Impact of formulation and processing parameters on silicone extraction from cyclic olefin copolymer (COC) syringes

D Shah, J Cronin, M Chacko, A Gillum - PDA journal of …, 2011 - journal.pda.org
The effect of various formulation and process parameters on the extraction of silicone from
siliconized cyclic olefin copolymer (COC) syringes is reported. The impact of proprietary …

Variables impacting silicone oil migration and biologics in prefilled syringes

K Gentile, C Huang, X Liu, L Whitty-Léveillé… - Journal of …, 2023 - Elsevier
Prefilled syringes (PFS) as a primary container for parenteral drug products offer significant
advantages, such as fast delivery time, ease of self-administration and fewer dosing errors …

[HTML][HTML] The impact of syringe age prior to filling on migration of subvisible silicone-oil particles into drug product

J Song, G Hu, H Hamzaoui, Y Krishnamachari… - Journal of …, 2022 - Elsevier
Silicone oil is often applied to the inner surface of glass syringes and cartridges to reduce
friction between the glass surface and elastomeric plunger stopper. This oil can appear as …

Characterization of Silicone from Closed System Transfer Devices and its Migration into Pharmaceutical Drug Products

M Wozniewski, A Besheer, AS Sediq, J Huwyler… - Journal of …, 2024 - Elsevier
Abstract Closed System Transfer Devices (CSTDs) are increasingly used in healthcare
settings to facilitate compounding of hazardous drugs but increasingly also therapeutic …

Distribution of silicone oil in prefilled glass syringes probed with optical and spectroscopic methods

ZQ Wen, A Vance, F Vega, X Cao, B Eu… - PDA Journal of …, 2009 - journal.pda.org
Prefilled glass syringes (PFSs) have become the most commonly used device for the
delivery of recombinant protein therapeutics in parenteral formulations. In particular, auto …

Analysis of silicone oil in prefilled syringes and biopharmaceutical drug products using high-performance liquid chromatography

J Liu, M Ronk, K Fujimori, H Lee… - AAPS PharmSciTech, 2021 - Springer
As the packaging of choice for many therapeutic proteins, prefilled syringes have been
widely used in biopharmaceutical industry as primary containers, where silicone oil is …

Characterization of the initial level and migration of silicone oil lubricant in empty prefilled syringes for biologics using infrared spectroscopy

JS Bee, VV Frey, U Javed, J Chung… - PDA Journal of …, 2014 - journal.pda.org
Glass prefillable syringes are lubricated with silicone oil to ensure functionality and a
consistent injection for the end user. If excessive silicone is applied, droplets could …

Methods to determine the silicone oil layer thickness in sprayed-on siliconized syringes

V Loosli, O Germershaus, H Steinberg… - PDA journal of …, 2018 - journal.pda.org
The silicone lubricant layer in prefilled syringes has been investigated with regards to
siliconization process performance, prefilled syringe functionality, and drug product …

[PDF][PDF] The stability of insulin solutions in syringes is improved by ensuring lower molecular weight silicone lubricants are absent

L Nayef, MF Khan, MA Brook - Heliyon, 2017 - cell.com
Protein drugs such as insulin are almost universally delivered via glass syringes lubricated
with silicone oil. It is not uncommon for prefilled syringes (PFS) to become cloudy, which …

[HTML][HTML] Dimethylsilanediol from silicone elastomers: Analysis, release from biopharmaceutical process equipment, and clearance studies

R Menzel, A Korzun, C Golz, T Maier, I Pahl… - International Journal of …, 2023 - Elsevier
Polysiloxanes are considered one of the most important commercial families of synthetic
elastomers. They are frequently employed in biopharmaceutical manufacturing equipment …