Within the pharmaceutical industry, cleanrooms play a critical role and have become an essential requirement rather than a choice. clean room bukan lagi pilihan, melainkan keharusan. Setiap proses produksi yang berkaitan dengan obat-obatan, vaksin, atau alat kesehatan harus dilakukan di lingkungan yang terkendali untuk mencegah kontaminasi. Clean room menjadi jantung dari fasilitas farmasi modern—dan desain yang tepat adalah kunci keberhasilan implementasinya.
What Is a Cleanroom and Why Is It Important?
A cleanroom is a controlled environment designed to strictly regulate:
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The number of airborne particles
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Temperature and humidity
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Air pressure
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Airflow patterns and microbial filtration
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Materials and personnel entering the room
According to ISO standards, cleanrooms are classified from ISO 1 (the most stringent) to ISO 9. The pharmaceutical industry typically uses ISO Class 5–8, depending on the stage of the process (e.g., mixing, filling, or sterile packaging).
Without a properly designed cleanroom, pharmaceutical products are at high risk of contamination, audit failure, or even market recall.
Cleanroom Design Approach by Amidef
Amidef Rekatehnik Indonesia provides comprehensive cleanroom design and installation solutions in compliance with GMP, CPOB, and ISO standards. Our approach includes:
1. Layout Design
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Separation of clean zones, dirty zones, and transition areas
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Logical material and personnel flow to prevent cross-contamination
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Proper positive and negative pressure zoning
2. Material Selection & Finishing
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Wall and ceiling panels made of non-porous, chemical-resistant, and easy-to-clean materials
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Epoxy flooring that is antibacterial, anti-slip, and seamless
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Automated doors, pass boxes, and air showers appropriate for room classification
3. Supporting System Integration
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HVAC systems with HEPA (High-Efficiency Particulate Air) filters
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Temperature, humidity, and pressure monitoring systems
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High-quality LED lighting with intensity control
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Access automation and alarms for cleanliness protocol violations
Cleanroom Applications in the Pharmaceutical Industry
Cleanrooms are used not only for production but also in:
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Active Pharmaceutical Ingredient (API) mixing areas
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Sterile product filling and packaging
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Quality Control (QC) laboratories
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Research and Development (R&D) formulation
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Storage of sensitive products
With proper design, workflows become more efficient, error risks are significantly reduced, and facilities are better prepared for inspections from BPOM, WHO, and other certification bodies.
Brief Case Study
One of Amidef’s pharmaceutical clients producing herbal capsules successfully improved their CPOB audit rating after constructing a 150 m² ISO 7 cleanroom. The installation was completed within 45 working days, and IQ/OQ validation passed with a 100% result and no major findings.
Conclusion
A properly designed and installed cleanroom is a long-term investment that delivers significant benefits in product quality, production efficiency, and regulatory compliance. Amidef serves as your trusted partner in building functional, efficient, and globally competitive cleanroom facilities.
