With the Falsified Medicines Directive 2011/62/EU coming in to force by February 2019, Newman Labelling Systems is providing customers with two labelling solutions - the CTE350 and CTE450 - to ensure compliance.
The Falsified Medicines Directive requires two mandatory safety features that will enable medicines to be verified and authenticated along the supply chain: tamper evident features on the carton and a unique identifier (2D data matrix code and human readable information) on the carton.
Newman CTE350 and CTE450 automatic tamper evident labellers enable customers to meet these new regulations, whilst also providing high levels of flexibility, quality and reliability.
Designed to apply a range of self-adhesive tamper-evident, anti-counterfeit and hologram labels, a single machine can handle a wide range of carton types and sizes without the need for change parts.
The CTE350 operates at speeds of up to 350 cartons per minute and, measuring just over 1m in length, is ideal for integrating in to lines where space is at a premium.
Where higher speeds are required, the CTE450 operates at speeds of up to 400 cartons per minute with a low energy consumption.
Newman Labelling Systems is able to integrate different print and inspection systems with both the CTE350 and CTE450, giving full compatibility with the Track and Trace requirements of the Falsified Medicines Directive and other global Serialisation initiatives.
Specifically designed for healthcare applications, the CTE350 and CTE450 have a stainless steel/GMP construction and are available with full Validation Documentation Package.
Established in 1943, Newman Labelling Systems has a customer base that includes the world’s top ten pharmaceutical companies. The company provides a combination of excellent service, accuracy and reliability of equipment, quality and speed of validation, plus the capability of engineers and staff experience.
Newman Labelling Systems’ purpose built systems are fully compliant with FDA cGMP requirements and can be supplied with validation completed up to PQ.