A Predictive Modeling Approach to Support the Overfill Volume Definition of Liquid-in-Vial Drug Products

S Dasnoy, L Simonin, S Radulovic, A White… - PDA Journal of …, 2022 - journal.pda.org
Liquid-in-vial drug products are typically overfilled to meet the label claim volume
specification while taking into account losses in the container-closure system and …

Tolerance interval approach for the determination of overfill of liquid parenteral drug products

B Schmelzer, M Sutter - PDA journal of pharmaceutical science and …, 2023 - journal.pda.org
Liquid parenteral products contain an overfill to ensure withdrawal of the declared volume.
The overfill must be sufficiently high to compensate for the expected loss during product …

Use of a predictive regression model for estimating hold-up volume for biologic drug product presentations

SB Mehta, S Subramanian, R Brown… - PDA Journal of …, 2020 - journal.pda.org
A drug delivery system is designed to administer a therapeutic dose according to its label
claim. Upon delivery of a parenteral drug product, the volume remaining inside the container …

Impact of the Design of Different Infusion Containers on the Dosing Accuracy of a Therapeutic Drug Product

M Wozniewski, A Besheer, J Huwyler… - Journal of …, 2023 - Elsevier
Residual volumes of infusion solutions vary greatly due to container and dimensional
variances. Manufacturers use overfill to compensate, but the exact amounts vary …

[PDF][PDF] Residual volumes and final weights in different types of plastic infusion containers

P STRBOVA, M SILLER, K URBANEK… - Intern J Pharm …, 2016 - academia.edu
Objective: To compare the residual volumes, the drained volumes, and the final weights of
different infusion containers with different volumes and degrees of flexibility. The risk of drug …

[PDF][PDF] Establishing target fills for semisolid and liquid dosage forms

P Cholayudth - Pharmaceutical Technology, 2005 - alfresco-static-files.s3.amazonaws …
To meet the requirements of the USP 755 Minimum Fill and 698 Deliverable Volume tests,
target fill levels greater than 100% must be established. This article proposes a criterion for …

A vial container closure system performance optimization case study using comprehensive dimensional stack-up analyses

A Bucci, L Ho, L Orme, Q Zeng - PDA Journal of Pharmaceutical …, 2020 - journal.pda.org
Compatible vial container closure system (CCS) components in combination with a proper
capping process are crucial to ensuring reliable performance, maintaining container closure …

Advancing injection force modeling and viscosity-dependent injectability evaluation for prefilled syringes

L Wu, H Li, Y Wang, C Liu, Z Zhao, G Zhuang… - European Journal of …, 2024 - Elsevier
The development of PFS requires a detailed understanding of the forces occurring during
the drug administration process and patient's capability. This research describes an …

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 …

[HTML][HTML] Determination of pressure resistance of a partially stoppered vial by using a coupled CFD-0D model of lyophilization

B Kamenik, M Hriberšek, M Zadravec - European Journal of Pharmaceutics …, 2022 - Elsevier
Modeling lyophilization in a vial is frequently done on a single vial level. When setting up a
numerical model, the main focus is on heat and mass transfer inside the lyophilizate …