+86 18186671616
Jason@cleanroomequips.com
1. Purpose
Establish a management procedure for monitoring, use and maintenance of clean rooms to ensure that the environment of clean rooms meets production requirements.
2. Scope
100,000-level clean area in the workshop.
3. Responsibilities
Director of the production and manufacturing department, director of the equipment and power department, and QC personnel.
4. Contents
4.1 Use of clean rooms
4.1.1 Before the newly built or renovated clean room is put into operation, the company's production and manufacturing department, equipment and power department, quality department and construction unit must jointly verify the purification and air conditioning system, and it can only be put into use after the relevant indicators are tested and qualified.
4.1.2 All personnel entering the clean room must wear the clean work clothes of this area in accordance with the process hygiene management regulations and enter the clean room according to its purification procedures.
4.1.3 Operators in different positions in the clean area shall not visit each other during work.
4.1.4 Approval procedures must be followed to enter the clean room, approved by the production and manufacturing department, and temporary personnel entering the clean room should be guided and supervised.
4.1.5 All materials, instruments, process water, and cleaning and sanitation water used in the clean area must be purified before entering.
4.1.6 The purification air conditioning system should maintain a relative positive pressure. During normal production, the air conditioner starts to supply air normally half an hour before production to ensure that the cleanliness of the room meets the requirements before production.
4.1.7 Air disinfection is performed for 60 minutes with an ozone generator every week.
4.2 Clean room monitoring
4.2.1 In order to ensure the purification environment and cleanliness of the clean room, the clean room needs to be monitored, and the monitoring items and frequency are tested under static conditions as required.
4.2.2 If the overhaul or shutdown lasts for more than 10 days, the clean room should be processed according to the cleaning procedures before production, and all indicators should be tested before it can be put into use.
4.2.3 After 3 months of continuous production, the number of dust particles and wind speed and volume in the clean area should be tested statically, and the number of colonies should be tested and recorded every week.
4.2.4 The monitoring work is organized by the Quality Department, and QA, QC personnel and workshop negative meters monitor and keep monitoring records. When the test results deviate, they should be handled in time according to the management procedures for clean room deviations.
4.2.4.1 When the wind speed, dust particle number, and pressure difference deviate, the primary, medium, and high efficiency filters should be replaced.
4.2.4.2 When the number of microorganisms deviates, the workshop should carry out process sanitation disinfection according to the relevant cleaning procedures.
4.2.4.3 When the air volume of the high efficiency Air Filter is 70% of the original air volume, or when the air flow speed drops to the minimum, the high efficiency filter should be replaced.
4.3 Clean room maintenance
4.3.1 Establish management procedures for materials and personnel entering the clean area.
4.3.2 The clean room is cleaned by the user, that is, the operator at the post, to maintain the cleanliness of the clean room, and keep records in the post record.
4.3.3 According to the monitoring results, clean the primary and medium efficiency air filters in time according to the cleaning procedures of the primary and medium efficiency air filters and the replacement operating procedures of the high efficiency filters.
4.3.4 Regularly inspect and maintain the air conditioning system and purification Equipment of the clean room.
Environmental Parameters
| Parameter | Required Range | Actual Value | Status (OK/Out of Range) | Comments/Action Required |
|---|---|---|---|---|
| Temperature | [e.g., 18–24°C] | [Enter Actual Temperature] | [OK/Out of Range] | [Notes, e.g., "Adjust HVAC settings"] |
| Relative Humidity | [e.g., 40–60%] | [Enter Actual Humidity] | [OK/Out of Range] | [Notes] |
| Airflow Velocity | [e.g., 0.45 m/s] | [Enter Actual Velocity] | [OK/Out of Range] | [Notes] |
| Air Pressure Differential | [e.g., Positive Pressure] | [Enter Actual Pressure] | [OK/Out of Range] | [Notes, e.g., "Check seals or vents"] |
| Particle Count (0.3 µm) | [e.g., ISO7 max: 35,200/m³] | [Enter Count] | [OK/Out of Range] | [Action Required: e.g., "Replace filters"] |
| Particle Count (0.5 µm) | [e.g., ISO7 max: 8,800/m³] | [Enter Count] | [OK/Out of Range] | [Action Required] |
| Microbial Count | [e.g., <1 CFU/plate] | [Enter Count] | [OK/Out of Range] | [Action Required] |
Air Filtration and Ventilation
| Filter Type | Location | Filter Status | Change Date | Next Change Due | Pressure Drop (if applicable) |
|---|---|---|---|---|---|
| HEPA Pre-filter | [Enter Location] | [Clean/Needs Replacement] | [Date] | [Date] | [Pressure Drop] |
| HEPA Main Filter | [Enter Location] | [Clean/Needs Replacement] | [Date] | [Date] | [Pressure Drop] |
| Activated Carbon Filter | [Enter Location] | [Clean/Needs Replacement] | [Date] | [Date] | [Pressure Drop] |
| UV Light or Sterilization System | [Enter Location] | [Working/Needs Maintenance] | [Date] | [Date] | [Notes] |
Equipment Calibration & Maintenance
| Equipment | Calibration Date | Next Calibration Due | Status | Notes/Action Required |
|---|---|---|---|---|
| Particle Counter | [Date] | [Date] | [Calibrated/Needs Calibration] | [e.g., "Last calibration OK"] |
| Temperature/Humidity Sensor | [Date] | [Date] | [Calibrated/Needs Calibration] | [e.g., "Replace batteries"] |
| Pressure Gauge | [Date] | [Date] | [Calibrated/Needs Calibration] | [e.g., "Inspect for leaks"] |
Frequently asked questions
1. What are cleanroom management procedures?
This question is about the overall processes and best practices that ensure cleanroom environments maintain the required cleanliness standards. It typically includes procedures for air filtration, contamination control, personnel behavior, and maintenance.
2. How do you maintain cleanliness in a cleanroom?
Users often seek guidance on practical steps to ensure Cleanroom cleanliness, such as procedures for cleaning surfaces, handling materials, and using proper cleaning agents to maintain air and surface cleanliness.
3. What are the steps involved in cleanroom certification?
Many users want to know the process for certifying A CleanRoom according to standards like ISO 14644. This involves particle counting, airflow tests, and verifying compliance with environmental control systems.
4. What is the role of HEPA filters in cleanroom management?
HEPA filters play a critical role in maintaining the required air cleanliness in a cleanroom. This question typically addresses their function, maintenance, and replacement schedules in cleanroom environments.
5. How often should cleanroom air filters be replaced?
Users frequently inquire about the recommended replacement cycle for various air filters (e.g., HEPA, carbon, or ULPA filters), as well as how to determine when a filter is no longer effective.
6. What are cleanroom gowning procedures?
This question relates to the steps for properly gowning and de-gowning in a cleanroom, including the use of coveralls, gloves, masks, and shoe covers to prevent contamination.
7. How do you monitor air quality in a cleanroom?
This question focuses on how air quality is measured, including methods for monitoring particulate levels, airflow, temperature, humidity, and microbial contamination within the cleanroom.
8. What are the best practices for cleanroom personnel?
Users ask for guidelines on how to train and manage personnel who work in cleanrooms, including hygiene practices, behavior protocols, and the importance of minimizing contamination risks.
9. How do you clean and disinfect a cleanroom?
This question covers the methods and protocols for cleaning surfaces, equipment, and floors, including the use of disinfectants that won’t compromise the cleanroom’s sterility or damage sensitive equipment.
10. What are the key ISO standards for cleanroom management?
Users often want to know about the relevant ISO standards (such as iso 14644-1 for CleanRoom Classification and ISO 14698 for microbiological contamination control) that govern cleanroom operation, classification, and certification.
