Risk Analysis of Sterile Production Plants: A New and Simple, Workable Approach

Guenther Gapp; Peter Holzknecht

doi:10.5731/pdajpst.2011.00693

Research ArticleTech Report

Risk Analysis of Sterile Production Plants: A New and Simple, Workable Approach

Guenther Gapp and Peter Holzknecht

PDA Journal of Pharmaceutical Science and Technology May 2011, 65 (3) 217-226; DOI: https://doi.org/10.5731/pdajpst.2011.00693

Guenther Gapp

Find this author on Google Scholar
Find this author on PubMed
Search for this author on this site
For correspondence: guenther.gapp@sandoz.com

Peter Holzknecht

Find this author on Google Scholar
Find this author on PubMed
Search for this author on this site

Article
Figures & Data
References
Info & Metrics
PDF

Article Information

vol. 65 no. 3 217-226

DOI

https://doi.org/10.5731/pdajpst.2011.00693

PubMed

22293233

Published By

Parenteral Drug Association (PDA)

Print ISSN

1079-7440

Online ISSN

1948-2124

History

Published online June 20, 2011.

Author Information

Guenther Gapp1,* and
Peter Holzknecht2

¹Quality Assurance Microbiology, Sandoz GmbH/Novartis, Kundl, Austria and
²Biotechnological Production, Sandoz GmbH/Novartis, Kundl, Austria

*↵ Corresponding author: Guenther Gapp, Sandoz GmbH, Biochemiestrasse 10, A-6250 Kundl, Austria. Phone: +43 5338 2002562. Fax: +43 5338 2003441. Email: guenther.gapp{at}sandoz.com

View Full Text

Cited By...

6 Citations
Google Scholar

This article has been cited by the following articles in journals that are participating in Crossref Cited-by Linking.

Strengths, weaknesses, opportunities and challenges for long acting injectable therapies: Insights for applications in HIV therapy

Andrew Owen, Steve Rannard

Advanced Drug Delivery Reviews 2016 103
Microorganisms in Confined Habitats: Microbial Monitoring and Control of Intensive Care Units, Operating Rooms, Cleanrooms and the International Space Station

Maximilian Mora, Alexander Mahnert, Kaisa Koskinen, Manuela R. Pausan, Lisa Oberauner-Wappis, Robert Krause, Alexandra K. Perras, Gregor Gorkiewicz, Gabriele Berg, Christine Moissl-Eichinger

Frontiers in Microbiology 2016 7
Attomol‐level ATP bioluminometer for detecting single bacterium

Masahiro Okanojo, Noe Miyashita, Aya Tazaki, Hiroko Tada, Fumiaki Hamazoto, Mitsuko Hisamatsu, Hideyuki Noda

Luminescence 2017 32 5
Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals

Tim Sandle

2013
Comprehensive Analysis of Environmental Monitoring Data from the Department of Nuclear Medicine and Molecular Imaging (NMMI) of the University Medical Center Groningen (UMCG)

Hendrikus H. Boersma, Mirte M. Woerdenbag, Sascha Mulder, Tirza W. T. Poiesz, Lucas B. S. Bekhof, Hein T. Tholen, Gert Luurtsema, Marjolijn N. Lub-de Hooge, Danique Giesen, Herman J. Woerdenbag

Hygiene 2024 4 3
Quality Risk Management in the Final Operational Stage of Sterile Pharmaceutical Manufacturing: A Case Study Highlighting the Management of Sustainable Related Risks in Product Sterilization, Inspection, Labeling, Packaging, and Storage Processes

Bassam Elmadhoun, Rawidh Alsaidalani, Frank Burczynski

Sustainability 2025 17 4

PreviousNext

In This Issue

PDA Journal of Pharmaceutical Science and Technology

Vol. 65, Issue 3

May/June 2011

Table of Contents
Index by Author

Download PDF

Article Alerts

User Name *

Password *

Email *

Email Article

Thank you for your interest in spreading the word on PDA Journal of Pharmaceutical Science and Technology.

NOTE: We only request your email address so that the person you are recommending the page to knows that you wanted them to see it, and that it is not junk mail. We do not capture any email address.

Your Email *

Your Name *

Send To *

Enter multiple addresses on separate lines or separate them with commas.

You are going to email the following Risk Analysis of Sterile Production Plants: A New and Simple, Workable Approach

Message Subject (Your Name) has sent you a message from PDA Journal of Pharmaceutical Science and Technology

Message Body (Your Name) thought you would like to see the PDA Journal of Pharmaceutical Science and Technology web site.

Your Personal Message

CAPTCHA

This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.

Math question * 1 + 10 =

Solve this simple math problem and enter the result. E.g. for 1+3, enter 4.

Citation Tools

Risk Analysis of Sterile Production Plants: A New and Simple, Workable Approach

Guenther Gapp, Peter Holzknecht

PDA Journal of Pharmaceutical Science and Technology May 2011, 65 (3) 217-226; DOI: 10.5731/pdajpst.2011.00693

Citation Manager Formats

BibTeX
Bookends
EasyBib
EndNote (tagged)
EndNote 8 (xml)
Medlars
Mendeley
Papers
RefWorks Tagged
Ref Manager
RIS
Zotero

Risk Analysis of Sterile Production Plants: A New and Simple, Workable Approach

Guenther Gapp, Peter Holzknecht

PDA Journal of Pharmaceutical Science and Technology May 2011, 65 (3) 217-226; DOI: 10.5731/pdajpst.2011.00693

Share This Article:

Tweet Widget
Facebook Like
Google Plus One

Jump to section

Article
Figures & Data
References
Info & Metrics
PDF

No related articles found.

PubMed
Google Scholar

Cited By...

No citing articles found.

Google Scholar

Main menu

User menu

Search

Risk Analysis of Sterile Production Plants: A New and Simple, Workable Approach

Article Information

Author Information

Cited By...

In This Issue

Citation Manager Formats

Related Articles

Cited By...

More in this TOC Section

Similar Articles

Readers

Author/Reviewer Information

Parenteral Drug Association, Inc.