtering thru filters.

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DS Duplex softner. 2 softners from which 1 acts as a working while 2nd as a
safety (when first is not working or can‘t be used). Safety softner is regenrated
after 3 reg cycles of working softner.
Main purpose is to remove hardness by removing Mag and Cal ions which is
replaced by Na ion.
Principle: Ion exchange resin.
Regenerated with NaCl (Brine soln.).
SMBS dosing b4 utility softener Sod. Metabisulphite dosing system. SMBS is
reducing agent which removes chlorine traces from water. ORP should be < 400
mV.
Utility softner Same as DS.
HPS-1 for utility To supply water in utility area.
ACF Activated Carbon Filter. After UF, it is ACF.
Principle: Absorption of Chlorine, impurities, color, odor, halogens from the
water.
Backwash @ every 20 hrs for 15-20 mins.
Chloriantion by Sod hypochlorite. Water after ACF is stored in a storage tank
so to remove contaminants, water is chlorinated. After chlorination, water is
passed thru 5 µ cartridge filter to remove suspended particles.
HPS-2 for water supply to supply water for further processing.
CIP for UF when there is UF membrane choking and fouling CIP is required.
Components CIP tank, CIP pump, 10 µ cartridge filter, valves.
Chemicals used for CIP: Acidic: Citric acid or Basic: NaOH
20
water treatment
Dosing systems:
pH correction by NaOH
CO2 in water is converted to ionic form by NaOH and removed by RO.
SMBS removes chlorine traces left after softner. SMBS is a reducing agent.
After SMBS, water will have ORP of < 400 mV.
Antiscalant It avoid scaling of RO by silica.

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RO Rverse Osmosis
RO will remove > 95% solids. RO water will have conductivity of <20µS/cm @
250
C.
Cartridge filter: 5 µ filter

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EDI Electro De-Ionization
Cathode will attract all the + ions and send
these ions to concentrate chamber.
Anode will attract all the - ions and send
these ions to concentrate chamber.
Ions other than H+ and OH- will be removed from conc. waste
chamber. Water will be filtered and pass thru Ion Exchange
Resin bed followed by product water line.

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PWDS
List of parameters checked by QA person at the time of Validating
Purified Water Distribution System:
1. Slope Verification >10 mm
2. Velocity > 1.5 m/s
3. Passivation NH3
4. Orbital Welding
5. Boroscopy 10%/100 %
6. Ra (Average Roughness) 0.8-0.4 µm
7. Pneumatic test & Hydraulic test
8. Reynolds Number (Re): >4000
9. Dead legs <1.5 times
1. Slope verification:
The ratio of the slope to the length of pipe should not be more than 1:100.
That means every 1 meter of pipe should have > 10 mm slope.
Pipe slopes are maintained such that water from the system is drainable to a low
point drain (by gravitational force).
2. Velocity:
Velocity of water should not be less than 1.5 m/s.
3. Passivation:
After welding i.e. orbital welding; HNO3 (Nitric acid) is used to passivate the piping
to remove excess carbon or any other impurities generated during welding.
After HNO3 flush, pH of water will decreased up to 3.5. Hence to maintain pH 7, PW
(Process water) is flushed till get 7 pH.
4. Orbital Welding:
Orbital Welding is Automatic Tungsten inert gas welding. It eliminates the chances
of manual errors. Provide accuracy in welding.
Principle: The Orbital Welding Process uses the Gas Tungsten Arc Welding process
(GTAW) as the source of the electric arc that melts the base material and forms the
fusion weld b/w two open mouths of pipe. The metal to be welded is melted by the
intense heat of the arc and fuses together.

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Reasons: The ability to make high quality, consistent welds repeatedly at a speed
close to the maximum weld speed offer many benefits to the user.
Where it should be used? : Where a tube or pipe to be welded cannot be rotated or
where rotation of the part is not practical.
5. Boroscopy:
Boroscopy is used to capture the photographs of those areas inside the piping where
a human eye cannot see.
Boroscope / Videoscope is an instrument which is used for the inspection of piping
internal surface and weld joints.
Normal Practice is to do 10% of Boroscopy / Videoscopy of the total welding joints
and 100% in critical application.
6. Ra (Average Roughness) of piping should be b/w 0.8 µm to 0.4 µm.
How it is measured? : Measured by an instrument in which a stylus travel across the
surface, the movement of stylus is amplified and the signal recorded.
7. Pneumatic test: To ascertain that system doesn’t have any leakage. This test is used to
measure air leakages.
Hydraulic test: To ascertain that system doesn’t have any water leakage. It should be
performed at pressures of at least 2 times the anticipated maximum operating pressure or
150 psig which is equivalent to 10.55 kg/cm2
(1 psi = 0.070 kg/cm2
), whichever is more.
Normally water passes through the line have ~ 6 kg/cm2
pressure.

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8. Reynolds Number (Re):
The Reynolds number measures the turbulence of water flowing in the distribution
pipelines.
If the Reynolds number is >4000 = turbulent flow.
If the Reynolds number is <2000 = laminar flow, which may lead to biofilm
development.
B/w 2000 and 4000 flow could be either laminar or turbulent.
V: Free-stream fluid velocity
D: pipe diameter
ρ (ro): Fluid density
µ (myu): Fluid viscosity (dynamic),

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9. Dead legs:
WHO: it should not be > 1.5 times the diameter of pipe.
USFDA: 6d rule (not >6 times)
Case study:
Question:
If a PW system is in validated state (IQ/OQ completed, PQ1 and PQ2 completed,
system released for production and PQ3 is ongoing), and a new user point will be
added to a loop, how do we proceed with the validation?
User point addition includes cutting a spool piece and welding with the new user
point. For sure, the water quality will be followed by PQ and daily samples will be
taken from the user point for physical and microbiological values.
Do we have to clean and passivate the whole loop or can we just clean and passivate
the additional piping before welding?
What other tests need to be repeated from IQ and OQ?
Answer:
You need to raise a change control.
It must be accepted and acknowledged by QA as well as Eng teams.
Then they will look into the changes in the Design and risks associated with design
(Risk assessment should be done).
You need to know how water is flowing thru this sampling point.
You need to give all material specifications including the Boroscopy and welding
tests.
After installation you should passivate this piece of equipment. Practically it is
better to passivate whole loop rather than this piece alone. It does take some pain
and time; nevertheless the results will be uniform.
Since a new point is added -the challenge remains how do you do an enhanced
testing at this point to match the earlier criterion that you have set?
All the material specifications, material testing certificates and specifications
associated with sampling valves are to be attached similar to your IQ and OQ.
Please make sure this attachment would not disturb the Reynolds number and or
turbulence in your system at that point and create a dead leg.

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Limits of Water:
Type of water Upper Bacterial limit(CFU/ml ) Upper Endotoxin Limit(EU/ml)
PW 100 0.25
WFI 0.1 0.25
TOC: < 500 ppb
Conductivity: <1.3 µS/cm@ 250
C as per USP / <5.1 as per India
pH: 5-7
Velocity: >1.5 m/s
Dead legs: NMT 1.5 X pipe diam.

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Sanitization:
Hot water sanitization:
Components captured via hot water sanitisation is RO/EDI/HP Pump

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Sanitization of UF:
Sanitization of RO:
Acid cleaning by Citric acid / Nitric Acid to remove inorg. foulants followed by
Alkaline cleaning by NaOH to remove org foulants.
Then system is sanitized by Formaldehyde / H2O2 or Peracetic acid+H2O2.
Rinse with PW b4 changing the chemicals.

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Actual qualification of PW system
IQ
Refer Classical IQ testing image.
Physical verification:
 Overall cleanliness
 Epoxy floor
 Slope verification
 Instrument calibration
 Pressure testing: Pneumatic test and Hydro test
 Tagging of components
 Calibration tags
Rupture disk is imp as a safety point of view.
Pressure realeasing valve is also imp.
 Dead legs
 Dedicated computer (If required) system.
 Verify that system is attached with the printer.
 Boroscopy
 Physical verification of all components as per drawing and protocol.
Documentation:
 Welding report includes time and date of welding
 Welder’s PQ report
 OEM SOPs
 Manuals
 Spare part lists
 Spare parts manual
 Welding procedures
 MOC certicates
 Calibration certificates

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OQ
 Sanitization cycle test
 System maintains temperature of water @ 850
C for 30 mins.
During Sanitization, UV lights should be shut off so as to prevent
deterioration of UV lamps.Ideally, UV lights should be shut off
automatically whentemp reaches @ 500
C. So check these
parameter also.
 Chemical test
 Conductivity
 pH
 TDS +TSS = TS
 Chlorine
 Sulphate
 Ammonia
 Calcium
 Co2
 Heavy metals
 Oxidizable substance
 Microbial tests
 @ each POU
 Check that pressure relesing valves are working properly.
 Check that the values added in the control system are matching with the
actual value.
 Manualy check (by calibrated instrument) water for different parameters
and verify it against installed instruments.
 Check that system has history/ trend report and print can be taken from
the system.

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 A dedicated computer should be given.
 Password protection of system.
 Documentation
 Training Verification of Eng. Personnel
PQ
1st phase
 Chemical and Micro test for 9 days
 Each POU is tested 1 time b4 Sanitization and 2 times after sanitization.
 Sanitization b/w day 3rd
and 4th
.
 Recalibration of all the instruments to get assurance.
2nd phase
 Less intensive but more than routine.
 For 3 months
After 2nd phase, routine monitoring starts. It involves sampling and testing critical
POU weekly.

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LUX Level measurement
By instrument called LUX meter
Location for checking the LUX should be minimum of 5 locations per room
Measure the LUX @ 1 meter height from the floor. (Range: 1-3 m)
Average reading of all the LUX readings per room will be the LUX level of the room
Acceptance criteria:
Minimum requirement is 500 LUX.
# Area LUX
1 Production 400
2 Sampling and Dispensing 300
Frequency: Once in a year

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Cleaning Validation

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