In the food, pharmaceutical, cosmetic, and even medical device manufacturing industries, the top priority for entrepreneurs and business owners is "safety and production standards." Especially in the current era where the Food and Drug Administration (FDA) is updating and tightening regulations to comply with international standards such as GMP (Good Manufacturing Practice) and HACCP, controlling the production environment has become an undeniable necessity. This is why "clean rooms" play such a crucial role.
This article will take business owners and purchasing departments on an in-depth look at the standards for designing and constructing clean rooms for the food and pharmaceutical industries, ensuring your production processes are clean, safe, and that you achieve FDA (Food and Drug Administration) certification smoothly and without worry.
What is a clean room and why is it indispensable for the food and pharmaceutical industries?
Cleanroom, often called a "clean room," is a room where the amount of particulate matter, contaminants, and microorganisms in the air are controlled to a level below a specified threshold. In addition to dust control, a perfect cleanroom system must also be able to precisely control other environmental factors, such as...
- Temperature: To maintain the stability of medications and food ingredients.
- Relative Humidity: Prevents antibiotics or chemicals from clumping together and inhibits the growth of fungi.
- Room Pressure: Managing air pressure to prevent outside air from entering and contaminating the room.
Why do the food and pharmaceutical industries need to use them?
In pharmaceutical manufacturing, even a single milligram of contaminant can have a life-threatening impact on consumers. Similarly, in food production, if mold or bacterial spores escape during the packaging process, it can shorten product shelf life, cause premature spoilage, and potentially lead to lawsuits or product recalls, causing immense reputational damage.
ISO 14644-1 standard and cleanroom classification.
The cleanliness of a clean room is not determined by subjective criteria, but by an internationally recognized standard, ISO 14644-1, which categorizes rooms into grades or "classes" based on the number of dust particles ranging in size from 0.1 microns to 5 microns per cubic meter.
| ISO Class | Equivalent grade (Fed Std 209E) | Primary industrial applications. |
|
ISO Class 5 |
Class 100 |
Injectable drug packaging lines, culture labs, and direct drug contact areas. |
|
ISO Class 7 |
Class 10,000 |
Tablet manufacturing room, supplement packaging line, chemical preparation room. |
|
ISO Class 8 |
Class 100,000 |
Changing area before entering the production room, outer packaging area. |
According to the Thai FDA standards, which are based on PIC/S GMP guidelines, clean areas are graded A, B, C, and D. High-risk operations, such as sterile packaging of injectable drugs, must be conducted under Grade A conditions, equivalent to ISO Class 5.
Key factors in designing and installing cleanroom systems.
Constructing a cleanroom that meets FDA standards and is designed for long-term, problem-free operation requires calculations and material selection by expert engineers. Three key pillars are key:
1. Selecting thermal insulation wall panels (Sandwich Panels).
The walls of cleanrooms should not be made of plastered walls or ordinary gypsum walls, as these materials can absorb moisture and generate dust. In the food and pharmaceutical industries, sandwich panels (prefabricated insulated panels) are commonly used, especially those with PIR (Polyisocyanurate) insulation, because...
- It has a perfectly smooth surface, with no pores, and does not accumulate dust or germs.
- Highly resistant to wiping with strong chemicals or disinfectants.
- It has fire-resistant and high thermal insulation properties, helping to maintain a constant temperature inside the room.
2. Calculating the HEPA filter air filtration system.
The air supplied to a cleanroom must undergo the highest level of filtration using a HEPA (High-Efficiency Particulate Air) filter, which is capable of capturing particles as small as 0.3 microns with an efficiency of up to 99.97%. Engineers must calculate the appropriate air change rate (Air Change per Hour) for the room class to ensure that the air inside the room remains clean at all times.
3. Air Pressure and Humidity Control.
- Positive Pressure: For most pharmaceutical and food factories, production rooms must be designed with positive pressure, meaning the air pressure inside the room is higher than outside. This ensures that when the door is opened, the clean air inside is pushed out, preventing dust and insects from entering.
- Humidity Control: Humidity levels must be maintained between 40% and 60% RH (or lower depending on the product type) to prevent moisture buildup and deterioration of food or pharmaceutical products.
Conclusion
For pharmaceutical factories, cleanroom design involves more than just partitioning and air conditioning; it encompasses advanced engineering work including structural engineering and MEP (Mechanical, Electrical, and Plumbing) systems. Gathering information on crew members who understand FDA regulations and engineering principles helps organizations save costs through vigilance and sustainable growth.
Bliss Construction We are a full-service factory construction and engineering company. Our team of expert engineers provides consultation, design, and installation of clean rooms according to ISO and FDA standards, using high-quality materials. We are happy to provide consultation to upgrade your factory's standards.
Interested in designing and installing an internationally standardized clean room? Contact Bliss Construction engineers today for a free consultation.
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