Driving quality, traceability

and production efficiency by

using container traceability
in Lyophilization.
Speaker
Tod Urquhart is the founder and CEO of Eagas SLU - a company
which specializes in product traceability. Tod has more than
twelve years’ experience of working in the field of product,
serialisation, traceability and anti-counterfeiting

He has an extensive knowledge of planning, managing and

delivering cross functional serialisation projects for
pharmaceutical regulatory compliance as well as product
interaction and traceability.

Tod is currently supporting the Stevanato Group as the

Traceability Lead for Primary Container Traceability [PCT]. The
project covers product and process development, systems
integration across the different pharmaceutical manufacturing
steps and the creation of a common standard for the
Pharmaceutical industry.

2 COPYRIGHT © PDA 2021 PDA Lyophilization Conference 14th - 15th Sept 2021
1
Technical Overview

3 PDA Lyophilization Conference 14th - 15th Sept 2021

Creating container traceability
• Serialisation/Product traceability is a well known
technique used for regulatory compliance
covering >80% of prescription drugs globally

• A traceable container is a primary glass

container that has a unique digital identity

• The identity should be machine readable to

enable easy traceability in fill & finish processes

• A digital identity can be integrated with the data

management systems of modern manufacturing
machines

4 COPYRIGHT © PDA 2021 PDA Lyophilization Conference 14th - 15th Sept 2021
Process and testing data
COMPLETED TESTING

• Readability - Full range of camera systems

• Ink migration study
• Abrasion
• Accelerated ageing
• Stress analysis
• Mechanical testing
• Acid attack test
• EP 2.6.1 Sterility tests or equivalent
• FE-SEM analysis
• VHP Testing
NEXT PHASE TESTING

• Inspection testing – 1ml syringe

• Inspection testing - 10R Vial

5 PDA Lyophilization Conference 14th - 15th Sept 2021

Process overview

6 PDA Lyophilization Conference 14th - 15th Sept 2021

2
Container Traceability

7 PDA Lyophilization Conference 14th - 15th Sept 2021

The case for “container traceability”

• Today there is increased regulatory scrutiny on traceability for parenteral

manufacturing processes

• This scrutiny will increase as new drug types and formulation reach the market.

• Current traceability technologies are reaching the end of their technical limitations.

• New approaches are required where the solution is not constrained by the container
type or size.

• Any investments should be based on a flexible solution that can be scaled as

traceability and data requirements increase

8 PDA Lyophilization Conference 14th - 15th Sept 2021

Industry benefits – improving the entire drug life cycle

• Individual container visibility and traceability within each

parenteral process step

• Trace back potential issues within each process stage

• Drive prevention of product mix-ups

• Enable better segregation in the event of a process issue

• Improve patient safety and reduce drug shortages

• Maintaining ownership of the identity even if the

packaging/label has been damaged.

9 PDA Lyophilization Conference 14th - 15th Sept 2021

Container traceability through the internal supply chain

10 PDA Lyophilization Conference 14th - 15th Sept 2021

Unique container traceability through the manufacturing process

11 PDA Lyophilization Conference 14th - 15th Sept 2021

Current situation in the Freeze Drying process
• All vials are identical/equal
• Tracing per batch
• No detailed information about:
− Time
− Positions
− Batch information

ALL VIALS ARE IDENTICAL/EQUAL

ALL VIALS ARE IDENTICAL/EQUAL

12 COPYRIGHT © PDA 2021 PDA Lyophilization Conference 14th - 15th Sept 2021
100% Traceability → Unique Identifier
• Tracing per individual container LYODATA®
• Detailed information about:
– Batch ID
– Loading time
– Exact vial position during freeze-drying
– Unloading time
– PAT Data (for example online residual moisture)

ALL VIALS UNIQUE

13 COPYRIGHT © PDA 2021 PDA Lyophilization Conference 14th - 15th Sept 2021
 LYODATA® - Continuous traceability of primary packaging
GEA LYODATA® provides unique marking, clear identification
and consistent traceability of pharmaceutical freeze-dried
products, making drug counterfeiting practically impossible. The
system offers continuous quality inspection, 100% line clearance
and precise sampling.

Customer benefits:
• 100% traceability of product
• Compatible with GEA ALUS® automatic loading
and unloading system
• Unique marking and clear detection of product
• Continuous process and product monitoring
• 100% line clearance
• A reliable anti-counterfeiting system
• Promotes patient safety

14 COPYRIGHT © PDA 2021 PDA Lyophilization Conference 14th - 15th Sept 2021
3
Commercial Status

15 PDA Lyophilization Conference 14th - 15th Sept 2021

Current commercial status

• Pharmaceutical companies purchasing and using the product

• Samples under test in an additional 10 pharma customers in Europe, USA & Asia

• All formats & sizes are available

• Integration development with:

▪ Filling lines companies
▪ Inspection companies
▪ Lyophilisation manufacturers

16 PDA Lyophilization Conference 14th - 15th Sept 2021

Creating a common approach - ISPE Discussion document – Activity & participants

• Working group was established and supported

by ISPE. Participants are shown opposite

• The aim has been to create a common industry

standard for the use and implementation of
primary container serialisation

• The group met weekly to cover all topics from

glass through filling to automated inspection.

• Document was published by the ISPE on the 2 nd

February 2021

• ISPE is considering extending the work into 2022

with a Special Interest Group [SIG]

17 PDA Lyophilization Conference 14th - 15th Sept 2021

Summary
• Container traceability is an extension of existing regulatory solutions to deliver fill & finish
process insights and optimization

• Robust processes have been developed to ensure there is no impact on the container
integrity and they pass all process and sterilization requirements.

• There is a proven value proposition and business case for implementation

• Proven benefits within the Lyophilization process

• Project aim is to deliver Multiple stakeholders are involved to facilitate technology access
and an “Open Access” technology & solution for the industry.

• ISPE is looking to extend the existing discussion document into a more formal structure
to develop the concept for the industry

18 PDA Lyophilization Conference 14th - 15th Sept 2021

Acknowledgements

GEA Lyophil GmbH

Stevanato Group S.p.A