Serialization

Introduction

SoftGroup® SaTT (Serialization and Track & Trace) is an integrated mass serialization system for centralized management of pharmaceutical packaging lines. It is a scalable, cost-effective and ‘smart’ solution, which can be customized to enterprise-specific needs. The system allows full traceability of any single or aggregate packaging unit within the supply chain. SoftGroup® SaTT complies with GS1’s Electronic Product Code Information Services (EPCIS) standard for holding and communicating serialization-based events, ensuring interoperability with existing systems.

New!

Solution for pharmaceutical manufacturers with one or two lines

The newest SoftGroup® SaTT Cloud solution provides pharmaceutical manufacturers with one or two lines the flexibility to choose a more cost-effective way to meet the requirements of Directive 2011/62/EU. With SoftGroup® SaTT Cloud, there is no need to buy additional software for reporting to the EU Hub (EMVS).

You can find more information about our SoftGroup® SaTT Cloud solution in the section below.

Our Software

SoftGroup® SaTT (Serialization and Track&Trace)

Serialization is a process of assignment and application of a unique, verifiable product identifier to an individual product item. Meaning, a single item can not only be identified by its product type, expiration date, lot / batch number, etc. associated with the item, but also distinguished from other items of the same type & batch.

SoftGroup® SaTT supports:

  • Sequential series of unique numbers
  • Random series of unique numbers
  • 1D barcode
  • 2D barcode
  • Human-readable

Aggregation

A number of tracked items can be aggregated into one container (Bundle, case, pallet, etc.), which also possesses a unique tracking number.

SoftGroup® SaTT Line Controller

The SoftGroup® SaTT Line Controller software provides serialization of packaged products at Unit level. It is the software that manages the SoftGroup® SaTT Stand-alone machine.

SoftGroup® SaTT Line Contoller software starts the serialization process on item level after the carton is filled. It prints and verifies the batch and serialization data. It supports high quality of the printed data up to 300 packages per minute.

After completing the serialization process, the final batch and serialization data are stored in а local database and can be exported or transferred to the SoftGroup® SaTT Site Controller software.

Functionalities:

  • The system manages serialized and non-serialized items
  • The system guarantees serial number uniqueness at each packaging line for all printed serialized barcodes (1D or 2D)
  • Reworking station functionality is available during line operation and at the end of work
  • The system provides different kind of reports
  • The solution offers a unified authentication in HMI and server
  • Unlimited number of users are supported
  • S1 standard code and Annex 11 compatible
  • The Line Controller software is able to load a batch created in advance from the Site Controller software

SoftGroup® SaTT Site Controller

SoftGroup® SaTT Site Controller is an integrated mass serialization software system for centralized management of pharmaceutical packaging lines. It controls all packaging lines and their modules, regardless of the ERP system, serialization repository, machine vision technologies and packaging automation deployed across the plant.

SoftGroup® SaTT Site Controller sends the batch and serialization data to the relevant SoftGroup® SaTT Line Controller. In addition, the software can be integrated with different ERP systems, allowing data transfer to international and national repositories, all through a user-friendly interface.

SoftGroup offers an outstanding functionality of SoftGroup® SaTT Site Controller – the system allows allocation of the batch to multiple packaging lines and distributes the batch and serialization data simultaneously to all of them. This significantly decreases the batch production time and increases the production performance.

Functionalities:

  • Creation of nomenclatures (lines, devices, templates)
  • Batch management process: create / update / approve EBR (Electronic Batch records)
  • Update of batch statuses
  • Generation of serial numbers
  • Import of serial numbers
  • Export of batch and serial numbers (to CMOs)
  • Import of results from CMOs
  • Reworking station functionality
  • Reports (from Line level) – Batch info report and Audit trail report
  • Audit trail report
  • Centralized management possibility for all serialization and aggregation modules

SoftGroup® SaTT EU HUB Connector

SoftGroup® SaTT EU Hub Connector provides the technical connection between SoftGroup® SaTT Site Controller and SoftGroup® SaTT Cloud. This module ensures the security data transfer between SoftGroup® SaTT Site Controller and EMVS (European Medicines Verification System) realized by Solidsoft Reply. The scope of SoftGroup®SaTT EU Hub Connector is to realize the technical connection between the aforementioned systems.

 

Connection with Arvato or TraceLink

The connection with Arvato/TraceLink will allow automatic data exchange between the Arvato/TraceLink system (Level 4) and SoftGroup® SaTT Site Controller (Level 3). The process is the following: A “request file” is generated at Level 3 for a given batch in xml format and it is automatically uploaded to a specified directory in the Level 4 system. A response is then generated at Level 4 (containing the necessary serialization data) and it is imported to Level 3 for the same batch. After finalizing and locking the serialized batch, a specific batch report (end batch report) is generated in xml format and this report is uploaded back to the specified directory in the Level 4 system.

SoftGroup® SaTT Cloud

SoftGroup® SaTT Cloud offers upload/update of Product Master Data (PMD) and Product Pack Data (PPD) to the EU HUB (EMVO). Via this Cloud solution, the MAH / Parallel distributor could select which serialized batch should be reported to EMVO. The system allows verification of status of any reported serial number and supports all possible statuses according the URS document designed by EMVO:  active, expired, stolen, decommissioned, supplied, exported, recalled, withdrawn, destroyed, free sample, sample for NCA, locked. After transmission of data (from EMVO to the National Blueprint system), a confirmation message is sent to the source system. SoftGroup®SaTT Cloud will also support all incoming messages (alerts) from EMVS. Here is the full list of all functionalities of our SoftGroup® SaTT Cloud solution:

 

Functionalities:

  • Upload product master data
  • Upload product pack data
  • Update product master data
  • Update product pack data
  • Recall batch
  • Withdraw batch
  • Verify pack (The system has to support all possible statuses: active, expired, stolen, decommissioned, supplied, exported, recalled, withdrawn, destroyed, free sample, sample for NCA, locked)
  • Export pack from EU
  • Mark pack as Stolen
  • Mark pack as Intended for Destruction
  • Decommission pack
  • Mark pack as free sample
  • Mark pack as sample NCA
  • Mark pack as Locked
  • Request report
  • Incoming messages (alerts) from EMVS
  • Create a repacking buffer (for Parallel distributors only)
  • Mark as checked-out (for Parallel distributors only)

SoftGroup® SaTT Web Connect

Interface for Wholesalers:

  • Web application providing connection to Bulgarian Medicines Verification System (BgMVS)
  • Quick and efficient access to check and release any inbound serialized product (drug)
  • User-friendly interface: easy and intuitive
  • Works with a wide range of barcode readers
  • Supports all functionalities requested by the EMVO:
    • Verify
    • Supply
    • Mark as locked
    • Mark as stolen
    • Mark as Exported outside of EU
    • Mark as Free Sample
    • Mark as Sample for NCA
    • Reactivate
    • Mark as Intended for destruction

Our Hardware

SoftGroup® SaTT Stand-alone

SoftGroup® SaTT Stand-alone is a carton print-and-verify module for pharmaceutical packaging lines, which provides serialization of packaged products at Device level. It can be an integrated part of an automated packaging line or serve as a stand-alone machine. The SoftGroup® SaTT Stand-alone machine is designed according to the latest GMP standards and offers highest reliability.

Specifications:

  • The machine is designed in a way that permits safe access for performing maintenance
  • The system is designed to work with cartons based on customer’s requirements
  • The conveyor system (along with the mounting kit and the devices) is separately adjustable in front and back directions
  • The height of the transport belt is flexible and can be adjusted between 800mm and 950mm
  • The direction of the movement of the transport belt is from left to right (could be realized from right to left according customer’s requirements)
  • Emergency stop button is provided at an easily accessible location
  • Rotary pulse encoder
  • Front or back 2-axis adjustable mounting kit for printing head and camera (additional software options for adjustment on the third direction)
  • Optional back or front 2-axis adjustable mounting kit for second print head and camera
  • Ejector with collecting container, air pressure: 2- 6 Bars
  • System size: based on customer requirements
  • Maximum production speed: up to 200 cartons/min (up to 60 m/min)
  • Electrical control cabinet made out of stainless steel with 4 winding feet
  • Light and sound alarm
  • Power supply: 220V/50Hz/10A
  • Optional ejector (depending on carton`s form and weight); guide rollers; protection covers

SoftGroup® SaTT Tamper Evident

SoftGroup® SaTT Tamper Evident is a compact label dispenser for protection against manipulation of pharmaceutical packaging.

SoftGroup® SaTT TE is a compact labelling unit, which can be integrated into existing data matrix stations or weighing systems. Self-adhesive label seals are applied on both sides of the flap of the medicine packaging. Perforation on the labels will expose manipulation by destruction of the labels. It is recommended to use transparent and circle labels.

Special features:

  • Sealing labelling for protection against counterfeits
  • Two-sided corner labelling of folding boxes
  • Highly compact design to allow integration into existing plant
  • Output clocking up to 300 items per minute
  • Stepper motor driven applicator
  • Short set-up times when switching to other product formats
  • Processing of transparent, perforated labels
  • Speed-independent labelling via Tam-Wipe-On method
  • Dual label roll unwinding
  • Labels options: round and square (20mm to 30mm)
  • Options to be labeled – possible on all 4 sides (2 by 2)

Make Your Own Configuration

Use our price configurator to create your own serialization system with our SoftGroup® SaTT Stand-alone and SoftGroup® SaTT Tamper Evident modules

SoftGroup® SaTT Manual Serialization Machine

SoftGroup® SaTT MSM (Manual Serialization Machine) is a carton print-and-verify machine for manual pharmaceutical packing areas, which provides serialization of packaged products at Device level. It can serve only as a stand-alone manual machine. SoftGroup® SaTT MSM is designed according to the latest GMP standards and offers highest reliability.

Specifications:

  • The machine is designed in a way that permits safe access for performing maintenance
  • The system is designed to work with different carton sizes, including bigger than the standard (example: product with the following dimensions – width: 440 mm / height: 250 mm / depth: 360 mm)
  • The conveyor system (along with the mounting kit and the devices) is separately adjustable in front and back directions
  • Rotary pulse encoder
  • System size: width: 1650 mm / height: 850 mm / depth: 685 mm
  • Electrical control cabinet made out of stainless steel with 4 winding feet
  • Power supply: 220V/50Hz/10A

Functionalities:

  • Dynamic carton marking
  • Printing, reading and verifying 1D and 2D codes, geometrical shapes and logos
  • Printing Data Matrix and human readable elements according to EU requirements for serialization.
  • Verifying and grading the printed information
  • Reworking Station application – possibility to check the barcode string, the grade of the barcode, and the reason of the rejection (in case of bad cartons). The application allows the user to decommission a serial number and to specify the reason for decommissioning

SoftGroup® SaTT Aggregation

Aggregation of bundle and case

  • Scan of cartons “one by one” – An operator scans each carton box separately, places it into the case, and when the case is filled with boxes, prints the aggregation label.
  • Scan multiple cartons in one layer – An operator prepares the layer manually, positioning the cartons with 2D codes pointing up. Once all boxes are placed beneath the top sensor, the operator triggers the scanning process through the software on the HMI. As soon as all 2D codes on the layer are scanned, the operator prints the label and sticks it manually on the layer box.
  • Aggregation of bundle and cases in one module – This solution unifies the aggregation for bundle and case in one module. The serialized cartons from the previous module will be set in a bundle by the operator. This bundle will be placed on the scanner of the aggregation station and the barcode scanner will scan all serial numbers from the cartons in the bundle. If all cartons in the bundle are scanned successfully, the operator will be able to place them in the case. Once the case is filled with all required scanned cartons, the system will allow the operator to print a new label for the case with a new serial number (containing the information about all serial numbers from the aggregated cartons in the case). If one of the aggregated cartons is not scanned by the operator, the system will not allow printing.

Aggregation of pallet / Warehouse reworking station

This solution is designed specifically to meet the complex needs of the warehouse. The main functionalities of this station are aggregation at Pallet level, disaggregation and re-aggregation at the same level.

Upgrade of case packer to aggregate cases

Upgrade for the existing case packer to be able to aggregate on case level. The update includes SoftGroup® Integration Kit and full pack of Line Controlling software.

Our Hardware Partners

We offer the option to choose between our own hardware, as well that of other vendors according to your preferences and requirements.

SoftGroup integration with machines

Our key partnerships with well-known hardware manufacturers provide us with the opportunity to be flexible and to better meet our customers’ specific needs and strict requirements.

Our software is compatible with most of the hardware equipment available on the market, which makes SoftGroup preferable partner in serialization.

We have integration with machines from known hardware producers, such as:

  • Etipack Pharma 4
  • Germark Multibox Series
  • PAGO systems

SoftGroup OEM equipment

SoftGroup is using well-known equipment for its machines. We are currently using one of the best camera vision and marking systems for the pharmaceutical industry.

Our hardware equipment is compatible for working with most of the OEM equipment providers. We could customize our hardware according to the customer’s requirements.

We usually use the following quality OEM equipment vendors:

  • Weber Marking Systems
  • Wolke Marking Systems
  • Cognex Vision Systems

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