Validation

Our Approach

Our approach to validation services is based on a thorough understanding of our clients’ needs and regulatory requirements. We provide comprehensive services that cover all aspects of validation, including planning, protocol development, execution, and final reporting. Our experienced team uses state-of-the-art equipment and industry best practices to ensure that all validation activities are conducted accurately and efficiently. We are committed to providing our clients with high-quality validation services that meet their specific requirements and exceed their expectations.

Validation Services we provide

Clean Room Validation

Clean room validation is a critical aspect of pharmaceutical manufacturing, ensuring that the environment meets the necessary standards for product quality and safety. The validation process includes a range of tests and measurements, such as particle count and air flow velocity, to verify that the clean room meets specified cleanliness levels. Other tests, such as air pressure differentials and temperature and humidity monitoring, ensure that the environment is properly controlled to prevent contamination. By performing thorough clean room validation, pharmaceutical companies can maintain a high level of product quality and safety, while complying with regulatory requirements.

Air Velocity Test, ACPH Measurement
Filter Integrity Test (PAO Test)
Non-Viable Partical Count Test
Recovery Test
Air Flow Visualization / Air Flow pattern Test
Light Intensity Measurement
Sound Level Measurement
T+RH Monitoring
DP Monitoring

Clean Room Equipment Validation

Clean room equipment validation is crucial in ensuring that the equipment is performing as per the required specifications and standards, and that it is free from any contamination that may pose a risk to the products being produced or to the personnel working in the cleanroom. Specific tests and measurements are performed for each type of equipment, including Laminar Air Flow (LAF), Dynamic Passbox, Bio-Safety cabinet, Reverse Laminar air flow, Ceiling suspended LAF, Mobile LAF, Filling LAF, Isolator, Sterilizing tunnel, Horizontal LAF, Fume Hood, Dust Extractor.

Air Velocity Test, ACPH Measurement
Filter Integrity Test (PAO Test)
Non-Viable Partical Count Test
Recovery Test
Air Flow Visualization / Air Flow pattern Test
Light Intensity Measurement
Sound Level Measurement

Compressed Air Validation

Compressed air validation is a vital aspect of pharmaceutical production that directly impacts the quality of the final product. It is also utilized in various other industrial sectors, such as oil and gas, manufacturing, nuclear, diving, and medical applications. Proper validation ensures that the compressed air is free of contaminants and meets the required standards, ensuring the safety and efficacy of the products and processes it is used in.

As per ISO 8573 we cover following parameters under this service for validation.

Dew Point Measurement
Oil Mist
Water Vapour
Non-Viable Particle count Test
Gaseous Parameter – CO,CO2,N2,Nox,SO2,HC,O2
Viable count
0.2 Micron filter Integrity Test

Thermal Validation | Process Validation

Thermal validation is crucial in ensuring that temperature-sensitive products or environments comply with legal requirements. This service is particularly important for manufacturers and transporters who are responsible for maintaining optimal temperature standards in a variety of applications to ensure product quality and safety.

As per WHO Guideline we cover following System under this service for validation.

Incubator
BOD Incubator
Deep Freezer
Ultra-Low deep Freezer.
Industrial Refrigerator
HPHV (High Pressure High Vacuum) Sterlizer (Autoclave).
Vertical Autoclave.
Lyophilizer
Vial Sterilizing Tunnel.
Ampule Sterilizing Tunnel.
Compounding vessel.
Filtration Vessel.
Laboratory Oven
Vacuum Oven
Heating Block
Stability Chamber
Cold room
Walk in Chamber.
ETO Sterlizer
Area / Room T+RH Mapping.
Pure Stem Generator (Based on BS EN285)

Water (GPM) Balancing

Hydronic balancing is crucial to ensure that a building’s heating or cooling system operates effectively and efficiently. Properly balanced systems provide consistent temperatures throughout the building, preventing hot and cold spots. The process also reduces energy consumption and operating costs, as balanced systems require less energy to maintain the desired indoor climate. By optimizing water distribution, hydronic balancing helps ensure the system operates at peak performance, reducing the risk of equipment failures and prolonging the life of the system.

Application

CFM & DP Balancing / TAB (Testing, Adjusting & Balancing)

Air balancing is a crucial step in HVAC system commissioning and maintenance, as it ensures that the air distribution system is functioning efficiently and effectively. Properly balanced air flow can improve indoor air quality, reduce energy consumption, and prevent equipment damage due to improper airflow. By testing and adjusting the flow rates of each branch in the distribution system, air balancing ensures that the system is optimized for the specific needs of the building, resulting in a comfortable and healthy indoor environment.

Application : ISO Clean Room & Respective AHU.

Computer Systems Validation

Computer Systems Validation is crucial for the pharmaceutical and medical device industries as it ensures that computer systems used in the manufacturing, testing, and distribution of products are operating in compliance with regulatory requirements. The process includes testing and documenting every aspect of the system, from the hardware and software to user access controls and data security, to ensure that the system is reliable, secure, and operates consistently and accurately.

As Per GAMP 5 & 21 CFR Part 11 Guideline we cover the Following system for validation under this service.

Benefits of Validation

Ensures product quality
Reduces production costs
Increases efficiency
Complies with regulations
Improves customer satisfaction
Enhances company reputation

Our Expertise

Our team of experts specializes in providing validation services across various industries. With years of experience, our professionals possess a deep understanding of regulatory requirements and industry best practices, allowing us to offer comprehensive validation solutions. We are proficient in conducting equipment and process validation, cleanroom validation, computer systems validation, and more.

Our team is also equipped to handle documentation, testing, and reporting aspects of the validation process with precision and accuracy. We pride ourselves on our attention to detail and commitment to delivering reliable and cost-effective validation services to our clients.