10 Effective and Easy Steps to Clean Room Design, ISO 14644

In clean room design, where we create and maintain an environment with low levels of environmental pollutants such as dust, airborne microbes, aerosol particles and chemical vapors. Designing a delicate environment like a clean room is not an easy thing, but under 10 steps will definitely help you and describe the easy way to design it.

Most of the cleanroom manufacturer processes required the extremely stringent conditions provided by the cleanroom. Because cleanrooms have complex mechanical frameworks and high development, operation and vitality costs, cleanroom design in any orderly fashion is crucial. The following steps present evaluation methods and cleanroom design, people/material flow in factories, classification of space cleanliness, space pressurization, space supply air flow, space air infiltration, space air balance, variables to be evaluated, mechanical system selection, heating/calculations. cooling load and support space requirements.

1. People/Materials Flow Evaluation Pattern:

It is important to evaluate the flow of materials and people within the cleanroom suite. All critical processes must be isolated from personnel access doors and paths; this helps cleanroom workers because they are a cleanroom’s biggest source of pollutants.

There should be a strategy for critical areas, as compared to less critical areas, the most critical areas should have a single access to prevent the area from becoming a path to another. Some pharmaceutical and biopharmaceutical processes are susceptible to cross contamination from other pharmaceutical and biopharmaceutical processes. Process cross-contamination needs to be carefully considered for material process isolation, raw material entry routes and containment, and finished product exit routes and containment.

2. define Classification for Area Cleaning:

It is very important to know the primary cleanroom classification standard and what the particle performance requirements are for each cleaning classification at the time of selection. It is very important to know the primary cleanroom classification standard and what the particle performance requirements are for each cleaning classification at the time of selection. There are different cleaning classifications (1, 10, 100, 1000, 10000 and 100000) and the number of particles allowed in different particle sizes provided by the Institute of Environmental Science and Technology (IEST) Standard 14644-1.

3. define Pressurization for Cavity:

Maintaining a positive air gap pressure adjacent to areas with a more polluted layout is essential to prevent contaminants from entering a cleanroom. It is extremely difficult to reliably maintain the regularity pattern of a space when it has neutral or negative space pressure. What should be the gap weight difference between the spaces? Different reviews evaluated contaminant penetration into the cleanroom and the difference in area weight between the cleanroom and the junction uncontrolled condition. These reviews found that a weight difference of 0.03 to 0.05 in weight was valid to reduce contaminant invasion. Area weight differences above 0.05 inch weight try not to give significantly better contaminant penetration control than 0.05 inch weight.

4. define Field Supply Airflow:

Space cleanliness classification is the primary variable in determining a cleanroom’s supply airflow. Looking at Table 3, each clean classification has an air exchange rate. For example, a Class 100,000 cleanroom has a range of 15 to 30 ach. The air exchange rate of the cleanroom should take into account the expected activity within the cleanroom. A Class 100,000 (ISO 8) cleanroom with low occupancy, low particulate generating process and positive field pressure relative to adjacent dirtier cleaning areas can use 15 ach, while the same cleanroom can use high occupancy, frequent ingress/exit traffic, high particle generation or neutral area pressurization will probably need 30 ach.

5. define Air Leak Flow of Space:

The majority of cleanrooms are positively weighted, which means air leaking out arranged in connection areas with lower static weight, and electrical outlets, light fixtures, window outlines, entryway outlines, divider/floor interface, divider/roof interface, and improvised air leakage. brings with it. access entryways. It is very important to understand that the rooms are not hermetically fixed and there are spills. A stable all round cleanroom will have a volumetric spill rate of 1% to 2%. Is this spill terrible? Not exactly.

6. define Air Balance of Space:

The majority of cleanrooms are positively weighted, which means air leaking out arranged in connection areas with lower static weight, and electrical outlets, light fixtures, window outlines, entryway outlines, divider/floor interface, divider/roof interface, and improvised air leakage. brings with it. access entryways. It is very important to understand that the rooms are not hermetically fixed and there are spills. Each stationary cleanroom will have a volumetric spill rate of 1% to 2%. Is this spill terrible? Not exactly.

7. Evaluate the Remaining Variables:

Different factors waiting to be evaluated include:

Heat: Cleanroom professionals wear a frock coat or full bunny suit over their regular clothing to reduce particulate age and potential staining. As a result of additional clothing, it is crucial to maintain a lower space temperature for specialist comfort. An extended space temperature somewhere between 66°F and 70° will provide acceptable conditions.

Moisture: Due to the high wind current of the clean room, a large electrostatic charge is created. At the point where the roof and partitions have a high electrostatic charge and the area has low relative humidity, airborne particles will add themselves to the surface. When the area relative humidity expands, the electrostatic charge is released and all captured particles are discharged in a short period of time, causing the cleanroom to leave detail. Having a high electrostatic charge likewise electrostatic release can damage sensitive materials. It is vital to keep the relative humidity of the space high enough to reduce the electrostatic energy generation nature. Relative Humidity or 45% + 5% is considered the ideal level of adhesion.

Laminarity: Very basic procedures may require laminar flow to reduce emissions of contaminants entering the airflow between the HEPA duct and the procedure. IEST Standard #IEST-WG-CC006 gives wind current laminarity requirements.

Electrostatic discharge: Beyond field humidification, few procedures are extremely susceptible to electrostatic oscillation damage and it is important to introduce a grounded conductive deck.

Vibration and Noise Levels: Some forms of precision are extremely sensitive to noise and vibration.

8.Mechanical System Layout Description:

A variety of factors influence the mechanical framework design of a cleanroom: space accessibility, accessible subsidy, process requirements, regularity arrangement, required constant quality, vitality cost, construction standards, and neighborhood atmosphere. Not like typical A/C frames, clean room A/C frames have much more supply air than expected to handle cooling and heating loads.

Cleanrooms with Class 100,000 (ISO 8) and Class 10,000 (ISO 7) lower each can enjoy the full-weather experience of the AHU. Referring to Figure 3, arrival air and outside air are mixed, separated, cooled, heated and humidified before being fed into terminal HEPA ducts on the roof. Arrival air is taken in with low divider returns to prevent pollutant dispersal in the clean room. For higher class 10,000 (ISO 7) and cleaner clean rooms, wind currents are too high for all the air to experience the AHU. Referring to Figure 4, a small portion of the arrival air is returned to the AHU for molding. The rest of the air returns to the route fan.

9. Make Cooling/Heating Calculations:

When doing cleanroom heating/cooling calculations, consider the following:

Benefit from the most moderate atmospheric conditions (99.6% warm-up plan, 0.4% dry bulb/mid-bulb cooling sill, and 0.4% wet bulb/mid-dry bulb cooling outline).

  • Include filtering in the numbers.

  • Include the humidifier complex temperature in the figures.

  • Include the process stack in the figures.

  • Include the hot distribution fan in the estimates.

10. Mechanical Room Space Fight

Cleanrooms are mechanically and electrically concentrated. As the cleanroom layout moves towards being cleaner, more mechanical frame space is expected to provide satisfactory assistance to the cleanroom. For example, when using a 1,000 square feet cleanroom, a Class 100,000 (ISO 8) cleanroom will require 250 to 400 square feet of assistance area, while a Class 10,000 (ISO 7) cleanroom will require 250 to 750 square feet of assistance area. A Class 1,000 (ISO 6) cleanroom requires 500 to 1,000 square feet of relief space, and a Class 100 (ISO 5) cleanroom requires 750 to 1,500 square feet of relief space.

For Clean Room Design under Specialization, also read https://www.operonstrategist.com/clean-room-design-consultant/.

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