Extrapolate To Production: Quality and Economics | Controlled Environments Magazine.
Let us assume there is a promising prototype for a critical product, a prototype for which we have reached the “ah-ha” moment. Perhaps half a dozen have been produced and pilot tested. If the product is a medical device, biocompatibility testing or even clinical trials may have started.
Production is imminent. The product must be cleaned; and appropriate contamination control is a must. Extrapolating from one or two products in a beaker to production runs of thousands per day (or even thousands per hour) can be daunting, particularly when the need for controlled environments is anticipated.
PROTOTYPE DESIGN
First, look at the design. Determine where cleaning and contamination control issues are most likely to occur. Can you redesign the prototype to avoid these problems? Perhaps not, but it is worth consideration. In fact, many clients now factor in the concept of “design for cleaning.” It can be productive to invite your design engineers to tour an applicable fabrication facility and to involve design engineers in your production team.
