Equipment Qualification comprises a series of qualifications defining designs, installation, operational, and performance qualification assuring consistent and anticipated equipment functionality. Operating parameters and environment, documented routine maintenance, and continuous performance checks contribute to a life-cycle approach to maintaining equipment in a validation state. MEDVACON's experienced team of equipment qualification experts can assist you with:
MEDVACON's Facilities and Utilities Commissioning and Qualification specialists help clients ensure their facility, utilities, and equipment perform as intended. By applying a risk-based methodology, our experiences commissioning, and qualification team maximize time and cost efficiencies through focused qualification. MEDVACONS ability to apply industry trends and analyses to help define and implement best practices ensures rapid adaption to client project requirements.
MEDVACON designed and implemented a matrix approach to qualifying all of our pharmaceutical client's OSD packaging lines. To ensure compliant validation and cost and time efficiency, MEDVACON's team of experts evaluated the client's product specifications and packaging line specifications and capabilities that required a matrixed approach. MEDVACON further evaluated the existing equipment qualification protocols to identify deficiencies, outline new intended uses, and conduct performance qualifications of the integrated packaging lines. This approach allows the client to onboard new products to the packaging lines with a systematic, compliant, efficient and defendable validation approach.
MEDVACON assisted a pharmaceutical client manufacturing oral solid dose (OSD) tablets to qualify production equipment. MEDVACON developed and executed Installation and Operational Qualification (IQ/OQ) protocols for Mixers, Blenders, Fluid Bed Drier's and Tablet Presses.
MEDVACON provided a multitude of facility activities for the qualification of 16 air handling HVAC units, two facility-duty air compressors, and two dust collection unites all serving the GMP packaging and alb areas. MEDVACON's team of utility qualification engineers developed and executed Installation and Operation Qualification (IQ/OQ) protocols for all of the equipment and developed all of the qualification reports.
In partnership with a medical device component manufacturer, MEDVACON evaluated the impact of a planned manufacturing facility relocation on equipment qualification. MEDVACON identified components from the point of order generation to the completion of manufacturing to the movement of the component to shipping. The manufacturing process was assessed for reproducibility and operational efficiency and a report was developed for the manufacturer to satisfy their medical device customer's quality units.
For a pharmaceutical company manufacturing various types of products, MEDVACON evaluated the design for their flammable mixing vessel, explosion proof Room, and transmission of the product to the filling line for packaging. MEDVACON conducted a regulatory and design analysis of the process, room, equipment, and transmission lines that the client used for regulatory compliance.