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Jason@cleanroomequips.com
1. Purpose
According to the relevant regulations, standards and specific product requirements of medical devices, the quality requirements and testing methods of Clean air are specified to ensure that the hygiene of equipment and instruments in the clean area meets the product process requirements.
2. Scope
Applicable to the clean room purification area of medical device companies.
(Figure 1: Medical device clean room)
3. Responsibilities
The Quality Department is responsible for testing the relevant clean room indicators;
The Production and Procurement Department is responsible for the arrangement, rectification and maintenance of the clean room hygiene.
4. Procedures
4.1 General Principles
According to the requirements of Appendix B of VV0033, the company belongs to the previous paragraph of Clause B3. The clean room in the production area of the company is Class 100,000, and the clean room in the experimental area is Class 10,000.
4.2 Environmental requirements
According to relevant requirements, the clean room needs to be tested once a year by a qualified testing department for full performance;
According to the requirements of YY0033, either settling bacteria or floating bacteria can be selected. The company chooses to use settling bacteria for Environmental testing;
According to the requirements of YY0033, the test items include dust, settling bacteria, temperature and humidity, wind speed, ventilation times, and pressure difference.
The requirements and cycles of the test items are as follows.
| Project | monitoring method | Standard | Determine the location | Measurement frequency | |
| Temperature | Thermometer or continuous recording average value | 18~28℃ | In the control area | 1 time/shift | |
| Humidity | Hygrometer or continuous recording average value | 45~65% | In the control area | 1 time/shift | |
| Air changes | Anemometer | 20 times for level 10000, 15 times for level 100000 | Indoor air inlet | 1 time/month | |
| Static pressure difference | Indoor and outdoor pressure difference | Between clean rooms of different levels and between clean rooms and non-clean rooms ≥5Pa | Indoor and outdoor | 1 time/month | |
| Clean room and outside ≥10Pa | |||||
| Dust particles | 1 meter above the ground, within 2 meters, measured by light scattering particle method | 100,000 level, ≥0.5 micron particle number, ≤3,500,000/m3 | Passageways, changing rooms and key operation points | 1 time/season | |
| ≥5 micron particles, ≤20,000/m3 | |||||
| 10,000 level, ≥0.5 micron particle number, ≤350,000/m3 | |||||
| ≥5 micron particles, ≤2,000/m3 | |||||
| Settling bacteria | Take a 9 cm double dish and leave it exposed for half an hour, then culture it for 48 hours | 100,000 level, average ≤10/dish1 | Key operation points | 1 time/week | |
| 10,000 level, average ≤3/dish1 | |||||
| Note: 1. The number of ventilation changes per hour in the clean room Air volume = Wind speed at the air outlet x area of the air outlet x number of air outlets x 3600; Ventilation times = air volume/room volume; 1. Room volume, m3; 1. Wind speed, m/s; Area of the air outlet, m2; The wind speed at the air outlet can be measured using an anemometer, averaging 5 groups; 2. After the control area is renovated, the Air Filter is replaced and other maintenance work is done, all the above items need to be checked once, and they can be used normally only after they meet the requirements in the table. | |||||
4.3 Detection of total bacteria on workers' hands, air and surfaces
The inspector should conduct a weekly test of the total number of bacteria in the air, on the surface of objects and on the hands of production workers at the key operation points of the production workshop (control area). The indicators should meet the requirements of the following table. The specific methods are shown in the appendix.
| project | index | project | index |
| Total bacteria count on workers' hands | ≤300cfu/each hand | Total number of bacteria on the surface of objects | ≤10cfu/cm2 |
| Total number of air bacteria | ≤500cfu/m3 | —— | —— |
4.4 Process gas monitoring
In order to ensure that the gas used for product testing can meet the requirements of the initial contamination bacteria index of the product and ensure product quality, it is necessary to regularly monitor the process gas indicators to ensure that the process gas is qualified and stable.
The process gas is monitored once a month. The two workshop leak detection inspection places are national monitoring points, and the inner packaging sealing place and printing workshop are randomly monitored.
The monitoring indicators of process gas are mainly: dust particle number and colony number. The dust particle number should meet the index requirements of the 100,000-level purification workshop in VY0033-2000, and the colony number should meet the total bacterial count standard of the product pipeline lumen. The detection method is shown in the appendix.
(Figure 2: Process gas monitoring)
4.5 Non-continuous Clean room environment monitoring
If the clean room is out of use for more than 7 days (including 7 days), the clean room should be fully monitored. After the test results are qualified (since the sedimentation bacteria results take a long time, other parameters must be qualified in addition), the production personnel can enter the clean room for production. If the sedimentation bacteria test results are unqualified, the production procurement department will isolate all the products produced previously. After the initial contamination bacteria and the re-test of sedimentation bacteria are qualified, the batch of products can be used. If the test results of the initial contamination bacteria are unqualified, the batch of isolated products will be reported.
4.6 Risks that may be caused by the loss of control of each environmental monitoring project
The products produced by our company are all disposable sterile medical devices. The main materials are high polymer materials, stainless steel needles, thermistors, etc. The main production processes include bonding, baking, molding, ultrasonic welding, assembly, etc.
If the temperature and humidity, ventilation times, and static pressure difference items in the test items exceed the standard, it will basically have no effect on the product characteristics.
If the number of dust particles, sedimentation bacteria, worker hand bacteria, surface bacteria, and total number of air bacteria exceed the standard, it may cause the initial contamination bacteria of the product to exceed the standard.
