Container Closure Integrity Testing of Prefilled Syringes

Peláez, Sarah S.; Mahler, Hanns‐Christian; Matter, Anja; Koulov, Atanas V.; Singh, Satish K.; Germershaus, Oliver; Mathaes, Roman

doi:10.1016/j.xphs.2018.03.025

Cited by 14 publications

(10 citation statements)

References 7 publications

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“…We have observed (see also Ref. [27]) that syringes gives typical leakrates ṗa V a = (1 − 100) × 10 −8 mbar × l/s . If we assume p b = 0.1 MPa (atmospheric pressure) and p a ≈ 0 (vacuum) and L y ∕L x = 100 we get from (28…”

Section: Application To Syringe He-gas Leakage Testingmentioning

confidence: 80%

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Air, Helium and Water Leakage in Rubber O-ring Seals with Application to Syringes

Tiwari

Rotella

et al. 2022

Tribol Lett

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We study the leakage of fluids (liquids or gases) in syringes with glass barrel, steel plunger and rubber O-ring stopper. The leakrate depends on the interfacial surface roughness and on the viscoelastic properties of the rubber. Random surface roughness is produced by sandblasting the rubber O-rings. We present a very simple theory for gas flow which takes into account both the diffusive and ballistic flow. The theory shows that the interfacial fluid flow (leakage) channels are so narrow that the gas flow is mainly ballistic (the so called Knudsen limit). We compare the leakrate obtained using air and helium. For barrels filled with water we observe no leakage even if leakage occurs for gases. We interpret this as resulting from capillary (Laplace pressure or surface energy) effects.

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Section: Application To Syringe He-gas Leakage Testingmentioning

confidence: 80%

“…The quantity ṗa V a = Ṅa k B T , with units Pa × m 3 ∕s or mbar × l/s , is often measured in He leakage experiments [26][27][28]. Sometimes the leakrate is given as volume of gas at the pressure p b passing through the constriction per unit time.…”

Section: Application To Syringe He-gas Leakage Testingmentioning

confidence: 99%

Air, Helium and Water Leakage in Rubber O-ring Seals with Application to Syringes

Tiwari

Rotella

et al. 2022

Tribol Lett

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“…number of ribs), rubber formulation, coating type and area (1,29), additional analysis would be required to understand impact of frictional force on plunger-stopper displacement.. In many cases, more conservative approaches to determine sterility barrier of PFS would result in a lower range of acceptable plunger-stopper displacement.. A previous study performed by Pelaez S et.al. showed that one single plunger rib was adequate to maintain CCI (30). They also investigated tip cap/RNS movement and its impact on CCI of PFS (30) which was outside the scope of this article.…”

Section: Discussionmentioning

confidence: 99%

Risk Mitigation of Plunger-Stopper Displacement Under Low Atmospheric Pressure by Establishing Design Space for Filling-Stoppering Process of Prefilled Syringes: A Design of Experiment (DoE) Approach

Mehta

Cook

Liu

et al. 2022

Journal of Pharmaceutical Sciences

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This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

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“…32 Second, the technical characterization of the elastomer-glass interface has long been used for specifying the forces related to the pre-filled syringe sterility barrier and needle exposure. 33 However, the US Food and Drug Administration (FDA) now investigates manufacturers about user-centric design principles in the design and development of new drug delivery devices and recommends specifications based on rigorous usability research rather than technical properties of device components. 34 Third, autoinjector-based treatment options alleviate chronic debilitating conditions associated with cognitive and motor impairments, such as multiple sclerosis, psoriasis, and rheumatoid arthritis.…”

Section: Introductionmentioning

confidence: 99%

User-Centric Approach to Specifying Technical Attributes of Drug Delivery Devices: Empirical Study of Autoinjector-Cap Removal Forces

Schneider¹,

Richard²,

Mueller³

et al. 2021

PPA

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Purpose The subcutaneous delivery of biologics using pre-filled autoinjector devices continues to attract broad scholarly interests. However, research still lacks a detailed understanding of user perceptions as the basis for specifying the clinically relevant technical attributes of a device, such as the cap-removal force. Therefore, this article studies the ability of users to remove the autoinjector cap, as well as the effects of the cap-removal force and user characteristics on the perceived ease of decapping. Patients and Methods Forty-two participants among patients, caregivers, and healthcare professionals removed the protective cap using non-functional devices with different target cap-removal forces between 25 N and 55 N. Data were collected on the ability of the users to effectively decap the device and their perceived ease of decapping. Linear regression was then applied to quantify the impact of the decapping force and patient characteristics on the perceived ease of decapping. Results The participants of the study effectively decapped all autoinjector devices irrespective of age, sex, and dexterity impairments. Moreover, the study reveals that the perceived ease of decapping decreases significantly with increasing decapping force and participants’ dexterity impairments. Conclusion The study provides initial empirical evidence on the ability of users to decap autoinjector devices and shows how increasing the cap-removal force and dexterity impairments reduce the perceived ease of decapping.

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Container Closure Integrity Testing of Prefilled Syringes

Cited by 14 publications

References 7 publications

Air, Helium and Water Leakage in Rubber O-ring Seals with Application to Syringes

Air, Helium and Water Leakage in Rubber O-ring Seals with Application to Syringes

Risk Mitigation of Plunger-Stopper Displacement Under Low Atmospheric Pressure by Establishing Design Space for Filling-Stoppering Process of Prefilled Syringes: A Design of Experiment (DoE) Approach

User-Centric Approach to Specifying Technical Attributes of Drug Delivery Devices: Empirical Study of Autoinjector-Cap Removal Forces

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