Discrimination Between Silicone Oil Droplets and Protein Aggregates in Biopharmaceuticals: A Novel Multiparametric Image Filter for Sub-visible Particles in Microflow Imaging Analysis

2011 ◽  
Vol 29 (2) ◽  
pp. 594-602 ◽  
Author(s):  
René Strehl ◽  
Verena Rombach-Riegraf ◽  
Manuel Diez ◽  
Kamal Egodage ◽  
Markus Bluemel ◽  
...  
Keyword(s):  
Silicone Oil ◽  
Protein Aggregates ◽  
Imaging Analysis ◽  
Oil Droplets ◽  
Image Filter

scholarly journals SCORE Study Report 7: Incidence of Intravitreal Silicone Oil Droplets Associated With Staked-on vs Luer Cone Syringe Design

2009 ◽  
Vol 148 (5) ◽  
pp. 725-732.e7 ◽  
Author(s):  
Ingrid U. Scott ◽  
Neal L. Oden ◽  
Paul C. VanVeldhuisen ◽  
Michael S. Ip ◽  
Barbara A. Blodi ◽  
...  
Keyword(s):  
Silicone Oil ◽  
Oil Droplets ◽  
Score Study ◽  
Study Report

Manual Removal of Intraocular Lens Silicone Oil Droplets and Dystrophic Calcifications Using a Nitinol Loop: A Case Series

2017 ◽  
Vol 48 (5) ◽  
pp. 422-426 ◽  
Author(s):  
Kareem Moussa ◽  
Theodore Leng ◽  
Julius T. Oatts ◽  
Robert B. Bhisitkul ◽  
David G. Hwang ◽  
...  
Keyword(s):  
Intraocular Lens ◽  
Silicone Oil ◽  
Case Series ◽  
Oil Droplets ◽  
Manual Removal

scholarly journals An Assessment of the Ability of Submicron- and Micron-Size Silicone Oil Droplets in Dropped Prefillable Syringes to Invoke Early- and Late-Stage Immune Responses

2019 ◽  
Vol 108 (7) ◽  
pp. 2278-2287 ◽  
Author(s):  
Elena Krayukhina ◽  
Masami Yokoyama ◽  
Kayoko Kakuhou Hayashihara ◽  
Takahiro Maruno ◽  
Masanori Noda ◽  
...  
Keyword(s):  
Immune Responses ◽  
Late Stage ◽  
Silicone Oil ◽  
Oil Droplets ◽  
Micron Size

scholarly journals Silicone Oil Microdroplets and Protein Aggregates in Repackaged Bevacizumab and Ranibizumab: Effects of Long-term Storage and Product Mishandling

2011 ◽  
Vol 52 (2) ◽  
pp. 1023 ◽  
Author(s):  
Lu Liu ◽  
David A. Ammar ◽  
Lindsey A. Ross ◽  
Naresh Mandava ◽  
Malik Y. Kahook ◽  
...  
Keyword(s):  
Silicone Oil ◽  
Protein Aggregates ◽  
Long Term Storage ◽  
Term Storage

Silicone oil droplets in repackaged anti–vascular endothelial growth factors for intravitreal injections: In search of the main source of contamination

2019 ◽  
Vol 30 (4) ◽  
pp. 774-779 ◽  
Author(s):  
José Luis Olea ◽  
María Gómez-Resa ◽  
María Mercedes Cervera-Peris ◽  
Juan Antonio Aragón
Keyword(s):  
Growth Factors ◽  
Silicone Oil ◽  
Average Frequency ◽  
Intravitreal Injections ◽  
Vascular Endothelial Growth Factors ◽  
Routine Practice ◽  
Vascular Endothelial ◽  
Oil Droplets ◽  
Oil Droplet ◽  
Endothelial Growth Factors

Introduction: Repackaging of anti–vascular endothelial growth factors in polypropylene syringes lubricated with silicone oil for intravitreal use is associated with the presence of intravitreal silicone oil droplets. The objective of this study is to assess how the use of silicone-free syringes (for storage and/or administration) would reduce the amount of silicone oil droplets in the product to be administered. Methods: Two 16 mL vials of bevacizumab were repackaged at the compounding pharmacy to obtain four sets of product, each consisting of three 1.2 mL tubes of the drug repackaged in different ways. Set A was repackaged according to routine practice, that is, the drug was placed into 1 mL siliconized syringes and 60 µL aliquots were extracted with 0.5 mL insulin siliconized syringes until reaching 1.2 mL. In set B, a 1-mL silicone-free syringe was used, followed by a 0.5 mL siliconized syringe. In set C, only 0.5 mL siliconized syringes were used. In set D, only the 1-mL silicone-free syringe was used. Micro-Flow Imaging technology was used for quantifying silicone oil droplet–like particles below 25 µm. Results: Silicone oil droplet–like particles were absent in set D. Set C had the highest average frequency of these particles, which was much lower in sets A and B. Set B had the lowest frequency. Conclusion: 0.5 mL insulin syringes with staked-in needles used for supplying the product seem to be the main source of silicone oil contamination in repackaged anti–vascular endothelial growth factors. Silicone-free insulin syringes with staked-in needles would be strongly recommended for supplying anti–vascular endothelial growth factor intravitreal injections from compounding pharmacies.

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