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PAS-X Start-up Packages
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| Start-up Package for Weighing and Dispensing
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The PAS-WD Start-up Package is a classical first-step product for a modular, paperless MES production environment. PAS-WD is a standard weighing and dispensing system designed especially for pharmaceutical processes and in full compliance with all GMP requirements. Main features:
- System-guided "easy-to-operate" workflows
- Fully automated dispensing and filling controls
- Campaign processing
- Scale calibration and scale management
- Container management for weighing operations
- Complete integration with ERP systems
- Standard interfaces to all commercially available brands of scales
- High level of equipment integration into complex material flow control systems
- Compliance with FDA/GMP requirements
- 21 CFR Part 11-compliant Electronic Records / Electronic Signatures
- Audit trail functions
- Validation support
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| Incremental Deployment / Expandability |
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The PAS-WD Start-up Package enables you to introduce a MES system with minimum risk and a manageable investment. Due to its modular structure, the system can be upgraded to a functionally complete, paperless PAS-X Manufacturing Execution System at any time.
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| Integration with ERP Systems |
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The system electronically adopts the weighing orders directly from the ERP
system, then executes and documents them. PAS-WD acquires material consumption
data as well as adjustment postings associated with an order and supplies the
information directly to the materials management system. It is equipped with
certified interfaces to integrate PAS-WD into basically any ERP system.
"Out of the box" interfaces especially for SAP integration are available, they support all commercially
available SAP interfaces and technologies.
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| Order Processing |
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There are various approaches for integrating PAS-WD into the procedures of order processing:
- a stand-alone weighing solution based on manual input of orders
- an integrated system interfaced with intelligent ERP order control systems.
PAS-WD provides a wide scope of functions, among them all features required for automatic campaign processing for weighing and dispensing.
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| Material Weighing |
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PAS-WD enables a high level of integration with material flow control systems.
The material quantities to be added can be flexibly adapted depending on the potency of:
- raw materials,
- active ingredients,
- compensating ingredients,
- auxiliary ingredients.
The weighing functions of PAS-WD calculate the required quantities of active and compensating
ingredients to be used. The integration with ERP systems, or systems for material flow control,
facilitates the selection of materials according to criteria of reservation or FIFO.
The correct handling of input materials is essential and the system fully supports the operator.
The system displays standard operating procedures relating to materials handling as well as all
important information on harzardous material and industrial safety regulations to be observed.
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| Batch Processing / Weighing Report |
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In addition to the flexible processing of input material batches, weighing operations in batch-based pharmaceutical production also have to consider the handling of multi-material intermediate and finished product batches. PAS-WD can handle batch changes providing the required material identification and documentation. PAS-WD generates a weighing report, and integrates it into the batch documentation. Via interface, PAS-WD reports material postings and inventory reconciliation data to the higher-order ERP system, thus ensuring a consistent data pool in the two systems.
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| Deviation and Event Management |
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PAS-WD detects all deviations and offers an electronic workflow to comment and to process them.
Comments on the registered deviations can be entered at any time.
Any violations of the defined limit values are displayed in due time by means of traffic light functions. The system documents all deviations and provides them to the responsible persons and departments for assessment and approval.
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