Volume XIII, Issue 8 - August 2016

Who knew cleaning could be cool?
UCLA Cleaning Workshop
Always Question Authority – Including BFK Solutions
Ed and Barbara Kanegsberg

Learn from us!



Critical Cleaning and Cleaning Validation Course – New Jersey and Amsterdam
Sterilizing is not enough! Failure to clean properly poses risks. In this three-day accredited course, Ed and Barbara Kanegsberg of BFK Solutions teach principles and practice of critical cleaning and cleaning validation in life-science applications.

Topics include cGMPs for critical cleaning processes, coordinating chemistry, equipment and process methods, regulatory and economic issues, standards/guidance documents, adherent residue, and detecting residue. We invite you to participate and to discuss your vexing process problems.

Two opportunities to attend “Quality Critical Cleaning and Cleaning Validation Processes”

October 5-7, New Brunswick, NJ

November 16-18, Amsterdam, Netherlands

Feature Article

“Perfect” Cleaning Process? New Guidance

Barbara Kanegsberg, BFK Solutions

High-value product has to be clean to function reliably; but nearly all manufacturing processes inevitably generate soils. You should know about an important new guidance document. While it is designed for medical device manufacturing, it should be of value to anyone concerned with cleaning and contamination control.

“Tell me the perfect cleaning process for medical device manufacturing so that nothing will go wrong.” We hear that request from the manufacturing and regulatory communities. Our response? “Sure thing! We’ll get right on that after we give you the formula for eternal youth.” A single cleaning process for the entire medical device community would be wonderful. However, given the variety of shapes, materials of construction, and usage requirements, a universally-applicable, fool-proof cleaning process is not possible. For near-term solutions, we suggest you consider a consensus document that we were involved in developing: ASTM F3127-16 “Standard Guide for Validating Cleaning Processes Used During the Manufacture of Medical Devices.”(1) Even if you don’t manufacture medical devices if you are concerned with cleanliness, contamination control, and reliability for high value product, consider perusing the guide. We think it provides sensible, practical guidance for manufacturers. Here are a few highlights.

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About BFK Solutions

We’re independent consultants. We don’t sell chemicals or cleaning equipment; and we don’t take commissions. Instead, we work for you. This saves you cold hard cash. We use our 30 years of experience to help you make good decisions about your cleaning processes, your manufacturing processes, your business. Check our website; send us an email; give us a call. We always like to hear from you.