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PHARMACEUTICS - FMD

(Falsified Medicines Directive)

Directive

FMD regulation pertaining to the labelling of pharmaceutical products

On 09.02.2016, the delegated regulation (EU) 2016/161 pertaining to the implementation of safety features on the packaging of prescription-only medicinal product was published in the official gazette of the EU.

 

With this move, the three-year implementation period for the players in the medication provision industry commences.

 

As of 09.02.2019 in Germany, it will only be possible to market medicinal products subject to prescription with an individual serial number visible on their packaging whose integrity has not been tampered with.


The objective of the Falsified Medicines Directive and the published delegated legal act is the protection of patients in that the legal delivery chain is to be protected against the penetration of falsified medicines by means of the new safety features.

 

In the end-to-end system, the pharmaceuticals company generates an individual serial number during the production of the medicine, making each pack unique which, in future, is to be inspected for its authenticity by the wholesale trade and pharmacies.

 

These specifications are presenting the pharmaceuticals companies with technical and financial challenges.

 

The management of the serial number from its generation, its application on the packaging through to the successful forwarding to the database requires an adaptation of the IT solutions and processes in the company. 


Wholesalers in the pharmaceutical trade also play an important role in ensuring the legal supply chain. According to the regulation, the wholesalers have to inspect all medication packaging which do not come directly from pharmaceutical companies or on their behalf. 

 

In addition to the binding authenticity inspection before the medication is dispensed to the patient, pharmacists are able to inspect the packaging at the time of goods receipt. This has various advantages for pharmacists, such as the assumption of the batch and expiry date into the merchandise management system in accordance with the rules and the clear allocation of non-dispensable medicines to the pertinent supplier.

Global standards such as GS are used in order to guarantee the utmost consistency, sustainability and flexibility.

As a rule, the data matrix code content is

structured as follows:

(01) GTIN (Global Trade Item Number)

(10  Batch number

(17) Expiry date

(21) Serial number / serialisation number

The application of a cost reimbursement number might be required, depending on the destination country.

Because of the difference in carton sizes it`s possible that on side of coding is not sufficient enough and the coding one both ends is required. As an option we offer a solution to split the print on two carton flaps. Only GTIN and serial number information will stay next to the 2D code according to the legislation.

Our b+b SiteServer and its modules ensure the smooth and standardised data exchange between higher data systems, the individual line components through to the registration of the flow sheet of your products.

Various upload variations depending

on your choice of connection to the

repository system (EU-Hub or other

national database solutions) are

at your disposal.

 

​As a complete service provider, we

supply you with a solution aligned

perfectly with your requirements.
Irrespective of semi or fully automatic,
irrespective of contract manufacturers
(CMO) or producers of own brands.

We also have various solutions for the field of aggregation which, naturally, can be flawlessly integrated in our b+b SiteServer.

 
Systems for pharmaceutics
 

LSS - semi-automated serialisationmodul

Technical data

Dimensions:                         

 

Format range:

Standard:

 

Conveyor speed:

  

Electrical connection:

  

Compressed air connection:

  

Ambient conditions:

 

 

Length:  1200 mm

Width:      700 mm

Height:     800 - 900 mm (adjustable)

 

According to customer specifications

 

Length up to 124 mm,

width up to 135 mm

max. 25 m/min
(continuously adjustable)

  

230 V, 16A

  

6 bar, cleaned compressed air

  

 

+15°C to +40°C (non-condensing)

The affordable semi-automated serialisation solution:
transporting - printing - scanning - evaluating

LSS is a technically advanced yet affordable labelling system for pharmaceutical companies, food producers and contract packers. It has been designed for integration into continuous production lines or manual packaging lines. 

The LSS combines a printer, camera, ejection station and IPC touch panel along a conveyor belt of only 1,200 mm in length.

Process description

The products are placed manually or automatically on the conveyor belt that transports them through the printing station where they are labelled with serialisation information in the form of 2D barcodes, data matrix codes or text. Depending on the customer requirements, the unit can be equipped with thermal printers, laser coding or labelling and dispensing systems. The printed data is then read by the downstream camera and evaluated, for instance with the b+b Site Manager software. Products whose data cannot be read are automatically removed from the process at the ejection station. 

The unit is operated through a 15" touch screen with password protection. Its screen shows the order details, statistical data and the last captured image in a user-friendly layout. The IPC touch panel and the USP (uninterruptible power supply) are built into the base frame of the unit.

The production rate of the LSS can be continuously adjusted from 10 to 25 metres per minute. The fixed and steering castors can be adjusted in height and make the unit portable for use in various production lines

 

HSS - High Speed Serialization Unit

Secure serialization! Product identification to protect your brand

The standardised Track&Trace module guarantees compliance with relevant standards and regulation. It is easy to operate and efficient to run. Its main features are the closed cell concept, efficient design and user-friendly format creation and management tools. It allows for aggregation and works at speeds of up to 400 cycles per minute, making it an indispensible component in the quality control chain. 

After the tracking data has been printed on the packaging, each unit is automatically verified by a camera system that records every single printed digit and code. The system is extremely flexible, even when installed in already existing machines. It can be configured for any conventional marking solution such as 1D and 2D data matrix codes or customer-specific RFID labels. The module can be extended to serve as a complete control unit with HMI for the centralised management and configuration of all production, printing and layout data. 

b+b trace communicates with the printing and camera technology of the customer.

Tecnical data:

 

Dimensions:                         

  

Conveyor Speed:
 

Electronical condition:

  

Compressed air condition:

  

Length:   1000 mm

Width:     1000 mm

Height:    1800 mm 

up to  400 products/min
(dependent on product)

  

400 V, 16A

  

6 bar, cleaned compressed air 

  

 

HSF - High-Speed Friction Feeder

Techical data:

 

Dimensions:                         

Format range:

Conveyor speed:

  

 

Electrical connection:

  

Compressed air connection:

Ambient conditions:

Length:  4600 mm

Width:      900 mm

Height:   1000 - 1100 mm (adjustable)
 

Carton length:  54 - 300 mm

Carton width:   75 - 350 mm

  

10 - 30 m/min,

(continuously adjustable)

  

400 V, 16A

  

6 bar, cleaned compressed air

  

 

+15°C to +40°C (non-condensing)

Product information

The HSF high-performance friction feeder is the ideal solution where empty folding cartons are to be labelled with variable data outside the production line. The modular design of the machine allows operators to combine it with the labelling technology of their choice.

Process description

The HSF separates the folding cartons from the stack. An electromechanical or ultrasound-based sensing system ensures that the packaging units are correctly separated. The cartons are then fed by two parallel conveyor belts to the printing station. Where they are labelled as required, for instance with serialisation data in the form of 2D barcodes, datamatrix codes or text. Depending on the requirements, the unit can be equipped with thermal printers, lasercoding or labelling and dispensing systems.

The printed data is then read by the downstream camera and evaluated, for instance with the bb-SiteManager so ware. Cartons with codes that are deemed illegible by the camera are automacally ejected at the ejection station. The labelled folding cartons are bundled by the downstream shingling outfeed conveyor for manual removal. 

The production rate of the HSF can be continuously adjusted from 10 to 30 metres per minute. 

The HSF is controlled through an intuive IPC touch panel and is easy to operate. Its fixed and steering castors can be adjusted in height and make the unit portable for use in various production lines

 

TE – Labels Tamper Evident

Tamper-proof sealing of folding cartons

Product information​

Your products must reach the end consumer in their original packaging and fully protected against tampering. Self-adhesive tamper evident safety seals guarantee optimum protection against tampering and counterfeiting. They are designed to show instantly whether a packaging has been opened or tampered with. In other words, any tampering attempt must result in an irreparable damage to the packaging and/or the label. This is normally achieved by applying transparent seals that do not obstruct the packaging print or the 2D data matrix code. 

To protect the folding carton against tampering, the two side flaps are sealed at the top or the bottom. In a next step, the seal is checked for proper application. Thanks to its flexible conveyor belts, the system can be integrated into any machine along the packaging line, for example the horizontal cartoner.

Unit features

  • Self-adhesive tamper evident safety seals protect your products against tampering and counterfeiting

  • The moment the packaging is opened, the label is visibly and irreparably damaged

  • Fully automated application system for folding cartons

  • Suitable for all conventional adhesive materials

 
 

HSS-TE – Serialisation with Tamper Evident and Bolini Application

Serialisation and anti-tampering sealing of folding boxes with the application of vignettes

Product information​

This variant of the fully automatic combination of one-sided or both-sided serialisation, application of sealing labels and the optional labelling with a Bolini dispenser can fulfil all current requirements.

Various camera systems and sensors serve the purpose of the all-round inspection of all markings and labelling.

As with all our systems, integration in our b+b SiteServer solution is possible at all times.

STS – semi-automatic aggregation of folding boxes in shipping boxes or bundles and/or of bundles in shipping boxes and/or shipping boxes onto pallets:

Technical data:

Dimensions:                         

 

 

Format range:

Electrical connection:

 

 

Ambient conditions:

Length:  1000 mm

Width:    1200 mm

Height:     800 - 900 mm (adjustable)

 

According to customer specifications

   

230 V

  

+15°C to +40°C (non-condensing)

Intelligent database integration 

Product information

- for the recording of serialised pharmaceutical products
- for data input and retrieval (reworking) of products with serial numbers

 

Process description

The STS retrieves the data of the current job (packing scheme, number of products per carton or shipping box) from the format database. This information is displayed on the screen. 

The operator places the single or bundled packaging units bearing serial numbers on the camera windows in the workbench. The operator actuates a foot switch and the camera below the workbench takes a picture. All captured serialisation codes are recorded and forwarded to the integrated database. 

When the preset number of products per carton is reached, the STS generates a signal. At the same time, an order-specific label is produced for application to the carton or shipping box. The operator removes the label from the dispenser and scans it with the hand-held scanner, sending an acknowledgement to the database. Subsequently, the STS is ready for the processing of the next packaging unit. 

If required, the format database can be configured so that the unit produces pallet labels that are printed after a certain number of cartons have been processed.

  • Aggregation of individual containers into bundles or

  • cardboard boxes

  • Aggregation of cardboard boxes on pallets

  • Data collection with vision system and/or hand scanner

  • Available with automatic travel system for several layers in a shipping box

  • Up to three label printing systems can be integrated

  • Generation of bundle, shipping-box and pallet labels (SSCC label)

  • Prepared for integration in the b+b SiteServer architecture

 

Fully automatic aggregation of containers in a bundle or
cardboard boxes / aggregation of cardboard boxes on pallets:

  • Aggregation of individual containers into bundles or cardboard boxes

  • Data collection with vision system (multi-pixel camera) or sensor

  • Hand scanner for removal during in-process control

  • Automatic application of the bundle, cardboard-box or pallet label

  • Integration in the existing system or as a stand-alone unit following
    the bundler

  • Prepared for integration in the b+b SiteServer architecture 

 

 

Fully automatic labelling of pallets
(NVE/SSCC label): 

  • Application and generation of the NVE/SSCC label
    (one or two-sided)

  • Label presence check and data verification

  • Prepared for integration in the b+b SiteServer architecture

Technical data:

Dimensions:                         

 

 

Conveyor speed:

Electrical connection:

 

 

Ambient conditions:

Length: 1400 mm

Width:   1200 mm

Height:  according to prior agreement

 

2 - 3 Pallets/min

   

230 V

 

  

+15°C to +40°C (non-condensing)

 

Technical data:

 

Camera:                          

 

Light source:

Input/Outputs:

  

Operating temperature:

  

Storage temperature:

  

Dimensions and Weight

  Depth:

  Height:

  Width:

  Weight:

  

Supported symbologies:

 

 

 

 

Supported standards:

Monochrom Camera; 5 Mega-pixel

 

 

LED; Red light 660 nm; 

12 vdc @ 1.6 A

 

USB 2.0 port 12 vdc @ 1.10 A

  

10 °C to 30 °C

  

0 °C to 40 °C

  

 

230 mm

285 mm  

275 mm

2,8 Kg

Aztec Code • CC-A • CC-B, CC-C • Codabar, Code 128 • Code 39 •

Code 93 • DataBar expanded •
DataBar limited, DataBar stacked • DataBar14 • EAN-13, EAN-8,  

DataMatrix (ECC200) • GS1-128 • Hanxin Code,  Interleaved 2 of 5 (ITF) ITF-14 • Japan Post • MaxiCode, 

Micro QR Code • Micro PDF417 •

MSI Plessey, PDF417,  Pharmacode (Laetus) • QR-Code • UPC-A,

UPC-E, USPS Intelligent Mail Barcode

ISO / IEC 15415 • ISO / IEC 15416 • ISO / IEC 15426-1 •  ISO /

IEC 15426-2 • MIL STD. 130 • ITS199-002 (7-02) • GS1 General Spezifikations • UID Guidelines

The inspection system for the in-process control for
1-D and 2-D barcodes

 

Product information

The INTEGRA 9510 is designed to ISO grade most 1D & 2D barcodes on various label sizes and finished products with flat or rounded sides. The Flat Bed Verifier Boasts a massive 7” x 5” Field of View on the optional High Density unit. The LVS Flat Bed Verifier is connected to a customer supplied PC via a USB cable and is designed to fully comply with the ISO/IEC Standards. Place a barcode on the viewing stage and software does the rest. A NIST Traceable Calibrated Conformance test card is used for calibration. 

The INTEGRA 9510 inspects all nine of the ISO (ANSI) parameters PLUS added features of determining Blemishes, Opacity, and Human Readable Validation. More detailed analysis of the barcode is possible with a few clicks of the mouse.

The system owns neither measuring-relevant movable components nor laser diodes which cause measuring inaccuracies on account of the normal ageing process. Equipped with the calibrating map NIST (GS1-checked), the device (appliance) can be simply calibrated, fast and back pursuance bar.

  • Grade to ISO Print Quality Standards for Linear and 2D with
    one system

  • Field of View Range from 3" to over 6" (76-156 mm)

  • Verify all common linear and 2D codes

  • Certified by GS1 US

  • 21 CFR Part 11 Complaint Ready

  • Inspects all 9 of the ISO (ANSI) parameters, plus added
    features of determining blemishes, opacity, and human readable validation

 

HSF-I – parallel inspection of folding boxes and package inserts

Product information

Products and medications should be safely packed and contain the correct information and packaging components such as the correct package insert and the correct folding box. This can even be guaranteed for a low cost in the manual packaging processes of producers and contract manufacturers. This module enables the parallel inspection of folding boxes and package inserts. Every stacking, counting and control unit has its own HMI (Human Machine Interface) to enable them to work as independently of each other as possible. When the batch starts, the codes to be inspected are entered according to 21 CFR Part 11. Any necessary counters can be selected. Alternatively, the system can work independently until the operator ends the batches by means of a button.  

Various 1-D/2-D barcode scanners / camera systems from various manufacturers can be integrated as an inspection module. 

Optionally, this module can also be used for serialisation purposes. Further options such as reject discharger with counter control, thermal transfer printer, TIJ (thermal ink-jet) printer or CIJ (continuous ink-jet) printer, DOD (drop-on-demand) printer or labelling laser equipment are possible.