Validation of elastomeric closures for parenteral use: an overview

RT Wood - PDA Journal of Pharmaceutical Science and …, 1980 - journal.pda.org
Validation and qualification of eiastomeric closures are complex operations involving the
coordinated efforts of both the pharmaceutical manufacturer and the closure manufacturer …

Quantitative and Mechanistic Measurements of Container/Closure Integrity: Viscoelastic Measurements of Eiastomeric Closures

DK Morton, NG LOrdi - PDA Journal of Pharmaceutical Science and …, 1988 - journal.pda.org
A method of characterizing the viscoelasticity of elastomeric closures is demonstrated using
a DuPont 983 Dynamic Mechanical Analyzer (DMA). Using the fixed frequency mode of …

Evaluation of current compendial physiochemical test procedures for pharmaceutical elastomeric closures and development of an improved HPLC procedure

CJ Milano, LC Bailey - PDA journal of pharmaceutical science and …, 1999 - journal.pda.org
The interaction between elastomeric container closures and the solutions they confine
presents a potential hazard to the consumer due to extraction of closure ingredients into the …

Parenteral container closure systems

R Mathaes, A Streubel - Challenges in Protein Product Development, 2018 - Springer
Parenteral container closure systems are in direct contact with the drug product formulation
and can significantly impact the product quality. The interaction between the drug product …

Practical fundamentals of glass, rubber, and plastic sterile packaging systems

GA Sacha, W Saffell-Clemmer, K Abram… - Pharmaceutical …, 2010 - Taylor & Francis
Sterile product packaging systems consist of glass, rubber, and plastic materials that are in
intimate contact with the formulation. These materials can significantly affect the stability of …

Reducing the risk of contamination of sterile parenteral products via ready-to-use closure components

W Curry, S Conway, C Goodfield, K Miller… - AAPS …, 2010 - Springer
The preparation of sterile parenteral products requires careful control of all ingredients,
materials, and processes to ensure the final product has the identity and strength, and meets …

A systematic approach for screening glass containers and elastomeric closures for use with parenteral solutions

F White, M Koberda, R Chilamkurti - PDA Journal of Pharmaceutical …, 2008 - journal.pda.org
The purpose of this study is to systematically screen different packaging options for a
particular pharmaceutical application using a multi-stage strategy. This approach includes …

Industry perspective on a holistic container closure integrity approach to parenteral combination products

K Wuchner, HC Brown, F Canal, D Bonvin… - European Journal of …, 2024 - Elsevier
Biologics are being developed more and more as parenteral combination products with drug
delivery devices. The maintenance of sterility is imperative for such medical devices …

Elastomeric components for the pharmaceutical industry

EJ Smith - Encyclopedia of pharmaceutical technology. 3rd ed …, 2007 - api.taylorfrancis.com
Pharmaceutical packaging has allowed the widespread distribution of drugs; without it there
would be no pharmaceutical industry and the quality and quantity of life we have come to …

Ensuring Product Stability–Choosing the Right Excipients

N Veronica, PWS Heng, CV Liew - Journal of Pharmaceutical Sciences, 2022 - Elsevier
The stability of pharmaceuticals is an important product quality attribute. Of the known factors
affecting stability, moisture is often perceived as the most common cause of drug …