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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