C.Brewer PRP™ — Our proprietary product realization process

Engineers at C. Brewer Co. have taken the science of medical molding to a new level: The C.BrewerPRP™ (Product Realization Process). This process planning breakthrough is made possible by embracing section 7.1 of the ISO 9001:2000 standard, "Planning of Product Realization." The more stringent validation demands by the FDA have increased the level of detail and discipline required of medical device manufacturers.

In response to the FDA, C. Brewer Co. conducts a series of scientific studies that define and document key variables for controlling the molding process. Traditional tools, specialized techniques and automated inspection equipment are utilized to achieve robust validations including statistical capability studies, Gauge R&R's and DOE's. All data from these studies are correlated to produce solid IQ, OQ & PQ Validations, which are only some of the documented products of the C.BrewerPRP™.

The C.BrewerPRP™ clearly translates the development and validation activities into production process protocols that consistently deliver molded parts at six-sigma quality levels.

Ten years ago, Brewer pioneered the use of Scientific Molding principles as a basic foundation to all molding process development. Today, a stable and repeatable process is only the first step, explains Chuck Brewer III, CEO of C. Brewer Co.

In addition to the four pillars that already make up the company's PRP competency (Time, Temperature, Pressure, and Cooling), C. Brewer Co. has now taken its three generations-deep expertise and parlayed it into a sophisticated proprietary methodology for developing and validating the molding process.

"The key to successful validation is to understand the unique correlation of dimensional, variable, and process outputs for each product produced," Brewer says. "We can now offer engineers a cohesive validation package that demonstrates repeatability, identifies key process and dimensional control variables, and correlates process control ranges to the desired outputs."