AHU VALIDATION IN PHARMA PDF

To ensure that the design of the facility is fit for its intended purpose; to ensure that the facility, equipment, and environment meets User Requirement Specifications URS ; to ensure that the facility, equipment, and environment meet defined regulatory requirements; to ensure that the facility, equipment, and its environment function together as a system to meet defined standards. We provide and extensive range of services pertaining to clean room validation by our panel of expert professionals available with us. The level of cleanliness chosen is driven by user requirements. Cleanroom classes are defined in ISO

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To ensure that the design of the facility is fit for its intended purpose; to ensure that the facility, equipment, and environment meets User Requirement Specifications URS ; to ensure that the facility, equipment, and environment meet defined regulatory requirements; to ensure that the facility, equipment, and its environment function together as a system to meet defined standards.

We provide and extensive range of services pertaining to clean room validation by our panel of expert professionals available with us. The level of cleanliness chosen is driven by user requirements. Cleanroom classes are defined in ISO A constant monitoring program is required after certification.

Requirements for compliance are found in ISO Statistical analysis for cleanroom parameters is encouraged as a tool for monitoring the cleanroom after certification to ensure compliance.

The tool of choice is statistical process control, SPC. Methods for evaluation and measurements for Certification are specified in ISO It calls out for the following ten tests. Once certified to a particular class the cleanroom factors are monitored to ensure that parameters have not drifted, or changed, and that the environment is under control.

The average airflow velocity is calculated by dividing the total of the airflow grid velocities by the number of readings taken. Air Exchange Rate tests determine the total air volume get in to the room within a clean room.

The hood measures air volume flowing through registers, diffusers and grills. Weighing just 3. These hoods simply hold the accubalance up to a diffuser or grill and read direct supply or exhaust airflow on the large digital display.

These are offered for both the Pharmaceutical and Microelectronics industries. Testing and evaluating filters minimum once annually and potentiality twice annually is required for optimum performance. Proper documentation and certification is provided by us and this also helps predict potential performance issues and increases filter life.

We are Autocal a reputed name in offering clean room validation services. Our Particle Count Test provides complete airborne particle count cleanliness classification. The test is performed to determine the actual particle count level within the facility at the time of the test. The particle size s of interest, 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. 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. We offer Airflow Visualization Test as a part of the validation process. Visualization is carried out by using water fogger and taking Video Graph. The purpose of the airflow visualization test is to show the actual airflow pattern throughout the unidirectional clean room.

The test can also be used to demonstrate the effects on airflow caused by equipment. It is best to perform this test after all airflow velocity and uniformity tests and room pressurization tests have been performed. The test determining the airflow patterns within a room using ISO guides.

This visual monitoring service is important in:. Clean Room laminar flow tests Airflow balancing. Pressure balancing between rooms and spaces. We conduct Room Pressurization Test for industrial clean rooms. As a part of the validation process, this test verifies that a pressure differential meet the specified requirements. We conduct Containment Tests for client's clean room facility. The test is carried to demonstrate that airborne contamination does not enter from a higher pressure area adjacent to the clean room by means of leaks in the construction materials.

The test is conducted by trained and experienced technicians using modern instruments that assure accurate results. Two levels of temperature and humidity tests are used by us depending on the requirement. In the first level, general temperature and humidity uniformity are tested. The general level test is used to ensure that the clean room's HVAC system maintains the specified levels of temperature and humidity required for occupant comfort.

The second level or the comprehensive level test identified that the clean room HVAC systems needs to maintain the specified levels of temperature and humidity required for both occupant comfort and process temperature control.

The purpose of the lighting level tests is to verify that the installed light levels and uniformity meet the specified requirements.

We make use of modern testing instruments for assessment of lighting lux levels and intensity. We perform noise level test that measure the sound pressure. The measurements will vary based on the occupancy state-of-the-art clean room.

The purpose may vary but the procedures of testing are identical. Cleanroom Certification validated cleanrooms are validated to a required class of cleanliness. Recovery Test We execute recovery tests for clients across Industries. This visual monitoring service is important in: Clean Room laminar flow tests Airflow balancing Fuming Hoods Point Exhaust tests Personnel safety exhausts verification Pressure balancing between rooms and spaces Leak detection in ducts Air Pressure Balancing We conduct Room Pressurization Test for industrial clean rooms.

Containment Test We conduct Containment Tests for client's clean room facility. Light Intensity Measurement The purpose of the lighting level tests is to verify that the installed light levels and uniformity meet the specified requirements. Sound Level Measurement We perform noise level test that measure the sound pressure.

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HVAC SYSTEM VALIDATION TESTS

Ankur Choudhary Print Question Forum 25 comments. The sterile area is validated through the following tests. The air velocity should be within the higher limit of the HEPA filter. Take the suitable particle counter and operate it to check the particles in the room at non-working operation. The particles should be count when more than one hour of work has been progressed in the area. Record the data in the format.

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