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

In October 2023, a high-level meeting was held at the headquarters of JSC Schelkovo Agrokhim, bringing together representatives from INEX (Project Consult LLC), Ce-Tech, and the customer, Betaren Pharma LLC.

The discussion focused on two strategic workstreams:

1. Finished Dosage Forms (FDF) Facility in Dubna The teams reviewed the progress of the conceptual design and "Stage P" (Project Stage) documentation for a new FDF manufacturing building in Dubna. Key technical points included:

• Risk Analysis: Developing a comprehensive risk assessment for multi-product manufacturing.

• Toxicological Evaluation: Determining design parameters based on the toxicological profiles of the planned medicinal products.

• Contamination Control: Evaluating equipment and facility cleaning efficiency to eliminate any risk of cross-contamination.

2. Licensing of the Ipidacrine API Unit The meeting also addressed the licensing process for the previously designed Ipidacrine Active Pharmaceutical Substance (API) production unit located at the Schelkovo Agrokhim site.

On-Site Supervision: Specialists from INEX periodically conduct site visits to Schelkovo Agrokhim to provide professional supervision of the cleanroom installation and the integration of technological equipment for the Ipidacrine API unit. This hands-on approach ensures that the physical implementation aligns perfectly with the engineering designs and GMP requirements.

Regulatory Compliance (RF)

All engineering, risk management, and licensing support activities are conducted in accordance with:

• EAEU Good Manufacturing Practice (GMP): (EEC Decision No. 77) regarding the prevention of cross-contamination and qualification of facilities.

• Order of the Ministry of Industry and Trade No. 916: National standards for pharmaceutical manufacturing and licensing.

• ISO 14644: International standards for cleanrooms and controlled environments.