The answer depends on the end-use of your product, on customer expectations, and sometimes on regulations. BFK Solutions has the experience and expertise to support you in:
Cleaning Validation
Cleaning process acceptance
Supply chain acceptance
Process monitoring
Cleaning equipment acceptance
Cleaning Validation; Process Acceptance
First, bake the cake
Cleaning Validation and Cleaning Process Acceptance are the frosting on the cake. Baking the cake involves designing the cleaning process and setting up good manufacturing processes. BFK Solutions works with clients to design cleaning processes that stand up to the rigors of validation requirements or cleaning process acceptance requirements, that can be scaled-up for high volume production, that are rugged, and that can be monitored to assure consistent, quality production.
Cleaning Validation
The idea of “cleaning validation” is often associated with medical device manufacturing or pharmaceutical processes. In pharmaceuticals, it may be associated with an acceptably low level of the Active Pharmaceutical Ingredients (API). In manufacturing implantable medical devices, validation is associated with achieving minimal leachable residue. BFK Solutions has a solid background in the biomedical field. Barbara Kanegsberg has degrees in biology and biochemistry. We help device manufacturers and their suppliers to achieve defendable processes that can be validated and maintained.
Cleaning Process Acceptance
Companies involved in electronics and aerospace often refer to cleaning process acceptance. In electronics assembly, concerns may focus on ionic contamination; for high-value applications, there may be issues with other residue. In aerospace, the emphasis tends to be on achieving acceptably low levels of particulates and of non-volatile residue (NVR). In some applications, specific contaminants have to be documented. BFK Solutions has decades of experience in electronics, aerospace, and military-related projects.
Supply Chain Acceptance and Monitoring
BFK Solutions works with final assemblers to develop exacting, achievable requirements for the supply chain. We also help specialized job shops to achieve well-document, consistent critical cleaning and manufacturing processes that satisfy the needs of their customers.
Process Monitoring
Process monitoring programs reduce aggravation with both new and well-established cleaning processes. BFK Solutions works with small companies and large clients to set up monitoring programs that mean business, and that can be readily maintained. Aspects include chemical certification, bath monitoring, process control, and employee education/employee performance.
Cleaning Equipment Acceptance
When you spend cold hard cash on new cleaning equipment, live by the adage “trust but verify. BFK Solutions reviews equipment design, regulatory acceptability, initial acceptance testing at the equipment vendor facility, equipment installation, and production run performance.
