Oliver Stauffer, vice president and COO of Packaging Technologies and Inspection (PTI), talks testing, quality control, inspection and detection as it pertains to medical and pharmaceutical applications.
Q: When it comes to QC (quality control), how does one determine its parameters for testing and inspection? Is there a general baseline of what to look for, or is it really on a case-by-case basis?
A: Generally, certain classes of products fall under similar inspection requirements. Based on the nature of the product, the package and the end use, a risk-based approach would evaluate what the maximum allowable leakage would be for a particular product. The maximum allowable leakage is primarily focused on the effects of environmental contaminants and risk level is based on the impact it has on the end user. To identify the maximum allowable leakage, one must understand what leak size may cause the ingress and synergistic effects of environmental contaminants.
Q: Can tweaks be made to testing instruments when flaws or inconsistencies are discovered?
A: Any tweak or adjustment in the pharmaceutical space is not done lightly, and is also a clear indicator that other critical-to-quality failures may exist from this deviation. Any tweak would only be back to a validated state. Ideally, a package integrity test method provides significant quantitative support and assurance of quality such that a quality deviation is captured before significant quantities are produced.
Q: When we’re talking about film and substrate inspection, what types of equipment are best used?
A: Inspection of thin films can be performed using a variety of methods. PTI offers a test solution that measures the physical properties of the thin film system using airborne ultrasound. Slight deviations in thickness, density and layering properties of a film can be detected non-destructively using this technology.
Q: Say a flaw is found – what are the next steps?
A: Typically in any production environment, defects must be removed from the production stream immediately upon identification. Using a non-destructive method provides the personnel to investigate the failure further and understand what the probable causes of the deviation are. A destructive method would leave questions as to the exact source of failure and why it may have happened. FP
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