What Matters

Seven Steps for Serialization-Ready Machines

Serialization requires a comprehensive control system to track-and-trace

products in manufacturing and through the entire supply chain.

This system must be designed to address the increasing threat from

vulnerabilities, such as counterfeit and misbranded prescription drugs.

The process starts at the manufacturing and packaging line, with

serialization-ready machines.

Here are seven actions machine builders can take to help ensure their

machines are serialization-ready for customers:

1. Migrate to an o�� -the-shelf control system: When building

serialization-ready machines, OEMs need commercial, o -the-shelf

technology that’s modular, scalable and uses standard communication

and protocols. Users with “black box control” (i.e., custom control

systems) often face issues with long-term support, parts and knowledge

transfer that make it di cult to accommodate new serialization

legislation. O -the-shelf control and information technology – such as

vision, printing and checkweighing equipment, MES software and an

information-enabled programmable controller – can save customers time

and money as new legislation is passed.

In This Issue of

What Matters

Pharmaceutical counterfeiting is on

the rise – and a growing health and

safety issue with deep consequences

for consumers and manufacturers

alike. A number of factors contribute to

counterfeiting, including:

• Increased involvement of

under-regulated wholesalers and

repackagers in the supply chain,

• Proliferation of online pharmacies,

• Counterfeiting technology

advancements, and

• Increased importation of

gray-market medicines.

To combat counterfeiting, pharmaceutical

manufacturers are putting serialization

processes in place – whereby each item

is assigned and marked with a unique

serial number. Manufacturers and retailers

can then identify and track each unit

throughout the supply chain, providing

greater visibility and traceability.

But before this can happen,

manufacturers need machines that

are designed for serialization. These

machines are information-enabled so

they can receive serial numbers from

a manufacturer’s IT layer, print and

inspect the codes on the product, and

feed the authenticated data back up to

the IT layer or MES. For pharmaceutical

manufacturers, machines that are

serialization-ready will be the

obvious choice.

This issue of What Matters discusses

actions OEMs can take to help ensure

their machines are serialization-ready

for customers.

Information from Rockwell Automation for OEMs

2. Build a modular and scalable machine: A modular

machine combines serialization data management with

high-speed device management to help conform to

current and potential regulations, without compromising

Overall Equipment E ectiveness (OEE). To cater to varying

legislation, end markets and cost pro les, end users

need modular machines using commercial o -the-shelf

products for each step of the serialization process.

The typical process involves three stages: printing and

verifying, product handling with serialization aggregation,

and  nally product traceability with integrated data

systems that share information with operations, IT,  nance

and supply-chain business units.

3. Examine the machine’s data segmentation capabilities:

The data  owing through the serialization process needs

to be kept secure and segmented. OEMs can use industrial

managed switches to help customers properly segment

their networks. The managed switches can help these

sensitive applications run securely and reliably on an

EtherNet/IP™ network, while providing customers with

easier access to manufacturing metrics.

4. Choose a control system designed for high-speed,

mass data handling: A serialization-ready machine’s

control system should include an operator interface

integrated with a programmable automation controller

by a dedicated Ethernet control network architecture,

for streamlined data communication across the end-user

plant. The system should provide for the generation,

randomization, aggregation, synchronization and

management of serial numbers on all product-packaging

levels. It should be in accordance with EPC Information

Services (EPCIS) standards and support the transaction of

serialization data to third-party systems, such as SAP, IBM

and contractor systems. It also should support transactions

to global-hosted serialized data vaults and databases from

authorities and government organizations.

5. Allow for device-independent integration: Printers,

vision-inspection camera systems, handhelds and

RFID equipment should be able to integrate with the

control system for all serialization line-level components

from one cabinet. This add-on capability helps ensure

minimal interruption of the production process and

simpli ed validation. Integration of high-speed coding

and veri cation capabilities also should meet industry

standards, including EPCIS.

6. Take a proactive approach to supporting customers:

OEMs need to stay ahead of the curve when meeting

current and future customer needs. By partnering with a

supplier of modular and  exible control and information

systems, OEMs can deliver serialization-ready machines

that meet existing regulations and are easy to modify for

future requirements.

OEMs also can partner with suppliers to provide remote-

support services. Once a production line is serialized, all

assets within the serialization system become production

critical. If any part of the system stops working, the

entire serialization process and subsequently the entire

packaging line must stop. End users often call their

OEM to dispatch a service technician if machinery isn’t

working properly. For OEMs doing business on a national

or global scale, this type of support can be costly and

time-sensitive. Working with a supplier that can service a

machine in areas where the OEM cannot cost-e ectively

send resources helps cut operational costs throughout the

life cycle of equipment.

Remote support also can be an additional revenue

source for OEMs. For example, using the Virtual Support

Engineer™ service from Rockwell Automation allows OEMs

to respond to critical situations and execute preventive

maintenance remotely, while realizing a new source of

revenue through aftermarket support.

7. Build machines that ease validation: Before operating

a new machine, an end user needs to test that the

machine will do what it is designed to do. Prior to that,

the OEM needs to do the same. Building machinery with

a modular, standardized control and information system

can help ease the validation process for both parties

because OEMs can create a re-usable template for the

validation documents.

By following these seven tips, OEMs can deliver

serialization-ready machines that allow end users to more

easily combat product-counterfeiting issues. Building

serialization-ready machines is a powerful way for OEMs to

di erentiate themselves and uncover new revenue sources.

Case In Point

As the demand for baby formula in China skyrockets, consumers are becoming more informed about selecting quality

formula in the wake of recent news of contaminated product in stores. In order to sell in China, a major European pro-

ducer of infant formula needed to meet quality standards and improve consumer con dence in its products. The com-

pany implemented a serialization solution from Rockwell Automation, based on Allen-Bradley® ControlLogix® controllers

and FactoryTalk® ProductionCentre® software, to secure its supply chain in Asia and provide peace of mind to consumers.