Track&Trace: Getting Prepared

Transcription

1 Track&Trace: Getting Prepared Florian Maurer Seidenader Maschinenbau GmbH 1

2 Agenda Introduction Körber Seidenader Track&Trace, why? Seidenader Track&Trace Solutions 2

3 COMPANY PROFILE. 350 Employees worldwide 78 Local branches worldwide Headquarter: Markt Schwaben T&T Software competence center: Schwäbisch Hall 120 Years of experience in pharma 2011 A company of Körber Medipak Systems AG Seidenader Headquarters Markt Schwaben / Germany 3

4 OUR PARTNER. MICHAEL KURAKO LTD. 16 Highly Qualified Employees Headquarter: Moskow Industries: Pharmaceutical industry, Food industry, Cosmetic industry Area: Russia, Ukraine, Belarus, Georgia, Kazakhstan Expertise: One stop shop for the above mentioned industry ranges for the sourcing of special machinery and project delivery. One-hand responsibility from Michael Kurako Ltd. Success story: More then 300 machines and fully equipped lines were sold in CIS countries Seidenader Headquarters Markt Schwaben / Germany 4

5 TRACK&TRACE, WHY? 5

6 RISK OF A PHARMACEUTICAL PRODUCTION. Counterfeiting Manufacturing of inferior copies of a genuine branded product labeled with the original brand name. Gray Marketing Unauthorized distribution of branded products.. Product Mix- Up The risk of the wrong product being put into distribution. Risks Loss in revenue Loss in profit Loss in brand equity Potential lawsuits SERIALIZATION: The Solution to significantly reduce the impact of these issues. AGGREGATION: Guarantees full traceability of each single item throughout the distribution chain. 6

7 GETTING PREPARED FOR THE RUSSIAN REGULATION General Russian Track & Trace pilot System for the Monitoring of the Movement of Drugs from the Manufacturer to the End Consumer via Labeling Applicable Regulation: Priority project pass (October 2016); Draft of Track & Trace related changes to the Federal Law 61. Serialization Requirements (according to GS1 specification) AI (01) = GTIN 14 digits created locally at GS1 RUS AI (21) = Serial number 13 digits AI (10 ) = Batch number not obligatory to be included in code not more then 20 digits. Important Notes: Requirements for the current Pilot phase are expected to be directly used for obligatory implementation Scope covers all human drugs Serialization & Aggregation Tamper evidence is voluntary AI (17) = Expiry date not obligatory to be included in code YYMMDD (6 symbols) can use 01 instead of DD AI (240) = Customs code 4 symbols 7

8 Who is affected by integration of a serialization project? A serialization project has much more complexity than it seems to have. The following internal departments need to be involved: Management Procurement Production Maintenance IT (incl. ERP, MES, Logistic etc.) Supply Chain QA Marketing Art Work etc. 8

9 Who is affected by integration of a serialization project? A serialization project has much more complexity than it seems to have. The following external suppliers / partners need to be involved: SW-Provider (ERP, MES etc.) Machine OEM(s) Engineering companies System integrator(s) Supply Chain Partner Packaging material supplier (e. g. Rondo) Print Shop Customer Public authorities (e. g. to accept changes of flip carton layout) etc. 9

10 Lessons learned and feedback from our customers A serialization project has much more complexity than it seems to have. Our customers and we learned a lot: Start Early pilot early Do not underestimate complexity especially information technology aspects Partner with your serialization provider and align on the deployment schedule Build technical and operational knowledge Consider all impacts to your organization Develop tools and toolkits to enhance competencies through your organization Communicate never too much 10

11 Seidenader Track&Trace Solutions 11

12 Seidenader Track&Trace Solutions Your request, our solution! Serialization/aggregation on each packaging level Requirements of different target markets (e.g. French Coding, China Coding, Korean Coding) Manage multiple lines and centralized data management Interface to MES and ERP systems Interface to MOH-Hub Integration into 3 rd party machines 12

13 Seidenader Track&Trace Solutions Comprehensive Track&Trace Solution from one single source for the whole packaging line Consulting/Feasibility Software Hardware incl. machine building Project engineering Service Project / Program Management Documentation Training SLA (Service Level Agreement) Life Cycle Management 13

14 Serialization and Aggregation at a glance Seidenader Track&Trace ItemUnit (in-line and off-line) Printing and verification (serialization) With label applicator (e.g. Bollini) Tamper evidence (product security) AggregationUnit (e. g. at case level) Optimized for more safety and convenience manual or integrated AggregationUnit S/N tracking optimized 14

15 Seidenader Track&Trace Solutions Expert Software Features Same HMI look & feel throughout all Seidenader Track&Trace products Easy to use for switching personal between different stations Intuitive HMI Support of different printing and labeling systems: Direct printing (Laser, Ink-jet) Label printing & application Integrated Label Designer for all supported printing systems 15

16 Seidenader Track&Trace Solutions Item Expert Software Features Support of different vision systems Seidenader Vision System 3 rd party vision kits (e.g. Cognex) Integrated Label Designer for all supported vision systems 16

17 Seidenader Track&Trace Solutions Item Serialization ItemUnit Advantages: Modular design Subsequently expandable Wide range of product dimensions Features: Four-belt product transport Print (Thermal-Inkjet or Laser) Verification by camera Item Serialization 1-2 rejects by compressed air or pusher 17

18 Seidenader Track&Trace Solutions Item Serialization ItemUnit-Tamper Evident Advantages: Meets all regulations especially Europe 02/2019 Tamper Evident and Print&Verify with only about 1,24 m machine length Features: Item Serialization and Tamper Evident Label application 1-2 rejects by compressed air or pusher 18

19 Seidenader Track&Trace Solution Aggregation of serialized elements to each pack level: - modular - scalable Manual Workstation Line Controller Aggregation Expert Seidenader AggregationUnit-Single Element, -Side Layer and -Top Layer Integrated (combined solution inline) Line Controller Aggregation Expert Seidenader AggregationUnit- Integrated 19

20 Seidenader Track&Trace Solutions Seidenader work with global and local packaging solution providers and integrate hard and software solutions with the full feature set and proven stability into 3 rd party machines. References Seidenader Track&Trace Solutions 20

21 Seidenader Track&Trace Solutions Serialization/aggregation on each packaging level! Seidenader has been implementing Track&Trace Solutions for ten years and provides this experience in a reliable modular software solution to realize serialization and aggregation on each packaging level. Focus Reduce integration effort Use Seidenader Track&Trace Solutions know-how Adapt flexibly to customer needs Stability of customers investment Seidenader Track&Trace Solutions 21

22 Seidenader Track&Trace Solution Questions? Visit us at the Kurako booth No. Pav.2, Hall 8, Booth B

23 Thank you very much for your attention! Seidenader Track&Trace Solutions 23