Cleanrooms are indispensable in industries like pharmaceuticals, electronics, medical devices, and biotechnology, where stringent environmental conditions are crucial for product quality. As the economic powerhouse of Southeast Asia, Indonesia has developed a robust system of cleanroom engineering design standards. This article offers a detailed overview of the main cleanroom standard frameworks in Indonesia and their key requirements.
1. Indonesia's Cleanroom Standard System
The cleanroom engineering in Indonesia is governed by a dual - standard structure:
1.1 SNI ISO 14644 Series
The Indonesian National Standard (SNI) has adopted the ISO 14644 standards for cleanrooms and associated controlled environments, which consist of:
- SNI ISO 14644 - 1: Focuses on the classification of air cleanliness in cleanrooms.
- SNI ISO 14644 - 2: Sets out the requirements for cleanroom testing and monitoring.
- SNI ISO 14644 - 3: Details the cleanroom test methods.
1.2 Industry - Specific Standards
To meet the unique needs of different sectors:
- Pharmaceutical Industry: Adheres to the GMP (Good Manufacturing Practice) requirements to ensure the safety and efficacy of drug production.
- Electronics Industry: Incorporates special requirements for semiconductor manufacturing processes.
- Medical Devices Industry: Imposes additional biosafety requirements to guarantee the hygiene of medical devices.
2. Key Design Parameters
2.1 Air Cleanliness Classification
Indonesia utilizes the ISO 14644 - 1 9 - class system (ranging from ISO 1 to ISO 9):
- ISO Class 5 (formerly Class 100): The most rigorous level, applied in critical pharmaceutical production and high - end semiconductor manufacturing.
- ISO Classes 7 - 8 (formerly Classes 10,000 - 100,000): Commonly used in the production of medical devices and general pharmaceuticals.
- ISO Class 9: The baseline requirement, similar to a typical air - conditioned environment.
2.2 Air Change Rate Requirements
The air change rate requirements vary significantly based on the cleanliness level:
- ISO Class 5: ≥240 air changes per hour
- ISO Class 6: 90 - 150 air changes per hour
- ISO Class 7: 30 - 60 air changes per hour
- ISO Class 8: 10 - 20 air changes per hour
2.3 Temperature and Humidity Control
The typical control ranges are as follows:
- Temperature: 20 - 24°C with a control accuracy of ±2°C
- Humidity: 45 - 55% RH with a control accuracy of ±5%. However, some special processes may demand more precise control.
3. Design Considerations
3.1 Airflow Organization
- Airflow Pattern Selection: Options include unidirectional (laminar) and non - unidirectional (turbulent) airflow, depending on the cleanroom's function and cleanliness level.
- Filter Coverage: The ceiling coverage ratio of HEPA filters needs to be carefully planned.
- Return Air Design: Proper design of return air locations is essential for efficient airflow circulation.
3.2 Pressure Differential Control
- Inter - clean Zone: Maintain a 10 - 15Pa pressure differential between different clean zones.
- Clean vs. Non - clean Zone: Ensure a pressure differential of over 15Pa between clean and non - clean zones.
- Isolation Design: Incorporate airlocks or buffer rooms in the design to enhance isolation.
3.3 Material Selection
- Walls: Opt for anti - static and easy - to - clean materials such as stainless steel or special coatings.
- Floors: Seamless epoxy resin or PVC flooring is preferred.
- Ceilings: Select materials that are resistant to microbial growth.
3.4 HVAC System
- Filtration: Employ a three - stage filtration system (pre - filter + medium filter + HEPA/ULPA).
- Control: Use variable frequency control to adapt to changing load conditions.
- Efficiency: Integrate energy - efficient design elements to reduce operating costs.
4. Certification and Validation Requirements
Cleanroom projects in Indonesia must go through a comprehensive certification process:
- Design Qualification (DQ): Ensures the design meets all requirements.
- Installation Qualification (IQ): Verifies the correct installation of all components.
- Operational Qualification (OQ): Confirms the proper operation of the cleanroom systems.
- Performance Qualification (PQ): Tests the cleanroom's performance against set standards.
- Periodic Re - certification: Conducted annually to maintain compliance.
5. Localization Considerations
When designing cleanrooms in Indonesia, several local factors must be taken into account:
- Climate: The tropical climate necessitates special HVAC system designs to maintain stable temperature and humidity.
- Geology: In earthquake - prone areas, the structural safety of cleanrooms should be enhanced.
- Economy: Evaluate the availability and cost of local materials to optimize the design.
- Regulations: Ensure full compliance with Indonesian national electrical standards and building codes.
6. Conclusion
Indonesia's cleanroom standards are well - aligned with international best practices. However, successful cleanroom design and implementation in the country require careful consideration of local environmental, geological, and industry - specific factors. Striking the right balance among standard compliance, operational efficiency, and project cost is key. With the continuous growth of Indonesia's manufacturing sector, the demand for high - quality cleanrooms is expected to increase steadily. Companies planning to build cleanrooms in Indonesia are strongly advised to collaborate with professional design teams with in - depth knowledge of local standards and approval processes. This will ensure seamless project execution and full compliance with all regulatory requirements.