Foreign Matter Inspection (Vial Inspection - Intrinsic & Extrinsic) also helps to identify any defects in the vials which may affect the quality of the drug. This ensures that the pharmaceutical products are safe for use and meet all regulatory requirements.
Foreign matter inspection is a process used to detect and identify any extrinsic or intrinsic contaminants that may have been introduced into the contents of the vial. Extrinsic contaminants are those that originate from the external environment, such as dust, hair, and debris, while intrinsic contaminants are those that are generated from within the vial itself, such as glass particles or metal fragments. The inspection process typically involves a visual examination of the vial’s contents under magnification and/or chemical analysis. The aim is to ensure that the contents are safe for human use and that any contaminants are removed before the product is released for sale.
Inherent particulates, which can originate from the vial's materials or components during various stages of manufacturing, filling, and storage, constitute an additional focal point of foreign matter inspection. These particulates, often including glass fragments resulting from vial delamination or residual materials from production processes, hold the potential to compromise product stability and efficacy. Employing meticulous inspection techniques, such as advanced microscopy and analytical methods, is imperative to not only identify the presence of inherent particulates but also to characterize their attributes and ascertain their source. This granular understanding aids in implementing targeted corrective measures to preserve the pharmaceutical product's quality and safety throughout its lifecycle.
To ensure that any extrinsic contaminants are removed, the vial is typically inspected using a light source, such as a magnifying glass or microscope, to detect any visible particles. If any particles are detected, they are then collected and analyzed using a variety of techniques, such as microscopy depending on the nature of the particle.
For the inspection of intrinsic contaminants, the vial is typically subjected to advanced analytical technique. This analysis can involve the use of various techniques, such as Microscopy to detect any metal or glass particles present. The results of this analysis will provide information about the particle size, shape, and composition, which can be used to identify the source of the contamination.
In addition to visual and chemical analysis, other techniques, such as particle size analysis, may also be used to further investigate the potential presence of foreign matter. The results of these tests can provide additional insight into the possible source of the contamination, allowing for more effective corrective action to be taken.
Informational USP Chapter <1790> Visual Inspection of Injections addresses the topic of prevention of particulates, including packaging components. Common sources of particulates in packaging components are extractables and leachable, silicone oil, and glass delamination. It is recommended that each step of the washing and rinsing processes for container and elastomeric components are evaluated for particulate matter reduction opportunities. The methods of light obscuration (LO), membrane microscopy, or other automated particulate counting method, may be used to demonstrate reduction of subvisible and visible particulates during washing. Finally, siliconization processes should be evaluated to minimize excess silicone levels.