Clean room design in the pharmaceutical industry:
Cleanrooms are used in various industries, especially pharmaceuticals. Cleanroom design principlesare of particular importance. In addition to manufacturers, clean room users should also have information about these principles .
Many ISO standards and specialized pharmaceutical standards such as GMP should be considered in designs. Many things such as the type of product and production volume and even the amount of investment and budget of the projectwill have a direct impact on the design of lines and clean space . As an introduction, pay attention to the following points :
Personnel flow diagram
The personnel working in the clean room are the main source of contamination. For this reason, it is necessary to isolate all the sensitive processes of the clean room through separate and controllable inputs. Also, personnel must use special equipment before entering the clean room.
Clean room classification
Clean room classification is done based on the standards compiled in this regard and with the criteria of the amount of particles allowed in the clean room. Clean room classification is based on the volume of particles and pollutants suspended in the air. The most important standards defined for the classification of cleanrooms are three standardsISO, BS and the American system.
Pressure difference diagram
To prevent the transfer of contamination to the clean room , there must be a pressure difference between the interior and exterior of the clean room. This pressure difference prevents polluted air from entering the clean room from the dirty area. This pressure difference is often around 10 It is up to 15 pascal. A pressure difference greater than this amount is not suitable and causes energy loss.
Amount of air intake
In the clean room , the amount of incoming air is determined based on the usage, production process and class of the clean room. This air should also be introduced through air filters so as not to cause additional pollution in the environment. In addition to controlling the incoming air, the amount of outgoing air flow must also be adjusted to balance the clean room.
Specialized services of Raymon Group in the field of design of cleanroom and pharmaceutical building:
Raymon Group using international standards and licensed by the companyRK India andBAPAREX Germany performs the design phase of production and factory construction projects as follows:
Two-dimensional and three-dimensional construction design:
1- Carrying out feasibility and geotechnical studies.
2- Phase 1 of construction, including structural design and calculations.
3- Phase 2 of construction including the design of mechanical and electrical facilities.
4- Phase 3 includes the preparation of a detailed list of materials and materials (MTO) or BOM
5- Designing a schedule and Gantt chart for project implementation.
Pharmaceutical design:
In this section, the design services of pharmaceutical projects and production lines will be explained in detail.
In the pharmaceutical design phase, just like the construction design of the projects, the following phases should be prepared and prepared by Raimon's design team. In addition, the necessary approvals from the competent companies, including
the company RK India andBAPAREX Germany is prepared to the smallest detail according to the latest domestic rules and standards(IFDA) and international should be considered in the plan. Therefore, the following steps are an integral part of any executive project, especially pharmaceutical industries, which are highly sensitive in facing human lives and must be implemented very correctly and precisely..
Phases of drug design:
1-Preparation and review of feasibility studies including estimation of production volume, amount of investment and type of planned products as well as production machines and facilities that are inFS, BS should be analyzed.
2-convenience maps Conceptual, Basic, Detail Design in two dimensions.
3- Designing and converting maps Conceptual, Basic, Detail Design in 3D.
4- Harmonization of construction phase maps and pharmaceutical maps and making changes on them if needed.
5- Preparation of simulation andSimulation of production line and clean environment.
6- Preparation of detailed list of materials and materials (MTO) or (BOM)
7- Designing the project schedule and Gantt chart.
Each of the mentioned items will be explained in detail below:
Conceptual designconceptual design
In this section, the following maps are presented to the employer:
- Room plans
- Environmental pressure difference maps
- Air flow diagram
- Map of medicinal water consumption points
Basic designBasic design
In this section, the following maps are presented to the employer:
- Air maps
- Return air maps
- Hot and cold water piping plans
- Maps of water consumption
Detail design : In this section, the following plans are presented to the client:
- 3D mapsconceptual, basic design
- urs, specification Machines and production line
- Preparation of documentation for each room and mechanical and electrical consumers(Room Book)
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