Advanced search
ISPE Good Practice Guide: Unique Identification of Glass Primary Containers in Pharmaceutical Fill and Finish Operations cover image

ISPE Good Practice Guide: Unique Identification of Glass Primary Containers in Pharmaceutical Fill and Finish Operations

Published:May 2024

Pages:86

Many current challenges facing the pharmaceutical industry revolve around increasing product complexity, reduced batch sizes, and higher flexibility requirements, coupled with increased requirements for product traceability, both internally and by regulatory bodies. Additionally, as the industry moves toward a continuous manufacturing process model, defining the production stage at which something started to go wrong proves to be challenging.

One technology that helps to address these factors is uniquely coded containers that allow for traceability at the individual container level.

There are other strong business drivers for adopting uniquely coded containers. These include improved batch visibility and accountability as well as streamlined investigations into deviations during fill and finish operations. These benefits can mitigate the direct financial impact from missed revenue and benefit patients by potentially resulting in fewer drug shortages.

The ISPE Good Practice Guide: Unique Identification of Glass Primary Containers in Pharmaceutical Fill and Finish Operations describes processes for applying a Unique Identifier (UID) on each primary parenteral container. The Guide outlines best practices for developing, implementing, and managing a traceability project across one or more processes.

The unique identification of single glass containers described in this Guide represents a technological advancement that can support the robustness of pharmaceutical manufacturing processes. It encompasses all types of glass primary containers made from tubular glass or molded glass for the containment of pharmaceutical liquids or lyophilized products. Covered topics include:

  • UID methods/technologies for the different container types
  • The UID structure
  • Performance requirements for glass containers
  • Barcode readability and verification
  • Radio-Frequency Identification (RFID) technologies
  • Reading different formats
  • Automated inspection processes
  • Traceability in processes

This Guide also discusses how to manage the container UID without affecting package serialization required by the EU and FDA.

Traceability in any process entails two essential components – the UID and the management and storage of the data collected, generated, and associated with the UID as it travels through the different steps of a process or line. This Guide leads the user through the key considerations in data management across different processes, data systems architecture, and validation.

The development and compilation of this Guide involved a cross functional team of industry experts and professionals engaged in parenteral/injectable medicine manufacturing. The working groups included industry competitors who worked together to establish a common approach and provide a balanced, industry-wide perspective on the use of containers with unique identities.

  • 1 Introduction
  • 1.1 Background
  • 1.2 Key Concepts of Using a Container Unique Identifier
  • 1.3 Benefits of Unit-Level Identification
  • 1.4 Purpose and Scope
  • 2 Selection and Design
  • 2.1 Existing Regulatory Mandates for Drug Products
  • 2.2 Container Unique Identifier (CUID)
  • 2.3 Selecting a CUID Data Carrier
  • 2.4 Approaches for the CUID Structure
  • 2.5 CUID Stability Requirements
  • 3 Using DMC as CUID Carrier
  • 3.1 Bar Code Structure in General
  • 3.2 DMC Manufacturing Technologies
  • 3.3 DMC Dimension and Positioning
  • 3.4 Specific Requirements for DMC Reading
  • 4 Using an RFID Tag as a CUID Carrier
  • 4.1 RFID Technology Brief
  • 5 Implementation and Use
  • 5.1 General Considerations
  • 5.2 Reading the CUID in a Filling Line
  • 5.3 Reading CUID in an Automated Inspection Machine
  • 5.4 Reading CUID in Labeling/Assembly Line/Packaging Line
  • 6 Data Management
  • 6.1 The Shift Register
  • 6.2 Traceability Data Collection Best Practice – Single Machine
  • 6.3 Traceability Data Collection Best Practice – Process Machines/Lines
  • 6.4 Types of Data That Can Be Shared Between Machines
  • 6.5 Data System Architecture
  • 6.6 Data Sharing Method
  • 6.7 Data Volumes
  • 6.8 Data Retention Time
  • 7 Program Objectives versus Validation Approach
  • 7.1 Intended Use (Specific Internal Needs)
  • 7.2 Regulatory Impact and Regulatory Compliance
  • 7.3 Validation Approach
  • 7.4 Implement an Adequate Concept Phase
  • 7.5 Validation of The Intended Use
  • 7.6 Audit Trail
  • 7.7 Data Integrity
  • 8 Appendix 1 – Barcode Verification Equipment
  • 9 Appendix 2 – Barcode Grading Parameters and Scales
  • 10 Appendix 3 – Camera Installations Considering Different Primary Container Formats
  • 10.1 Managing Different Formats of Primary Containers
  • 11 Appendix 4 – References
  • 12 Appendix 5 – Glossary (Acronyms and Abbreviations)
  • Alexander Bauer, Boehringer Ingelheim, Germany
  • Andreas Böhme, Körber Pharma Inspection, Germany
  • Francesco Brazzarola, Antares Vision SpA, Italy
  • Maria Victoria De La Torre, SCHOTT Pharma AG & Co. KGaA, Germany
  • Tobias Dombrowski, groninger GmbH & Co. KG, Germany
  • Laurent Fleuret (Co-Lead), GSK Biopharm, Belgium
  • Arno Fries, PhD, Nipro PharmaPackaging International N.V., Belgium
  • Maurizio Grassi, IMA, Italy
  • Yacine Haddadi, BD, France
  • Sumant Kapoor, APKID, India
  • Gregor Kotyrba, PhD, KTS GmbH, Germany
  • Robert Lindner, PhD, SCHOTT Pharma Schweiz AG, Switzerland
  • Daniel Martinez, Stevanato Group SpA, Italy
  • Bruno Morchain, Aptar Pharma, France
  • Mario Nagler, Groninger & Co. GmbH, Germany
  • Joseph P. O’Connor, Eli Lilly & Co., USA
  • Alessandro Pelizzi (Co-Lead), LifeBee | A ProductLifeGroup Company, Italy
  • Louis Petit, Becton Dickinson, France
  • Damiano Pierro, Merck, Italy
  • Federico Piutti, Bormioli Pharma, Italy
  • Thierry Protas, Jekson Vision Ltd., France
  • Alberto Reghenzi, Antares Vision, Italy
  • Armin Rehberger, Bausch + Ströbel SE + Co. KG, Germany
  • Rudolf Renfurm, Agillox Benelux BV, The Netherlands
  • Andrea Sardella, PhD, Stevanato Group SpA, Italy
  • Johannes Selch, GEA Lyophil GmbH, Germany
  • Herve Soukiassian, BD, France
  • Daniel Sturm, Syntegon Technology, Germany
  • Tod Urquhart (Co-Lead), CIM A/S, United Kingdom
  • Jens Vanneste, Alcon Couvreur NV, Belgium
  • Sabine Wohlfart, Gerresheimer Regensburg GmbH, Germany
  • Michele Zanin, Brevetti CEA SpA, Italy

Between 2016–2019 a range of container traceability solutions were introduced to the pharmaceutical market. These solutions are designed to deliver unit level visibility and traceability of parenteral containers within the filling and finishing operations. The value propositions include the prevention of mix ups, enable better segregation in the event of a process issue, and provide more robust root cause identification and corrective actions.

In response to these new technologies, the ISPE Supply Chain, Operations, and Packaging Excellence (SCOPE) Community of Practice launched a discussion paper that explores the use and implementation of these technologies. This started with a small group of stakeholders from the industry and a discussion paper published in February 2021.

The discussion paper received positive feedback from the industry. This, combined with the view from within ISPE that this was an important topic for the future of the injectable medicines industry, led to the creation of a new, much larger, working group.

The participants included many of the major players in the industry and were drawn from across all the key technology areas. The working groups included industry competitors, all of whom were involved in the Guide’s development and compilation, and worked together to agree on the commonality of approach.

This Guide provides the framework for implementing container traceability by leveraging the extensive experience of our international and interdisciplinary team of contributors and authors. The team brings a breadth and depth of experience to provide the reader with the tools to implement their traceability journey.

We extend our heartfelt thanks and recognition to the continuous support of the senior management team within ISPE as well as the guidance of the quality and regulatory team who guided and enhanced the development of this Guide.

Discussion of proprietary technologies is included to convey practical information to the readers. In no way does this Guide endorse or promote their use.