NTpharma LLCNTpharma LLC

Production of vaccines and biopharmaceuticals based on pseudoadenoviral nanoparticles and special nanostructuresProduction of vaccines and biopharmaceuticals based on pseudoadenoviral nanoparticles and special nanostructures

Environmental safety

According to epidemiology specialists, an obvious advantage of our project is the usage of safe strains for the production of vaccines. This meets the latest global trends in safety of vaccine production.

The project involves development of all the necessary documentation for production of new dosage forms in accordance with the standards of Good Manufacturing Practice (GMP).

The International GMP standard includes a wide range of indicators to be met by companies producing a particular product. GMP for pharmaceutical companies determines the parameters of each stage of production – from the floor material in production facilities and the number of organisms per cubic meter of air to the clothes of employees and product labeling.

GMP is a set of basic requirements and methods to be followed in the production and quality control of medicines according to the latest achievements of science and practice.

Under current Russian Federation Sanitary Rules and Standards (SanPiN 2.2.1/2.1.1.567-96), the production plant is classified as to biosafety level 3 (there are five in total). For comparison production of nutritional yeast is classified at the same level 3.

The plant is a production with low environmental pollution and no harmful effects on the environment surrounding the premises.

The main measures ensuring environmental safety include:

  • clear zoning and authorization of personnel access;
  • keeping microorganisms in closed technological systems that are physically separated from the environment;
  • control of air flows in rooms by differences in air pressure;
  • controlled air supply and exhaust to the environment only through HEPA-filtration;
  • inactivation/neutralization of industrial gases and liquids released.

 

The project is implemented with strict observance of general requirements for biosafety of microbiological and biotechnological productions and their products:

  • absence of actual or anticipated undesirable effects of microorganisms used in production and control of drugs on human and animal health and the environment;
  • complete information about the microorganisms, materials, and equipment used in the production.
  • conclusion on safety of microbiology and biotechnology products is based on a comprehensive assessment of the hazardous effect of products on humans, animals and the environment;
  • production process ensures safety inside and outside of production facilities, provides actions to prevent release of potentially hazardous microorganisms (toxins) that are used in the production into the environment;
  • the safety of microbiological/biotechnology products and guarantee of their compliance with the requirements of regulatory documents. Monitoring of the products safety after placement in the market. Similar responsibilities are assigned to the state executive authorities in the sphere of healthcare.
  • a permanent security body (commission) to be established for monitoring of compliance with the security regime at the production facilities and analysis of emergency security breaches.

Global practice

It is quite common for biotech productions to be located within city limits. Here are some examples:

  • GlaxoSmithKline, Dresden (Germany). Production of a flu vaccine at Sachsisches Serumwerk plant. This plant existing since the late XIX century is a global leader in vaccine production.
  • Gedeon Richter, Budapest (Hungary). Production of pharmaceuticals, active ingredients and intermediates. The largest producer of medical products in Central and Eastern Europe.
  • WZF Polfa, Warsaw (Poland). One of the largest pharmaceutical companies in Poland. The head office of the company and its plants are located almost in the center of Warsaw.

 

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