-
« Übersicht |
- GMP-Verlag Peither AG
- GMP-Shop
- GMP-Publikationen
- Englisches GMP-Fachwissen
Aseptic Processing of Sterile Medicinal Products
Geben Sie die erste Bewertung für diesen Artikel ab
e-book
39 Seiten
ISBN: 978-3-943267-88-4
1st edition 2014
Excerpt from the GMP Compliance Adviser
Whereas in Europe aseptic processing is regarded as last option for the manufacturing of sterile medicinal products when all sterilisation methods in the final container have been excluded, the FDA regards aseptic processing as a freely selectable alternative to terminal sterilisation.
In this e-book you will find answers to the following questions:
- What requirements are rooms and personnel expected to meet for aseptic processing?
- How is the bioburden reduced by means of sterile filtration?
- How is sterile filtration validated?
- How is the aseptic filling method proved?
- What interventions should take place in the processes?
- What must be borne in mind with respect to personnel qualification in the context of media fills?
- What measures must be taken when acceptance criteria are exceeded in the context of media fills?
Table of Contents
1 Introduction
2 Room requirements
3 Monitoring
4 Personnel
5 Sterile filtration
5.1 Mode of operation of sterile filters
5.2 Materials, designs and use of filters
5.3 Filter integrity test
5.4 Executing sterile filtration
5.5 Validating sterile filtration
6 Validating aseptic processing (media fill)
6.1 Documentation
6.2 Preparing the culture medium
6.3 Filling the culture media
6.4 Qualification of personnel
6.5 Environmental controls for media fill
6.6 Incubation of containers
6.7 Optical check of the containers
6.8 Growth promotion test
6.9 Reconciliation and evaluation of the media fill
7 Author
Weitere Informationen
Reading Sample "Aseptic Processing of Sterile Medicinal Products"
Technical Requirements
This file is in PDF format!
Filesize: 1,5 MB
To view PDF files, we recommend using the Adobe Reader.
https://get.adobe.com/de/reader/
The e-book is password protected to prevent copying and modification of content.
Please note the following procedure guidelines:
For payment by invoice:
- You will receive an advance invoice by e-mail within 1-2 working days. You payment is required for the download.
- After receipt of payment you will receive an e-mail with the download information.
When paying by credit card:
- Immediately after the credit card payment you will receive an email with the download information.
- Your invoice will be sent in a separate e-mail within 1-2 working days.
69,90 € netto
74.79 - 7.00
87,00 € netto
93.09 - 7.00
26,90 € netto
28.78 - 7.00
495,00 € netto
529.65 - 7.00
99,00 € netto
105.93 - 7.00
59,00 € netto
63.13 - 7.00
LOGFILE
Der Newsletter des GMP-Verlags
News und aktuelle Trends: Mit dem LOGFILE sind Sie immer up-to-date!
> Jetzt kostenlos abonnieren!Ihre Währung
Bitte wählen Sie Ihre Währung aus