Oral diagnostic and therapeutic instruments are Class II medical devices that come into direct contact with the human oral mucosa. Therefore, strict sterility control is directly related to clinical safety.
1. Zoning and Planning by Cleanliness Grade
Based on the manufacturing process of Class II sterile oral instruments, clean zones are established according to the risk level of each process:
Class 10,000 (ISO 7) Cleanroom: Suitable for high-risk processes such as sterile assembly, primary packaging, and sealing.
Class 100,000 (ISO 8) Cleanroom: Used for component cleaning, semi-finished product processing, and pre-processing for secondary packaging.
Strict Separation of Flows: The workshop strictly enforces the separation of personnel, materials, and waste flows.
Personnel Flow: Non-clean area → Primary changing room → Secondary changing room → Air shower → Clean area.
Material Flow: Outer packaging removal → Air shower / Pass-through box → Clean production area.
Waste Flow: Production waste is transported through independent channels to prevent cross-contamination caused by reverse airflow.
Pressure Differential Control: A stable pressure gradient is maintained between clean zones. The pressure differential between a clean zone and a non-clean zone must be ≥10 Pa, and between different grades of clean zones, it must be ≥5 Pa. Double-door interlocking airlocks are used to prevent air backflow.
2. Enclosure Structure Engineering Design
Wall and Ceiling Panels: Antibacterial color steel sandwich panels are used. Internal and external corners of walls and ceilings are rounded to eliminate dust accumulation dead spots.
Flooring: Seamless epoxy self-leveling flooring is applied, which is corrosion-resistant, easy to clean, and suitable for daily disinfection.
Doors and Windows: Sealed cleanroom doors and double-layer observation windows are installed. Pass-through boxes are equipped with built-in UV sterilization devices. All pipelines are concealed to minimize exposed dust accumulation points and meet the requirements of on-site regulatory inspections.
3. Purified Air Conditioning and Environmental Control System
Filtration: A three-stage air filtration system (primary, medium, and high efficiency) is used to precisely control suspended particles and airborne microorganisms.
Temperature and Humidity Control: The system continuously and stably controls the temperature (18–26℃) and relative humidity (45%–65%). This inhibits microbial growth while preventing adverse effects of static electricity on plastic oral instruments.
Monitoring: The entire purification system is equipped with reserved monitoring points to support routine testing of dust particles, microorganisms, and pressure differentials, meeting the needs of GMP validation and continuous monitoring.
4. GMP-Compliant Supporting Facilities
Complete configuration of graded changing rooms, hand-washing and disinfection stations, and buffer zones.
Independent instrument cleaning rooms, disinfection areas, and semi-finished product storage areas.
Supporting purified water and disinfection pipeline systems in the clean area, designed with no blind pipes or dead corners.
Clear area demarcation with physical isolation between production, inspection, and storage areas to prevent product mix-ups.
5. Core Focus for Project Implementation
The construction of a Class II sterile medical device facility for oral instruments differs from standard cleanrooms. The entire design process must be tailored to meet the GMP inspection requirements for medical devices. From floor plan layout and material selection to HVAC solutions, post-completion testing, and cleanroom validation, all phases must proactively address common deficiencies found in regulatory inspections.
Suzhou Pharma Machinery is deeply rooted in the fields of biopharmaceutical and medical device cleanroom engineering. We possess comprehensive capabilities in the design, construction, and commissioning of Class 1,000 and Class 10,000 cleanrooms. We provide one-stop purification engineering services for Class II medical device enterprises, including oral instruments and biological reagents, covering everything from solution planning and on-site construction to completion and acceptance. We are dedicated to helping enterprises smoothly complete facility construction and meet the standards for production licensing inspections.
Suzhou Pharma Machinery Co.,Ltd.
2026/08/28
Gino
