A study comparing visual inspection methods for sterile pharmaceutical preparations found that manual visual inspection (MVI) and semi-automated visual inspection (SAVI) were more effective when balancing performance and cost considerations than an automated visual inspection (AVI).
MVI and SAVI detected 100% of visible particles compared with 28% for AVI, which showed a deficiency in detecting textile fibres.
To determine the efficiency of the three inspection methods, three hospital pharmacy technicians examined 41 type I clear glass vials, which were either 10mL or 50mL, using either MVI, SAVI, or AVI techniques.
Some 16 vials of water were contaminated with either glass particles (224 µm or 600 µm), stopper fragments or textile fibres. Five vials were each filled with different sterile injectable pharmaceutical products to determine how well each inspection method performed in real-world scenarios. The remaining 20 vials of water were prepared under varying conditions to determine how the pre-production conditions influenced contamination levels.
All three visual inspection methods successfully identified that vials of sterile pharmaceutical preparations did not contain any visible particles. In addition, all three methods successfully detected particles in vials prepared under the International Organization for Standardization (ISO) 9 pre-production conditions, highlighting the ability to identify contamination in a less controlled environment.
The use of MVI and SAVI to identify particles in vials maintained under ISO 8 pre-production conditions, which are cleaner and more controlled than ISO 9 conditions, was deemed satisfactory. AVI failed to detect particles in vials prepared under ISO 8 conditions.
The researchers concluded that MVI and SAVI inspection methods are more effective than AVI, offering a better return on financial investment as well as investment in training and implementation.
Reference
Jambon, A et al. Comparing visual inspection methods for parenteral products in hospital pharmacy: between reliability, cost, and operator formation considerations. European Journal of Hospital Pharmacy 2024; May 24: DOI: 10.1136/ejhpharm-2024-004143.
