If you manufacture high value product, you should be concerned with cleanliness, contamination control, and reliability. Two new documents that are directed at the medical device community provide sensible, practical guidance for all manufacturers of high value product. Guidance for validation of cleaning processes ASTM standard F3127-16: “Guide for Validating Cleaning Processes Used During the…
New Product Cleaning and Validation Courses – Two Locations
Cleaning is essential for effective sterilization or disinfection. Residue removal is a must for reliable product performance. Barbara and Ed Kanegsberg, critical cleaning experts at BFK Solutions and long-time contributors to Controlled Environments, will teach a course that focuses on cleaning, contamination control, and residue detection for product and product-contact surfaces. The course will be…
The Awful English Language
Anyone who has navigated the wonderful world of standards will appreciate “The Awful German Language,” Mark Twain’s iconic essay about the challenges in navigating sentence structure. The English language can be even more awful, even more subject to interpretation. There is a need for simplicity and clarity in standards and specifications. Understanding the nuances of…