Products

A joint cross-company development project between groninger and SKAN resulted in a unique line concept for vial processing – called integra. The integra product family is a sophisticated line concept integrating both isolators and filling machines which revolutionizes the pharmaceutical industry. This joint vision of groninger and SKAN could be realized in a very short time and includes different lines offering top speeds and standardized isolator technology. The integra filling line is the latest member of the groninger and SKAN business line.

 

Key data of the integra isolator system

  • The isolator has EU GMP Class A (ISO 5) production chamber for highest product protection.
  • integra offers highest safety for operators as well as for the whole process.
  • The integrated skanfog® technology allows fastest decontamination cycles.
  • A new, exclusive cleaning validation process is used.
  • The isolator system offers unique ease of operation and ultra-slim machine design.
  • integra allows optimal access to operate the entire line from only one side.
  • The isolator is suitable for aseptic and highly potent/toxic products.
  • integra – A new era of isolator technology

    The integra isolator for filling lines combines the best of both worlds: Aseptic and potent/toxic design. The sophisticated isolator is suitable for a wide range of liquid products up to new drug substances with BSL 2 or higher requirements. The isolator line with the fully integrated filling machine is combined with a lyophilization, capping and washing process. The integra family also offers first-class products for these process steps, with excellent accessibility and user-friendliness.

  • The tailor-made isolator for your filling line

    Together with groninger, we have reinvented and accelerated the manufacturing and design phases to deliver the best products in the shortest time.
    Together we put special emphasis on a simple and fast configuration phase for our customer including a virtual walkthrough of the individual product line. Preconfigured and tested options guarantee the fastest delivery times and uncomplicated engineering phases up to the FAT (Factory Acceptance Test).
    Not only time to market is important, but also the individual needs of the customer. With the integra family we offer more than just a tailor-made isolator filling line, it is a journey to perfection.

  • integra as a result of a strong partnership

    According to current Good Manufacturing Practice (cGMP), aseptic pharmaceutical products require validated aseptic process methods. Therefore, it is very important to work with experienced partners from the beginning.
    The partnership of SKAN and groninger has been based on shared knowledge and trust for decades.
    Together with groninger, we have clearly defined the interfaces of cooperation, which is manifested in positive effects on compliance, quality requirements, costs, deadlines, and performance. We support our customers throughout the lifecycle of their filling systems and isolators and, with our performance guarantee, we take responsibility for the decontamination of the entire system.

  • Fields of operation for the integra isolator

    The integra product line offers a variety of solutions for all types of manufacturing process and application.
    The fields of operation of integra isolators range from purely aseptic production to potent/toxic processes through to BSL requirements.
    The filling machines used in the isolator are flexible and can be customized. Quality, performance, and user-friendliness are always in focus. We are also guided by current trends such as robust processes with less operator intervention and a focus on the first-air principle. The results of CFD and smoke studies also convinced the authorities.

  • Automation

    SKAN automation solutions are developed according to current GAMP and GMP regulatory requirements.

    • GMP guidelines, CFR 21 Part 11, EndraLex Volume 4
    • Supervisory Control And Data Acquisition (SCADA)
    • PLC Siemens or Allen Bradley
    • HMI Beckhoff Industrial PC
    • Beckhoff touchscreen monitor
    • Active Directory
    • Decontamination report
    • Batch report
    • Campagne report
    • Audit trail functionalities
    • Electronic records
    • Electronic signature
    • OPC interface
  • Documentation

    Each project is accompanied by an experienced SKAN project team to achieve the best possible results in a short time.
    We attach great importance to the quality of the documentation of each inspection. All our products and projects include the required GMP design and validation documents defined in our Quality Project Plan (QPP).
    At SKAN, this includes the Factory Acceptance Test (FAT). Our qualification and validation service includes the IQ, OQ protocol and report as well as the micrological qualification and validation package.

Get in touch with our sales team!


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