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 …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
would be no pharmaceutical industry and the quality and quantity of life we have come to …
Ensuring Product Stability–Choosing the Right Excipients
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 …
affecting stability, moisture is often perceived as the most common cause of drug …