KEY TASKS IN THE DESIGN OF PHARMACEUTICAL ENTERPRISES

The modern pharmaceutical industry has a wide variety of industries, different products. Study of the requirements for the proper design of pharmaceutical production taking into account the nature, physical and chemical properties of the initial substances, intermediate and final products, the nature and conditions of technological processes.

Design of pharmaceutical companies - is engineering, universal design solutions set out in graphic and text format and meet the requirements and rules of the GMP standard.

The general task of designing pharmaceutical enterprises is the search, coordination and implementation of optimal design solutions.

The main objective of the design of pharmaceutical factory created the concept of the production of pharmaceuticals, appropriate regulations of GMP.

Development of the project according to GMP requirements for pharmaceutical companies and warehouses is a crucial stage of preparation for construction. At the design stage, all the technological features of the future production are taken into account and all the rooms and life support systems of the plant are planned. Therefore, it is very important that all elements are properly placed and function after construction.

It is necessary to make sure that the clean room used in the production of sterile medicines is absolutely safe, the water used in injections is clean. Such important points are taken into account in the design of pharmaceutical enterprises.

Conceptual design development

Conceptual design is the first stage of design, the fundamental basis for the creation of any project. It allows you to assess the possibility, ways and means to implement the project.

A conceptual project is a task for design with the adopted technological solutions, a common understanding of the project by the Customer and the Designer, the definition of problem areas of the project and decision-making on their elimination, the definition of the volume of subsequent design work, project planning and resources, reducing the amount of work at the next stages of the project.

Why do we need a conceptual project?

The concept allows you to make sure the rational use of the allocated area, to see how the object will look like, to obtain information about technical and technological solutions, to plan the stages of the project implementation.

Conceptual design allows us to build a modern facility with high profitability, meeting modern requirements of safety, energy efficiency and environmental friendliness. Conceptual design allows to expand the functionality of the object, to equip it with modern automated systems and high-tech equipment.

The conceptual design includes:

Drawings:

• Layout of premises and equipment;
• The size of the premises (specification for design of architectural and construction part);
• Points of connection of communications (task for design of electrical part, water supply and Sewerage);
• Flow charts of personnel, materials, products, waste;
• Classes of clean rooms and differential pressure between rooms;
• Service areas of ventilation systems.

Explanatory note:

• Technology of work;
• Description of flows, materials, products, personnel;
• Equipment specification;
• Preliminary calculation of the required power capacity;
• Staff requirement;
• Technological task for the design of electric lighting;
• Technological task for the design of power electrical equipment;
• Technological task for the design of ventilation and air conditioning system;
• Technological task for the design of water supply and Sewerage.
• During the design process, we will evaluate the necessary equipment and its performance to meet all technology needs.

Composition of the pharmaceutical plant project

The design of the pharmaceutical factory includes the development of the necessary sections of drawings and an explanatory note detailing:

• procedural processes for the preparation of personnel to work with;
• placement of pharmaceutical equipment;
• planning and interior decoration;
• the device sewers, troughs, ladders, fire gateways;
• preparation, transportation and storage conditions of air, water (injection or purified);
• schemes of flows of movement of finished goods, raw materials and working people;
• fire safety for the proposed categories of premises.

Design of pharmaceutical systems

Air and water systems

Developing projects for air purification and water supply systems used for pharmaceutical production that support aseptic or sterile processing while adhering to the quality system used in this highly regulated environment.

Clean room layout

Create clean room design and pressure profiles to control the environment needed to meet the materials and personnel flows at the production facility.

Design of devices and processes

Design of pipelines construction, instrumentation and technological processes for creation and distribution of clean engineering systems.

Storage and packaging

Design of pharmaceutical warehouses and premises for packaging of medicines.

Bibliography:

1. Основы проектирования химических производств: Учебник для вузов / Под ред. А.И. Михайличенко.-М.: ИКЦ “Академкнига” 2010
2. Концептуальный проект https://val-center.com/ru/service/conceptual-project
3. Проектирование фармзаводов, Фамастрой строительная компания https://famastroy.ru/proektirovanie/proektirovanie_farmacevticheskih_predpriyatiy/
4. Основы проектирования химических производств: Учебное пособие / Дворецский С.И, Кормильцин Г.С, Калинин В.Ф – Издательство “Машиностроение-1”