Track & Trace

Track & Trace

GS1 Module Controller (HIES-3000)

This system records and retains the result of various inspections, such as print/cross-check/verification of GS1 codes and human readable texts including serial numbers and pass-fail judgement, etc.

Advantages

  1. Customization to comply with regulation of target country
  2. Installable for both new and existing lines
  3. Consolidated management of production log data, by connecting with PLC and other systems (visual inspection system, weight checker, etc)
  4. Access control by 3-hierarchized ID/Password(for ER/ES)
  5. Audit trail (access to and retention of change log data)
  6. Versatility to expand into serialization/aggregation systems in future
  7. High level of customization available for special situation or needs of production process

Functions

  • Compliant to a wide range of GS1 codes

Example)

One-dimensional code(GS1 Databar)

Two-dimensional code (GS1 Data Matrix)
(01)・・・Product Identifier
(17)・・・Expiry Date
(10)・・・Batch/Lot Number
(21)・・・Serial Number
  • Compliant to CSV (Computerized System Validation)
  • Master data management
    Retains Master data of product type, print format or text for each drug product, etc.
  • Log data management
    Outputs print log data in Excel, PDF and XML format.
  • Print command and inspection
    Sends print data to a connected print controller and printer, sends inspection data to a connected inspection machine and receives inspection result.
  • Serial number data management
    Generates and controls unique serial numbers to be assigned to each package (for Track & Trace).
  • ER/ES
    Complies with 3-hierarchized ID/Password and audit trail.

GS1 code Inspection/Verification/Cross-check System

This system inspects printed GS1 codes and human readable texts, and is supplied together with GS1 Module Controller (HIES-3000). Performance and accuracy of inspection/verification/cross-check is secured by validation.

Functions

  • Inspection
    GS1 codes and human readable texts are inspected on printing accuracy, similarity of texts, smear, missing text and product mix-ups.
  • Verification
    Validity of GS1 code grading is secured by LVS Barcode Quality Station (INTEGRA).
    The value on LVS is set at the same grade as requirement, or slightly higher.

Grading of GS1 code:
※ Recommended grade is C or higher.

  • Grade A(3.5~4.0)
  • Grade B(2.5~3.4)
  • Grade C(1.5~2.4)
  • Grade D(0.5~1.4)(slightly visible smear)
  • Grade F(0~0.4)(remarkable smear)
    ※ Some portable readers read Grade F.
  • Cross-check
    Read GS1 code is cross-checked with the printed corresponding human readable texts.
    Serial numbers sent by Module Controller is also cross-checked with the printed serial numbers.

Various types of inspection system are also available. Please contact.
※ Inspection of sealing tape existence
※ Visual inspections for scratch, wrinkle, defect, etc.

Printers

There are various methods of printing GS1 codes and human readable texts. Every method has advantages and disadvantages.
We will select the most suitable printer according to customers’ needs and circumstances.
Printers are supplied as an integrated system together with GS1 Module Controller HIES-3000.

UV inkjet printer(for object in motion)

  • Uses special ink which is curable by UV irradiation. Once cured, no smear occurs. Highly resistant to water, oil and scratch.
  • Alcohol-proof. Once ink is cured, alcohol contact does not affect print quality.
  • High contrast rate. Achieves higher print grade than laser printing. (Grade A 3.5~4.0)
  • Fast printing speed. 300 pcs/min (in case of GS1 code printing on labels)
  • Requires constant purchase of consumables (ink).
  • Delicate handling. Operators need training and experience.
  • Productivity dramatically improves once operators become accustomed to the system.
  • Printable GS1 code module width (in mm) :
    • In case of 360dpi resolution=
      (3 dot print=0.211)
      (4 dot print=0.281)
      (5 dot print=0.351)
    • In case of 600dpi resolution=
      (4 dot print=0.169)← Minimum module width of GS1 Databar : 0.169
      (5 dot print=0.211)
      (6 dot print=0.254)
      (7 dot print=0.295)
      (8 dot print=0.338)

    ※ Print grade tends to fail if a width of 1 module is printed with less than 3 dots.
    ※ GS1’s recommendation : minimum module width = 0.254mm.

Thermal printer (for object in motion)

  • Widely used for printing on labels(Thermal transfer method)
  • Moderate printing speed. 150 pcs/min (in case of GS1 code printing on labels)
  • Stable print quality. Mostly achieves Grade A.
  • Easy handling. Reasonable running cost
  • Requires constant purchase of consumables (ink ribbon)
  • Printable GS1 code module width (in mm):
    • In case of 300dpi resolution=
      (3 dot print=0.254)
      (4 dot print=0.317)
      (5 dot print=0.38)

    ※ Print grade tends to fail if a width of 1 module is printed with less than 3 dots.
    ※ GS1’s recommendation : minimum module width = 0.254mm.

Laser printer(for static object)

  • Print on a static object enables to achieve higher print grade, due to a high score in “modulation”.
  • Transfer conveyer should be controlled in intermittent motion, which impacts conveyor cost.
  • Dust collector should be installed for removal of emitted fume and dust.
  • Print speed and achievable final grades are as follows (in case of printing GS1 code):
    • With a print speed 80 cartons/min, final grade A can be achieved in general.
      (It depends on conveyor quality. Quality of blacked area on cartons may lead to final grade B)
    • Printing grade of laser printer is between 3.0 and 4.0, that is, grade B or A.
      (Need to select a carton material suitable for laser marking. Quality of blacked area affects the final grade.)
    • With a print speed 90-100 cartons/min, modulation score falls, and consequently, final grade goes down to C or B. Print module width must basically be kept 0.254mm or larger (GS1’s recommendation). Any smaller will result in a lower grade.
    • CO2 laser marking method which burns off the print surface is widely used.

Laser printer(for object in motion)

  • Results in lower final code grades than that of printing on static object.(Affected by low score in modulation)
  • No need of intermittent control on transfer conveyor, which saves conveyor cost.
  • Dust collector should be installed for removal of emitted fume and dust.
  • Print speed and achievable final grades as follows (in case of printing GS1 code):
    • With a print speed 60 cartons/min, final grade B or A can be achieved. With 80 cartons/min, grade C or B.
    • Print module width must basically be kept 0.254mm or larger (GS1’s recommendation). Any smaller will result in a lower grade.
    • CO2 laser marking method which burns off the print surface is widely used.

Label printer(for object in motion)

  • Used for labels on secondary or tertiary packages (for the purpose of bundling smaller cases). Secondary and tertiary codes are printed on such labels and attached on those packages.
  • GS1’s recommendation on the minimum module width is 0.254 mm.

Special laser printer (for both static and in-motion object)

  • Uses a special ink which comes out only after irradiated by laser.
  • Special ink is placed underneath the top coating, which is different from conventional inkjet/thermal printer. Therefore, printed texts are highly resistant to water, oil, alcohol and scratch. This also contributes to a protection from counterfeit risk.
  • No fume emission, unlike CO2 laser making system. Therefore, no need of dust collector.
  • No solvent. Printing environment can be kept clean.
  • Contributes to improving a pharmaceutical printing environment.
  • Applicable to YAG, YVO4, fiber laser marker.
  • Not applicable to CO2 laser marker (burns print surface).
  • Need to change to a packaging material which goes well with the special ink.
  • Effective for YUPO paper and film materials which do not go well with CS2 laser marker.
  • This method has been employed in food industry since 2015.

Serialization System / Aggregation System (For Track & Trace)

What is Track & Trace?

Track & Trace is a term used in logistics activity. Tracking is to identify current situation (location, status, etc) of the object in a supply chain. Tracing is to identify situation of the object at a certain time in the past by going back the way it went through. In recent years, pharmaceutical industry is accelerating the discussion how to lockout counterfeit drugs, and Track & Trace has drawn attention as one of effective countermeasures.

「Serialization」 is an essential part of Track & Trace

Serialization is one of integral elements which realize Track & Trace. It means to assign a unique serial number to each item individually. A representative example is tracking number shown on a slip of courier service. Every parcel is assigned with a unique number so that we can identify and locate (=track) the specific parcel.

「Aggregation」 is a concept developed from serialization

Aggregation means to “link” serial numbers assigned to smaller packages (=children) to a serial number assigned to a larger package (=parent) which contains the children.

For example with PTP sheet of tablets,

Unique serial numbers are issued and labelled individually on “cartons”, each of which contains 10 x PTP sheet of tablet. Next, 5 x cartons are bundled into a larger package called “case”, and a new serial number is issued and labelled on the case. The serial number of the case (parent) and serial numbers of the 5 cartons inside (children) are linked together, and that linked data is recorded and saved. By repeating this process to the final package for shipping, complete relationship between parent and children will be saved in a database, which enables you to immediately locate a specific package by searching for the serial number in the database.

Track & Trace in the world

A WHO report of November 2017 tells that one medicinal product out of ten on a market in low-mid income countries are counterfeit drug or genuine drug but not meeting quality requirement. In recent years, on the initiative of developed countries, serialization and registration to national database has become mandatory worldwide. Some countries have fully implemented the system by legislation, and the others are busy in preparation before their law shortly takes effect. Japan, being thought to be a nation with “zero counterfeit drug in the market” for a long time, was shocked by the incident in 2017 that a pharmacy unknowingly sold to patient a counterfeit drug for hepatitis C treatment, which was the first case that fake drug was discovered in a formal drug supply chain.

Being sparked by this incident, Japan has started to actively discuss possible countermeasures against fake drugs even with an eye to implementation of Track & Trace system in future.

Advantages for drug manufacturers

How does Track & Trace system work in the pioneering countries? In a drug manufacturing process, individual package is labelled with a unique identification code (Note 1) and those codes are registered in a database which is run by nation. After shipment, those codes are read by code readers at various points of supply chain and referenced to the code data already registered in the database. By this, counterfeit drug is immediately detected and retrieved because no matching code is found in the database. Once Track & Trace system is thoroughly implemented nationwide, all electrical data of specific product, including which route it went through on the supply chain and even which patient finally consumed it, can be tracked and traced.

(Note 1:Unique identification code normally contains such data as product name, lot/batch number, expiry date and serial numbers. However, what data is to be labeled on what package level of what type of drug differs from country to country.)

Any advantage for pharmaceutical manufacturer?

Anti-counterfeiting

  • Unique identification code is read at many points in the supply chain and referenced with the code registered in the database. If the code does not match or is duplicated, the product is immediately judged as a fake product.
  • In case of theft, precise identification of stolen drugs will eliminate risk of resale or counterfeiting.
  • Labelling a unique code on package itself has an effect to discourage counterfeiting.
  • Eliminates the risk of sales loss of genuine product, loss of trusted brand image, tremendous recall activity, etc.

Improved productivity

  • Higher recall efficiency in case of defects (Quick identification of location and status of recalled products, and quick information sharing)
  • Every event of a specific product can be traceable in case of defect
  • Eliminates mix-ups in shipping → Streamlined distribution
  • Comprehensive management and analysis of data from production to distribution → Improvement in production/distribution plans

Serialization System (HIES-5000SZ)

This system controls GS1 codes and human readable texts for pharmaceutical packages, communicates print data and inspection data with connected printers and inspection machines, and records and retains the printing and inspection results.

Advantages

  1. Customization to comply with regulation of target country
  2. Installable for both new and existing lines
  3. Versatility to expand into Aggregation System in future
  4. Consolidated management of production log data, by connecting with PLC and other systems (visual inspection system, weight checker, etc)
  5. Access control by 3-hierarchized ID/Password(for ER/ES)
  6. Audit trail (access to and retention of change log data)
  7. High level of customization available for special situation or needs of production process

Installation Example

GS1 Module Controller (HIES-3000)

Functions

  1. Serial number data management
    Generates and controls unique serial numbers to be assigned to each package
  2. Print and inspection
    Sends print data to the connected printer → Prints → Sends inspection command to the inspection machine (inspection/verification/cross-check) → Receives inspection result
  3. Log data management
    Outputs print data in CSV (readable in Excel) and PDF format
  4. Master data management
    Retains master data of product type, print format or text for each drug product, etc
  5. ER/ES
    Complies with 3-hierarchized ID/Password and audit trail

Maximum effect by minimum effort

Do not worry if you are concerned about modification of existing line in order to accommodate Serialization System. Our system is highly extensible and easily incorporated into existing production lines. Serialization system has a number of comprehensive advantages. High consistency in the drug supply chain not only enhances compliance, reverse logistics control and recall efficiency, but also leads to more accuracy of forecast and even to establishment of customer-specific marketing program. Keep your attention to such various advantages. Serialization System has immense potential.

References

Pharmaceutical manufacturer “S”

Pharmaceutical manufacturer “Y”

Aggregation System (HIES-7000AG)

In addition to the functions of Serialization System HIES-5000SZ, this system aggregates pharmaceutical packages – between the smallest packaging unit “carton” (primary code), case (secondary code) and shipping case (tertiary code). Aggregated data is recorded and output to arbitrary folder in PDF, XML or CSV format.

Advantages

  1. Customization to comply with regulation of target country
  2. Installable for both new and existing lines
  3. Versatility to retrofit to existing Serialization System in future
  4. Consolidated management of production log data, by connecting with PLC and other systems (visual inspection system, weight checker, etc)
  5. Access control by 3-hierarchized ID/Password(for ER/ES)
  6. Audit trail (access to and retention of change log data)
  7. High level of customization available for special situation or needs of production process

Installation Example

System flow overview

①Read primary codes

Serial numbers which are labelled on each carton (primary code) are read one by one or simultaneously until the reading reaches a pre-set quantity.

②Issue a secondary code

When reading of the primary codes is done, a secondary code (new serial number) is generated and issued on a label.

Sticker the label on the case (secondary package)

③Read the secondary code

The secondary code on the case is read and linked to the primary codes of the contained cartons.

Repeat above procedures and put those cases into a shipping case (tertiary package)

④Read secondary codes

Serial numbers labelled on each case (secondary code) inside the shipping case are read one by one or simultaneously until the reading reaches a pre-set quantity.

⑤Issue a tertiary code

When reading of the secondary codes is done, a tertiary code (new serial number) is generated and issued on a label.

Sticker the label on the shipping case (tertiary package)

⑥Read the tertiary code

The tertiary code on the shipping case is read and linked to the secondary codes on the contained cases.

Functions

  1. Data management
    Database manages all data which is handled inside this system.
  2. Import of codes
    Codes for carton, case and shipping case are taken into the system and registered.
    Compliant to various GS1 codes for pharmaceutical labelling. Automatic generation of codes is also possible.
  3. Creates a packaging plan
    Creation of packaging plans is possible.
  4. Perform a packaging plan
    ①Reads primary codes on cartons (one by one or simultaneously) for the pre-set quantity, and issues a secondary code label and stickers it on a case (secondary package).
    ②Reads the stickered secondary code, and aggregate it to the already read primary codes only if both codes are confirmed valid.
    ③Reads the secondary codes on cases (one by one or simultaneously) for the pre-set quantity, and issues a tertiary code label and stickers it on a shipping case (tertiary package).
    ④Reads the stickered tertiary code, and aggregate it to the already read secondary codes only if both codes are confirmed valid.
  5. Master data management
    Retains master data of product type, print format or text for each drug product, etc.
  6. Output of aggregated data
    Result of aggregation between cartons (primary code), cases (secondary code) and shipping cases (tertiary code) can be output as a file in PDF, XML or CSV format.
  7. Coordination with Serialization System
    Product master data, user master data can be shared by communication with Module Controller PC.

References

Pharmaceutical manufacturer “S”

Primary codes (on carton) are read, and secondary code labels (for case) are issued and stickered in this area. In this case, 10 x cartons are simply bundled (without a case). All 10 codes are read simultaneously at once, and the label of secondary code is stickered on a surface of the bundle.

Ease Limited provides highly customized Serialization/Aggregation Systems according to various country-specific regulations. Feel free to contact us.

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