Start-Up of Sterile Products Production in International Facilities

GL Fourman - PDA Journal of Pharmaceutical Science and …, 1983 - journal.pda.org
The major elements of smoothly starting sterile products operations in international facilities
are presented by using recent start-up experiences in Taiwan and Korea as models. The …

Sterile product manufacturing

J Agalloco, J Akers - Pharmaceutical Manufacturing Handbook …, 2008 - books.google.com
Sterile product manufacturing Page 116 2.1 STERILE PRODUCT MANUFACTURING James
Agalloco1 and James Akers2 1Agalloco & Associates, Belle Mead, New Jersey 2Akers …

Zone in on: manufacturing: ISPE to publish updated sterile-product manufacturing guide

E Greb - Pharmaceutical Technology, 2011 - go.gale.com
The International Society for Pharmaceutical Engineering (ISPE) will soon publish an update
to its guide to sterile-product manufacturing facilities. The new publication will replace the …

[BOOK][B] Sterile Manufacturing: Regulations, Processes, and Guidelines

SA Hout - 2021 - taylorfrancis.com
This book highlights key ideas and factors to coach and guide professionals involved in
learning about Sterile Manufacturing and operational requirements. It covers regulations …

Points to Consider for Continuous Manufacturing of Biotechnological Drug Products

S Okudaira - Yakugaku Zasshi: Journal of the Pharmaceutical …, 2022 - europepmc.org
Continuous Manufacturing is a manufacturing method in which raw materials enter the
manufacturing process continuously, and products are discharged continuously throughout …

[PDF][PDF] Basic Requirements For Aseptic Manufacturing Of Sterile Medicinal Products A Comparison Between Europe And USA

G Greger - dgra.de
In the early 1900s, the first parenteral drugs were manufactured on an industrial scale. The
need arose to find suitable sterilisation methods for heat sensitive products that could not be …

Değişime cesaret

W Renders - jag.journalagent.com
Bu yazıda, World Forum for Hospital Sterile Supply (WFHSS) eski başkanı olarak,
sterilizasyon dünyası hakkındaki görüşlerimi paylaşmak istiyorum. Öncelikle ulusal …

Using single-use systems in aseptic fill-finish: material compatibility, material sourcing, facility layout, and training are crucial aspects of a successful disposable fill …

J Markarian - Biopharm International, 2016 - go.gale.com
Single-use systems (SUS), also called disposable technology, can improve manufacturing
efficiency by reducing the time needed for cleaning and cleaning validations. In addition …

[PDF][PDF] A novel proposition of facilities required for sterile pharmaceutical preparation

MM Hasan, MJ Hossain, S Chowdhury… - The Pharma …, 2017 - thepharmajournal.com
Sterile facility is required for Realizing the crucial importance of quality, safety and efficacy of
sterile pharmaceutical preparations such as eye drops, intravenous admixtures, parenteral …

Transfer of processes from development to manufacturing

DF Gerson, V Himes, R Hopfer… - Drug information …, 1998 - journals.sagepub.com
The transfer of new biotechnological processes from research and development to
manufacturing is always fraught with difficulties. At this stage in the creation of a new …