Difficult-to-inspect pharmaceutical products—like lyophilized drugs, suspensions, and opaque solutions—pose major challenges for visual inspection due to their complex formats and particulate detection limitations.
These products often blur the line between inherent drug matter and foreign particles, making it hard to distinguish defects during inspection. For example:
- Lyophilized (freeze-dried) drugs can obscure particles within the cake structure.
- Suspensions and emulsions contain non-homogeneous mixtures that complicate visual clarity.
- Clear solutions in clear containers make it difficult to spot small or irregular-shaped particulates.
Regulatory standards like USP <790> require 100% visual inspection of parenterals, pushing manufacturers to adopt advanced manual and automated inspection systems. Innovations such as inline automated inspection, secondary destructive testing, and tailored inspection protocols are helping overcome these hurdles.
If you’re working with these types of products, partnering with experts in inspection validation—like Syrviatek—can streamline compliance and ensure product safety.