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Analysis of morphology, amount and size of particles in vaccines of Pfizer and Sputnik for COVID-19
per Dra. Marcela Sangorrin y Lic. Lorena Diblasi, Neuquén, Argentina, 2025	13 jun 2026
Analysis of morphology, amount and size of particles in vaccines of Pfizer and Sputnik for COVID-19
Analysis of morphology, amount and size of particles in vaccines of Pfizer and Sputnik for COVID-19 Dr. Marcela Sangorrin and Lic. Lorena Diblasi Neuquén, Argentina 2025 Characterization by images of particles For the morphological characterization of the samples we used the instrument Morphologi G3 series No. MAL800525, a fully automated system for analyzing static images which provides a complete detailed description of the morphological properties of particulate materials. It generates images of each particle analyzed, it verifyes quantitatively the results of morphology and quantitatively the results of size. This is important for detecting agglomerates, fibers, contaminant particles, etc. It reports specific particle properties and has high resolution and sensitivity and detailed information of the sample. It provides a statistically relevant sampling (typically 5,000 to 500,000 particles per measurement). laboratory ARROBA cas-instrumental.com.ar Good Aires, Argentina PFIZER-BIONTECH COVID-19 PAA194469 BATCH. GK0925 The instrument classified 2311 particles the size parameter, CE diameter volume, number, in the three (3) samples done (10 uL), the quantification of the particles it turned out in 77,000 particles /mL. The distribution by size and percentage of the particles present in the sample is shown below. 7240 particles/mL bigger than 25 µm The following images are representative of the particles found in the sample. We observe particles elongated, translucent, and other irregular, opaque     SPUTNIK COVID-19 BATCH. 11- 840621 The instrument classified 1989 particles by the parameter of size, EC diameter volume, number, in the three (3) samples taken, the quantification of the particles resulted in 66,300 particles/mL . The size distribution and percentage of particles present in the sample are shown below. 10,608 particles/mL bigger than 25 µm The images are representative of the particles found in the Sample. Elongated, Translucent particles are observed, as well as other irregular, opaque particles. None of the brands analyzed comply with the limits established for the quantity and size of particles in injectables, as established in chapter 788 of the USP: “ For products whose vial volume is less than 25 mL, a mix of the units is performed to reach the 25 mL, such volume is analyzed and is referenced to a unit (mL). Per each unit there must not be more than 6000 particles bigger than 10 µm, nor more than 600 particles bigger than 25 µm.” By he study of Morphologi G3: In Sputnik we found 63,300 particles/mL and 10,608 particles/mL larger than 25 µm In Pfizer we found 77,000 particles/mL and 7,240 particles/mL greater than 25 µm As it is shown (the particles) exceed further of 10 times the quantities allowed in the two ranges of size established. These products could not be approved in the routinary quality controls for an injectable product, since they don’t comply with the number nor the size of particles allowed by the different pharmacopoeias.
Análisis de cantidad y tamaño de partículas en.pdf (638,08 KiB)
Mira també: https://publicar.argentina.indymedia.org/?p=40052 https://publicar.argentina.indymedia.org/?p=40028
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