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Reference project

Automation and qualification
of an assembly and packaging line

A pharmaceutical company wants to redesign its production system. Bottles with ingredients (vials) in stacks are supplied on euro pallets. The stacks are removed from the pallets, the bottles are taken from the stacks and put together into rack packs of 1, 2 or 3. Then, the packs are labelled and stacked in boxes with inserts. The boxes are then checked to ensure they are complete and loaded onto euro pallets.

The complete structure, commissioning and qualification of an assembly and packaging line should be carried out by a general contractor (GC). EXCO supports the GC on behalf of the manufacturer.

Implementation

EXCO undertakes:

1. Automation management / responsibility / synchronization

EXCO is commissioned by the pharmaceutical manufacturer to ensure that the new machinery supplied by the general contractor (GC) will fit into the automation concept of the manufacturer.

  • Collaboration in the creation and optimization of specification and requirements specification
  • Determination of data interfaces between packaging unit and HMI and SCADA systems
  • Consultation and support of the GC in complying with client specifications in the design, realization and commissioning phase (alarm concept, automation concept, HMI, hardware structure, security concept, interfaces to production systems, etc.)
  • Preparation, execution and documentation of function tests (machinery / systems)
  • Support of the GC before handover: Training concept, replacement parts and documentation inspection
  • Evaluation of project progress for automation
  • Interface to production, packaging development and maintenance

2. Management of system qualification

EXCO takes on the management of the system qualification of the assembly and packaging line:

  • Development of the qualification strategy
  • Creation of design documents (specifications, requirements specification, functional risk assessment)
  • Creation of qualification documentation for DQ, IQ, OQ phases
  • Execution of tests
  • Coordination with and support of overall project management 
  • Execution of factory acceptance test (FAT)

3. Qualification of SCADA system EXCO assumes the qualification of the SCADA system.

The SCADA system manages and monitors the packaging line and communicates with 10 machines. Each machine exchanges approx. 500 signals with the SCADA system. About 80 of these signals are analog.

  • Equipment qualification
    • Development of qualification strategy
    • Creation of design documents (specifications, requirements specification, functional risk assessment)
    • Qualification documentation for DQ, IQ, OQ including test planning, execution and reporting
  • System qualification
    • Development of qualification strategy
    • Specification of qualification documentation needed from the suppliers
    • Creation of all qualification documents, such as Qualification Project Plan (QPP), System Impact Analyses (SIA), Criticality Assessment (CA), Risk Assessment (RA), etc.
    • Creation of FAT tests in cooperation with those responsible for mechanics / process engineering, automation and suppliers
    • Providing assistance during the execution of the IQ/OQ test and reporting

We are the link between pharmaceutical producers and their suppliers, as we ensure that all our clients’ requirements are implemented by suppliers.

Dirk Weißling, Project Manager Process Qualification - Automation Systems
Customer benefits
  • EXCO develops the suppliers of clients on their behalf so that all client requirements regarding automation are complied with.
  • The client receives a qualified system in accordance with the current norms and standards. In addition, compliance with client-specific quality assurance concepts is also fulfilled.
Client

Pharmaceutical company, Mannheim

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