Monday, December 26, 2016

SERVICES IN MKP VALIDATION




VIDEOGRAPHY/SMOKE PATTERN
VALIDATION OF LAF
CLEAN ROOM
TEMPERATURE MAPPING
FILTER INTEGRITY TEST (DOP/PAO)
RH MAPPING
RECOVERY TEST
PARTICLE COUNT


1.VIDEOGRAPHY/SMOKE PATTERN


        Smoke pattern tests are conducted to confirm the unidirectional airflow exiting high efficiency particulate air i.e. HEPA filters or ultra low particulate air i.e. ULPA filters. This test provides visual evidence of airflow direction which is a useful demonstration and diagnostic of facility performance.
        Smoke pattern today is of prime importance in evaluating clean room performance. This pattern indicates the air flow pattern in a room and is helpful in air flow pattern analysis. The prime function of clean room is also to maintain proper air flow to generate necessary scavenging tool. Videography is a tool which can be used for deriving above important criteria.
2.VALIDATION OF LAF

        Bio-safety Cabinet - A biosafety cabinet (BSC) is an enclosed, ventilated laboratory workspace specially designed for safely working with materials contaminated with (or potentially contaminated with) pathogens, requiring a defined biosafety level. Pathogens are a group of microscopic organisms that are capable of reproducing on their own, causing human disease by direct invasion of body tissues. Bacteria often produce toxins that poison the cells they have invaded.

        The primary purpose of a bio safety cabinet is to protect the laboratory personnel, product and the surrounding environment from pathogens and other biohazards  during routine procedures. These bio safety cabinets are designed to meet diverse applications in the life science, clinical, pharmaceutical and industrial laboratory. All exhaust air is HEPA-filtered as it exits the biosafety cabinet, removing harmful bacteria and viruses.

        Reverse LAF - Reverse Laminar Air Flow Unit operates on a re-circulatory airflow principle providing containment by air movement. The pre-filters located at the base of the rear wall capture the airborne contaminants generated. Intake velocity at pre-filters increases to ensure scavenging effect. A small percentage of air is discharged from the booth through the bleed exhaust HEPA filter to maintain the working space under negative pressure. The advantages of these units are that there is no cross contamination and also no risk or inhalation of powders.

        Dynamic Pass Box - Dynamic Pass Box is designed to allow material transfer through controlled environment without much personnel movement to minimize man /material movement & avoid cross contamination between different classified areas. This is specifically installed to minimize movement of personnel for transfer of material into and from the clean room. Dynamic Pass Box provides a barrier between the areas and sweeps away particulate load if present on the surface of object.

3.CLEAN ROOM

        Cleanroom is a modular environment in which the important parameters such as air flow, differential pressure, relative humidity, temperature, airborne particles and microbes are kept under control.

CLEAN-ROOM VALIDATION IS PERFORMED FOR THE FOLLOWING PURPOSES:

       To ensure that the design of facility meets with its intended purpose; to ensure that the facility, equipment, and environment conforms to the User Requirement Specifications (URS); to ensure that the facility, equipment, and environment comply with the defined regulatory requirements; to ensure that the facility, equipment, and its environment function together as a system meets with the defined standards.
        Post validation, cleanrooms are certified to a chosen class of ISO 14644-1. Each class of ISO14544-1 has its unique requirements that must be made for a facility to be classified in the specified classification.
4.TEMPERATURE MAPPING

       We perform validation tests for Temperature and Humidity Measurement in two stages. In the first stage, general temperature and humidity uniformity are tested. This stage of test is done to ensure that the clean room's HVAC system maintains the specified levels of temperature and humidity required for occupant comfort.
        The second level is done to ensure that the clean room's HVAC system maintains the specified levels of temperature and humidity required for both the occupant comfort and process temperature control.
5.FILTER INTEGRITY TEST (DOP/PAO)

       We perform detailed HEPA/ULPA filter integrity tests. These tests are mainly performed for the Pharmaceutical and Microelectronics industries. The tests are done in accordance with IES-RP-CC-001-86 & ISO 14644. We have sophisticated equipment to perform HEPA Filter Integrity Test with both DOP (i.e. Di-Octal Phthalate) and PAO (i.e. Poly Alpha Olefin), depending upon client-facility's specific requirements. The above tests assure that client's filters are in conformance with various standards/norms and/or governing agency requirements.
        It is recommended to do the Testing and evaluation of filters minimum once annually and potentiality twice annually for achieving optimum performance. We provide proper documentation and certification which helps to the predict potential performance issues and increases filter life.
6.RH MAPPING

        We perform validation tests for Rh Mapping at two stages. In the first stage, general Rh Mapping uniformity are tested. This stage of test is done to ensure that the clean room's HVAC system maintains the specified levels of Rh Mapping required for occupant comfort. The second level is done to ensure that the clean room's HVAC system maintains the specified levels of Rh Mapping required for both the occupant comfort and process temperature control.
7.RECOVERY TEST

        We execute recovery tests for clients across Industries. These tests demonstrate the ability of the clean room to remove particulate by purging the area with filtered air. It also testifies if the room can change from a "dirty" to "clean" state within the specified time. The test is conducted by experienced technicians from team. Our technicians have enriching experience and provide clients with high quality service.
        The ultimate goal of our company is to assure complete satisfaction of clients through effective execution of services and by providing best array of clean room equipment. We ensure that client's clean room facility is performing properly and accurately.
8. PARTICLE COUNT

        The Particle Count Test done by us provides complete airborne particle count cleanliness classification. This test determines the actual particle count level within the facility at the time of the test. The test determines particle count on basis of As-Built, At-Rest, or  Operational as per ISO 14644 . The desired particle size(s) , the room occupancy state and the room classification shall be known prior to the beginning of the tests and shall be as specified in the URS documents.

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