Equipment Qualification

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.