Whether your serialization process is manual or fully automated across multiple production lines, METTLER TOLEDO PCE has the systems necessary to implement a successful program. Manufacturers with the need for a custom solution can purchase one of our OEM kits for easy creation of a serialization solution.
How can we assist you?
Fully Scalable Systems
Compliance with Pharmaceutical Regulations
Track & Trace legislation is primarily concerned with the pharmaceutical industry. Our solutions are built and programmed to ensure complete compliance with global pharmaceutical standards, including the EU's Falsified Medicines Directive (EU-FMD), the FDA's Drug Supply Chain Security Act (DSCSA), and other regulations across the globe. This not only includes item level serialization, but the application of additional anti-counterfeiting measures such as tamper-evident seals.
Flexible Packaging Options
Item level serialization makes no distinction between oriented and un-oriented packaging: it is required regardless of shape or size. METTLER TOLEDO offers solutions for any package shape, allowing flexible serialization to fit your product.
Central Line Management
PCE Line Manager software ensures a smooth serialization process along the production line. PCE Site Manager links multiple production lines together, coordinating all serialization activities and connecting to ERP/MES and cloud solutions.
Adaptable Printing and Scanning
Implementing a serialization machine cannot come at the cost of production speeds, so our systems are designed to maintain pace with your current rate of production.
Documentation
Further reading on other topics related to serialization
Track & Trace Guide
This guide covers everything you need to know about serialization and aggregation, to implementing an effective Track & Trace programme for use in the...
Brochures
ProdX™ allows you to connect and control your entire product inspection management process from a single point or from multiple remote locations, elim...
White Papers
This white paper describes the legal frameworks adopted by the European Union and the United States and the resulting requirements for pharmaceutical...
The global threat of counterfeit medicines is growing. Quickly learn how to reliably track and trace medicinal products by integrating serialization s...
This white paper explains the implications of the EU directive 2011/62/EU and EN 16679 and how this will affect pharmaceutical packaging. It specifica...
This white paper looks at the Communicating Reliable Information and Standards for Agriculture and Logistics (CRISTAL); a communications framework for...
Case Studies
Catalent Biologics, a leading provider of advanced delivery technologies and development solutions for biologics, turned to METTLER TOLEDO for afforda...
R-Pharm Germany GmbH has rounded out its service portfolio with the Case Aggregation Kit from METTLER TOLEDO PCE – in combination with a compatible ca...
In a first for the industry, a manufacturer of lubricants and other petrochemicals recently elected to implement a complete Track & Trace program in t...
The XMV datamatrix station from METTLER TOLEDO PCE supports August Faller in providing sustainable marking and verification of cardboard boxes, carton...
FAQs
What are the requirements for serialization in the pharmaceutical production process?
A number of countries across the globe have requirements mandating the serialization of pharmaceuticals. These requirements can vary slightly from region to region, of course, but the basics remain the same. Each individual product carton must be marked with a unique identifying number in alpha-numeric and barcode formats – usually a 2D barcode. These numbers need to be recorded and uploaded to a central database. At the point of sale, the code is scanned and checked against the central database to ensure authenticity. It may also be necessary to scan products along each step of the supply chain, depending on regulations.
What is package serialization?
Package serialization is the marking of a package on the production line with a unique identifying number. These numbers are usually printed on the surface of the packaging or on a label which is then applied to the package in both human and machine-readable formats (usually a 1D or 2D barcode). These numbers are recorded and uploaded to a central database.
How much space on my production line do I need for serialization?
As a rule of thumb, in-line serialization can take anything from 60-100 cm of space on the production line, depending on the shape and size of the packaging.
What industries can benefit from the serialization process?
A large number of industries benefit from serializing their products – any industry in which counterfeit products are a problem will appreciate serialization's anti-counterfeiting capabilities. This is particularly useful in the electronics and pharmaceutical industries, as well as for luxury goods such as premium alcohols and even caviar.