Integrated IT solution for packaging

PAS-X Packaging solution

Performance, compliance and serialization are the key challenges of today’s pharma and biotech packaging operations. Shop floor operators face three major tasks:

  • Operate the line and ensure right-first-time operation
  • Optimize performance of the packaging process, including changeover
  • Manage the serialization and aggregation process

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Shawn Opatka

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PAS-X: standard system for EBR, OEE and Track & Trace

In order to meet these challenges, Werum supports pharma and biotech companies with its modular PAS-X Packaging Solution – a combination of PAS-X software functions, PAS-X Content Packages and PAS-X Services relevant for packaging operations. It is a smart option to get started with Werum’s manufacturing IT solutions.

The solution offers functions that include Electronic Batch Recording (EBR), Overall Equipment Effectiveness (OEE) and Track & Trace Serialization Aggregation with a single user interface. This way, both operators and administrators need to use only one easy-to-use system. As the central level 3 application, the PAS-X Packaging Solution integrates the ERP system and the Central Serialization Repository with the shop floor packaging equipment and line controllers.

PAS-X is scalable. Customers can start with a small solution on the shop floor level (with equipment from any supplier) and extend it on a step-by-step basis – up to a functionally complete, full-scope PAS-X MES system. In cooperation with Seidenader all architecture levels come from a single source.

Faster creation and maintenance of packaging MBRs

Packaging processes always follow the same workflow and differ only in terms of product specific characteristics. All common parameters are summarized in Generic Master Batch Records (GMBRs). Thus, the number of recipes can be reduced from hundreds or even thousands of MBRs to only a few GMBRs. The benefits for the customer lie in the reduced administrative effort and the easier maintenance of the MBRs, and therefore in much more efficient processes.

A faster creation and easier maintenance of packaging MBRs is additionally ensured by predefined, packaging-specific “Process Libraries” Content Packages. They are based on the best practice of the industry and comprise GMP-compliant templates for the simple creation of packaging MBRs. For instance, “Setup” covers all processes related to prepare the packaging line for production.

Together with a Werum consultant, the templates will be configured to suit the customer’s specific business processes.

Efficiency gains and standardization through integration with PAS-X

Integrating the PAS-X Packaging Solution with an existing PAS-X MES is the easiest and most beneficial way for enhanced efficiency. For customers already running PAS-X, this is only a small step. However, it is also possible for customers to first implement a Track & Trace or KPI Solution and later expand the system step-by-step into a complete PAS-X MES.

The benefits of integrating the PAS-X Packaging Solution with the PAS-X MES: All functionalities are provided by the same standard system, only one user interface for the shop floor operators, and a seamless data exchange. Combining all functionalities in one standard system guarantees easier processes with improved cost efficiency.

Why PAS-X Packaging solution

  • Only one user interface for shop floor operators
  • Easy-to-operate electronic execution, track & trace functions and documentation
  • Performance optimization including real-time analysis of OEE
  • Support of all equipment suppliers
  • One-Stop-Shop in connection with Seidenader
  • Scalable: easily extended to complete PAS-X MES
  • Future-proof investment