Investigating liquid leak from pre-filled syringes upon needle shield removal: effect of air bubble pressure

E Chan, YF Maa, D Overcashier… - PDA Journal of …, 2011 - journal.pda.org
This study is to investigate the effect of headspace air pressure in pre-filled syringes on
liquid leak (dripping) from the syringe needle upon needle shield removal. Drip tests to …

Risk mitigation of plunger-stopper displacement under low atmospheric pressure by establishing design space for filling-stoppering process of prefilled syringes: a …

SB Mehta, J Cook, W Liu, C Brisbane - Journal of Pharmaceutical Sciences, 2022 - Elsevier
There is a concern that low atmospheric pressure typically encountered during shipment
could result in plunger-stopper displacement in prefilled syringes impacting sterility and …

Syringe filling of high-concentration mAb formulation: slow suck-back pump speed prevented filling needle clogging

S Hanslip, KG Desai, M Palmer, S Bell… - Journal of …, 2017 - Elsevier
Partial and complete clogging of filling needles occurred during syringe filling of a high-
concentration mAb formulation. This caused nonvertical liquid flow, which eventually led to …

Unraveling Pre-filled Syringe Needle Clogging: Exploring a Fresh Outlook Through Innovative Techniques

G Hu, D Bonanno, Y Su, X Zhao… - Pharmaceutical …, 2024 - Springer
Objective This study aimed to investigate the movement of liquid in the needle region of
staked-in-needle pre-filled syringes using neutron imaging and synchrotron X-ray …

Needle clogging of protein solutions in prefilled syringes: A two-stage process with various determinants

S Scheler, S Knappke, M Schulz, A Zuern - European Journal of …, 2022 - Elsevier
Clogging of staked-in-needle prefilled syringes (PFS) is a sporadic and scarcely predictable
event, which occurs particularly in highly concentrated protein solutions and can result in the …

On the needle clogging of staked-in-needle pre-filled syringes: Mechanism of liquid entering the needle and solidification process

M De Bardi, R Müller, C Grünzweig, D Mannes… - European Journal of …, 2018 - Elsevier
Staked-in-needle prefilled syringes (SIN-PFS) are widely used for the parenteral
administration of drug product solutions. During stability studies, clogging of the injection …

Clogging in staked-in needle pre-filled syringes (SIN-PFS): Influence of water vapor transmission through the needle shield

M De Bardi, R Müller, C Grünzweig, D Mannes… - European Journal of …, 2018 - Elsevier
Staked-in needle pre-fillable syringes (SIN-PFS) are a convenient delivery system widely
established in the growing pharmaceutical market. Under specific storage conditions, the …

Syringe filling of a high-concentration mAb formulation: experimental, theoretical, and computational evaluation of filling process parameters that influence the …

S Hanslip, KG Desai, M Palmer, I Kemp, S Bell… - Journal of …, 2019 - Elsevier
This article summarizes experimental, theoretical, and computational assessments
performed to understand the effect of filling and suck-back cycle factors on fluid behaviors …

Very small air bubbles (10–70 μl) cause clinically significant variability in syringe pump fluid delivery

C Davey, T Stather-Dunn - Journal of Medical Engineering & …, 2005 - Taylor & Francis
Aim: The goal of this study was to analyse flow disturbances resulting from the presence of
small air bubbles in syringe pump delivery lines incorporating pressure-sensing discs …

Impact of drug formulation variables on silicone oil structure and functionality of prefilled syringe system

GH Shi, G Gopalrathnam, SL Shinkle… - PDA Journal of …, 2018 - journal.pda.org
Use of prefilled syringes to self-administer biologics via subcutaneous administration
provides convenience to patients. The barrel interior of prefilled syringes is typically coated …