Particulate contamination from siliconized rubber stoppers—a statistical evaluation

LC Li, J Parasrampuria, Y Tian - PDA Journal of Pharmaceutical …, 1993 - journal.pda.org
Siliconized stoppers, when used with parenteral drug products, have been shown to be a
source of particulate contamination. In this study, five different variables: pH of the solution …

Particulate contamination from siliconized rubber stoppers

F Pavanetto, B Conti, I Genta, T Modena - International journal of …, 1991 - Elsevier
Elastomeric closures are an essential packaging for parenteral drug products and they
represent a possible source of particulate matter. The purpose of this study was to analyze …

Comparison of different rubber stoppers; the effect of sterilization on the number of particles released

JP Mannermaa, E Muttonen, J Yliruusi… - PDA Journal of …, 1992 - journal.pda.org
The effect of sterilization on the number of particles released from five different types of
rubber stoppers, as well as on their surface roughness and elemental composition before …

[HTML][HTML] Rubber coring of injectable medication vial stoppers: an evaluation of causal factors

P Chennell, D Bourdeaux, Q Citerne… - … Technology in Hospital …, 2016 - degruyter.com
Purpose: Coring of a medication vial's rubber stopper has been reported as a major cause of
visible particle presence in injectable preparations. In this study, we investigated and …

Effects of direct spiking of silicone oil into a model pMDI formulation

JK Fallon, ID Peyron, AJ Hickey - Drug Development and Industrial …, 2013 - Taylor & Francis
Context: Silicone oil is used as a valve lubricant in pressurized metered dose inhalers
(pMDIs). Its possible impact on drug delivery, through such effects as particle aggregation …

[PDF][PDF] Comparative Study of Particulate Contamination from Ampoule and Prefilled Syringe

CK Shim, YH Han, DS Kwon - Journal of Pharmaceutical …, 1991 - koreascience.kr
Particulate is the foreign insoluble material in injectable solution inadvertently present in a
given product. Considerable efforts have been made to avoid or minimize particulate …

Comparison of the Levels of Rubber Stopper-Related Organic Leachables in Commercially Available Vialed Liquid and Lyophilized Drug Products

SA Zdravkovic - Pharmaceutical Research, 2020 - Springer
Purpose Rubber stoppers that seal the primary packaging systems of parenteral
pharmaceutical products have the potential to introduce impurities into the drug during …

[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 …

[HTML][HTML] Assessing filling technologies for contamination risk

B Verjans - BioPharm International, 2012 - biopharminternational.com
The authors compare four well-established aseptic filling technologies, open vial, ampul,
blow-fill-seal (BFS) and prefilled syringes, to the recently developed closed-vial technology …

Evaluation of incremental siliconization levels on soluble aggregates, submicron and subvisible particles in a prefilled syringe product

S Bai, P Landsman, A Spencer, D DeCollibus… - Journal of …, 2016 - Elsevier
The evaluation of stability with respect to particles in prefilled syringes is complicated by the
presence of silicone oil. The mobility, colloidal characteristics, and kinetic instability of …