July/August 1998
Volume 18, Number 4

Theme: Medical Devices/Alternative Drug Delivery Systems

Table of Contents

Articles

Qualification of Medical Device Product Software by Orlando Lopez This article discusses the qualification of medical device product software developed for a medical device manufacturer to comply with the Food, Drug and Cosmetic Act. Download Article...

Cleaning Validation – Oral Solid Packaging Equipment by Craig R. Garvey, Seth Levy, RPh & Thomas McLoughlin This article reviews the requirements of a cleaning validation program specifically for the packaging equipment utilized for oral solid dosage forms in the clinical environment. Download Article...

Pharmaceutical Engineering Interviews HIMA’s Chairman – John W. Galiardo by John W. Galiardo Pharmaceutical Engineering Interviews HIMA’s Chairman – John W. Galiardo Download Article...

Calibration of a Near-Infrared (NIR) H2O2 Vapor Monitor by Gary P. Brown, Claire Fritz, Terry R. Todd, PhD & Dave Adams This article describes the studies that were performed to verify the calibration of a H2O2 vapor monitor for the measurement of VPHP and water vapor concentrations. Download Article...

Influence of pH on the Particle Size of Human Insulin by Antoine Al-Achi, Robert Greenwood & Thayer Harris pH is an important factor in determining particle size of insulin and may influence its G.I. absorption from an oral formulation. Download Article...