In regulated industries like pharmaceuticals, biotech, healthcare, food, and manufacturing, equipment isn’t just a tool—it’s the backbone of quality and compliance. Any deviation or malfunction in equipment can result in compromised product quality, regulatory violations, and patient safety risks. This is where equipment qualification and validation play a critical role. At Prism Calibration, we offer NABL-accredited equipment validation and qualification services in Ahmedabad and across Gujarat, ensuring that your equipment performs consistently, safely, and in line with regulatory requirements. From autoclave validation to validating complex systems in medical device manufacturing, our team brings deep expertise and a commitment to excellence.
Equipment qualification is a documented process that confirms a piece of equipment is installed correctly, operates as intended, and consistently produces expected outcomes under defined conditions. It typically involves four major stages:
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PQ (Performance Qualification) – Proves the equipment performs reliably in routine production.
Each stage is critical in achieving full confidence in your system’s capabilities before it goes into commercial operation.
Equipment validation goes beyond qualification by establishing documented evidence that a system performs its intended function effectively and reproducibly in the actual production environment. It includes:
Validation is especially vital in medical devices, pharmaceutical manufacturing, sterilization equipment like autoclaves, and cleanroom environments. It also supports compliance with global regulations such as US FDA, WHO, EU-GMP, and Schedule M.
Autoclaves are widely used for sterilization in pharmaceutical, medical, and lab settings. However, without proper validation, their performance can’t be trusted. Autoclave validation involves verifying that sterilization cycles achieve desired outcomes (like temperature, pressure, and time) and meet biological efficacy using tools such as:
Our autoclave validation test services include:
Heat penetration analysis
At Prism Calibration, we follow NABL-compliant procedures to ensure that your sterilizers consistently deliver the highest level of microbiological safety.
Medical device manufacturers operate under strict regulatory frameworks. Whether it’s a surgical tool, implant, or diagnostic system, each device must meet global standards. Validation in medical devices is essential for:
We provide customized validation protocols for medical device companies, covering both equipment validation and process validation as per ISO 13485 and FDA 21 CFR Part 820 guidelines.
The National Accreditation Board for Testing and Calibration Laboratories (NABL) ensures laboratories meet high standards for technical competence and reliable results. Our NABL-accredited validation services provide:
Having NABL-certified validation not only ensures peace of mind but also strengthens your documentation during audits and client inspections.
 Autoclave validation should be performed annually or whenever there is a change in load configuration, maintenance, or relocation of equipment.
 Absolutely. Our team can visit your facility anywhere in Ahmedabad or Gujarat to carry out complete validation and qualification services.
 Yes, we provide complete validation documentation, including DQ, IQ, OQ, PQ, raw data, and final validation reports suitable for regulatory inspections.
