The mixing of biological products is delicate business, but concerns about shear sensitivity can be overblown. Rational process development, rules of thumb and tools like CFD can lead to fearless mixing.
Author: Thomas A. Post, Ph.D., Consultant, Post Mixing Optimization and Solutions
Filtration can be the quickest, most cost-effective means to achieve sterilization for large volumes of simple buffers or aqueous solutions. However, finding the right flow rate and filter sizing is essential to meeting FDAs aseptic guidelines.
When gas chromatography problems arise, most people think the gas in the cylinder is the problem. Its more likely to be the gas management system, as Frank Kandl of Airgas discusses in this myth-busting primer.
Author: Frank Kandl, national technical manager of specialty gas equipment, Airgas, Inc.
Bar codes are the short-term answer, as long as manufacturers strive to understand FDA guidelines at all levels of packaging, says George Wright IV, vice president of Product Identification & Processing Systems, Inc.