The Manufacture of Sterile Pharmaceuticals and Liquid Medical Devices Using Blow-Fill-Seal Technology: Points to Consider
By K. Downey, M. Haerer, S. Marguillier and P. Åkerman
()
About this ebook
Related to The Manufacture of Sterile Pharmaceuticals and Liquid Medical Devices Using Blow-Fill-Seal Technology
Related ebooks
Equipment Qualification in the Pharmaceutical Industry Rating: 4 out of 5 stars4/5GMP in Pharmaceutical Industry: Global cGMP & Regulatory Expectations Rating: 5 out of 5 stars5/5How to Scale-Up a Wet Granulation End Point Scientifically Rating: 4 out of 5 stars4/5Cost-Contained Regulatory Compliance: For the Pharmaceutical, Biologics, and Medical Device Industries Rating: 0 out of 5 stars0 ratingsHow to Design and Implement Powder-to-Tablet Continuous Manufacturing Systems Rating: 0 out of 5 stars0 ratingsMedical Device: A Primer Based on Best Practices Rating: 0 out of 5 stars0 ratingsPharmaceutical Engineering Rating: 0 out of 5 stars0 ratingsIndustrial Process Scale-up: A Practical Innovation Guide from Idea to Commercial Implementation Rating: 0 out of 5 stars0 ratingsMedical Devices and IVDs: Fit for the new EU-Regulations: Your complete seminar for projekt, study and job Rating: 0 out of 5 stars0 ratingsPharmacovigilance Medical Writing: A Good Practice Guide Rating: 4 out of 5 stars4/5Good Manufacturing Practices (GMP) Modules for Pharmaceutical Products Rating: 0 out of 5 stars0 ratingsFundamentals of Biologicals Regulation: Vaccines and Biotechnology Medicines Rating: 5 out of 5 stars5/5An Overview of FDA Regulated Products: From Drugs and Cosmetics to Food and Tobacco Rating: 5 out of 5 stars5/5CGMP Starter Guide Rating: 4 out of 5 stars4/5How to Validate a Pharmaceutical Process Rating: 4 out of 5 stars4/5Accelerated Predictive Stability (APS): Fundamentals and Pharmaceutical Industry Practices Rating: 5 out of 5 stars5/5Concepts of Quality Management in Pharmaceutical Industry Rating: 0 out of 5 stars0 ratingsIntroduction to Quality by Design for Pharmaceuticals Rating: 0 out of 5 stars0 ratingsDesign and Manufacture of Pharmaceutical Tablets Rating: 4 out of 5 stars4/5Principles of Parenteral Solution Validation: A Practical Lifecycle Approach Rating: 5 out of 5 stars5/5Pharmaceutical Quality by Design Using JMP: Solving Product Development and Manufacturing Problems Rating: 5 out of 5 stars5/5Leachables and Extractables Handbook: Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products Rating: 0 out of 5 stars0 ratingsProduction of Plasma Proteins for Therapeutic Use Rating: 3 out of 5 stars3/5Drug Stability for Pharmaceutical Scientists Rating: 3 out of 5 stars3/5How to Integrate Quality by Efficient Design (QbED) in Product Development Rating: 0 out of 5 stars0 ratingsGMP Certified A Complete Guide - 2021 Edition Rating: 0 out of 5 stars0 ratingsPharmaceutical manufacturing Complete Self-Assessment Guide Rating: 0 out of 5 stars0 ratingsMedical Device Quality Management Systems: Strategy and Techniques for Improving Efficiency and Effectiveness Rating: 0 out of 5 stars0 ratingsA History of a cGMP Medical Event Investigation Rating: 0 out of 5 stars0 ratingsPharmaceutical Packaging Technology: Pharmaceutical Packaging Technology Rating: 4 out of 5 stars4/5
Medical For You
The 40 Day Dopamine Fast Rating: 4 out of 5 stars4/5The Vagina Bible: The Vulva and the Vagina: Separating the Myth from the Medicine Rating: 5 out of 5 stars5/5The Lost Book of Simple Herbal Remedies: Discover over 100 herbal Medicine for all kinds of Ailment Inspired By Barbara O'Neill Rating: 0 out of 5 stars0 ratingsHolistic Herbal: A Safe and Practical Guide to Making and Using Herbal Remedies Rating: 4 out of 5 stars4/5The Diabetes Code: Prevent and Reverse Type 2 Diabetes Naturally Rating: 4 out of 5 stars4/5Mediterranean Diet Meal Prep Cookbook: Easy And Healthy Recipes You Can Meal Prep For The Week Rating: 5 out of 5 stars5/5Rewire Your Brain: Think Your Way to a Better Life Rating: 4 out of 5 stars4/5The Amazing Liver and Gallbladder Flush Rating: 5 out of 5 stars5/5The Hormone Reset Diet: Heal Your Metabolism to Lose Up to 15 Pounds in 21 Days Rating: 4 out of 5 stars4/5What Happened to You?: Conversations on Trauma, Resilience, and Healing Rating: 4 out of 5 stars4/5Tight Hip Twisted Core: The Key To Unresolved Pain Rating: 4 out of 5 stars4/5Adult ADHD: How to Succeed as a Hunter in a Farmer's World Rating: 4 out of 5 stars4/5Period Power: Harness Your Hormones and Get Your Cycle Working For You Rating: 4 out of 5 stars4/5The Art of Dying Well: A Practical Guide to a Good End of Life Rating: 4 out of 5 stars4/5Woman: An Intimate Geography Rating: 4 out of 5 stars4/5Herbal Healing for Women Rating: 4 out of 5 stars4/5Healthy Gut, Healthy You: The Personalized Plan to Transform Your Health from the Inside Out Rating: 4 out of 5 stars4/5Summary of Dr. Gundry's Diet Evolution: Turn off the Genes That Are Killing You and Your Waistline Rating: 3 out of 5 stars3/5ATOMIC HABITS:: How to Disagree With Your Brain so You Can Break Bad Habits and End Negative Thinking Rating: 5 out of 5 stars5/5Working Stiff: Two Years, 262 Bodies, and the Making of a Medical Examiner Rating: 4 out of 5 stars4/5Women With Attention Deficit Disorder: Embrace Your Differences and Transform Your Life Rating: 5 out of 5 stars5/5Gut: The Inside Story of Our Body's Most Underrated Organ (Revised Edition) Rating: 4 out of 5 stars4/5"Cause Unknown": The Epidemic of Sudden Deaths in 2021 & 2022 Rating: 5 out of 5 stars5/5The Butchering Art: Joseph Lister's Quest to Transform the Grisly World of Victorian Medicine Rating: 4 out of 5 stars4/5
Reviews for The Manufacture of Sterile Pharmaceuticals and Liquid Medical Devices Using Blow-Fill-Seal Technology
0 ratings0 reviews
Book preview
The Manufacture of Sterile Pharmaceuticals and Liquid Medical Devices Using Blow-Fill-Seal Technology - K. Downey
Former editions:
1st edition September 1993 by S. Probert, S. Forrester-Coles
1st main revision September 1998 (general update)
2nd main revision October 2002 (general update) by A. Löfgren
small revision January 2003(small revision/update of integrity testing sections) by A. Löfgren
3rd main revision April 2007 (update in general and regarding the revised FDA guidance)
by E. Dewhurst
4th main revision Nov. 2011/March 2012 (general update, Media Fills, SIP, implementation of
rotary machine type 4010) by K. Downey, M. Haerer, S. Marguiller, P. Åkerman
5th corrected version December 2016
The pictures on the front cover are sponsored by Brevetti Angela, Rommelag and Weiler Engineering.
Bibliographic data available from the German National Library
The German Library catalogs this publication in the German National Bibliography; detailed bibliographic information can be found on the internet website: http://dnb.ddb.de.
The Manufacture of Sterile Pharmaceuticals and Liquid Medical Devices Using Blow-Fill-Seal Technology: Points to Consider
ISBN 978-3-87193-443-8
© 2017 ECV · Editio Cantor Verlag für Medizin und Naturwissenschaften GmbH, Aulendorf (Germany).
All rights, in particular those of duplication, distribution, and translation are reserved by BFS International Operators Association c/o Melitek A/S, DK-4840 Nørre Alslev, and the publisher without any limit in time. No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise without the prior written permission of the publisher. The absence of the symbol ® after any name does not imply that this name is not under trademark protection.
ECV · Editio Cantor Verlag on the internet www.ecv.de
Typesetting: Reemers Publishing Services GmbH, Krefeld
Printing: HOLZMANN DRUCK GMBH & CO. KG, Bad Wörishofen
Contents
Disclaimer 7
1. INTRODUCTION 9
2. OBJECTIVE 11
3. BFS PROCESS OUTLINE 12
3.1 Shuttle Type Machines 12
3.2 Rotary Filling Machines 14
3.3 Additional Applications 16
4. ADVANTAGES & CHALLENGES OF BLOW-FILL-SEAL TECHNOLOGY 18
4.1 Advantages 18
4.2 Challenges 19
5. DESIGN 21
5.1 Product Design 21
5.1.1 Aseptic processing versus terminal sterilisation 21
5.1.2 Terminal sterilisation 21
5.1.3 Polymer 22
5.1.4 Container design 23
5.1.5 Secondary packaging 24
5.2 Equipment Design 25
5.2.1 General 25
5.2.2 Control of critical zone environment 26
5.2.3 Air shower design (shuttle type machines) 27
5.2.4 Product pathway 28
5.2.5 Mould design 28
5.2.6 Deflashing 29
5.2.7 Equipment Monitoring 29
5.2.8 Container closure system leak detection 30
5.3 Facility Design 31
5.3.1 Aseptic Processing Area (APA) 31
5.3.2 Support areas 34
5.3.3 Polymer storage and distribution 34
5.3.4 Utilities 35
6. QUALIFICATION AND VALIDATION 36
6.1 PRODUCT VALIDATION 36
6.1.1 Container/Closure integrity testing 36
6.1.2 Process capability 36
6.2 Equipment Validation 37
6.2.1 Extruder 37
6.2.2 Air Flow 38
6.2.3 Clean in Place (CIP) of the product pathway 38
6.2.4 Sterilisation in Place (SIP) of the product pathway 38
6.2.5 Process simulation (media fill) for aseptic filling lines 40
6.2.6 Moulding and filling system 44
6.2.7 Downstream process 44
6.2.8 Controls 44
6.2.9 Filtration 45
6.3 Facility Validation 45
7. OPERATION 46
7.1 Process Operation