Cleanroom Validation Services
Leading Wholesale Trader of cleanroom validation, air velocity testing services, operation theater (ot) validation, particle count testing, hepa filter integrity test and cleanroom validation services from Navi Mumbai.Cleanroom Validation
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Product Details:| Application/Usage | Lab |
| Cleanroom Type | Modular Cleanroom |
| Room Size | >500 Square Feet |
| Prevention Particle | Dust |
| Validation Type | Recovery Test |
| AMC Required | Yes |
Testings are carried out in accordance with relevant standards (ISO 14644-2, 3, 4, EU GMP/EC GMP, FS 209E, WHO 2002, USFDA, MHRA, Drug and Cosmetic Act of India, 2005)
We carried following services in validation, 1. Air Velocity (Flow) Test ACPH test ,2. HEPA filter integrity Test, 3. Particle count Test 4. Recovery Test 5. Pressure balancing Test, 6. Air flow Pattern Test
Air Velocity Testing Services
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Product Details:| Test Location | In Laboratory |
| Need Standard Certification | Yes |
| Mode of Report | Soft Copy, Hard Copy |
| Application Type | Hospital |
| Need Test Result | <2 Hours |
Air Velocity Measurement is carried out to determine the filter face velocity, uniformity and the total room airflow volume within a Clean room. This test has been performed in accordance to different international guidelines i.e. ISO14644-2, 3, 4, EU GMP/EC GMP, FS 209E, WHO 2002, USFDA, MHRA, Drug and Cosmetic Act of India
Operation Theater (OT) Validation
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Product Details:| Application/Usage | Healthcare Industry |
| Number of Rooms | >3 |
| AMC Required | Yes |
| Certification Type | Biosafety Certification |
| Prevention Particle | Dust |
| Room Size | >500 Square Feet |
| Cleanroom Type | Modular Cleanroom |
We carried following services in OT validation,
Air Velocity (Flow) Test ,
HEPA filter integrity Test
Particle count test
Recovery test
Air flow Pattern Test
Particle Count Testing
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Product Details:| Analysis Type | Particle Size |
| Application Type | Manufacturing |
| Particle Count Time | At Operation |
| Periodic Review Required | Yes |
This is one of the most important Test as per Cleanroom validation concern using TSI Particle Counter (100LPM or 50 LPM) .This test is required to qualify the status of Cleanliness class of Cleanroom, Laminar Airflow Unit, Bio-safety cabinet, Isolators, FBD, FBE, Autoclave, Dry heat sterilizers, Air Showers, Coaters, Garment Cubicles, Vial Sterilization Tunnels, etc.
HEPA Filter Integrity Test
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HEPA filter integrity test is known as PAO Test. Actually PAO is well known aerosol reagent used in HEPA Filter Integrity Test or HEPA Filter Leakage Test as a challenge aerosol. This test has been conducted by using well known testing instruments i.e. Calibrated TEC Aerosol Photometer & Aerosol Generator.
Particle Count Testing
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This is one of the most important Test as per Cleanroom validation concern using TSI Particle Counter (100LPM or 50 LPM) .This test is required to qualify the status of Cleanliness class of Cleanroom, Laminar Airflow Unit, Bio-safety cabinet, Isolators, FBD, FBE, Autoclave, Dry heat sterilizers, Air Showers, Coaters, Garment Cubicles, Vial Sterilization Tunnels, etc.
Cleanroom Validation Services
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Testings are carried out in accordance with relevant standards (ISO 14644-2, 3, 4, EU GMP/EC GMP, FS 209E, WHO 2002, USFDA, MHRA, Drug and Cosmetic Act of India, 2005)
We carried following services in validation, 1. Air Velocity (Flow) Test ACPH test ,2. HEPA filter integrity Test, 3. Particle count Test 4. Recovery Test 5. Pressure balancing Test, 6. Air flow Pattern Test
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Komal Dhavare (Assistant Manager)
Navi Mumbai - 400701, Maharashtra, India
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