Medical Devices
BFK Solutions provides consulting services in medical device manufacturing, including traditional devices and combination devices. Examples of activities include • Materials compatibility studies • Employee work practice, employee education • Cleaning process validation • Supply chain quality • Leachable residue • Analytical test protocol, assess results • Regulatory issues, e.g. FDA, EPA, OSHA • Process scale-up • Failure analysis Process refinement, dental devices A company had relocated. Local safety and environmental requirements impelled cleaning process changes; some where initially thought to be at non-critical points during assembly. In addition, an extensive supply chain provided diverse components. The potential for leachable residue had increased. Working with engineering and production personnel (including the third shift), we developed cleaning process options, evaluated new cleaning agents and cleaning equipment, discussed work cell and centralized cleaning process options, and revisited safety and environmental requirements. New process development, combination device The innovative device included a pharmaceutical portion, so there were issues of minimizing leachable residue and of avoiding undesirable interaction with the pharmaceutical. The cleaning processes were at laboratory-scale. The company was in the process of scaling-up production levels by orders of magnitude. Cleaning equipment design and process flow options were developed. Cleaning process optimization, implantable device The company needed to validate cleaning. While the product design had been optimized, the cleaning processes were at a more rudimentary stage. The device was totally new, so direct benchmarking, relating leachable residue to the performance of an existing device, was not an option. BFK Solutions worked with the client to achieve quality cleaning processes that could be validated. We also developed a validation test plan; the plan included analytical testing for leachable residue. Troubleshooting, contaminants, diagnostic detector Pro-active education and evaluation, new diagnostic detector The client was concerned with particulate and thin film residue in an advanced detector. BFK Solutions provided an comprehensive, multi-day workshop program that included instruction regarding cleaning and contamination control, interpolated with questions and input from employees. Participants included engineering, production, and quality/regulatory. The project also included on-site review and evaluation of cleaning and assembly practices. The program included approaches to cleaning and manufacturing process improvement, in part based on input from attendees. One benefit of the program was improved communication between different departments. As cleaning and contamination control experts, BFK Solutions participate in ASTM working groups. We are active in the ASTM F04 committee concerned with standards and guidance documents for cleanliness, surface quality, and leachable residue in single use and reusable medical devices. "Interesting and full of information; comprehensive and clear; helpful; very instructive; excellent information. Both speakers (Barbara Kanegsberg; Ed Kanegsberg) were fantastic! Both speakers were very open for discussion. I liked the interaction with the audience." As an invited speaker at ASTM and NIST, Barbara Kanegsberg has delivered presentations concerning precision cleaning and materials compatibility issues relating to medical devices. Barbara conducted invited seminars and discussion sessions for residents and faculty at the University of Southern California, Graduate School of Periodontics. BFK Solutions has also conducted a number of workshops at MD&M and MEDTEC; and we regularly publish discussions of issues in medical device manufacturing. Because manufacturers supplying components to medical device manufacturers are increasingly concerned with providing a quality product to the final assembler, we also present and write articles addressing supply chain issues. Please refer to our publications section.
• Cleaning processes - design, review, determine efficacy, optimize
Particulate contamination in a diagnostic detector resulted in explosive failure during use. While not an immediate health hazard, such failure produced consternation among clinicians and patients. Part of the problem was that the product had not been designed for ease of cleaning during manufacture. Additional processes were developed to adequately remove particles.
Workshops, presentations, publications, standards, guidance documents
Medical Devices