OTHER EQUIPMENT VALIDATION SERVICES

OTHER EQUIPMENT VALIDATION SERVICES

i. PASS BOX VALIDATION

A dynamic pass box is an active cleanroom device used to transfer materials between different areas of controlled environments without causing contamination. Unlike a static version, it uses an internal air filtration system with a motor and blower, along with HEPA filters, to create a positive pressure environment and maintain cleanliness. These boxes are also equipped with interlocking doors to prevent both from being open at the same time.

Following tests are required to verify a dynamic pass box:

• Air velocity,
• Cleanroom classification using a particle counter
• Filter integrity test
• Smoke test to check for uniform unidirectional airflow
• Verify the door interlock system
• Check the differential pressure gauge

ii. DISPENSING BOOTH VALIDATION

A dispensing booth is a specialized, controlled enclosure used in industries like pharmaceuticals for weighing, sampling, and dispensing powders and chemicals. It protects the product, the operator, and the environment by using a HEPA filtration system and controlled airflow to prevent contamination and contain dust.

Performance and safety features are validated through a series of following tests:

• HEPA filter integrity test
• Checking Airflow Velocity and Laminarity
• Measuring Exhaust Volume
• Confirming proper Illumination, noise levels, and
• Cleanliness level using a non-viable particle counter

iii. SAMPLING BOOTH VALIDATION

A sampling booth is a controlled, enclosed space used for safely handling and taking samples of powders and other materials, primarily in the pharmaceutical, chemical, and food industries. It protects the operator from airborne particles, prevents product contamination, and stops dust from spreading to the surrounding cleanroom environment. These booths work by creating a clean, filtered airflow that captures and removes airborne particles.

Performance and safety features are validated through a series of following tests:

• HEPA filter integrity test
• Checking Airflow Velocity and Laminarity
• Measuring Exhaust Volume
• Confirming proper Illumination, noise levels, and
• Cleanliness level using a non-viable particle counter

iv. AIR SHOWER VALIDATION

An air shower is a specialized enclosure with high-velocity, HEPA-filtered air jets used to remove particulate matter from a person or material before entering a cleanroom or other controlled environment. These systems are crucial for industries like pharmaceuticals, electronics, and food processing to prevent contamination and maintain product quality.

Validating air velocity at nozzles is a major test for this equipment.

v. ISOLATOR VALIDATION

A biosafety isolator is a completely enclosed, sealed workspace designed for maximum containment, protecting both personnel and products. It creates a physical barrier using glove ports for manipulation, high-efficiency particulate air (HEPA) filtration to clean incoming and outgoing air, and either positive or negative pressure to control airflow. This allows for the safe handling of high-risk pathogens or potent compounds while also maintaining sterility for sensitive materials.

These are validated for on following parameters:

• Particle Count test
• HEPA Integrity
• Air Velocity Uniformity
• Air flow pattern
• Noise Level
• Lux Level
• UV intensity
• Vibration
• Integrity

vi. Fume Hood Validation / Calibration Parameters

Fume hood validation is a critical process to ensure the proper functioning and safety of fume hoods in laboratories. The validation process typically involves testing various parameters to verify that the fume hood meets specified performance standards.

Testing Parameters:

• Face Velocity
• Containment Performance
• Sash Movement
• Alarm Systems
• Emergency Shutdown
• Airflow Patterns
• Face Velocity Alarm
• Lighting
• Airflow Monitor Calibration
• Ductwork Inspection
• Vibration and Noise Levels