News | June 9, 2001

Dompé Pharmaceuticals Dompé S.p.A. implements POMS MES as quality guarantee for pharmaceutical production

Source: Honeywell-POMS
Honeywell-POMSé is one of the most dynamic, flexible and innovative companies in the European pharmaceuticals field. Having initially established a solid presence in the traditional areas of respiratory and osteo-articular therapies, Dompé has also established itself in the biotechnological field with is innovative drugs and creative services. Dating back to the twentieth century, today, Dompé is a growing company with more than 650 employees and a turnover exceeding 150 million Euros.

All research, development and production is carried out in Italy at the modern L'Aquila facilities, designed by Foster Wheeler and completed in 1993. All the plant's activities are carried out in compliance with GMP and GLP and GCP adhering to FDA directives. The production facilities, constructed and operated with the highest international standards, have the capacity to produce tens of millions of units of high quality, low unit cost pharmaceutical products as liquid or solid formulations for oral administration and ointments and creams for topical application.Honeywell-POMSé's association with the POMS suite of manufacturing solutions began with the need for an information tool able to work in a supervisory and managerial capacity during pharmaceutical manufacturing operations. Dompé set the goal of finding a defined Operation Management system that could be implemented throughout Dompé's entire production area.

The system Dompé required had to be able to:

  • keep data as close as possible to the generation point
  • avoid their manual handling
  • make input discriminations and
  • record electronically each executed operation and interaction with the system (Batch Record).
Dompé's goal was achieved through the use of the POMS Manufacturing Execution System (POMS MES) from Honeywell POMS, the global leader in the MES Area.

Recently, Dompé had to reevaluate that choice made years ago, when managers decided to install a POMS solution based on the OS/2 Operating System: When the time for upgrading the system came around, should the new version of POMS MES be Dompé's choice to optimize their production process? The answer, decided by Dompé's top management, was yes.

Honeywell-POMSé's management made the decision to retain and upgrade the POMS solution because of a firm belief that the use of POMS solutions results in the consistent improvement of quality they look for and because of the potential, offered by the newest generations of the POMS solution, based on BPO and Recipe Manager, to significantly shorten the implementation and validation time of Dompé's offerings.

Exceptional and flexible functionality led Dompé to the upgraded POMS Solution, which includes:

  • the ability to define and manage product parameters external to the application external to the application
  • the ability to communicate process parameters to POMS from Fix Dynamics and back, using OPC POMS Server
  • Direct Interface to scales
  • Exceptions and deviation handling
  • Software and Recipe reusability
  • Configurable system parameters
  • Label Printing
  • Report Printing
  • Electronic Signature Compliance
  • Automatic EBR generation in PDF format The selection of the latest POMS solution was the keystone of a project by Dompé's leaders to completely remake Dompé's hardware and software system, so as to optimise the system to consistently work in the best way, under the best of conditions. The project began with the upgrade of POMS MES from the OS/2 to a Windows NT version, and the use of BPO and Recipe manager, Dompé also upgraded an Intellution system from Fix DMACS to iFIX, the HMI/SCADA component of the Intellution Dynamics family, and their network from Token Ring to Fast Ethernet. New hardware was purchased for each step of the production process, including printers, workstations, servers, and scanners.

    POMS MES was installed in all production areas to maintain full control of all aspects of the production process. Throughout the full manufacturing process, the POMS system is found at each step along the way:

  • Warehouse
  • Dispensing
  • Syrups Bulk Manufacturing
  • Creams Bulk Manufacturing
  • Granulates Bulk Manufacturing
  • Syrup Packaging
  • Creams Packaging
  • Sachets Packaging
  • Ampoules Packaging Multiple workstations are involved at each step. During granulates manufacturing alone, the POMS procedure is distributed over five workstations, located on three different levels. This has had tremendous impact, as Dompé's system has to manage markedly different kind of production processes: syrup, granulates, creams.

    It is at the end of a batch production, that the system generates the Electronic Batch Record. At Dompé, an EBR is not considered complete until the following reports are generated and printed directly from the POMS system:

    • Dispensing Report
    • Weights Control Report
    • Manufacturing Yield Report
    • Materials Quantitative Report
    • Packaging Yield Report
    Additional key features factored into Dompé's renewed choice of the POMS system, and are outlined below:
    Dispensing main features:
    • multiple methods of dispensing (the most important for us is blending of dispensed raw material in Bins, large-volume movable containers)
    • pre assigned lot of raw material
    • WIP container management
    • direct Interface to scales
    • assets management
    • generation and print of labels
    • dispense Report
    Manufacturing and packaging main features:
    • recipe reusability
    • detailed instruction to the Operators
    • product parameters defined and managed external to the application
    • assets management
    • direct interface to scales
    • weigh in progress of WIP containers
    • process parameters management, retrieved directly from Fix Dynamics
    • in progress dosage control
    • statistical calculations
    • generations and print of labels
    • Weights control Report
    • Preparation Yield Report
    • Materials Quantitative Report
    • Packaging Yield Report
    The project was undertaken in accordance with the cGMP rules for the pharmaceutical and information technology arenas. The new system functionality, added by the developer to cover all the user requirements, was validated with the GAMP guidelines as a model. With the project now complete,Honeywell-POMSé is able to deal with GMP compliance with the security and confidence that comes from utilizing the most current version of the industry leading Pharmaceutical Operations information tool, POMS MES.

    Honeywell-POMS solutions enable e-business by providing solutions that address the entire product life cycle—from product development through manufacturing and packaging operations. Honeywell-POMS solutions increase cash flows for healthcare products and consumer packaged goods industries by reducing time to market for new products, improving manufacturing agility and effective capacity, reducing costs, ensuring that operations are integrated into the e-business supply chain. The combination of POMS and other Honeywell products provides a single source for process and production management and environmental control solutions.

    Honeywell-POMS products are used by more than 15,000 users across 15 countries in industries including commercial and clinical pharmaceuticals, biopharmaceuticals, primary pharmaceutical chemicals, medical device, food, beverage, and personal care products. Honeywell-POMS' customers include Baxter Healthcare, Boehringer Ingelheim, Aventis, Schering-Plough Research Institute, Johnson & Johnson Pharmaceuticals Research Institute, TNUVA Dairies, The J.M. Smucker Company, and R.P. Scherer.

    Source: <%=company%>

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