Taking a Closer Look at Parenteral Contaminants
Visual inspection of parenteral vials is the first step in a root cause investigation.
Gretchen Shearer, Ph.D.
Pharmaceutical Technology - September 2, 2016
Visual inspection of pharmaceutical containers is an important step to ensure quality control and patient safety. Observations of particulate matter in containers, either by visual inspection or by automated methods, often trigger corrective actions and preventative actions (CAPAs) or other investigations. Identification of the particulate matter is then required as part of root-cause investigations and safety evaluations.
The first inspection step is to visually examine the sample with the naked eye, usually against white or dark backgrounds with a strong light source, such as a fiber-optic light. The next step should be a microscopic examination of the container. The stereomicroscope is a valuable tool to better characterize the particulate and determine the best method for isolation and analysis.
There are a variety of pharmaceutical product packaging options, and the choice of packaging is dependent on many factors including the nature of the product and its end use. The focus of this paper is on parenteral glass vials and syringes. This paper discusses three sources of particulate issues that can be successfully evaluated using stereomicroscopic examination: container-related contamination (glass delamination), product-related particles (protein aggregates), and environmental contamination.