Purdue Pharma Serialization
Overview
Sajan Idicula
Sr. IT Lead, SAP Warehouse & Distribution
Tech Ops – IT
973 – 837 – 5401
John Corona
Sr. Manager – Packaging & Project Management
Tech Ops – Production
983 – 837 - 5050
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Purdue Pharma Serialization
Overview
Purdue Pharma L.P., is a privately held pharmaceutical
company founded by physicians John Purdue Gray and
George Bingham in 1892 in Manhattan and now located in
Stamford, Connecticut.
In its early years, Purdue was known for its antiseptic
product, Betadine Solution, and its Senokot laxatives.
Today, it is best known for its pain treatment products, but it
has also branched into other areas such as oncology and
nutraceuticals.
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1969 - Betadine® Surgical Scrub is used to decontaminate the
Apollo lunar module after Neil Armstrong's moonwalk.
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Purdue Pharma Serialization
Overview
• Purdue has been serializing CII product since 2004 to
satisfy a customer request.
• Approximately 4.5 million serial numbers are captured
per year.
• RFID was the preferred serialization method from 20042012.
• December 2012 Purdue upgraded their packaging line
and Warehouse systems to use 2D DataMatrix code to
serialize C II products in addition to RFID.
• Purdue has successfully Shipped RFID and 2D product
since Jan 2013 to customers.
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Purdue RFID Timeline
• First item-level RFID
implementation (Nov. 2004)
• Update/expansion of original pilot
(May 2007)
• 3rd party solution implementation
(April 2008)
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Original RFID Pilot (2004)
• October 2003 - Wal-Mart Requirement (RFID
Guidelines and Requirements for CII Pharmaceuticals)
• UHF Class 0 (Matrics/Symbol/Motorola) Tags used
• Bottles tagged at the item-level. No case-level tags –
no aggregation
• First item-level RFID implementation
• Limited Lifespan due to upcoming Gen2 UHF
technology
• Largely a “bolt-on” solution on one packaging line
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Lessons Learned (circa 2004)
• UHF Class 0 had potential but challenges remained
• Reading 48 tags (and only 48 tags) per case is a challenge
• A case tag aggregated to the items inside would have been
nice to limit the amount of times that full cases needed to be
read
• Tag quality is uneven so prequalification of the tags at label
converter is a necessity
• “Ghost tags” show up in the database occasionally
• Pre-writing the chips at the factory presented a logistical
nightmare
• The hardware necessary is relatively inexpensive, software
infrastructure necessary is expensive
• Software infrastructure is largely “frequency agnostic”
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Scope of UHF Gen2 project
• Select appropriate software vendors
• Select appropriate hardware vendors
• Select appropriate Gen2 tag suppliers
• Make process improvements from initial pilot:
• Integrate RFID functions into the existing packaging
lines
• Add a case-level tagging and aggregation
• Improve warehouse processing
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UHF Gen2 project -Decision Drivers
• Systech software was already running the packaging
lines and working well
• Experienced from most initial RFID pilots in pharma
• Packaging line software needed upgrading anyway
• Hardware was determined via a testing matrix that
combined multiple hardware vendors with different
tags using Systech software
• Testing occurred over a 2 week period at Systech
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UHF Gen2 project- Go Live
• The first Gen2 tagged lot packaged on May 31,
2007
• Original plan was to do a controlled launch for a few
partner pilots using one packaging line
• 2nd packaging line installation was scheduled to
begin approximately 2 months after the first
• The success of the Gen2 implementation on the first
packaging was apparent very quickly after
production packaging began….
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Transition to 2D Serialization
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2D- Serialization Data Overview
• Bottle Label- Pre-encoded at label converter
• Data- (01) GTIN + (21) serial number + (17) Expiration date +
(10) Batch/ Lot # + GS1 DataMatrix label. (please note current
GS1 standards require all 4 pieces of information)
• Bundle Label- Encoded and applied on packaging line and
represents 6 bottles shrink wrapped.
• Data- (01) GTIN + (21) Serial # + (17) Expiration date + (10)
Batch/ Lot # + (30) Count of Items GS1 DataMatrix with human
readable redundancy
• Case Label- Encoded and applied on packaging line and represents
48 bottles.
• Data- (01) GTIN + (21) Serial # + (17) Expiration date + (10)
Batch/ Lot # + (30) Count of Items GS1 DataMatrix with human
readable redundancy
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2D- Serialization- Process Overview
• On the label web the bottle label is inspected to insure that
the 2D code and the human readable serial number match.
• This inspection is done along with the lot number and
expiration date verification.
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2D- Serialization- Process Overview
• An unique identifier is printed on the cap with a Domino
inkjet printer.
• This code is printed and inspected on the infeed of a
Weiler Rotary labeler.
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2D- Serialization- Process Overview
• On the Weiler labeler turret this inspection reads the bottle
label 2D code and “Marries” it with the identifier code on the
cap.
• This inspection is done along with the label placement
verification.
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2D- Serialization- Process Overview
•
•
Once the bottles have been bundle they pass through an IMA bundle
labeler where this inspection reads all of the identifier codes and assigns
(aggregates) the bottles to a bundle.
If this inspection successfully reads all of the identifier codes and each
identifier code was successfully commissioned with a bottle label back at
the labeler, a bundle label will be applied to the bundle.
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2D- Serialization- Process Overview
Once the bundle label has been printed and
applied, it is inspected to insure the label is
correct.
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2D- Serialization- Process Overview
• Once the bundles have passed the labeling and inspection process,
they are collated and place in the shipper case by an IMA automatic
case packer.
• A camera is positioned high above the case and will inspect the bundle
labels after they are placed inside the case, if all of the bundles are
read and are verified to have completed the bundle labeling process a
case label will be printed and applied to the case.
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2D- Serialization- Process Overview
Once the case label has been printed and applied, it is
inspected to insure the label is correct.
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2D- Serialization- Data Interface to
SAP
• Serialization data captured in Packaging Line which has the
hierarchy relationship (Case Bundle Bottle) is transferred to an
application called Systech Guardian.
• Systech Guardian transfers the hierarchy data to SAP using an
SAP tool PI.
•
Some of the key Data passed to SAP
•
•
•
•
Material
Batch
Hierarchy info
Serial number
• SAP- The serialization data is held in core SAP ECC as Handling
units.
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2D- Serialization- Systech Guardian
Interface
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2D- Serialization- Sample XML file
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2D- Serialization- Data Interface to
SAP
• Parent Child Hierarchy is maintained in SAP Handling Units.
• Serialization Data stored in custom objects.
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2D- Serialization- Data Interface to
SAP
• The Serialization data is stored in SAP till a customer order is
received and ready for shipment.
• Outbound Shipment process links the serial numbers, Material,
Batch and Customer order number in a SAP system called XPS.
• Purdue uses both RFID and 2D hardware to capture and assign
serial numbers to the customer orders in the warehouse.
• The SAP user interface was custom built for Purdue in SAP
XPS.
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Purdue Pharma Serialization
Overview
All Items to
pack and
Ship to a
customer
order
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2D- Serialization- Data Interface to
SAP
Custom screen used to capture both RFID and 2D serialized product
information to customer order.
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2D- Serialization- Data Interface to
SAP
• SAP reports were built so end users can search serial
number information.
• Next Steps-Prepare for DQSA requirements going into
effect 2015.
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Purdue Pharma- DQSA
Requirements Overview
• Drug Quality and Security Act signed into law Nov 27, 2013
• Two Key Areas of the Bill:
• Drug Compounding
• Drug Supply Chain Security
• Federal solution for Rx lot level tracking and eventually unit/case
level serialization
• 1 year after enactment, FDA to issue final regulation
• Preempts California (and other state) legislation
• Defines requirements for Manufacturers, Wholesalers, Retailers
• Effective January 1, 2015
• Lot level transactions and tracking through entire supply
chain
• Ability to segregate suspect product and conduct recalls
based on lot traceability
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Purdue Pharma- DQSA
Requirements Overview
• Key deliverable for 1/1/15 requirement is for
manufacturers to provide in paper or electronic form
Lot Level:
• Transaction history
• Mfg is starting point, not CMO or CPO.
• Transaction information
• All required data is in SAP. Need to determine best methodology to
provide to customer
• Transaction statement
• Legal statement
• Next key deliverable - November 2017
• Manufacturers to provide 2D serialized units and case
coded product
• Include serialized data as part of Transaction Information
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DQSA FDA Guidance Development
• Public Docket
• Opening 2/20 to receive information and comments on
standards for the interoperable exchange of information
(TH, TI, TS)
• Expecting 2 public meetings.
• PhRMA Activities
• Working Groups
• Standards for Interoperable Data Exchange
• Suspect and Illegitimate Products
• Pharmaceutical Distribution Security Alliance (PDSA)
• GS1: standards development body (TI, TH construct)
• Final FDA Guidance due November 2014
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Purdue Pharma- DQSA Next Steps
• Created Steering committee- Commercial,
Operations, Quality, Supply Chain, Engineering, IT,
Package Design, Regulatory, Law, Security
• Meeting with external IT solution providers for Lot
data exchange capabilities
• Discuss with customers implementation
expectations
• Participate/monitor standards development
• Draft lot level implementation plan/timeline.
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Thank You!
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