WHITE PAPERS & CASE STUDIES
Be In Control Of Product Quality – Do Not Just Rely, But Understand
Past experiences have shown that too often product quality is based on sole reliance of vendor certifications, statements and promises. To diminish such reliance new technologies started to be implemented, like process analytical technologies (PAT), process controls, automation etc. often once again overexerted as the solution to all problems. Activities that supposedly result in higher product quality due to better process controls. Maik W. Jornitz, Chief Operating Officer, G-CON Manufacturing LLC
Containment Capabilities Of A Class II, Type A2 BSC Using A Chemo Pad On The Worksurface
The Test Objective is to study the containment capabilities of the BSC when using a chemo plus prep mat on the worksurface. A NuAire model NU-425-500 Class II, Type A2 BSC was set to its nominal average velocity airflow of 70 fpm downflow and 105 fpm inflow, and Personnel protection tests followed NSF/ANSI 49:2002 at nominal airflows using a chemo prep plus mat (10-3/8" x 16-1/2" size) on the worksurface in different configurations.
The Benefits Of Isolator And Aseptic Processing
Isolators have been around the Pharmaceutical Industry since the early 1980s and in the Nuclear Industry (glovebox technology) since the 1950s. The intent of isolators is to create an airtight barrier or enclosure around a piece of equipment or process which provides absolute separation between the operator and product. By Gary Partington
What Is A Particle Counter?
A particle counter is an electronic instrument that detects and counts airborne or liquid particles. Particles are detected using laser based optical systems that shine a powerful light through a detection chamber. By Dr. Hans-Walter Motzkus and Joe Gecsey
Airborne Particle Monitoring: Impact Of ISO 21501-4 Calibration
Dependable, consistent and repeatable results in monitoring airborne particles in cleanrooms and clean zones depends both on the sampling technique of the analyst and on the performance of the particle counting instrument. The control of the sampling technique often is the subject of a unique SOP (Standard Operating Procedure) while the performance of the instrument is typically reviewed and verified through an annual or semi-annual calibration process. By Joe Gecsey, MET ONE/Hach Company
Flexible Containment Solutions Guide: Document Transfer Enclosure
The Flexible Document Transfer Enclosure is designed to allow paperwork used in pharmaceutical processing to be handled in a contained way so that powders are not transferred onto the documents and to areas or individuals that are not protected.