Biomatic Validates Equipment
for Manufacturing Medical Device
Used in Surgical Procedures
Franklin, MA (April, 2004) -- A manufacturer of medical devices selected Biomatic to provide the comprehensive IQ, OQ, PQ validation program for an injection molding machine that produces cannulated drivers used for 5.0 mm corkscrew anchors employed in surgical procedures.
The IQ, OQ, PQ program included a draft of the protocol and testing at the client’s site in Florida. The purpose of the validation was to establish by objective evidence that the injection-molding machine was capable of consistently manufacturing products that met process specifications under challenge conditions in the actual production environment. The protocol set forth the procedure by which the Process Performance Qualification of the device was performed.
The test methodology for challenging the production process consisted of visual inspection of three batches of the product, each containing 200 cannulated drivers. Each driver was inspected for the precise positioning of the metal driver and to ensure that there were no burrs or air pockets on the handle.
The validation process included verification of proper system installation, including platform suitability, electrical and pneumatic connections, cooling system, and other factors affecting installation.
Next, the system operational qualification was performed to verify the operational integrity of all steps for the fully automated and computer-controlled device. The operational qualification involved verification of more than 100 functions of the injection-molding machine, including all safety-related functions critical to protecting machine operators.
The performance qualification tests were completed by randomly selecting 60 samples of the cannulated drivers from each batch and measuring the accuracy of the driver length, as determined by the client’s specifications. The acceptance criteria for this product were zero percent failure. In addition, data recording needed to adhere to cGMP guidelines.
The validation of the injection molding machine used for producing surgical instruments highlights Biomatic’s practice of customized validation services, whether for laboratory instruments or medical device production. Biomatic’s protocols are customized to meet our client’s requirements and, when necessary, meet GLP/GMP requirements.
Biomatic has performed IQ OQ PQ/PV validations on more than a thousand analytical systems and temperature-controlled devices such as environmental chambers, freezers, humidity and CO2 incubators, standard and walk-in refrigerators, and ovens across the United States. Our experienced technical chemists validate instruments using real-world testing procedures and NIST / vendor traceable tools and standards.
With offices in the Greater Boston region; at Bayer Pharmaceuticals in West Haven, CT; and Research Triangle Park, NC, Biomatic has the expertise to assess, develop and implement services that your company needs, whether for a GMP/GLP regulated facility or a standard laboratory. With our partner FullSpectrum Analytics, which has offices throughout the West, we are positioned to assist your company, wherever your labs are located.
Biomatic invites you to bring your validation and compliance questions to us as well as your other laboratory challenges so that we can improve your laboratory’s operation and the efficiency of your day-to-day tasks.
