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In 2015, West Pharmaceutical Services, Inc. (West) announced that two materials of construction of the West STERILIZABLEBAG™ packaging system will change:
Developed in the mid-90’s, the STERILIZABLEBAG™ packaging system is pivotal for West’s Ready-to-Sterilize (RS) and Ready-to-Use (RU) components, including Daikyo components. It is manufactured by sealing two materials:
Through extensive testing, West validated all designs and processes, and demonstrated that the updated STERILIZABLEBAG™ packaging system, comprised of the updated Tyvek 1073B packaging material and an alternative polyethylene film, is functionally equivalent to the current system – ensuring that RS and RU components will continue to have the same quality and sterility assurance – in particular: bioburden, endotoxin, particulate specifications, and release criteria. Moreover, the updated system meets the following:
West understands the criticality of the STERILIZABLEBAG™ packaging system to customers’ operations, and is committed to assisting the transition to the updated system by providing robust and comprehensive technical data packages that may minimize the need for additional testing. Technical data packages and supplemental documentation are available for:
©2016 by West Pharmaceutical Services, Inc.
All rights reserved. This material is protected by copyright. No part of it may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical, photocopying or otherwise, without written permission of West Pharmaceutical Services, Inc.
TYVEK® is a registered trademark of E.I. du Pont de Nemours and Company.
West and the diamond logo, STERILIZABLEBAG™, NovaPure®, Flip-Off®, and READY PACK® are trademarks or registered trademarks of West Pharmaceutical Services, Inc. in the United States and other jurisdictions.