EQUIPMENT, FACILITIES & UTILITIES QUALIFICATION
Equipment Qualification comprises a series of qualifications, such as Design, Installation, Operational, and Performance Qualification, that provide a high degree of assurance of the consistent, expected functioning of a piece equipment. Operating parameters and environment, as well as documented routine maintenance and on-going performance checks, contribute to a life-cycle approach to maintaining equipment in a validated state. MEDVACON's experienced team of equipment qualification experts can assist you with equipment needs including:
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MEDVACON's Facilities and Utilities Commissioning and Qualification specialists help clients ensure their facility, utilities, and equipment perform as intended. We do that through commissioning and qualification services, using a risk-based approach to maximize time and cost efficiencies through focused qualification efforts. Our experienced commissioning and qualification team has the technical skills and experience to make our clients' projects successful. By using current industry trends and methods to help define and implement best practices, we quickly adapt to the needs of each individual client, knowing each project has unique requirements.
Example Projects
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Packaging Equipment / Line Qualification
A Pharmaceutical client engaged MEDVACON to design and implement a matrix approach to qualifying all of their OSD packaging lines to ensure fully compliant validation in the most cost effective and efficient manner. MEDVACON's team of experts evaluated all of the client's product specifications and all of the packaging line specifications and capabilities to develop and implement the matrix approach. MEDVACON further evaluated the existing equipment qualification protocols to identify gaps. For the gaps, MEDVACON qualified each piece of packaging equipment to the new intended uses and conducted 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.
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Manufacturing Equipment Qualification
A Pharmaceutical client that manufactures oral solid dose (OSD) tablets engaged MEDVACON to qualify production their equipment. MEDVACON prepared. MEDVACON developed and executed Installation and Operational Qualification (IQ/OQ) protocols for Mixers, Blenders, Fluid Bed Driers and Tablet Presses.
HVAC, Air Compressors & Dust Collection Qualification
A Pharmaceutical client engaged MEDVACON on a multitude of Facility Qualification Activities. The engagement included the qualification of: 16 Air Handling HVAC Units, 2 Facility-Duty Air Compressors and 2 Dust Collection units all servicing the GMP Packaging and Lab areas. MEDVACON's Team of Utility Qualification Engineers developed and executed Installation and Operational Qualification (IQ/OQ) protocols for all of the equipment and developed all of the qualification reports.
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Medical Device Component Manufacturing
MEDVACON was engaged by a Medical Device Component manufacturer to evaluate the impact on equipment qualification related to the planned relocation of the manufacturing facility. 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.
Flammable Mixing Vessel Containment
A Pharmaceutical company that manufactures various types of products engaged MEDVACON to evaluate 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.
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