Closure and container considerations in lyophilization

FL DeGrazio - Freeze-Drying/Lyophilization of Pharmaceutical …, 2016 - taylorfrancis.com
INTRODUCTION Lyophilization is a process that was developed many years ago, yet became
more prominent in the pharmaceutical industry with the growth of biopharmaceutical drug …

Holistic considerations in optimizing a sterile product package to ensure container closure integrity

FL Degrazio - PDA Journal of Pharmaceutical Science and …, 2018 - journal.pda.org
A new major chapter dealing with container closure integrity was released by the United States
Pharmacopeial Convention. Chapter <1207> provides a significant amount of education …

[PDF][PDF] Parenteral packaging concerns for biotech drugs

FL DeGrazio - BioProcess Int, 2006 - eu-assets.contentstack.com
Despite significant effort and research in delivering peptides and proteins through means
such as inhalation, transdermal injection, and direct contact with mucous membranes, …

Container and Reconstitution Systems for Lyophilized Drug Products

TP McAndrew, D Hostetler, FL DeGrazio - … of Pharmaceuticals and …, 2019 - Springer
Lyophilization is the process of dehydrating a material at low temperature and reduced
pressure. It is used to extend the shelf life of many biologic drug products. This paper discusses …

Plastic packaging for parenteral drug delivery

VD Vilivalam, FL DeGrazio - Pharmaceutical Dosage Forms …, 2016 - taylorfrancis.com
INTRODUCTION Driven by the development of biotechnology products, newer drug therapies,
and reformulation of poorly soluble drugs, parenteral delivery is expected to provide …

Plastic packaging for parenteral drug delivery

L Waxman, FL DeGrazio… - Parenteral Medications …, 2019 - taylorfrancis.com
In pharmaceutical environments, the presence of contamination is of key concern to the quality
of the product. In addition to the presence of contamination, some contaminants are more …

Extractables and Leachables as Container Closure Considerations in Lyophilization

D Paskiet, FL DeGrazio - Freeze-Drying/Lyophilization of …, 2016 - taylorfrancis.com
INTRODUCTION The suitability of the container closure systems (CCS) for lyophilized
pharmaceutical and biological products can be enhanced using the principles of quality by design …

Silicone absorption of elastomeric closures—An accelerated study

FL Degrazio, T Hlobik, S Vaughan - PDA Journal of Pharmaceutical …, 1998 - journal.pda.org
There is a trend in the parenteral industry to move from the use of elastomeric closures which
are washed, siliconized, dried and sterilized in-house at the pharmaceutical manufacturers' …

[HTML][HTML] Understanding Risks Of Biologic Drugs And Injectable Drug-Device Combination Products

FL DeGrazio - pharmaceuticalonline.com
Background Growth in biologic drugs in the development pipeline of products has led to
growth in the use of injectable drug-device combination products. Figure 1 shows this growth …

Considerations in Lyophilization

FL DeGrazio - Freeze-Drying/Lyophilization Of Pharmaceutical & …, 2004 - books.google.com
Lyophilization as a parenteral process began in the early twentieth century as a way to prepare
pharmaceutical products that are unstable in liquid form. In the 1980s and with the birth …