Applying Forensic Science Methodologies to Tough Industry Problems
Forensics: the term usually conjures up images of lab coats, crime scenes and the evidence left behind. In actuality, the field of forensic science can encompass a broad range of scientific disciplines, applying material isolation, testing, comparison and ultimate source determination to investigations. Scientists employed in this field use analytical tests and problem-solving tactics to evaluate physical evidence, as well as the resulting data. Going beyond routine scientific data summaries, forensic scientists typically analyze the identity of unknown materials, any relationships between questioned and known samples and the significance of these associations.
With that in mind, forensic analyses are also well suited for areas outside of the criminal realm like pharmaceuticals and materials science. Common complex issues that arise in the pharmaceutical industry include: product or process contamination, glass fracture of vials or bottles, stains, packaging malfunctions and product counterfeiting. Similarly, industrial environments contain their fair share of deviations: contaminants in raw materials or finished products, product defects, failures and counterfeits, as well as quality control. All of these problems require a more holistic, investigative approach to scientific examination based on the evaluation and interpretation of the analytical sample data’s relevance.
The most significant aspect of a pharmaceutical investigation occurs in the initial evaluation, where the overall purpose is defined. Pharmaceutical forensics utilizes forensic expertise, analysis and problem solving principles to establish a scientific protocol. Protocols are generally determined through addressing relevant questions. In the instance where a contaminant occurs, these questions may consist of:
- What is this material?
- Where did it come from?
- What are common sources of this material?
- Does the questioned material “match” a known source material?
To answer these questions or any others established, it is imperative that analytical testing protocols and the environment in which a foreign or unknown material originated is understood. It is also important to understand the types of product materials inherent to the manufacturing and production process, as well as the main components present. For instance, if a particulate is found in a parenteral product, it is important to understand the environment where it was produced to create a population of known exemplar samples for comparison.
Industrial forensics takes investigative practices from forensic science and applies them to materials science to reveal fundamental information about a product’s raw materials, manufacturing environment, packaging and processes. These forensic science methods also extend outside of the detailed interrogation of commercial products and product failures into the areas of lead paint characterization and contaminated drywall. When situations arise that require expert problem-solving abilities combined with state-of-the-art analytical testing methods, forensic scientists are well prepared to bridge the gap between forensics and other scientific disciplines.