Make2Pack – An Overview DAu Seminar Nov. 9. 2010

1. Make2Pack – An OverviewDAu Seminar Nov. 9. 2010

2. NNE Pharmaplan at a glance • Over 80 years of experience in the pharmaandbiotechindustries • Spanned over 3 continents across Europe, North America and Asia • We employ over 1,600 people at more than • 25 locations in 12 countries around the world. Turnover 2009: DKK 1.488M, EUR 200M, USD 261M Automation & IT Knowledge & Experience • Independent Consultant & Implementation Partner • +300 employees many with 10+ years of experience • Deep cross disciplinary knowledge (API, Finished Goods, Devices, Laboratories) • Comprehensive business & regulatory understanding • Knowledge about how to use technology to provide business advantages • Setting the international standards & guidelines • Stay on site until the task is solved, even if others has given up

3. Agenda • Make2Pack – relations to OMAC, ISA, WBF • OMAC – Pack Standards • ISA 88 – Technical Report • ISA 88 Standards, Part 1,2,3,4 • ISA 88 Standard, Part 5 • Advantages by standardisation • Conclusions and recommendations

4. Relations – Who is OMAC? OMAC - Organization for Machine Automation and Control • Founded in 1994 as The Open Modular Architecture Controls User's Group • The global organization for automation and manufacturing professionals that is dedicated to supporting the machine automation and operational needs of manufacturing. • OMAC has about 500 members from end-user companies, OEM's, and technology providers and integrator companies. • Since 2005 a part of ISA but in 2010 OMAC separates from ISA.

5. Relations – Who is ISA? ISA - International Society of Automation • Founded in 1945, now with over 30,000 worldwide members • ISA is a leading, global, non-profit organization that is setting the standard for automation by helping members and other professionals solve difficult technical problems. • ISA develops standards and publishes books and technical articles • Provides education and training • Certifies industry professionals • Hosts conferences and exhibitions for automation professionals Mission • Become the standard for automation globally by certifying industry professionals; providing education and training; publishing books and technical articles; hosting conferences and exhibitions for automation professionals; and developing standards for industry. • Vision • To work in partnership with members, customers, and subject-matter experts to disseminate the highest quality, unbiased automation information worldwide.

6. Relations – Who is WBF? WBF - The Organization for Production Technology • WBF was founded in 1994, by people who were engaged in writing a new standard (SP88) about automation of procedural control in manufacturing in a batch processing environment, thus the name of the organization: “World Batch Forum”. Topics WBF addresses include: • Production Management Techniques • Information Integration • Automated Equipment Design • Control of Batch Process Operations • Process & Production Automation • Recipe Content, Format & Structure • Safety & Environmental Concerns • Compliance with FDA, EPA, OSHA • Application of Industry Standards • Evolving Technologies of Interest

7. Make2Pack – how did it start? • In May 2004 the WBF’s SP88 committee and OMAC held a meeting and decided to establish Make2Pack as an umbrella for collaboration between the two groups. • The Make2Pack Working Group provides a forum for the harmonization of models and concepts between OMAC PackML work and current work being done by the ISA's SP88 committee generally called Recipe-Equipment interface. • This work will result in direct input to the SP88 committee and the possible inclusion of packaging requirements as part of an SP88 Batch Control.

8. Guidelines for Packaging Machinery Automation V 3.1 OMAC Work Groups OMAC has two working groups: • Machine Tool Working Group • Machine Tool Working Group works with CNC controller vendors, CAD/CAM suppliers, and CNC OEMs to encourage support of OMAC-endorsed open-architecture specifications and other best practices through products and practices. STEP-NC and HMI-API are two subgroups. • Packaging Work Group • Packaging Working Group (PWG) seeks to maximize end-user and original equipment manufacturer (OEM) machine automation choices, increase flexibility, facilitate a smaller-footprint machine, achieve faster throughput, and reduce costs through greater industry openness and interoperability. Doing so will allow end users to “connect-and-pack” different technologies to meet business needs. • PWG has issued, • Guidelines for Packaging Machinery Automation v. 3.1 • PWG has five subgroups.

9. OMAC Packaging Work Groups Packaging Work Group’s five sub-groups: • PackAdvantage - Identifies and communicates to the packaging industry the benefits/Results of using "connect & pack" guidelines for packaging automation systems • PackConnect - defines the control architecture platforms and connectivity requirements for packaging automation systems • PackLearn - promotes awareness of Group initiatives by defining and developing programs to meet the educational and training needs of the industry • PackSoft - develops guidelines for machinery programming languages to ease learning, support transportability of software across platforms, and allow continuing innovation • PackML– develops naming convention guidelines for communications between production machinery within the packaging industry.

10. PackML V 3.0 PackTags V 3.0 PackAL V 1.0 OMAC Pack Documents The PackML sub-group has developed the following documents: • Packaging Machine Language Mode & States Definition Document, V3.0 • June 2006 • (PackML) • Tag Naming Guidelines, V3.0 • July 2006 • (PackTags) The PackSoft sub-group has developed the following document: • Packaging Application Function Library March 2006, V1.0 • March 2006 • PackAL

11. PackAL V 1.0 OMAC PackSoft Work Group • PackAL is an application library of common software elements used in packaging applications • 13 functions are machine functions, such as wind/unwind, dancer control, registration, and indexing • 9 functions are communication functions for horizontal line communications, and one function is for the PackML machine state model • The PackAL application library creates a common look and feel in software elements for functionality, communication and machine organization in packaging machinery

12. PackML V 3.0 OMAC PackML Content State Types • Acting, Wait, Dual States • Stopping, Stopped, Aborting, Aborted, Resetting, Idle, Starting, Execute, Suspending, Suspended, Unsuspending, Holding, Held, UnHolding Clearing, Completing, Complete • Execute is the only Dual State Unit Modes • Typical unit modes are Automatic, Semi-Auto, Manual, Index, Jog • Each Unit Mode has a State Model, consisting of a sub-set of above States. Unit Mode Manager • The mode manager determines how, and in what state a machine may change unit modes • The mode manager includes interlocks that prevent the machine changing at inappropriate states

13. PackML V 3.0 State Type: Dual State Type: Acting State Type: Wait State Commands OMAC PackML Content OMAC PackML State Model: Shown in Unit Mode: “Automatic”

14. PackML V 3.0 OMAC PackML Content OMAC PackML State Model: Shown in Unit Mode: “Maintenance”

15. PackML V 3.0 OMAC PackML Content Unit Mode Manager Unit Mode Manager: Controlled management of transition from one Unit Mode to another The mode manager determines how, and in what state a machine may change Unit Modes; ie. the Unit Mode Manager includes interlocks that prevent the machine changing at inappropriate states Mode transition

16. PackTags V 3.0 OMAC PackTags Content Tag Types • 3 Types exists – Control, Status and Administration Data Types, Units and Ranges • Integer, Real, Binary, String, Structure – a collection of data types. (This data type is typically reserved for higher level processors.) • Date/Time is not covered PackTag prefix • PML is used to identify that it is a PackML tag • PMLcwill represent that the tag is a “Control” tag with read / write access • PMLs will represent that the tag is a “Status” tag with read access • PMLa willrepresent that the tag is an “Administration” tag with read access • Example: • PMLc.UnitMode PMLs.UnitModeCurrent • Approximately 180 Pack Tags exists.

17. PackTags V 3.0 OMAC PackTags Content PackTags - Example

18. PackML V 3.0 PackTags V 3.0 ISA TR88.00.02 Technical Report • The Technical Report is an implementation guide, including examples • TR was issued August 2008 • It merges the PackML and PackTags – but not one-to-one ! • There are differences in terminology and definitions • PackAL – Function Libraries are not included • Contents: • Machine States • Acting State, Wait State, Dual State • Modes • Producing, Maintenance, Manual • PackTags • Status.StateCurrent • Date/Time • Implementation Examples • OEE Definitions • Alarm Codes • Weihen Stephan Harmonisation ISA88 Harmonisation and terminology

19. S88 Part 1 S88 Part 1 S88 Part 1 S88 Part 1 ISA S-88 Standard(s) • In daily speaking it is called S88 but it covers 4 parts • Part 1: Models and Terminology • Part 2: Data Structures and Guidelines for Languages • Part 3: General Site Recipe Models and Representation • Part 4: Batch Production Records

20. Automation & IT Functional Hierarchy S88

21. Automation & IT Functional Hierarchy Automation & IT Functional Hierarchy S95 S88

22. Automation & IT Functional Hierarchy Automation & IT Functional Hierarchy S95 S88 OMAC

23. Enterprise S88 Part 5 Contains one or more Site Site Contains zero or more Area Area Contains one or more ISA S-88 Standard – Part 5 • S88 Part 5,Working Draft no. 6 issued July 2010 • Part 5: Implementation Models & Terminology for Modular Equipment Control • Provide hierarchical structure for defining and implementing the control found in Control Module and Equipment Module entities.

24. Automation & IT Functional Hierarchy Automation & IT Functional Hierarchy S95 S88 OMAC S88 Part 5

25. S88 Part 5 ISA S-88 Standard – Part 5 Content • Control Module • Control Modules must ultimately combine with a device. • It may do so through other Control Modules, or be the first point of contract between the logical control realm and the physical world. • Equipment Module • Coordinate the functions of other Equipment Modules and Control Modules

26. S88 Part 5 ISA S-88 Standard – Part 5 Content • Procedural Interface State and Command Model

27. S88 Part 5 ISA S-88 Standard – Part 5 Content • Automation Object • Functional Strategy: • Core control in the Automation Module • Devices that would be implemented in a Functional Strategy are Servos, Material Transfers, Bipolar Devices, Two-way Valves, Motors, Pumps • Part 5 will not define functional strategies.

28. S88 Part 5 ISA S-88 Standard – Part 5 Content • Automation Object • Functional Manager: • Receives command and control attributes from a supervisory source (another AM, a HMI etc.) • Command attributes cause an action to be performed in the Functional Strategy • Includes status attributes that provide status of commands and control signals

29. S88 Part 5 ISA S-88 Standard – Part 5 Content • Automation Object • Resource Manager: • The Resource Manager is designed to regulate who is able to command the FS • Only the supervisory source specified by the Resource Manager will be allowed access to the functional strategy by the Function Manager

30. S88 Part 5 ISA S-88 Standard – Part 5 Content • Automation Object

31. Danish Keyboard Layout Swedish Keyboard Layout A world without standards!

32. Interfaces • Uniform • Easier to expand and integrate • Development • Independent of programmers • Faster implementation • Easier to test • Easier to test • Standard test plans • Ease of re-use • Support • Global support independent of “who made the program” • Maintenance • Only need to know one standard End User OEM • Interfaces • Easier to integrate with supervisory systems and other OEM machines • Flexibility • Less dependent on people and OEM’s • Re-use • Easier to re-use applications across customers Progress and Innovation Lowering costs • Operations • Uniform layout and “language” • Ease of operation Advantages by standardisation

33. Make2Pack – Conclusions • OMAC has come a long way with the Pack standards • PackML, PackAL and PackTags • OMAC is facing new challenges since they are now not part of ISA • Make2Pack organisation is in Idle mode! • Lately the effort has been used in updating ISA-88 Part 1 • Tehnical Report OK – but what about PackAL? • Too few people!? • Marketing is needed • ISA 88 Part 5, Working Draft July 2010 • Very difficult to find the link to the PackML standards! • More related to ISA 88 Part 1,2,3,4 • Much work is needed if it shall be used as a standard for Packaging • The risk! • Without agreed and approved standards we see propreiteray solutions from the automation suppliers

34. PackML V 3.0 PackTags V 3.0 Guidelines for Packaging Machinery Automation V 3.1 Recommendations • Read the OMAC documents first • PackML and PackTags • PackAL is included in “Guidelines for Packaging Machinery Automation” • Then read the Technical Report • ISA - TR88.00.02 • To avoid confusion…… • Don’t read the ISA88 Part 5, Working Draft yet!

35. The future dream!

36. Thanks!