cleanrooms in pharmaceutical industry

cleanrooms in pharmaceutical industry

There are many classification methods for cleanrooms in pharmaceutical industry.
According to the nature of their use, they are generally divided into three categories: industrial clean rooms, general biological clean rooms, and biosafety laboratories (clean rooms).

Generally, biological cleanrooms mainly control the pollution of living particles on the operating objects.
Decorative materials should be able to withstand the erosion of various disinfectants, and the interior of the space should be maintained at positive pressure through the configuration of HVAC engineering systems.
This distinguishes the biosafety laboratory (biosafety clean room), which not only requires controlling the pollution of living particles to the operating objects, but also requires controlling the pollution of potentially hazardous operating objects to the operators and the surrounding environment.
The control of pressure difference is more important, and negative pressure needs to be maintained indoors.

If the construction of cleanrooms in pharmaceutical industry workshop lacks comprehensive understanding of the cleanroom, it is difficult to pass the completion acceptance and comprehensive performance evaluation.

To address this, our design team often emphasizes the following key principles during the proposal stage:

1. Core Purpose of Biological Cleanrooms: 

Our design team often emphasizes repeatedly during design proposals that biological cleanrooms are established to prevent pollution and eliminate microorganisms.

2. Technical Considerations: 

• Load calculation and energy consumption analysis should be carried out during their design to achieve the specified purification function.
• From an economic and practical perspective, it is necessary to meet specifications but not completely adapt.

• The mature approach is to moderately streamline the plan according to process requirements and budget, to achieve safety, practicality, economy, and feasibility.

3. Zoning and Layout Design:

In addition to the design concept of reasonable zoning, separation of clean and dirty areas, and avoiding detours in personnel/flow lines, we also insist on making more considerations in the design of buffer rooms when facing tight factory areas.

4. Functional Area Planning:

In some cleanrooms in pharmaceutical industry, changing rooms and sanitary ware rooms can also be used as buffer functions simultaneously.

The production workshop of biologics should have a sterile environment, and clean areas, semi clean areas, and auxiliary areas should be divided before decoration.

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