Quality By Design

Quality By Design
Product Description

Identification of the Critical Process Parameters (CPP), to be studied during the (following) Design of Experiment (DoE) development step.
Development of a Proven Acceptable Range (PAR) and Normal Operative Range (NOR) for the micronization process to support the future Process Validation activity.

M UNIT SA

  • CH
  • 2017
    On CPHI since
  • 100 - 249
    Employees
Company types
CMO/CDMO

M UNIT SA

  • CH
  • 2017
    On CPHI since
  • 100 - 249
    Employees
Company types
CMO/CDMO

More Products from M UNIT SA (10)

  • De-lumping

    Product De-lumping

    MUNIT provides a wide range of services performed in our affiliates JETPHARMA and MICROCHEM, as de-lumping.  Spiral jet mills and a hammer mill can be used successfully not only to reduce the particle size, but also to remove lumps and agglomerates. Contact us for more information.

  • Dispensing

    Product Dispensing

    MUNIT provides a wide range of services performed in our affiliates JETPHARMA and MICROCHEM, such as dispensing.
    It contains clean rooms and isolators which be used to dispense and re-pack bulk APIs into small containers of any amount.
    Contact us for more information.

  • Micronization

    Product Micronization

    MUNIT provides a wide range of micronization services performed in our affiliates JETPHARMA and MICROCHEM.  These services are requirable for APIs, steroids, cytotoxics and cytostatics, HPAPIs, antibiotics (not Beta-lactams), using our spiral jet mills. Contact us for more information.
  • Milling

    Product Milling

    MUNIT provides a wide range of services performed in our affiliates JETPHARMA and MICROCHEM, such as milling.
    We are able to perform mechanical milling with hammer or pin mills for API and HPAPI. 
    Contact us for more information.
  • Packaging under an inert atmosphere

    Product Packaging under an inert atmosphere

    MUNIT provides a wide range of services performed in our affiliates JETPHARMA and MICROCHEM, such as packaging under an inert atmosphere.We provide packaging under nitrogen or argon which offers the highest degree of powder preservation to guarantee the integrity of the API.
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  • Sieving

    Product Sieving

    MUNIT provides a wide range of services performed in our affiliates JETPHARMA and MICROCHEM, such as sieving.  We offer to customers as standalone process, or in conjunction with the micronization process to obtain a characteristic particle size profile.
    Contact us for more information.
    ...
  • Blending

    Product Blending

    MUNIT provides a wide range of services performed in our affiliates JETPHARMA and MICROCHEM, such as blending.
    It involves blending of APIs with excipients and can be offered to customers as a standalone process, or in conjunction with the micronization process.
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  • Co-micronization

    Product Co-micronization

    MUNIT provides a wide range of micronization services performed in our affiliates JETPHARMA and MICROCHEM, such as co-micronization.
    It includes blending and particle size reduction of an API and excipient(s) as a single process step. Contact us for more information.

  • Contract analitical service for PSD analysis

    Product Contract analitical service for PSD analysis

    MUNIT provides a wide range of services performed in our affiliates JETPHARMA and MICROCHEM, such as contract analisys.
    We provide services for PSD analysis and related activities (method validation, method transfer, ecc.). Contact us for more information.

  • Cryogenic micronization

    Product Cryogenic micronization

    MUNIT provides a wide range of micronization services performed in our affiliates JETPHARMA and MICROCHEM.
    It is used to prevent the degradation of highly sensitive products, to avoid polymorphic changes, to avoid an increase in amorphous particles and to allow the micronization of polymers. Co...