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«Innovation expert clean rooms»®

Construction of a Prefabricated Modular Building for a Thermal Disinfection and Decontamination Station for Pathogenicity Groups III–IV Effluents

01.06.2023

Customer: LLC NPO "FarmVILAR"

In July, a team of INEX specialists conducted a site visit to the facilities of NPO PharmVilar LLC to initiate a new strategic partnership. For over 20 years, PharmVilar has been a key player in developing and manufacturing high-quality, innovative pharmaceutical products across Russia and the CIS.

The primary objective of this collaboration is to design and organize a production line for phospholipid emulsions, with a target capacity of 1,000 liters of intermediate product per month. During the visit, INEX experts performed a comprehensive audit of the proposed production areas and discussed technical requirements and architectural layouts.

[Image: Site audit showing INEX engineers and PharmVilar representatives discussing facility blueprints]

Cleanroom Specifications: The project covers several specialized zones designed to meet international standards:

  • Class C Cleanroom: 125 m³ for primary processing.

  • Class B Cleanroom: 100 m³ for high-purity operations.

  • Controlled Zone (Zone K): Approximately 160 m² for support and logistics.

The active participation and expertise of the PharmVilar team during these initial discussions ensure a solid foundation for achieving the project's technical goals. We are proud to support PharmVilar in expanding their production capabilities for life-enhancing medications.

[Image: Technical layout showing the segregation of Class B and Class C zones for emulsion manufacturing]

Regulatory Compliance (RF)

The engineering solutions for the PharmVilar project are developed in accordance with:

  • EAEU Good Manufacturing Practice (GMP): Ensuring strict quality control for sterile and non-sterile liquid dosage forms.

  • ISO 14644 (GOST R ISO 14644): Defining the classification and monitoring of cleanroom air purity.

  • SanPiN 2.1.3684-21: Regarding the sanitary and epidemiological safety of pharmaceutical manufacturing facilities.