Solutions for Serialization of Pharmaceutical Products AWS
Solutions for Serialization of Pharmaceutical Products
IDT Biologika
October 2017
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.
2
Facts and Figures Owners Hartmut, Carsten and Stefan Klocke via the Klocke Group
€190,3 million revenues in 2016
Executive Management Dr. Ralf Pfirmann Andreas Kastenbauer
Financing > 50% equity of balance sheet total flexible multi-year syndicated loan
1,680
8%
Worldwide
€380 million
employees in 2016
of revenue dedicated to research & development
IDT works with customers around the world
invested by IDT since 1993, €180 million between 2011 and today
3
IDT –CDMO Specialized for Sterile Injectables Injectable Sterile Biologic Finished Drugs – Efficient and Reliable Quality Production •
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
4
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 5
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 • • • •
•
Aggregation up to bundle (=case at IDT) •
•
GTIN (Global Trade Item Number) Serial Number Batch Number Expiry Date 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
6
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
7
Global Needs for Track & Trace Besides the US and EU, other countryspecific regulations already call for serialization to a variable extent. Examples: • China
• South Korea • Saudi-Arabia • Russia
8
Serialization Level IDT offers technical solutions for a multiple level aggregation from folding box, over bundle up to pallet.
9
Upgrade of Packaging Lines for Serialization Applications Strong Partnership with Wipotec-OCS
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 tailormade solutions for all project-specific demands.
10
Examples for Packaging Lines From Ampoules to PFS with Safety Device or Autoinjector • 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 • Automated denesting, blistering, cartoning • Optional: Assembly with safety device • Serialization station and tamperevidence sealing for EU market available in 2018 11
Examples for Packaging Lines From Ampoules to PFS with Safety Device or Autoinjector Multipurpose packaging line for various formats and kit packaging • 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))
12
Secure Data Exchange Options Atlantic 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) 13 Archiving of serial numbers/SSCC
Flexible Solution for Data Transfer Cooperation with Atlantic Zeiser 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
14
Flexible Solution for Number Generation and Handling Support on different levels 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 15
Thank You! For any questions please contact Dr. Kerstin Vieluf [email protected]
16
IDT Biologika
October 2017
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.
2
Facts and Figures Owners Hartmut, Carsten and Stefan Klocke via the Klocke Group
€190,3 million revenues in 2016
Executive Management Dr. Ralf Pfirmann Andreas Kastenbauer
Financing > 50% equity of balance sheet total flexible multi-year syndicated loan
1,680
8%
Worldwide
€380 million
employees in 2016
of revenue dedicated to research & development
IDT works with customers around the world
invested by IDT since 1993, €180 million between 2011 and today
3
IDT –CDMO Specialized for Sterile Injectables Injectable Sterile Biologic Finished Drugs – Efficient and Reliable Quality Production •
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
4
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 5
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 • • • •
•
Aggregation up to bundle (=case at IDT) •
•
GTIN (Global Trade Item Number) Serial Number Batch Number Expiry Date 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
6
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
7
Global Needs for Track & Trace Besides the US and EU, other countryspecific regulations already call for serialization to a variable extent. Examples: • China
• South Korea • Saudi-Arabia • Russia
8
Serialization Level IDT offers technical solutions for a multiple level aggregation from folding box, over bundle up to pallet.
9
Upgrade of Packaging Lines for Serialization Applications Strong Partnership with Wipotec-OCS
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 tailormade solutions for all project-specific demands.
10
Examples for Packaging Lines From Ampoules to PFS with Safety Device or Autoinjector • 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 • Automated denesting, blistering, cartoning • Optional: Assembly with safety device • Serialization station and tamperevidence sealing for EU market available in 2018 11
Examples for Packaging Lines From Ampoules to PFS with Safety Device or Autoinjector Multipurpose packaging line for various formats and kit packaging • 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))
12
Secure Data Exchange Options Atlantic 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) 13 Archiving of serial numbers/SSCC
Flexible Solution for Data Transfer Cooperation with Atlantic Zeiser 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
14
Flexible Solution for Number Generation and Handling Support on different levels 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 15
Thank You! For any questions please contact Dr. Kerstin Vieluf [email protected]
16
