OEM machine manufacturers who use the right technology to comply with the serialization requirement can have peace of mind in short order. With HBM as a partner for your weighing technology, you can meet the requirements for regulation 2016/161/EU in top form.
Serialization Requirement: Reliably Under Control With Weighing Technology From HBM
If counterfeit pharmaceuticals are placed in circulation they pose great risks for people as well as industry. To prevent further damage, the European Union (EU) is providing measures with delegated regulation 2016/161/EU designed to prevent counterfeit pharmaceuticals from entering into the legal supply chain.
Measures will include security features such as placing barcodes and seal labels on the packaging and ensuring that they remain intact from the beginning until the end of the supply chain by means of checkweighers.
This ensures that products will be traceable. For OEM manufacturers of packaging machines for the pharmaceutical industry this means the mandatory regulation also known as "Track and Trace": Act now.
Either convert existing systems or factor compliance with the requirements into the construction of new machines. The regulation will take effect on February 09, 2019. This means pharmaceuticals that require a prescription in the EU will be subject to a 100% serialization requirement.
- The simple solution to meet these requirements: Install checkweighers (automatic checkweighers) in the packaging machines.
- With HBM components you can develop and integrate the checkweighers yourself.
- HBM load cells and electronics are an important process building block for ensuring traceability of pharmaceuticals.
- Ultra-small design of the strain gauge load cell
- Compact measurement chain consisting of load cell and plug and play electronics for smaller packaging units such as stick packs
- Rugged load cell with integrated electronics for larger packaging units such as cartons or pallets.
Space-saving and rugged solutions for existing and new systems, for both In-the-Line/ multi-track applications (serialization) and End-of-Line applications (aggregation).
- Superior price-to-performance ratio of strain gauge technology compared to the principle of electromagnetic force compensation (EMF)
- Uniform PanelX operating software for extensive analysis and optimization of the entire construction
Efficient interaction of all components, which increases throughput, extends service life and improves usability during ongoing operation. This significantly reduces the total cost of ownership (TCO).
- HBM co-developed the first strain gauge based multi-track weighing module in ultra-compact design
- Leading specialist in weighing technology and innovation leader
- A reliable partner around the world for dependable delivery
- Strong sales and service team worldwide.
Play it safe with HBM as cooperating partner. You can rely on HBM with more than 60 years of experience to convert your packaging machines. Make yourself fit for serialization.
The binding delegated regulation (2016/161/EU ) takes effect on February 09, 2019 and with it the serialization requirement. What does that mean in concrete terms? Pharmaceuticals requiring a prescription must be serialized at the beginning of the supply chain according to the following requirements:
- Assign a unique serial number
- Place this information on the packaging by means of a data-matrix code
- Seal label as a safeguard to protect against tampering
- Meet Good Manufacturing Practice (GMP) requirements. This information must be recorded in a data program and forwarded to higher-level systems.
With flexible weighing technology from HBM you can choose between an In-the-Line solution or a multi-track application (serialization) and an End-of-Line solution.
The In-the-Line solution consists of a compact measurement chain with strain gauge load cells and plug&play electronics for smaller packaging units such as stick packs. This space-saving and high-precision solution ensures maximum system productivity.
The End-of-Line solution (aggregation) is suitable for larger packaging units such as cartons or pallets. It consists of a digital load cell with integrated electronics. Thanks to rugged, high-precision products you benefit from reduced downtimes of your machines, thereby increasing the overall availability of your systems.
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