Discover our solutions for medical devices
Medical device quality directly affects patient safety. For sterile medical devices and IVD products, GMP-compliant cleanrooms are mandatory.
OCCR delivers turnkey cleanroom system solutions for Indonesia, Southeast Asia and Africa, fully aligned with medical device GMP specifications.
We supply high-efficiency purification equipment including HEPA/ULPA filters, FFUs, laminar flow hoods, transfer windows and air showers to eliminate airborne particles and microorganisms. Our easy-clean anti-static wall & floor panels prevent dust buildup, while integrated temperature and humidity monitoring systems maintain stable production environments even under tropical high-humidity conditions.
Efficiently Purified Air
GMP Standards
Enhance Product Safety
Improve Product Quality
Key Challenges for Medical Device Cleanroom Projects
Tropical Humidity & Microbial Risk
High temperature and heavy rainfall across Southeast Asia & Africa easily trigger mold and microbial growth. Strict dehumidification is critical for sterile medical device & IVD manufacturing
Regional GMP & ISO Compliance
Medical device regulations vary in Indonesia and African markets. Poor cleanroom design may fail local authority audits, delaying product registration and market launch.
Reliable Temp & RH Control
High outdoor heat load in tropical regions increases HVAC burden. Fluctuating temperature and humidity will damage raw materials and compromise sterile medical production quality.
Local Construction & Delivery Risks
Limited experienced cleanroom contractors and supply chain issues in Southeast Asia & Africa. Improper construction leads to air leakage, long delays and extra rework cost.
Applications
Walls and Floor
Wall Panel Material
- Select fire-resistant, moisture-proof, and antibacterial wall panels specifically designed for cleanrooms, such as color-coated steel plates, rock wool sandwich panels, etc.
- The wall panel design should facilitate easy removal, cleaning, and maintenance.
Floor material
- It is recommended to use wear-resistant, anti-slip, and easy-to-clean medical-grade flooring such as PVC flooring, epoxy resin flooring, etc.
- Ensure that the flooring material meets cleanroom standards, featuring no gaps and being easy to disinfect.
Ceiling & lighting system
Ceiling Material
- It is recommended to use ceiling materials that are easy to clean and corrosion-resistant, such as color-coated steel panels or aluminum alloy panels.
- A concealed lighting system and ventilation ducts should be installed within the ceiling to ensure adequate indoor lighting and air circulation.
lighting system
Cleanroom lighting generally uses clean fluorescent lamps or LED lamps. These lamps should have good sealing performance to prevent dust and moisture from entering. The lighting intensity should meet the requirements of production operations. Generally, it is between 300 and 500 lux. At the same time, shadows and glare should be avoided to ensure that operators can clearly see production details.
Door and Windows
Door
Utilize materials that are corrosion-resistant, high-strength, abrasion-resistant, and easy to clean: color-coated steel doors, stainless steel doors, galvanized steel plates, and melamine resin board doors.
Window material
The door and window materials should be specialized for dust-free rooms, ensuring tight sealing and cleanliness.
Air Purification System
Medical device manufacturing requires strict particle and microbial control. HEPA/ULPA filters, FFUs and air showers prevent cross-contamination for sterile assembly, IVD reagent and implant production. Chemical filtration can also be added to remove volatile contaminants.
Temperature and Humidity Control System
The temperature and humidity control system in medical device clean rooms is a crucial aspect for ensuring the stability and safety of medical devices during production, storage, and use.
Strict temperature and humidity control:According to the production and storage requirements for Class II medical devices, the temperature in clean rooms generally needs to be controlled within the range of 18-28°C, and the relative humidity should be maintained at 45%~65% RH. n medical device cleanrooms, the use of rotary dehumidifiers is an efficient and reliable method for humidity control.
High accuracy and stability: Advanced sensors and control systems are employed to achieve temperature fluctuations within ±0.5°C and humidity fluctuations within ±3%RH, ensuring long-term stable operation.
Intelligent management: Integrated with Internet of Things (IoT) technology, it enables remote monitoring, intelligent regulation, and data visualization, improving management efficiency and ensuring production safety.
Energy-saving and environmentally friendly: Optimized control algorithms and energy-saving equipment are adopted to reduce energy consumption and comply with environmental protection requirements.
Furniture for medical device cleanroom
The furniture in medical device clean rooms is made of stainless steel or aluminum alloy, which are easy to clean, corrosion-resistant, and have smooth surfaces. This includes stainless steel workbenches, storage cabinets, shelves, ultrapure worktables, lockers, handcarts, handwashing sinks, and other items.
Our Services
Cleanroom Planning & Design
Custom medical device cleanroom layout design complying with GMP & ISO standards, adapted for tropical high-humidity climate in Indonesia, Southeast Asia and Africa.
Construction & Installation
Cleanroom wall, ceiling and flooring construction, plus purification equipment installation, executed by our local project teams across Southeast Asia & Africa.
HVAC & Environmental Control
High-load dehumidification and air conditioning systems to maintain stable temperature & humidity, resisting tropical heat and moisture for sterile medical manufacturing.
Purification System Supply
Complete purification equipment package including HEPA/ULPA filters, FFUs, air showers and pass boxes, tailored for medical device and IVD production workshops.
Validation & Commissioning
Cleanroom performance testing, documentation and GMP validation support to help clients pass local regulatory audits in Indonesia and African markets.
Long-term Maintenance Service
Ongoing filter replacement, routine inspection and system maintenance, preventing mold and contamination risks under local tropical operating conditions.
Customer Stories
Discover our products for medical device cleanroom
Why Choose OCCR for Medical Device Cleanrooms
Medical Device GMP Expertise
Deep knowledge of medical device GMP & ISO 14644 standards, delivering compliant cleanrooms for Class I, II and III medical device manufacturing workshops.
Turnkey EPC Delivery
Full EPC service covering layout design, cleanroom construction, HVAC installation, validation and commissioning for medical device manufacturing projects.
Precise Environment Control
Stable control of temperature, humidity and particle concentration, preventing moisture and contamination that may affect medical device quality and sterility.
Contamination Risk Control
Scientific airflow design, pressure cascade and isolation layout to avoid cross-contamination and protect sterile medical product production.
Southeast Asia & Africa Local Support
Local project teams in Southeast Asia and Africa, fast site survey, construction supervision and on-site validation support for medical factory projects.
Long-term Cleanroom Maintenance
Periodic inspection, HEPA filter replacement, system calibration and maintenance service to keep your medical cleanroom continuously compliant.