SlideShare a Scribd company logo
1 of 4
Download to read offline
OM CLEAN ROOM
SERVICES
Complete Range of
 HVAC VALIDATION
 PHARMA CLEAN ROOM
VALIDATION
from One Source
VALIDATION TESTS:
 Filter Integrity Leak Test
 Filter Face Air Velocity measurement
 Calculation of air changes/ Hour in room
 Air Velocity/ CFM measuremen
 Air Borne Particulate Count monitoring
 Recovery Period Study
 Room Temperature/ RH monitoring
 Airflow Visualization test
About Us:
Welcome to OM CLEAN ROOM SERVICES
Om Clean Room Services (A perfect Compliance company to regulatory requirements) is known for prompt Economical &
Reliable HVAC/ Clean Room Validation & Temperature/ RH mapping mainly in Pharmaceutical Industry, while leveraging
on high accuracy calibration equipment, well trained persons to execute site validation activities to meet the customer
requirements and to provide services at its best.
Quality Policy:
OM Clean Room Services (OCRS) Conducts HVAC & Validation activities under suitable conditions. It uses techniques that
have high reliability and follows majorly recognized Good Laboratory Practices (GLP).
It is our policy to provide the highest quality of services attainable to customers with the aim of achieving total customer
satisfaction. We also comply with all applicable statutory and legal requirements. We constantly customer satisfaction. We
are committed to the continual improvement of our Quality Management Systems (QMS). This responsibility &
Commitment for QMS is practices & communicated by management, by establishing, documenting, implementing and
maintaining there by continually improving the effectiveness of the system.
Services:-
OCRS provides services in HVAC/Clean Room validation & equipment qualifications. All test methods in use &
documentation of the same, follows latest cGMP Guidelines, traceable to national and international standards. Our
Organization is blessed by a team of experienced expertise from the variety of fields that has keen eyes on regulatory
body’s legal interpretation, guidelines frameworks & latest developments.
Clean Room Validations:-
OCRS performs HVAC validations as per ISO 14644, EU c GMP, US (FDA), Standards and MHRA(European Countries)
guidelines, for all category area and room Classifications.
 Filter Integrity Leak Test (Using PAO/DOP)
 Filter Face Air Velocity measurement
 Calculation of air changes/ Hour in room
 Air Velocity/ CFM measurement induct
 Air Borne Particulate matter monitoring
 Recovery Period Study
 Room Temperature/ RH monitoring
 Airflow Visualization test
Isolator Validation:-
 Filter leak
 Airflow Velocity
 Particle Count Test
 Recovery time determination
 Smoke Pattern
 Vibration
Temperature Mapping:-
Temperature mapping is described as a documented procedure for obtaining, recording and interpreting data required to
show that a process will consistently comply with predetermined specifications. Continuous update on methods
developments for validation has helped us a lot, in fulfilling customers need.
OCRS has Temperature mapping facilities for the following Instruments:-
 Double Door Autoclave
 Vertical Autoclave
 Dry Heat Sterilizer (DHS)
 Deep Freezer & Tray Dryer
 Reserve Sample room, Walk In & Stability Chamber (Temperature * RH)
 Tunnel Sterilizer
 Cold Room & Room (Temp & RH Study)
 Warehouse/ In process stores temp/ RH mapping
 Autoclave/ Sterilizers temperature mapping
 Dry Heat Sterilizers temperature mapping
OCRS is among the leading Calibration/ Validation service providers with rich experience and expertise. With service to its
credit with the best price/ performance ratio in the industry. OCRS has become a reliable service provider for the
complete Indian Pharmaceutical segment.
OM Clean Room Services (OCRS) has also provided unparalleled services to Hospitals:-
OCRS believes in maintaining its high standards of services and looks forward to continually improving and providing total
customer satisfaction through feedback from Hospitals.
LIST OF VALIDATING INSTRUMENTS:-
 Aerosol Photometer
o Make : ATI, USA
o Model : ATI-2i
 Six Nozzle Laskin style Generator C/W PAO Oil
o Make : ATI, USA
o Model : TDA-4B
 Smoke Generator
o Make : Concept
o Model : Minicolt 4SP
 Non- Viable Particle Counter
o Make : PMS
o Model : Lasair III 5100
 Hot Wire Anemometer
o Make : TESTO
 Vane Type Anemometer
o Make : Lutron
o Model : AM4206-M
M/s OM CLEAN ROOM SERVICES
REGD. ADD: 106, DATAR COMPLEX, OPPO GORWA ITI, REFINERY ROAD, VADODARA- 390016
EMAIL ID : omcleanroomservices@gmail.com
CONTACT PERSON:
MIHEER SINHA SHAILESH MAKWANA BHAVESH CHAUHAN
(M): 8980630251 9727678212 8980290971

More Related Content

Similar to validation.pdf

Amco division presentation
Amco division presentationAmco division presentation
Amco division presentationLiza Tallon
 
Test Rig And Laboratory Machine By Innovative Research Equipments
Test Rig And Laboratory Machine By Innovative Research EquipmentsTest Rig And Laboratory Machine By Innovative Research Equipments
Test Rig And Laboratory Machine By Innovative Research EquipmentsIndiaMART InterMESH Limited
 
Refinery meet
Refinery meet Refinery meet
Refinery meet rajeshvari
 
Scale up and c gmp manufacturing
Scale up and c gmp manufacturingScale up and c gmp manufacturing
Scale up and c gmp manufacturingphiliphayne
 
Prof. douaa m. sayed validation and verification of flowcytometry areas
Prof. douaa m. sayed   validation and verification of flowcytometry areasProf. douaa m. sayed   validation and verification of flowcytometry areas
Prof. douaa m. sayed validation and verification of flowcytometry areasHitham Esam
 
Krohne Hazardous Area Process Instrumentation Meters Measurement - Product Ov...
Krohne Hazardous Area Process Instrumentation Meters Measurement - Product Ov...Krohne Hazardous Area Process Instrumentation Meters Measurement - Product Ov...
Krohne Hazardous Area Process Instrumentation Meters Measurement - Product Ov...Thorne & Derrick UK
 
validation HPLC and HPTLC D-A star.pptx
validation HPLC and HPTLC D-A star.pptxvalidation HPLC and HPTLC D-A star.pptx
validation HPLC and HPTLC D-A star.pptxDevaPundkar
 
Performance qualification of High performance liquid chromatography
Performance qualification of High performance liquid chromatography Performance qualification of High performance liquid chromatography
Performance qualification of High performance liquid chromatography Atchaya Thalapathy
 

Similar to validation.pdf (20)

Amco division presentation
Amco division presentationAmco division presentation
Amco division presentation
 
Presentation for APPON
Presentation for APPONPresentation for APPON
Presentation for APPON
 
HVAC validation.pdf
HVAC validation.pdfHVAC validation.pdf
HVAC validation.pdf
 
Chromcol Catalog
Chromcol CatalogChromcol Catalog
Chromcol Catalog
 
Test Rig And Laboratory Machine By Innovative Research Equipments
Test Rig And Laboratory Machine By Innovative Research EquipmentsTest Rig And Laboratory Machine By Innovative Research Equipments
Test Rig And Laboratory Machine By Innovative Research Equipments
 
Royal Link Pharma
Royal Link PharmaRoyal Link Pharma
Royal Link Pharma
 
Refinery meet
Refinery meet Refinery meet
Refinery meet
 
Qualification of high performance liquid chromatography
Qualification of high performance liquid chromatographyQualification of high performance liquid chromatography
Qualification of high performance liquid chromatography
 
Sales Presentation
Sales PresentationSales Presentation
Sales Presentation
 
Scale up and c gmp manufacturing
Scale up and c gmp manufacturingScale up and c gmp manufacturing
Scale up and c gmp manufacturing
 
Prof. douaa m. sayed validation and verification of flowcytometry areas
Prof. douaa m. sayed   validation and verification of flowcytometry areasProf. douaa m. sayed   validation and verification of flowcytometry areas
Prof. douaa m. sayed validation and verification of flowcytometry areas
 
Krohne Hazardous Area Process Instrumentation Meters Measurement - Product Ov...
Krohne Hazardous Area Process Instrumentation Meters Measurement - Product Ov...Krohne Hazardous Area Process Instrumentation Meters Measurement - Product Ov...
Krohne Hazardous Area Process Instrumentation Meters Measurement - Product Ov...
 
validation HPLC and HPTLC D-A star.pptx
validation HPLC and HPTLC D-A star.pptxvalidation HPLC and HPTLC D-A star.pptx
validation HPLC and HPTLC D-A star.pptx
 
HVAC system
 HVAC system HVAC system
HVAC system
 
Automated Calibration
Automated CalibrationAutomated Calibration
Automated Calibration
 
Sunum Smal.pdf
Sunum Smal.pdfSunum Smal.pdf
Sunum Smal.pdf
 
Performance qualification of High performance liquid chromatography
Performance qualification of High performance liquid chromatography Performance qualification of High performance liquid chromatography
Performance qualification of High performance liquid chromatography
 
CALTECH Brochure
CALTECH BrochureCALTECH Brochure
CALTECH Brochure
 
All you Need to Know About Sampling and Analysis - OGSI
All you Need to Know About Sampling and Analysis - OGSIAll you Need to Know About Sampling and Analysis - OGSI
All you Need to Know About Sampling and Analysis - OGSI
 
SVS Firm Profile
SVS Firm ProfileSVS Firm Profile
SVS Firm Profile
 

Recently uploaded

Aspirin presentation slides by Dr. Rewas Ali
Aspirin presentation slides by Dr. Rewas AliAspirin presentation slides by Dr. Rewas Ali
Aspirin presentation slides by Dr. Rewas AliRewAs ALI
 
VIP Call Girls Pune Vani 9907093804 Short 1500 Night 6000 Best call girls Ser...
VIP Call Girls Pune Vani 9907093804 Short 1500 Night 6000 Best call girls Ser...VIP Call Girls Pune Vani 9907093804 Short 1500 Night 6000 Best call girls Ser...
VIP Call Girls Pune Vani 9907093804 Short 1500 Night 6000 Best call girls Ser...Miss joya
 
Call Girls Colaba Mumbai ❤️ 9920874524 👈 Cash on Delivery
Call Girls Colaba Mumbai ❤️ 9920874524 👈 Cash on DeliveryCall Girls Colaba Mumbai ❤️ 9920874524 👈 Cash on Delivery
Call Girls Colaba Mumbai ❤️ 9920874524 👈 Cash on Deliverynehamumbai
 
Call Girl Bangalore Nandini 7001305949 Independent Escort Service Bangalore
Call Girl Bangalore Nandini 7001305949 Independent Escort Service BangaloreCall Girl Bangalore Nandini 7001305949 Independent Escort Service Bangalore
Call Girl Bangalore Nandini 7001305949 Independent Escort Service Bangalorenarwatsonia7
 
High Profile Call Girls Jaipur Vani 8445551418 Independent Escort Service Jaipur
High Profile Call Girls Jaipur Vani 8445551418 Independent Escort Service JaipurHigh Profile Call Girls Jaipur Vani 8445551418 Independent Escort Service Jaipur
High Profile Call Girls Jaipur Vani 8445551418 Independent Escort Service Jaipurparulsinha
 
Russian Call Girls in Pune Tanvi 9907093804 Short 1500 Night 6000 Best call g...
Russian Call Girls in Pune Tanvi 9907093804 Short 1500 Night 6000 Best call g...Russian Call Girls in Pune Tanvi 9907093804 Short 1500 Night 6000 Best call g...
Russian Call Girls in Pune Tanvi 9907093804 Short 1500 Night 6000 Best call g...Miss joya
 
Call Girls Whitefield Just Call 7001305949 Top Class Call Girl Service Available
Call Girls Whitefield Just Call 7001305949 Top Class Call Girl Service AvailableCall Girls Whitefield Just Call 7001305949 Top Class Call Girl Service Available
Call Girls Whitefield Just Call 7001305949 Top Class Call Girl Service Availablenarwatsonia7
 
Call Girls Doddaballapur Road Just Call 7001305949 Top Class Call Girl Servic...
Call Girls Doddaballapur Road Just Call 7001305949 Top Class Call Girl Servic...Call Girls Doddaballapur Road Just Call 7001305949 Top Class Call Girl Servic...
Call Girls Doddaballapur Road Just Call 7001305949 Top Class Call Girl Servic...narwatsonia7
 
Russian Call Girls in Bangalore Manisha 7001305949 Independent Escort Service...
Russian Call Girls in Bangalore Manisha 7001305949 Independent Escort Service...Russian Call Girls in Bangalore Manisha 7001305949 Independent Escort Service...
Russian Call Girls in Bangalore Manisha 7001305949 Independent Escort Service...narwatsonia7
 
VIP Call Girls Tirunelveli Aaradhya 8250192130 Independent Escort Service Tir...
VIP Call Girls Tirunelveli Aaradhya 8250192130 Independent Escort Service Tir...VIP Call Girls Tirunelveli Aaradhya 8250192130 Independent Escort Service Tir...
VIP Call Girls Tirunelveli Aaradhya 8250192130 Independent Escort Service Tir...narwatsonia7
 
CALL ON ➥9907093804 🔝 Call Girls Baramati ( Pune) Girls Service
CALL ON ➥9907093804 🔝 Call Girls Baramati ( Pune)  Girls ServiceCALL ON ➥9907093804 🔝 Call Girls Baramati ( Pune)  Girls Service
CALL ON ➥9907093804 🔝 Call Girls Baramati ( Pune) Girls ServiceMiss joya
 
Russian Call Girls Chickpet - 7001305949 Booking and charges genuine rate for...
Russian Call Girls Chickpet - 7001305949 Booking and charges genuine rate for...Russian Call Girls Chickpet - 7001305949 Booking and charges genuine rate for...
Russian Call Girls Chickpet - 7001305949 Booking and charges genuine rate for...narwatsonia7
 
Call Girl Service Bidadi - For 7001305949 Cheap & Best with original Photos
Call Girl Service Bidadi - For 7001305949 Cheap & Best with original PhotosCall Girl Service Bidadi - For 7001305949 Cheap & Best with original Photos
Call Girl Service Bidadi - For 7001305949 Cheap & Best with original Photosnarwatsonia7
 
Sonagachi Call Girls Services 9907093804 @24x7 High Class Babes Here Call Now
Sonagachi Call Girls Services 9907093804 @24x7 High Class Babes Here Call NowSonagachi Call Girls Services 9907093804 @24x7 High Class Babes Here Call Now
Sonagachi Call Girls Services 9907093804 @24x7 High Class Babes Here Call NowRiya Pathan
 
Russian Call Girl Brookfield - 7001305949 Escorts Service 50% Off with Cash O...
Russian Call Girl Brookfield - 7001305949 Escorts Service 50% Off with Cash O...Russian Call Girl Brookfield - 7001305949 Escorts Service 50% Off with Cash O...
Russian Call Girl Brookfield - 7001305949 Escorts Service 50% Off with Cash O...narwatsonia7
 
Low Rate Call Girls Pune Esha 9907093804 Short 1500 Night 6000 Best call girl...
Low Rate Call Girls Pune Esha 9907093804 Short 1500 Night 6000 Best call girl...Low Rate Call Girls Pune Esha 9907093804 Short 1500 Night 6000 Best call girl...
Low Rate Call Girls Pune Esha 9907093804 Short 1500 Night 6000 Best call girl...Miss joya
 
Call Girl Chennai Indira 9907093804 Independent Call Girls Service Chennai
Call Girl Chennai Indira 9907093804 Independent Call Girls Service ChennaiCall Girl Chennai Indira 9907093804 Independent Call Girls Service Chennai
Call Girl Chennai Indira 9907093804 Independent Call Girls Service ChennaiNehru place Escorts
 
Call Girls Yelahanka Just Call 7001305949 Top Class Call Girl Service Available
Call Girls Yelahanka Just Call 7001305949 Top Class Call Girl Service AvailableCall Girls Yelahanka Just Call 7001305949 Top Class Call Girl Service Available
Call Girls Yelahanka Just Call 7001305949 Top Class Call Girl Service Availablenarwatsonia7
 
Call Girls Service Chennai Jiya 7001305949 Independent Escort Service Chennai
Call Girls Service Chennai Jiya 7001305949 Independent Escort Service ChennaiCall Girls Service Chennai Jiya 7001305949 Independent Escort Service Chennai
Call Girls Service Chennai Jiya 7001305949 Independent Escort Service ChennaiNehru place Escorts
 

Recently uploaded (20)

Aspirin presentation slides by Dr. Rewas Ali
Aspirin presentation slides by Dr. Rewas AliAspirin presentation slides by Dr. Rewas Ali
Aspirin presentation slides by Dr. Rewas Ali
 
VIP Call Girls Pune Vani 9907093804 Short 1500 Night 6000 Best call girls Ser...
VIP Call Girls Pune Vani 9907093804 Short 1500 Night 6000 Best call girls Ser...VIP Call Girls Pune Vani 9907093804 Short 1500 Night 6000 Best call girls Ser...
VIP Call Girls Pune Vani 9907093804 Short 1500 Night 6000 Best call girls Ser...
 
Call Girls Colaba Mumbai ❤️ 9920874524 👈 Cash on Delivery
Call Girls Colaba Mumbai ❤️ 9920874524 👈 Cash on DeliveryCall Girls Colaba Mumbai ❤️ 9920874524 👈 Cash on Delivery
Call Girls Colaba Mumbai ❤️ 9920874524 👈 Cash on Delivery
 
Call Girl Bangalore Nandini 7001305949 Independent Escort Service Bangalore
Call Girl Bangalore Nandini 7001305949 Independent Escort Service BangaloreCall Girl Bangalore Nandini 7001305949 Independent Escort Service Bangalore
Call Girl Bangalore Nandini 7001305949 Independent Escort Service Bangalore
 
High Profile Call Girls Jaipur Vani 8445551418 Independent Escort Service Jaipur
High Profile Call Girls Jaipur Vani 8445551418 Independent Escort Service JaipurHigh Profile Call Girls Jaipur Vani 8445551418 Independent Escort Service Jaipur
High Profile Call Girls Jaipur Vani 8445551418 Independent Escort Service Jaipur
 
Russian Call Girls in Pune Tanvi 9907093804 Short 1500 Night 6000 Best call g...
Russian Call Girls in Pune Tanvi 9907093804 Short 1500 Night 6000 Best call g...Russian Call Girls in Pune Tanvi 9907093804 Short 1500 Night 6000 Best call g...
Russian Call Girls in Pune Tanvi 9907093804 Short 1500 Night 6000 Best call g...
 
Call Girls Whitefield Just Call 7001305949 Top Class Call Girl Service Available
Call Girls Whitefield Just Call 7001305949 Top Class Call Girl Service AvailableCall Girls Whitefield Just Call 7001305949 Top Class Call Girl Service Available
Call Girls Whitefield Just Call 7001305949 Top Class Call Girl Service Available
 
Call Girls Doddaballapur Road Just Call 7001305949 Top Class Call Girl Servic...
Call Girls Doddaballapur Road Just Call 7001305949 Top Class Call Girl Servic...Call Girls Doddaballapur Road Just Call 7001305949 Top Class Call Girl Servic...
Call Girls Doddaballapur Road Just Call 7001305949 Top Class Call Girl Servic...
 
Russian Call Girls in Bangalore Manisha 7001305949 Independent Escort Service...
Russian Call Girls in Bangalore Manisha 7001305949 Independent Escort Service...Russian Call Girls in Bangalore Manisha 7001305949 Independent Escort Service...
Russian Call Girls in Bangalore Manisha 7001305949 Independent Escort Service...
 
VIP Call Girls Tirunelveli Aaradhya 8250192130 Independent Escort Service Tir...
VIP Call Girls Tirunelveli Aaradhya 8250192130 Independent Escort Service Tir...VIP Call Girls Tirunelveli Aaradhya 8250192130 Independent Escort Service Tir...
VIP Call Girls Tirunelveli Aaradhya 8250192130 Independent Escort Service Tir...
 
CALL ON ➥9907093804 🔝 Call Girls Baramati ( Pune) Girls Service
CALL ON ➥9907093804 🔝 Call Girls Baramati ( Pune)  Girls ServiceCALL ON ➥9907093804 🔝 Call Girls Baramati ( Pune)  Girls Service
CALL ON ➥9907093804 🔝 Call Girls Baramati ( Pune) Girls Service
 
Russian Call Girls Chickpet - 7001305949 Booking and charges genuine rate for...
Russian Call Girls Chickpet - 7001305949 Booking and charges genuine rate for...Russian Call Girls Chickpet - 7001305949 Booking and charges genuine rate for...
Russian Call Girls Chickpet - 7001305949 Booking and charges genuine rate for...
 
Call Girl Service Bidadi - For 7001305949 Cheap & Best with original Photos
Call Girl Service Bidadi - For 7001305949 Cheap & Best with original PhotosCall Girl Service Bidadi - For 7001305949 Cheap & Best with original Photos
Call Girl Service Bidadi - For 7001305949 Cheap & Best with original Photos
 
Sonagachi Call Girls Services 9907093804 @24x7 High Class Babes Here Call Now
Sonagachi Call Girls Services 9907093804 @24x7 High Class Babes Here Call NowSonagachi Call Girls Services 9907093804 @24x7 High Class Babes Here Call Now
Sonagachi Call Girls Services 9907093804 @24x7 High Class Babes Here Call Now
 
Escort Service Call Girls In Sarita Vihar,, 99530°56974 Delhi NCR
Escort Service Call Girls In Sarita Vihar,, 99530°56974 Delhi NCREscort Service Call Girls In Sarita Vihar,, 99530°56974 Delhi NCR
Escort Service Call Girls In Sarita Vihar,, 99530°56974 Delhi NCR
 
Russian Call Girl Brookfield - 7001305949 Escorts Service 50% Off with Cash O...
Russian Call Girl Brookfield - 7001305949 Escorts Service 50% Off with Cash O...Russian Call Girl Brookfield - 7001305949 Escorts Service 50% Off with Cash O...
Russian Call Girl Brookfield - 7001305949 Escorts Service 50% Off with Cash O...
 
Low Rate Call Girls Pune Esha 9907093804 Short 1500 Night 6000 Best call girl...
Low Rate Call Girls Pune Esha 9907093804 Short 1500 Night 6000 Best call girl...Low Rate Call Girls Pune Esha 9907093804 Short 1500 Night 6000 Best call girl...
Low Rate Call Girls Pune Esha 9907093804 Short 1500 Night 6000 Best call girl...
 
Call Girl Chennai Indira 9907093804 Independent Call Girls Service Chennai
Call Girl Chennai Indira 9907093804 Independent Call Girls Service ChennaiCall Girl Chennai Indira 9907093804 Independent Call Girls Service Chennai
Call Girl Chennai Indira 9907093804 Independent Call Girls Service Chennai
 
Call Girls Yelahanka Just Call 7001305949 Top Class Call Girl Service Available
Call Girls Yelahanka Just Call 7001305949 Top Class Call Girl Service AvailableCall Girls Yelahanka Just Call 7001305949 Top Class Call Girl Service Available
Call Girls Yelahanka Just Call 7001305949 Top Class Call Girl Service Available
 
Call Girls Service Chennai Jiya 7001305949 Independent Escort Service Chennai
Call Girls Service Chennai Jiya 7001305949 Independent Escort Service ChennaiCall Girls Service Chennai Jiya 7001305949 Independent Escort Service Chennai
Call Girls Service Chennai Jiya 7001305949 Independent Escort Service Chennai
 

validation.pdf

  • 1. OM CLEAN ROOM SERVICES Complete Range of  HVAC VALIDATION  PHARMA CLEAN ROOM VALIDATION from One Source VALIDATION TESTS:  Filter Integrity Leak Test  Filter Face Air Velocity measurement  Calculation of air changes/ Hour in room  Air Velocity/ CFM measuremen  Air Borne Particulate Count monitoring  Recovery Period Study  Room Temperature/ RH monitoring  Airflow Visualization test
  • 2. About Us: Welcome to OM CLEAN ROOM SERVICES Om Clean Room Services (A perfect Compliance company to regulatory requirements) is known for prompt Economical & Reliable HVAC/ Clean Room Validation & Temperature/ RH mapping mainly in Pharmaceutical Industry, while leveraging on high accuracy calibration equipment, well trained persons to execute site validation activities to meet the customer requirements and to provide services at its best. Quality Policy: OM Clean Room Services (OCRS) Conducts HVAC & Validation activities under suitable conditions. It uses techniques that have high reliability and follows majorly recognized Good Laboratory Practices (GLP). It is our policy to provide the highest quality of services attainable to customers with the aim of achieving total customer satisfaction. We also comply with all applicable statutory and legal requirements. We constantly customer satisfaction. We are committed to the continual improvement of our Quality Management Systems (QMS). This responsibility & Commitment for QMS is practices & communicated by management, by establishing, documenting, implementing and maintaining there by continually improving the effectiveness of the system. Services:- OCRS provides services in HVAC/Clean Room validation & equipment qualifications. All test methods in use & documentation of the same, follows latest cGMP Guidelines, traceable to national and international standards. Our Organization is blessed by a team of experienced expertise from the variety of fields that has keen eyes on regulatory body’s legal interpretation, guidelines frameworks & latest developments. Clean Room Validations:- OCRS performs HVAC validations as per ISO 14644, EU c GMP, US (FDA), Standards and MHRA(European Countries) guidelines, for all category area and room Classifications.  Filter Integrity Leak Test (Using PAO/DOP)  Filter Face Air Velocity measurement  Calculation of air changes/ Hour in room  Air Velocity/ CFM measurement induct  Air Borne Particulate matter monitoring  Recovery Period Study  Room Temperature/ RH monitoring  Airflow Visualization test
  • 3. Isolator Validation:-  Filter leak  Airflow Velocity  Particle Count Test  Recovery time determination  Smoke Pattern  Vibration Temperature Mapping:- Temperature mapping is described as a documented procedure for obtaining, recording and interpreting data required to show that a process will consistently comply with predetermined specifications. Continuous update on methods developments for validation has helped us a lot, in fulfilling customers need. OCRS has Temperature mapping facilities for the following Instruments:-  Double Door Autoclave  Vertical Autoclave  Dry Heat Sterilizer (DHS)  Deep Freezer & Tray Dryer  Reserve Sample room, Walk In & Stability Chamber (Temperature * RH)  Tunnel Sterilizer  Cold Room & Room (Temp & RH Study)  Warehouse/ In process stores temp/ RH mapping  Autoclave/ Sterilizers temperature mapping  Dry Heat Sterilizers temperature mapping OCRS is among the leading Calibration/ Validation service providers with rich experience and expertise. With service to its credit with the best price/ performance ratio in the industry. OCRS has become a reliable service provider for the complete Indian Pharmaceutical segment.
  • 4. OM Clean Room Services (OCRS) has also provided unparalleled services to Hospitals:- OCRS believes in maintaining its high standards of services and looks forward to continually improving and providing total customer satisfaction through feedback from Hospitals. LIST OF VALIDATING INSTRUMENTS:-  Aerosol Photometer o Make : ATI, USA o Model : ATI-2i  Six Nozzle Laskin style Generator C/W PAO Oil o Make : ATI, USA o Model : TDA-4B  Smoke Generator o Make : Concept o Model : Minicolt 4SP  Non- Viable Particle Counter o Make : PMS o Model : Lasair III 5100  Hot Wire Anemometer o Make : TESTO  Vane Type Anemometer o Make : Lutron o Model : AM4206-M M/s OM CLEAN ROOM SERVICES REGD. ADD: 106, DATAR COMPLEX, OPPO GORWA ITI, REFINERY ROAD, VADODARA- 390016 EMAIL ID : omcleanroomservices@gmail.com CONTACT PERSON: MIHEER SINHA SHAILESH MAKWANA BHAVESH CHAUHAN (M): 8980630251 9727678212 8980290971