SERIALIZATION AGGREGATION TRACEABILITY

Implementing drug serialization and aggregation: A CMO’s case studyThis case study examines a CMO’s multi-sites, multi-lines implementation of a serialization and aggregation software solution to address regulatory requirements from China, South Korea, Brazil and the USA.

CASE STUDY

Action Plan

In order to adapt to the existing installation and prepare for future implementation and upgrades, the Adents Pharma Suite was selected and deployed at 4 different sites on 7 lines. It included:

• For each site: A centralized configuration and process software at site level (Adents Pharma Supervisor) enabling interface with ERP and EPCIS systems, multi-line configuration and serialization parameters management for country-specific requirements.

• For each line: a line level process execution software (Adents Pharma Pilot) connected to site level software and operating with various line equipment to deliver unit serialization, multi-level aggregation and rework.

The first line was installed in 3.5 months and included the following steps:• Documentation (Project Quality Plan,

Functional analysis, protocols): 1 month• Set up and qualification by Machine builder

(FAT & SAT): 2 weeks• Set up in client plant by Adents

(configuration and installation : 1 week• Qualification in Adents office (FAT): 1 week• Qualification in client plant (SAT): 1 week

Each of the other lines were installed in less than 2 months, with the biggest impact to the timeline being the need to install in a new entire packaging module. A rework station was set up on each line as well.

Line downtime: Because a comprehensive Factory Acceptance Test (FAT) was performed by Adents upfront, line downtime reduced to a maximum of 1 week for new qualification (SAT / IQ / OQ /PQ) significantly minimizing the impact on production capabilities. Note: one of the lines initially equipped for South Korea was upgraded in 1.5 days to deliver medicines for Brazil (new printing format + quality test).

Business needs

Project scopeOne of the top five European Contract Manufacturer (CMO), owner of a dozen manufacturing sites, chose to address drug serialization requirements from the USA, Brazil, South Korea and China by implementing serialization on 7 packaging lines at 4 different sites.

The client’s request was to deliver, in the short term, serialization of saleable units for these 4 markets (especially South Korea & China) and have the ability to upgrade its installation to embrace 10 additional countries serialization requirements in Europe without specific new development work required.

The CMO plans to equip a total 80 lines to address the increasing demand for serialization due to approaching deadlines in the USA and Europe.

OrganizationThe client established a two-level decision-making organization for this serialization project: • A Group leadership team managing

procurement and global governance. • Serialization project management teams

at each site.

SpecificationsThe selected lines had differing specifications:

• Speed: Manual lines running 40 items/minute to semi-automatic lines running 300 items/minute.

• Equipment: One of the client’s requests was to leverage their existing equipment as much as possible to optimize their project budget, reduce training and documentation, and simplify support and vendor management.

- Packaging modules: 5 lines were already equipped with H2M and Seidenader modules, 2 lines needed brand new equipment for which the client selected new H2M modules.

- Devices: Installation supporting a variety of equipment best suited to their application including Domino (laser or G320) and Zebra printing systems along with Keyence, Cognex and Omron vision systems. The ability to support a diverse environment of devices was a critical factor in the vendor selection process.

Implementing drug serialization and aggregation: A CMO’s business case

Results / Key Figures

Our partners have been extremely committed and effective since the launch of the project. With regards to Adents, pilot lines using Adents software solution produce now batches for South Korea, Brazil and China and meet our customers’ requirements for drug serialization and aggregation.Client Serialization Project Leader.

> 7 lines were installed in 4 different sites in France.

> 10 different packaging formats have been enabled on a single line.

> Zero productivity loss on newly serialized lines has been observed by client thanks to Adents Pharma Suite’s robustness (even at high speed) and easy changeover management capabilities.

> Tens of millions of products have already been serialized and aggregated in compliance with four different regulations.

> The client now provides serialized production services for at least four big pharmaceutical companies and has the capacity to address a larger demand and a large variety of customers’ requirements.

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About AdentsAdents is a software specialist of unique product identification and traceability helping pharmaceutical companies and contract manufacturers to adapt to market changes and comply with regulations on drug traceability.

Adents Pharma Suite utilizes user-friendly, standardized software compatible with both information systems (ERP, MES) and existing production and packaging equipment. Easily upgradable, the software is designed to address both current and emerging regulations to help pharma companies remain in compliance long-term.

Founded in 2007, Adents operates in Europe, Canada, and in the United States.

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