Containment isolators and Glove boxes

Advanced solutions for the processing of oral solid dosage forms from High Potent Active Pharmaceutical Ingredients (APIs).

The production and handling of highly pharmacologically active compounds require specialized containment capabilities to ensure the highest safety for operators, the product, and the environment. Nicomac is able to provide complete lines integrated with European-made equipment for solid forms with high containment capabilities or under isolators ranging from OEB3 to OEB5.

Thanks to years of experience in the industry and collaboration with a specialized partner, Nicomac offers a range of high-performance isolators designed to ensure operational efficiency and compliance with the most stringent regulatory standards.

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Technology and Innovation for Containment

For the transfer between processing machines, Nicomac has developed multiple devices and solutions that ensure the required containment in every situation. The technologies and construction methods ensure the same level of containment even during cleaning and maintenance activities.

Nicomac provides, installs, and validates fully isolated lines for the production of Oral Solid Dosage Forms, with batch sizes ranging from 1kg to 65kg and containment levels from OEB3 to OEB5.

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Technical Specifications

The design of the isolators ensures proper ergonomics, efficiency, and operational safety of the process. The construction of a mock-up during the early design stages ensures the best possible configuration for the isolator. Our isolators offer a range of technological advantages that make them an ideal choice for high-potency pharmaceutical and nutraceutical production:

Structure made entirely of stainless steel

  • Control system compliant with CFR21 Part 11
  • Ergonomic study and high-quality finishes for optimal cleaning
    Small dispensing area, BIN washing
    Automatic sliding door
    FDA/EMA approved materials
    Constantly controlled negative pressure
    Leak test Class 2 according to ISO 10648-2
    Various transfer systems available
    Up to CTP<0.1 μg/m3 TWA (OEB5)
    HEPA H14 filters, BIBO or push-push cartridges
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Download the Catalogue

FULLY CONTAINED LINES FOR OSD FORMS

Discover the world of Nicomac's pharmaceutical isolators for High Containment Products.

CATALOGUE

FULLY CONTAINED LINES FOR OSD FORMS

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