By Michael J. Sadowski and Stephen E. Langille

Read our recent publication in the PDA – Parenteral Drug Association Journal of Pharmaceutical Science & Technology — “Parametric Release of Moist Heat Sterilized Products: History and Current State,” authored by Mike Sadowski, Lead Scientist, Sterility Assurance at Baxter Healthcare Corporation and Stephen Langille, Senior Microbiology Consultant at ValSource Inc.

By Amanda McFarland, M.Sc., Senior Consultant at ValSource, Inc.

This article presents the first four steps of an initial evaluation roadmap for modern microbial methods. These steps comprise the initial technology assessment, data and compliance risk, cost considerations and an overall instrument evaluation.

By ValSource’s Marc Glogovsky & Paula Peacos

PDA Technical Report No. 88, written by ValSource’s Marc Glogovsky & Paula Peacos, along with other industry experts, presents a holistic approach for performing a microbiological investigation. It provides a framework to assist with focusing on the investigational areas that may contain or contribute to the root cause of data deviations, such as sampling, test methodology, and suitability of the test, as opposed to providing methods for analysis of batch acceptability.

The distinct areas where microbial data is collected and inspected for deviation investigations are the focus of this document, including:

1) Roles and responsibilities of personnel, especially microbiologists, in the laboratory investigations and cross-functional teams responsible for manufacturing investigations,

2) Conducting laboratory investigations, and

3) Conducting manufacturing investigations.

The roles of other contributors to deviation investigations required for effective root cause analysis, such as representatives from manufacturing, process engineering, and quality assurance, are also briefly described.

This technical report promotes a lifecycle approach, but greater emphasis is placed on laboratory and manufacturing investigations of marketed drug products.

Full Technical Report available for download by February 13, 2022.

ValSource, Inc, a consulting and advisory service provider for the regulated biological, medical device, and pharmaceutical industries, today proudly announced two leadership team members will lead a live, interactive training webinar hosted by Pharma Webinars, “Are You Ready for Annex 1? Points to Consider When Doing an Annex 1 Self-Assessment.”

Good, robust aseptic technique is critical to achieving successful contamination control during manufacture of aseptically processed products. Proper execution of aseptic technique is a skill that requires detailed, in-depth, targeted training, and demonstrated proficiency.

Microbial data deviation investigations (MDDIs) are notoriously difficult to perform. They are time-consuming and labor-intensive. For even the most experienced microbiologists, determining the definitive root cause is often challenging. In most cases, the microbiologist is investigating a past event — sometimes by as much as a week or two. Evidence to support conclusions and decisions takes time to collect, and the available evidence is usually circumstantial and often scanty. Direct evidence (i.e., the “smoking gun”) is rare.

A contamination control program is like a puzzle. Each individual component, such as those mentioned above, represents a single piece of the puzzle. These pieces must fit together to form a whole in order to achieve the desired result.

In this article for Pharmaceutical Online, ValSource Principal Consultants Melissa Stappen and Stephen Langille discuss the amount of environmental control, environmental monitoring, and finished product testing necessary to ensure medicinal product microbiological safety and product quality.