Testing of parenteral drug products for visible particles: comparison of the Ph. Eur. method with an alternative method using polarised light.

OBJECTIVES: Parenteral drug products should be essentially free from visible particulate contamination. To ensure this, every batch produced must be subject to a 100% visual inspection. Monograph 2.9.20 of the European Pharmacopoeia (Ph. Eur.) describes a method for visual inspection of parenteral drug units in front of a black and white panel using a white light source. Nevertheless, several Dutch compounding pharmacies rely on an alternative method for visual inspection by means of polarised light. The objective of this study was to compare the performance of both methods. METHODS: Trained technicians in three different hospitals inspected a predetermined set of samples using both methods for visual inspection of parenteral drugs. RESULTS: The results of this study show that the alternative method for visual inspection yields a higher recovery than the Ph. Eur. method, while no significant difference in false positive results was found. CONCLUSIONS: Based on these findings, it can be concluded that the alternative method for visual inspection by means of polarised light can very well replace the Ph. Eur. method in pharmacy practice, provided that local validation of the alternative method is performed.

Performance and Prospects of [68Ga]Ga-FAPI PET/CT Scans in Lung Cancer.

Fibroblast activation protein (FAP) could be a promising target for tumor imaging and therapy, as it is expressed in >90% of epithelial cancers. A high level of FAP-expression might be associated with worse prognosis in several cancer types, including lung cancer. FAPI binds this protein and allows for labelling to Gallium-68, as well as several therapeutic radiopharmaceuticals. As FAP is only expressed at insignificant levels in adult normal tissue, FAPI provides a highly specific tumor-marker for many epithelial cancers. In this review, current information on the use of [68Ga]Ga-FAPI PET/CT in lung cancer is presented. [68Ga]Ga-FAPI shows a high uptake (standardized uptake value = SUVmax) and tumor-to-background ratio (TBR) in primary lung cancer lesions, as well as in metastatic lesions of other tumor types located in the lung and in lung cancer metastases located throughout the body. Where a comparison was made to [18F]FDG PET/CT, [68Ga]Ga-FAPI showed a similar or higher SUVmax and TBR. In brain and bone metastases, [68Ga]Ga-FAPI PET/CT outperformed [18F]FDG PET/CT. In addition to this strong diagnostic performance, a possible prognostic value of [68Ga]Ga-FAPI PET/CT in lung cancer is proposed.

The Development and Implementation of Airflow Visualization Studies ("Smoke" Studies) as a Training Tool in Aseptic Hospital Compounding Facilities.

In the compounding facilities of hospital pharmacies, extemporaneous preparations for parenteral administration are produced using aseptic handling. The designated environment for this practice is a clean area, such as a laminar airflow (LAF) cabinet placed in a classified cleanroom complying with good manufacturing practices (GMP) and International Organization for Standardization (ISO) 14644-1 guidelines. The European GMP Annex 1 (Revision 2020) and United States Pharmacopeia (USP) <797> monograph state that airflow visualization studies ("smoke" studies) should be performed to substantiate the cleanroom and LAF cabinet performance and their qualification status. Even though smoke studies are required by these guidelines, current literature does not describe detailed practical protocols and acceptance criteria. The objective of this study was to develop and implement a practical smoke study protocol to ensure compliance with aseptic handling guidelines in hospital pharmacies. First, a literature search was performed to collect information about smoke study protocols and acceptance criteria. Subsequently, a smoke study protocol was developed for a downflow and crossflow LAF cabinet as well as for grade C/B cleanroom areas. As a proof of concept, the smoke study protocol for the downflow LAF cabinet was executed in the at-rest and in-operation states. Video recordings of the smoke studies were analyzed to assess the performance of the cabinet. Finally, the video recordings obtained from the smoke studies were used in a training program for hospital pharmacy operators, which showed that smoke studies might aid in operators' aseptic handling awareness. To the best of our knowledge, the present study provides for the first time a practical approach for the development of smoke study protocols in a hospital pharmacy setting and shows potential for training operators, process optimization, and continuous quality improvement.