CLEAN ROOM and HVAC VALIDATION / AHU VALIDATION / QUALIFICATION
* HVAC validations as per ISO 14644-1,2,3, EU GMP/EC GMP, WHO-TRS-937, WHO-TRS-961, Schedule M (National Regulatory Body) guidelines for all room classifications.
CLEANROOM CERTIFICATION
Validated cleanrooms are validated to a required class of cleanliness. The level of cleanliness chosen is driven by user requirements. Cleanroom classes are defined in ISO1464-1:
Monitor And Control
A constant monitoring program is required after certification. Requirements for compliance are found in ISO 14644-2.
Methods for evaluation and measurements for Certification are specified in ISO : 14644-3. It calls out for the following ten tests.
Air flow Test & ACPH Calculations
Installed Filter System Leakage Test (using PAO)
Non-Viable Particle Count Test
Recovery Test
Air Flow Pattern Test (Using Water Fogger)
Air Pressure Balancing
Containment test
Temperature & RH Measurement
Light Intensity Measurement
Sound Level Measurement
Range of services pertaining to Clean Room Validation
High Pressure Diffuser
FOG Generator
Handy Camera
Particle Counter
Aerosol Photometer
Aerosol Generator
Air Capture Hood
Vane Type Anemometer
Laminar Air Flow Unit (LAF)
Reverse Laminar Air Flow Unit (RLAF)
Dispensing/Sampling Booth
Bio Safety Cabinet
Garment Cubicle
Sterilizing Tunnel
Dry Heat Sterilizer (DHS)
Animal Changing Station
Individual Ventilation Cage (IVC Unit)
Fluid Bed drier (FBD)
Autocoater – Tablet Coating machine
ULPA Filter Integrity test
HVAC Validation includes following Tests:
Air Velocity Test
Filter Leak Test
Air Flow Pattern Test
Non viable Particle Count
Viable Particle Count
Recovery Test
Differential Pressure Monitoring
Temperature & Relative Humidity Monitoring
Noise & Light Level Measurement
What is validation?
Validation is a process of establishing documentary evidence demonstrating that a procedure, process, or activity carried out in production or testing maintains the desired level of compliance at all stages.
In Pharma Industry it is very important apart from final testing and compliance of product with standard that the process adapted to produce itself must assure that process will consistently produce the expected results
Here the desired results are established in terms of specifications for out come of the process. Qualification of systems and equipment is therefore a part of process of validation.
It is a requirement of food and drug, pharmaceutical regulating agencies like FDA's good manufacturing practices guidelines. Since a wide variety of procedures, processes, and activities need to be validated, the field of validation is divided into a number of subsections including the following:
Validation Services
Clean Room and HVAC/AHU Validation/Qualification
Compressed Air/Nitrogen Gas Testing or Validation
Pure steam Quality test
Documentation services
Equipment validation
Facilities validation
HVAC system validation
Cleaning validation
Process Validation
Analytical method validation
Computer system validation
Packaging validation
Cold chain validation
Compressed Air Validation
HVAC Validation
Clean Room Validation
Cold chain Validation
PLC Validation
Thermal Validation
Steam Quality Test
Design validation services
Pharma Validation Services
Data-verification validation services
Clean Room AHU Area Validation Services
Calibration validation
Equipment Validation Services
Flow Calibration
IAQ - Indoor Air Quality
Isolator Validation
Biosafety, LAF Validation
The Validation Process:
The validation scope, boundaries and responsibilities for each process or groups of similar processes or similar equipment's must be documented and approved in a validation plan. These documents, terms and references for the protocol authors are for use in setting the scope of their protocols. It must be based on a Validation Risk Assessment (VRA) to ensure that the scope of validation being authorised is appropriate for the complexity and importance of the equipment or process under validation. Within the references given in the VP the protocol authors must ensure that all aspects of the process or equipment under qualification; that may affect the efficacy, quality and or records of the product are properly qualified. Qualification includes the following steps:
Design qualification (DQ)
Demonstrates that the proposed design (or the existing design for an off-the-shelf item) will satisfy all the requirements that are defined and detailed in the User Requirements Specification (URS). Satisfactory execution of the DQ is a mandatory requirement before construction (or procurement) of the new design can be authorised.
Installation qualification (IQ)
Demonstrates that the process or equipment meets all specifications, is installed correctly, and all required components and documentation needed for continued operation are installed and in place.
Operational qualification (OQ)
Demonstrates that all facets of the process or equipment are operating correctly.
Performance qualification (PQ)
Demonstrates that the process or equipment performs as intended in a consistent manner over time.
Component qualification (CQ)
This term refers to the manufacturing of auxiliary components to ensure that they are manufactured to the correct design criteria. This could include packaging components such as folding cartons, shipping cases, labels or even phase change material. All of these components must have some type of random inspection to ensure that the third party manufacturer's process is consistently producing components that are used in the world of GMP at drug or biologic manufacturer.
Validation List
Clean Room Validation Validation in chamba ,
HVAC Validation Validation in chamba ,
AHU Validation Validation in chamba ,
Qualification Validation in chamba ,
Mep Validation in chamba ,
Heating ventilation and air conditioning Validation in chamba ,
Validation and qualification of HVAC system ,
Heating, ventilation and air conditioning Validation in chamba ,
Validation, Qualification and Calibration ,
Validation tests for hvac system ,
Validation Qualification Services ,
Qualification and Validation in chamba ,
Compressed Air Validation in chamba ,
Nitrogen Gas Testing or Validation in chamba ,
Pure steam Quality test Validation in chamba ,
Documentation services Validation in chamba ,
Equipment Validation in chamba ,
Facilities Validation in chamba ,
HVAC system Validation in chamba ,
Cleaning Validation in chamba ,
process Validation in chamba ,
Analytical method Validation in chamba ,
Computer system Validation in chamba ,
Packaging Validation in chamba ,
Cold chain Validation in chamba ,
compressed Air Validation in chamba ,
HVAC Validation in chamba ,
Clean Room Validation in chamba ,
cold chain Validation in chamba ,
PLC Validation in chamba ,
Thermal Validation in chamba ,
Steam Quality Test ,
Design Validation in chamba ,
Pharma Validation in chamba ,
Data verification Validation in chamba ,
Clean Room AHU Area Validation in chamba ,
Calibration Validation in chamba ,
Equipment Validation in chamba ,
Flow Calibration Validation in chamba ,
IAQ Indoor Air Quality Validation in chamba ,
Equipment validation,
Facilities Validation in chamba ,
HVAC system Validation in chamba ,
Cleaning Validation in chamba ,
Process Validation in chamba ,
Analytical method Validation in chamba ,
Computer system Validation in chamba ,
Design qualification (DQ) ,
Component qualification (CQ) ,
Installation qualification (IQ) ,
Operational qualification (OQ) ,
Performance qualification (PQ) ,
Pharmaceutical Process Validation in chamba ,
Prospective Validation in chamba ,
Concurrent Validation in chamba ,
Retrospective Validation in chamba ,
Revalidation Periodic and After Change Validation in chamba ,
Compressed Air Validation in chamba ,
HVAC Validation in chamba ,
Clean Room Validation in chamba ,
PLC Validation in chamba ,
thermal Validation in chamba ,
Steam Quality Test ,
design Validation in chamba ,
pharmaceutical Validation in chamba ,
data verification Validation in chamba ,
Clean Room AHU Area Validation in chamba ,
Calibration Validation in chamba ,
Equipment Validation in chamba ,
IAQ Indoor Air Quality Validation in chamba ,
IAQ Indoor Air Quality Validation in chamba ...
Validation Services List
Clean Room validation Services in chamba ,
HVAC validation Services in chamba ,
AHU Validation Services in chamba ,
Qualification validation Services in chamba ,
Mep validation Services in chamba ,
Heating ventilation and air conditioning validation Services in chamba ,
Validation and qualification of HVAC system ,
Heating, ventilation and air conditioning Validation Services in chamba ,
Validation, Qualification and Calibration ,
Validation tests for hvac system Services in chamba ,,
Validation Qualification Services in chamba ,
Qualification and Validation Services in chamba ,
Compressed Air Validation Services in chamba ,
Nitrogen Gas Testing or Validation Services in chamba ,
Pure steam Quality test Validation Services in chamba ,
Documentation services Validation Services in chamba ,
Equipment validation Services in chamba ,
Facilities validation Services in chamba ,
HVAC system validation Services in chamba ,
Cleaning validation Services in chamba ,
process Validation Services in chamba ,
Analytical method validation Services in chamba ,
Computer system validation Services in chamba ,
Packaging validation Services in chamba ,
Cold chain validation Services in chamba ,
compressed Air Validation Services in chamba ,
HVAC Validation Services in chamba ,
Clean Room Validation Services in chamba ,
cold chain Validation Services in chamba ,
PLC Validation Services in chamba ,
Thermal Validation Services in chamba ,
Steam Quality Test Services in chamba ,
Design validation Services in chamba ,
Pharma Validation Services in chamba ,
Data verification validation Services in chamba ,
Clean Room AHU Area Validation Services in chamba ,
Calibration validation Services in chamba ,
Equipment Validation Services in chamba ,
Flow Calibration Validation Services in chamba ,
IAQ Indoor Air Quality Validation Services in chamba ,
Equipment validation Services in chamba ,
Facilities validation Services in chamba ,
HVAC system validation Services in chamba ,
Cleaning validation Services in chamba ,
Process Validation Services in chamba ,
Analytical method validation Services in chamba ,
Computer system validation Services in chamba ,
Design qualification (DQ) Services in chamba ,
Component qualification (CQ) Services in chamba ,
Installation qualification (IQ) Services in chamba ,
Operational qualification (OQ) Services in chamba ,
Performance qualification (PQ) Services in chamba ,
Pharmaceutical Process Validation Services in chamba ,
Prospective Validation Services in chamba ,
Concurrent Validation Services in chamba ,
Retrospective Validation Services in chamba ,
Revalidation Periodic and After Change validation Services in chamba ,
Compressed Air Validation Services in chamba ,
HVAC Validation Services in chamba ,
Clean Room Validation Services in chamba ,
PLC Validation Services in chamba ,
thermal validation Services in chamba ,
Steam Quality Test Services in chamba,
design validation Services in chamba ,
pharmaceutical validation Services in chamba ,
data verification validation Services in chamba ,
Clean Room AHU Area Validation Services in chamba ,
Calibration validation Services in chamba ,
Equipment Validation Services in chamba ,
IAQ Indoor Air Quality Validation Services in chamba ,
IAQ Indoor Air Quality Validation Services in chamba ...
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maharashtra |
manipur |
meghalaya |
mizoram |
nagaland |
odisha |
puducherry |
punjab |
rajasthan |
sikkim |
tamil nadu |
telangana |
the dadra and nagar haveli and daman and diu |
tripura |
uttarakhand |
uttar pradesh |
west bengal ...
list of our services following districts
alipur |
chanakya puri |
civil lines |
defence colony |
delhi cantonment |
dwarka |
gandhi nagar |
hauz khas |
kalkaji |
kanjhawala |
kapeshera |
karawal nagar |
karol bagh |
kotwali |
mayur vihar |
mehrauli |
model town |
najafgarh |
narela |
patel nagar |
preet vihar |
punjabi bagh |
rajouri garden |
rohini |
saket |
saraswati vihar |
sarita vihar |
seelam pur |
seema puri |
shahdara |
vasant vihar |
vivek vihar |
yamuna vihar |
adampur |
alewa |
ambala |
ambala cantonment |
assandh |
ateli |
babain st |
badhra |
badkhal |
badli |
badshahpur st |
bahadurgarh |
bahal st |
bahin st |
ballabgarh |
ballah st |
balsamand st |
bapoli |
barara |
barwala |
barwala st |
bass |
bawal |
bawani khera |
beri |
bhattukalan st |
bhiwani |
bhuna st |
bilaspur |
bondkalan st |
chhachhrauli |
dabwali |
dadri |
dahina st |
dayalpur st |
dhand st |
dharuhera st |
dhauj st |
ellenabad |
faridabad |
farrukhnagar |
fatehabad |
fatehpur pundri |
ferozepur jhirka |
ganaur |
gaunchi st |
gharaunda |
gohana |
goriwala st |
guhla |
gurgaon |
hansi |
harsaru st |
hassanpur st |
hathin |
hisar |
hodal |
indri |
ismailabad st |
israna |
jagadhri |
jakhal st |
jhajjar |
jind |
julana |
kadipur st |
kaithal |
kalanaur |
kalanwali |
kalayat |
kalka |
kanina |
karnal |
khanpur st |
kharkhoda |
kheri jalab st |
khizrabad st |
kosli |
kulan st |
ladwa |
lakhan majra st |
loharu |
maham |
mahendragarh |
manesar |
manethi st |
matenhail |
matlauda |
mohna st |
morni st |
mulana st |
nagina st |
nahar st |
nangal chawdhary |
naraingarh |
narnaul |
narnaund |
narwana |
nathusari chopta |
nigdu st |
nilokheri |
nising st |
nuh |
palhawas st |
palwal |
panchkula |
panipat |
pataudi |
pehowa |
pillukhera st |
punahana |
radaur |
raipur rani |
rai st |
rajaund st |
rania |
ratia |
rewari |
rohtak |
sadhaura st |
safidon |
saha st |
salhawas st |
samalkha |
sampla |
saraswati nagar st |
satnali st |
shahbad |
shahzadpur st |
sirsa |
siwani |
siwan st |
sohna |
sonipat |
taoru |
thanesar |
tigaon st |
tohana |
tosham |
uchana |
uklana st |
wazirabad st |
abohar |
ahmedgarh |
ajnala |
amloh |
amritsar -i |
amritsar- ii |
anandpur sahib |
baba bakala |
bagha purana |
balachaur |
banga |
barnala |
bassi pathana |
batala |
bathinda |
bhawanigarh |
bhikhiwind |
bhulath |
budhlada |
chamkaur sahib |
dasua |
dera baba nanak |
dera bassi |
dharamkot |
dhar kalan |
dhuri |
dinanagar |
dirba |
dudhan sadhan |
faridkot |
fatehgarh sahib |
fazilka |
firozpur |
garhshankar |
gidderbaha |
gurdaspur |
guruharsahai |
hoshiarpur |
jagraon |
jaitu |
jalalabad |
jalandhar - i |
jalandhar - ii |
kalanaur |
kapurthala |
khadur sahib |
khamanon |
khanna |
kharar |
kotakpura |
lehra |
ludhiana (east) |
ludhiana (west) |
majitha |
malerkotla |
malout |
mamdot |
mansa |
maur |
moga |
moonak |
morinda |
mukerian |
muktsar |
nabha |
nakodar |
nangal |
nawanshahr |
nihal singhwala |
pathankot |
patiala |
patran |
patti |
payal |
phagwara |
phillaur |
raikot |
rajpura |
rampura phul |
rup nagar |
samana |
samrala |
sangrur |
sardulgarh |
sas nagar (mohali) |
shahkot |
sultanpur lodhi |
sunam |
talwandi sabo |
tapa |
tarn taran |
zira...
list of our services following districts
alampur
amb |
ani |
arki |
aut |
baddi |
bagachnogi |
baijnath |
baldwara |
balh |
bali chowki |
bangana |
banjar |
baroh |
barsar |
bhadrota |
bhalai |
bharari |
bharmour |
bharwain |
bhattiyat |
bhawarna |
bhoranj |
bhota |
bhuntar |
bilaspur sadar |
birhu kalan |
chachyot |
chadiyar |
chamba |
chaupal |
chhatri |
chirgaon |
churah |
dadahu |
dadasiba |
dalhousie |
dareeni |
darlaghat |
deha |
dehar |
dera gopipur |
dhami |
dharmpur |
dharmsala |
dharwala |
dhatwal |
dhira |
dodra kwar |
dulahar |
fatehpur |
gagret |
galore |
gangath |
ghanari |
ghumarwin |
hamirpur |
hangrang |
harchakian |
haripur |
haripurdhar |
haroli |
holi |
indora |
ispur |
jaisinghpur |
jalog |
jangla |
jaswan |
jawalamukhi |
jawali |
jhanduta |
jogindarnagar |
jol |
jubbal |
junga |
kakira |
kalol |
kalpa |
kamrau |
kandaghat |
kangoo |
kangra |
karsog |
kasauli |
katoula |
khundian |
kotgarh |
kotkhai |
kotla |
kotli |
krishangarh |
kullu |
kumarsain |
kunihar |
kupvi |
lad bharol |
lagru |
lahul |
majheen |
makridi |
mamlig |
manali |
mandap |
mandi |
mehatpur |
morang |
multhan |
nadaun |
nagrota bagwan |
nagrota surian |
nahan |
naina devi |
nalagarh |
namhol |
nankhari |
narag |
nerwa |
nichar |
nihri |
nirmand |
nither |
nohra |
nurpur |
pachhad |
padhar |
pajhota |
palampur |
panchrukhi |
pangi |
pangna |
panjehra |
paonta sahib |
poo |
pragpur |
pukhri |
rajgarh |
rakkar |
rampur |
ramshahr |
renuka |
rewalsar |
rohru |
ronhat |
sainj |
saluni |
sandhol |
sangla |
sarahan |
sarawati nagar |
sarkaghat |
shahpur |
shalai |
shimla ( rural ) |
shimla (urban) |
sihunta |
solan |
spiti |
sulah |
sundarnagar |
sunni |
taklech |
tapri |
tauni devi bamson |
theog |
thunag |
thural |
tihra |
tikar |
tikken |
tira sujanpur |
udaipur |
una |
ajas |
akhnoor |
aloosa |
anantnag |
anantnag east |
aripal |
arnas |
arnia |
assar |
atholi (paddar) |
awantipora |
bahu |
balakote |
bandipora |
bani |
banihal |
baramulla |
barbugh |
bari brahamana |
basantgarh |
basohli |
batote |
beerwah |
beri pattan |
bhaderwah |
bhagwah |
bhalessa |
bhalla |
bhalwal |
bharath bagla |
bhomag |
bijbehara |
billawar |
bishnah |
bk pora |
boniyar |
bounjwah |
budgam |
chadoora |
channapora |
charar- e- shrief |
chassana |
chenani |
chhatroo |
chilly pingal |
chiralla |
chitragam |
chowki choura |
dachhan |
dangarpora |
danghiwacha |
dansal |
darhal |
devsar |
d h pora |
dinga amb |
doda |
dooru |
drabshalla |
drugmulla |
eidgah |
frisal |
ganderbal |
ghagwal |
gool |
gund |
gundna |
gurez |
hajin |
handwara |
haveli |
hermain |
hiranagar |
jchamba |
jchamba north |
jchamba south |
jchamba west |
jourian |
kahara |
kakapora |
kalakote |
kangan |
karnah |
kashtigarh |
kathua |
katra |
kawarhama |
keegam |
keller |
keran |
khag |
khansahib |
khanyar |
kharah balli |
khari |
khawas |
khoie |
khour |
kishtwar |
kokernag |
koteranka |
kralpora |
kreeri |
kulgam |
kunzar |
kupwara |
lalpora |
langate |
lar |
larnoo |
laroka |
latti |
lohai malhar |
lolab |
machail |
machil |
magam |
mahanpur |
mahore |
maira mandrian |
majalta |
mandal |
mandi |
manjakote |
mankote |
marh |
marheen |
marmat |
marwah |
mendhar |
mohalla |
moungri |
mughalmaidan |
nagri |
nagrota |
nagseni |
narbal |
nowshera |
pahalgam |
pahloo |
pampore |
panchari |
panthachowk |
pargwal |
pattan |
phigsoo |
pogal paristan |
pouni |
pulwama |
qaimoh |
qaziabad |
qazigund |
qila darhal |
rafiabad |
rajgarh |
rajouri |
rajpora |
rajpura |
ramban |
ramgarh |
ramhal |
ramkote |
ramnagar |
ranbir singh pura |
reasi |
sallar |
samba |
shahbad bala |
shahoora |
shangus |
shopian |
siot |
sonawari |
sopore |
srigufwara |
srinagar central |
srinagar (north) |
srinagar (south) |
suchetgarh |
sundarbani |
surankote |
tangmarg |
taryath |
thakrakote |
thana mandi |
thathri |
thuroo |
tral |
trehgam |
tulail |
tullamulla khirbhawani |
udhampur |
uri |
vijaypur |
wagoora |
wakoora |
warwan |
watergam |
yaripora |
zachaldara |
zainapora |
zaingeer |
277 chandigarh |
adibadri |
almora |
bageshwar |
bagwalipokhar |
bajpur |
balganga |
bangapani |
barakot |
barnigad |
basukedar |
berinag |
betalghat |
bhagwanpur |
bhanoli |
bhatwari |
bhikiasain |
bironkhal |
chakisain |
chakrata |
chamoli |
champawat |
chaubatta khal |
chaukhutiya |
chinyali saur |
dehradun |
devalthal |
devprayag |
dewal |
dhanaulti |
dharchula |
dhari |
dhaulchhina |
dhauntari |
dhoomakot |
dhyari |
didihat |
doiwala |
dugnakuri |
dunda |
dwarahat |
gadarpur |
gairsain |
gaja |
ganai gangoli |
gangolihat |
garud |
ghaat |
ghansali |
haldwani |
hardwar |
jainti |
jakhani dhar |
jakhanikhal |
jakholi |
jalali |
jaspur |
jilasu |
joshimath |
joshiyara |
kafligair |
kaladhungi |
kalsi |
kanalichhina |
kanda |
kandisaur |
kapkot |
karnaprayag |
kashipur |
khatima |
kichha |
kirtinagar |
kosya kutauli |
kotdwara |
laksar |
laldhang |
lalkuan |
lamgada |
lansdowne |
lohaghat |
machhor |
madannegi |
manch |
mori |
munsiari |
nainbag |
nainital |
nanakmatta |
nandprayag |
narayanbagar |
narendra nagar |
narsan |
okhalkanda |
pankhu |
pati |
pauri |
pawkidevi |
pithoragarh |
pokhari |
poornagiri |
pratapnagar |
pulla gumdesh |
puraula |
rajgarhi |
ramgarh |
ramnagar |
ranikhet |
rikhanikhal |
rishikesh |
roorkee |
rudraprayag |
rudrapur |
sankari |
satpuli |
shama |
sitarganj |
someshwar |
srinagar |
sult |
syalde |
tehri |
tejam |
thailisain |
thal |
tharali |
tyuni |
ukhimath |
vikas nagar |
yamkeshwar |
drass |
kargil |
khalsi |
leh |
nubra |
sanku |
shaker chiktan |
zanskar...