Cleanroom environments are designed to maintain precise levels of cleanliness, air quality, and contamination control. Whether it’s pharmaceuticals, biotechnology, semiconductors, or medical device manufacturing, the equipment used within cleanrooms must function flawlessly to ensure regulatory compliance, product safety, and operational reliability.
This is where Clean Room Equipment Validation becomes crucial. It verifies that all equipment operates according to predefined standards and regulatory expectations. At Prism Calibration, we offer NABL-accredited cleanroom validation services across Ahmedabad and Gujarat, ensuring your equipment meets the strictest industry benchmarks.
Equipment validation is a documented process of testing and verifying that instruments and systems are performing as intended within a controlled cleanroom environment. This includes:
– Temperature and humidity control systems.
– Laminar air flow cabinets.
– HEPA filtration systems.
– Particle counters.
– Biosafety cabinets.
– Autoclaves.
– Environmental monitoring devices.
Cleanroom validation also includes cleaning validation of dedicated equipment, ensuring the sterilization and disinfection processes used are effective and repeatable.
Industries like pharmaceuticals, life sciences, and medical devices are governed by strict protocols such as GMP, GLP, FDA, and ISO standards. Non-compliance can lead to product recalls, legal liabilities, and production halts. Validation ensures adherence to these standards.
Especially in validation of medical devices, equipment must operate within defined limits to ensure that products are safe for end users. A validated cleanroom environment helps eliminate contamination and variability in manufacturing.
By validating equipment, organizations can avoid unexpected failures, reduce downtime, and ensure optimal throughput in cleanroom operations.
At Prism Calibration, we follow a structured and traceable equipment validation process tailored to your operational needs and regulatory framework. Here’s how we do it:
We begin by understanding your specific equipment and cleanroom usage. A URS outlines the performance, regulatory, and process expectations of your cleanroom equipment.
This verifies that the equipment design meets all required specifications before it is installed. It’s particularly important in the validation of medical devices and pharmaceutical manufacturing setups.
IQ confirms that the equipment is installed correctly, using the right materials and documentation
OQ ensures the equipment functions within specified limits under controlled conditions. This involves testing alarms, sensor accuracy, air flow rates, and temperature controls.
PQ checks if the equipment performs reliably under real-world conditions. Cleanroom validation often includes environmental monitoring, airborne particle counts, and recovery time tests.
We provide complete documentation of all qualification steps, including calibration reports, NABL certificates, and audit-ready validation records.
At Prism Calibration, we provide calibration services across a wide array of industries, ensuring precision, compliance, and operational efficiency. Our services are tailored to meet the specific needs of the following key sectors:
Cleanroom hygiene isn’t just about sterile air — it’s about equipment too. Cleaning validation focuses on proving that cleaning methods effectively remove contaminants from dedicated equipment, without leaving behind residues or compromising the next batch or process.
We validate:
Cleaning cycles and disinfectant efficiency
Swab testing for microbial residues
Detergent and chemical residue analysis
Cleaning SOP effectiveness
This is especially crucial for industries dealing with biologics, injectables, and precision electronics.
We proudly serve pharmaceutical companies, hospitals, biotech labs, food processing units, and electronics manufacturers across Ahmedabad and wider Gujarat. Our cleanroom validation services include:
– Air Velocity & Uniformity Testing.
– HEPA Filter Integrity Tests.
– Recovery Time Validation.
– Non-viable Particle Count Testing.
– Viable Microbial Monitoring.
– Differential Pressure Testing.
Whether you need routine re-validation or a new equipment validation, Prism Calibration is your go-to partner.
– Improved compliance with NABL, ISO, and GMP.
– Â Reduced risk of contamination and batch rejection.
– Faster audits with complete documentation.
– Higher process reliability and reproducibility.
– Â Confidence in product safety and quality.
Yes, especially if you're governed by ISO, FDA, or GMP standards. NABL-accredited reports enhance your compliance during audits.
We provide a detailed non-compliance report and assist in rectification, retesting, and documenting corrective actions.
Absolutely. Prism Calibration’s field team can travel across Gujarat to provide on-site, NABL-traceable validation services.
