On November 14th, Dave Exline, Senior V.P. and Rebekah Wagurak, Forensic Scientist at Gateway Analytical hosted a webinar designed for laboratory and manufacturing personnel that are responsible for quality assurance and quality control of processes in the manufacturing of pharmaceuticals. This webinar discussed case studies and walked participants through the process of a failure analysis investigation, common methods used, and interpretation of analytical data to improve overall process development and quality control.
For more details on the webinar, you can use the links below.
We received a number of questions from attendees during the Q&A segment, and you can find those questions and answers below. If you have any questions about this or any other topic, please contact us.
- How critical is relative humidity in packaging process failures?
Related to humidity issues in the product packaging, we find that a lot of times humidity can affect things such as ink and packaging. Humidity can lead to various alterations of materials. Understanding the affects of humidity on packaging is certainly critical, and various humidity situations can be simulated to determine what caused failures in packaging.
- Do you use humidity cells for controlling humidity of samples in microscopy not only light but FTIR & Raman microscopy?
We typically do not use humidity cells. They exist and you can do studies on humidity using them, but we have not done this routinely in the past.
- Would you say that raw material, equipment failure, or environment are the leading sources of failure?
When we talk about failure as a whole, these causes are pretty equal.
- What are some causes of delamination?
Some common causes of glass delamination would include the chemical nature of contents, the chemistry/surface of glass itself, and thermal exposure.
- How do you determine what analytical methods you want to use for a particular sample?
Each sample is a little different; therefore choosing analytical methods is very sample dependant. The key is to know what types of information you get from different analyses and then to determine if that type of information will be beneficial in analyzing that particular sample.
- In cases like the nitrile glove in the stopper, can you ever say that a material definitely came from a particular source?
That type of situation is similar to what you would commonly see in criminal forensics trace evidence analysis. Generally we can never say anything definitely came from a specific source, unless a potential for a physical match exists. Usually, all we can say is that something is a likely source of the contamination or failure.