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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

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For any questions please contact

Dr. Kerstin Vieluf

kerstin.vieluf@idt-biologika.de

Thank You!