ISPE 良好实践指南包装、标签和仓储设施 2011 Packaging, Labeling, and Warehousing Facilities

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Safeguarding solutions through

innovative packaging

Corporate Description

Weiler Engineering, a leading provider of aseptic custom

packaging equipment for pharmaceutical and healthcare

applications, has virtually eliminated contamination concerns.

Committed to the highest standards of excellence and to further

expanding products and systems to enhance patient care, Weiler’s

proprietary ASEP-TECH® Blow/Fill/Seal packaging machines produce

shatterproof, durable, aseptically-packaged products in one uninterrupted

operation. This hands-free manufacturing process ensures parenterals,

ophthalmic solutions, and respiratory drugs reach the marketplace in the

most sterile, cost-effective manner possible—every time.

The ASEP-TECH® System is the culmination of 40 years of innovation

in machine design and sterile process development, producing the most

advanced aseptic liquid packaging process available today.

1395 Gateway Drive

Elgin, Illinois 60124 USA

PHONE: 847-697-4900

FAX: 847-697-4915

www.asep-tech.com/ispe

Weiler Engineering

TAKING A CUE FROM MOTHER NATURE

...IT’S SAFER INSIDE

14004-53 WEIL ISPE Guide Ad_2011.indd 1 4/25/11 10:56 AM

Packaging, Labeling,

and Warehousing

Facilities

Disclaimer:

This Guide describes a risk-based approach to CGMPs and encourages innovative approaches for the design and/

or reconguration of Packaging, Labeling, and Warehousing (PACLAW) facilities. ISPE cannot ensure and does not

warrant that a system managed in accordance with this Guide will be acceptable to regulatory authorities. Further,

this Guide does not replace the need for hiring professional engineers or technicians.

Limitation of Liability

 InnoeventshallISPEoranyofitsafliates,ortheofcers,directors,employees,members,oragentsofeach

ofthem,ortheauthors,beliableforanydamagesofanykind,includingwithoutlimitationanyspecial,incidental,

indirect,orconsequentialdamages,whetherornotadvisedofthepossibilityofsuchdamages,andonanytheoryof

liabilitywhatsoever,arisingoutoforinconnectionwiththeuseofthisinformation.

No part of this document may be reproduced or copied in any form or by any means – graphic, electronic, or

mechanical, including photocopying, taping, or information storage and retrieval systems – without written permission

of ISPE.

All trademarks used are acknowledged.

ISBN 978-1-936379-41-5

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标签： #ISPE #实践指南

摘要：

本指南由国际制药工程学会（ISPE）于2011年发布，系统阐述了制药与生物技术行业中包装、标签及仓储设施的设计、运行与合规要求。内容涵盖设施布局、物料流转、温湿度控制、防交叉污染措施、标签管理与追溯系统等关键环节，旨在帮助工程与质量管理人员实现符合GMP（良好生产规范）的高效运营。适用于新建项目设计、现有设施改造以及监管审计准备，是制药行业设施工程与质量管理领域的重要参考文档。

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ISPE 良好实践指南包装、标签和仓储设施 2011 Packaging, Labeling, and Warehousing Facilities

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