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IDT Biologika
October 2017
Solutions for Serialization of Pharmaceutical Products
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IDT Biologika
IDT Biologika is a specialized
CDMO for viral vaccines and
biologics.
IDT Biologika is a company of the
family-owned Klocke Group with
more than 2,300 employees at 9
producing and distributing
locations in Europe and North
America.
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Facts and Figures
OwnersHartmut, Carsten and Stefan Klocke via the Klocke Group
Executive ManagementDr. Ralf PfirmannAndreas Kastenbauer
Financing> 50% equity of balance sheet totalflexible multi-year syndicated loan
8%of revenue
dedicated to research &
development
€190,3 millionrevenues in
2016
1,680employees in
2016
€380 millioninvested by IDT
since 1993, €180 million between 2011 and today
WorldwideIDT works with
customers around the world
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• Leading state-of-the-art manufacturing
technology from sterile filling to final packaging
• Services from pharmaceutical development to
distribution-ready packaging of final drug
products
• Flexible capacities from clinical test samples
to commercial production
IDT –CDMO Specialized for Sterile Injectables
Injectable Sterile Biologic Finished Drugs – Efficient and Reliable Quality Production
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Capabilities and Capacities in Packaging
• Modern facility with more than 2,000 m² for
packaging processes
• Services from manual to full-automatic
packaging of vial, ampoules and pre-filled
syringes
• Packaging lines for single and multi component
packages
• Innovative packaging solutions in cooperation
with Klocke Group companies
• Track& Trace Capabilities
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Track & Trace –Regulatory Background US
• Law H. R. 3204 „Drug Supply Chain and Security Act“ was enacted in November 2013
• From November 2018 (postponed from 11/2017)
• Smallest sellable unit (folding box):
• Serialized GS1-compliant Data Matrix Code with
• GTIN (Global Trade Item Number)
• Serial Number
• Batch Number
• Expiry Date
• Aggregation up to bundle (=case at IDT)
• HDA guideline as FDA recommendation
• From November 2023 (USA)
• Aggregation up to pallet
• Documentation of serial numbers and logistic-events along the supply chain
(Track & Trace)Further Information: http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupplyChainSecurityAct
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Track & Trace –Regulatory Background EU
• Delegated regulation (EU) 2016/161 for the implementation of the anti counterfeit
guideline 2011/62/EU came in effect on 09 February 2016
• From February 2019
• Smallest sellable unit (folding box) :
• Tamper evident closure (safety seal)
• Sealing label at IDT technology to be implemented at every packaging line without glued flaps
• Glued flaps at IDT tamper evidence solution on high throughput multi component packaging line
• Integrated tamper evident closures
• Serialized DataMatrix Code with
• PPN (International Pharmacy Product Number)
• Batch Number
• Expiry Date
• Serial Number
Further Information: http://www.securpharm.de/fileadmin/pdf/Infopapier/Infopapier_2016.pdf
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Besides the US and EU, other country-
specific regulations already call for
serialization to a variable extent.
Examples:
• China
• South Korea
• Saudi-Arabia
• Russia
Global Needs for Track & Trace
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IDT offers technical solutions for a multiple level aggregation
from folding box, over bundle up to pallet.
Serialization Level
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Packaging lines are / will be equipped with machines for:• Tamper-evident seal application
• Serialization of folding boxes (printing and camera control)
• Aggregation units for bundles and pallets
On all current projects IDT works in a strong cooperation with the partner Wipotec-OCS.
With their TQS (traceable quality systems) modules IDT can offer tailor-made solutions for all project-specific demands.
Upgrade of Packaging Lines for Serialization Applications
Strong Partnership with Wipotec-OCS
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• Vial packaging line equipped for serialization for commercial
products for the Chinese market
• OCS serialization station and aggregation station (2 levels)
• Automated packaging line for PFS with and without safety
device
Examples for Packaging LinesFrom Ampoules to PFS with Safety Device or Autoinjector
• Automated denesting, blistering, cartoning
• Optional: Assembly with safety device
• Serialization station and tamper-evidence sealing for EU market available in 2018
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Multipurpose packaging line for various formats and kit packaging
Examples for Packaging LinesFrom Ampoules to PFS with Safety Device or Autoinjector
• Vials, injection pens, blistered syringes,
combination packs (e.g. vials + syringes)
• Actual project: Implementation of
Serialization Station and Aggregation
Station for different market needs
(US, EU, ROW (e.g. South Korea))
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Secure Data Exchange OptionsAtlantic Zeiser as Competent Partner
IDT Database solution for serial numbers/SSCC (Serial Shipping Container Code) is developed in collaboration with Atlantic Zeiser.
• The solution provides:• Exchange of serial numbers/ SSCC with customers
(number pools for upcoming productions and used numbers for finished productions)
• Open system for exchange with other data base systems
• Check of data logic and uniqueness of serial numbers
• Administration and dispatching of serial numbers for production
• Exchange of serial numbers/SSCC with packaging lines (unused for upcoming productions and used for finished productions)
• Archiving of serial numbers/SSCC
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Level 4 site manager solution named „MedTracker“ from Atlantic Zeiser
for Track & Trace will provide standard interfaces to connect the Track &
Trace solution of our customers (actual projects include SAP Pharma
Network & TraceLink).
EPCIS based Serialized Data transmission
Flexible Solution for Data TransferCooperation with Atlantic Zeiser
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Different options for generation/exchange of number pools can be
offered:
1. IDT generates S/N on its own corresponding to customer standards
2. The IDT Level 4 solution contacts the customer source of S/N
• IDT will send a standard message request with certain information to
identify via technical interface
• The customer solution or 3rd tier provider will respond in a specified
and coordinated way
Transfer of used number ranges:
• Each serialized order includes a customer specific report containing
used serial numbers as well as aggregation data, if needed
• Data will be organized and transferred via MedTracker
Flexible Solution for Number Generation and Handling
Support on different levels
