Clean Room / HVAC Validation

Cleanroom Validation/HVAC Validation is performed for a variety of reasons. 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. We performs the HVAC validations as per ISO 14644-1,2,3, EU GMP/EC GMP, WHO-TRS-937, WHO-TRS-961, Schedule M (National Regulatory Body) guidelines for all room classifications.

Cleanroom Certification

Validated cleanrooms are validated to a required class of cleanliness. The level of cleanliness chosen is driven by user requirements. Cleanroom classes are defined in ISO1464-1:

Monitor And Control

A constant monitoring program is required after certification. Requirements for compliance are found in ISO 14644-2. 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 ISO14644-3. It calls out for the following ten tests. Air flow Test & ACPH Calculations Installed Filter System Leakage Test (using PAO) Non-Viable Particle Count Test Recovery Test Air Flow Pattern Test (Using Water Fogger) Air Pressure Balancing Containment test Temperature & RH Measurement Light Intensity Measurement Sound Level Measurement 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. We carries out following tests to validate clean rooms/clean zones.

Air flow Test & ACPH Calculations

We conduct Air Velocity Measurement / tests to determine the average filter face velocity and uniformity, and the average room airflow velocity and uniformity within a clean room. 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 use of TSI Accubalance Air Capture Hoods of Model No.8375, assures accurate test results. The hood measures air volume flowing through registers, diffusers and grills. Weighing just 3.5 kgs, these air capture hoods are easy to use and carry. These hoods simply hold the accubalance up to a diffuser or grill and read direct supply or exhaust airflow on the large digital display.

Good Manufacturing Practices (GMP) in Process Plants

Today’s control software packages use a variety of programming languages such as function blocks, ladder logic, sequential function charts, etc. These programs must be clearly documented and easy to update in order to improve the plant’s productivity over its expected life. A simple, universal system of matrix-based documentation can be easily developed jointly by the process control system engineers and production engineers. Such a methodology of documentation has been created and applied to several batch control plants, the most recent of which are several multi-recipe, multi-product specialty chemical plants. This concept of software documentation, which involves mainly the sequence control and safety interlock logic functions, has proven to be an effective way to transfer process technology and operational know-how of an existing pilot scale operation to a new, fully automated, large-scale production plant. How do you go about validating a PLC system in the pharmaceutical industry? When a pharmaceutical manufacturer realises that validation of either an existing or new computer system is required, and enters into a contract with a supplier, it's important that a working relationship is established. This has to be more than a mere purchase order supply agreement, and has to account for the needs and responsibilities of both parties. Validation is the documented evidence that a process or system does what it's supposed to do. In the pharmaceutical industry, this means that a process must manufacture the final product within established limits and specifications and that each step of the process be recorded. A computer system which controls the process must operate in a manner that will maintain these product specifications.

Installed Filter System Leakage Test (using PAO)

We conduct complete HEPA/ULPA filter integrity testing services. These are offered for both the Pharmaceutical and Microelectronics industries. All filter integrity tests performed by us are executed in accordance with IES-RP-CC-001-86 & ISO 14644. We are equipped to perform HEPA Filter Integrity Test with both Di–Octal Phthalate (DOP) and Poly Alpha Olefin (PAO) depending on client-facility's specific requirements. The tests assure that client's filters are in conformance with various standards and/or governing agency requirements. 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.

Non-Viable Particle Count Test

We have 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 test identifies particle count on basis of As-Built, At-Rest, or Operational as per ISO 14644 , EU GMP . 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.

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.

Air Flow Pattern Test (Using Water Fogger)

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 14644 guides. 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. As a part of the validation process, this test verifies that a pressure differential meet the specified requirements.

Containment Test

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.

Temperature & RH Measurement

We conduct validation tests that include Temperature and Humidity Measurements / Tests. 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.

Light Intensity Measurement

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.

Sound Level Measurement

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.

HEPA Filter Integrity

The filter media and the housing will be checked to ensure that no airborne contamination passes into the cleanroom as a result of bypassing the filter installation.

Pressure Differential

Demonstrates that the airflow between areas in the cleanroom suite cascades in the correct direction and that the pressure differentials are correct. Air Velocity &Uniformity Demonstrates the effective unidirectional airflow for laminar flow workstations and rooms. Air Volumes &Air Change Rates Shows that the correct volume (turbulent ventilated cleanroom) or the velocity unidirectional cleanroom) is entering the clean area. This information is then used to calculate the number of air changes within the area to ensure compliance with specification. Containment Leak Test Demonstrates that airborne contamination cannot enter adjacent areas by means of leaks in the room fabric. This is typically performed on negative pressure containment suites. Airborne Particulate Counts Proves the classification of the area has been achieved with regards to the concentration of airborne particulate. See table below for selected BS EN ISO 14644-1 cleanroom classifications. The classification can be provided to any Standard required by the Client, e.g. EU cGMP.

Clean-up &Recovery

Demonstrates the ability of the room to remove particulate by purging the area with filtered air and that the room can change from a “dirty” to “clean” state within the specified time. Airflow Visualisation and Smoke This test, usually with video evidence, will show the airflow patterns and movement within the cleanroom, to show good coverage of critical operator and / or machine areas and highlight any zones with poor air movement.

Other tests include:

• Temperature and Humidity &Mapping • Noise • Lighting Level