2018 new version of 100,000 class clean room purification workshop standards
a. 100,000 class clean room standards are:Maximum permissible number of dust particles (per cubic meter);
The number of particles that are large or equal to 0.5 micrometers shall not exceed 3,500,000, and the number of particles that are large or equal to 5 micrometers shall not exceed 20,000;
Maximum permissible number of microorganisms ;
The number of planktonic bacteria shall not exceed 500 per cubic meter;
The number of sedimentary clonal bacteria shall not exceed 10 per petri dish.
Differential pressure: the same cleanliness level of the purification workshop pressure difference to maintain the same, for different cleanliness levels of the pressure difference between adjacent purification workshop to be ≥ 5Pa, purification workshop and non-purification workshop to be ≥ 10Pa.
Two, from the point of view of the number of times of air change:100,000 clean room requirements per hour 18-25 times of air change, complete air change after air purification time of 40 minutes or less. minutes.
Ten thousand clean room requirements per hour 25-30 times, complete ventilation after air purification time does not exceed 30 minutes.
Thousands of clean rooms require 40-60 air changes per hour, complete air changes after air purification time does not exceed 20 minutes.
three, "GB 50073-2013 clean plant design specification" 100,000 and purification workshop standards for reference: four, air cleanliness grading standardsAir cleanliness grading standards: ISO14644-1 (international standard)
Air cleanliness grading standards: GB/T16292-1996 (Chinese standard)
British 5295 standard clean room and air purification device classification
Comparison of various international cleanliness standards
To summarize the above standards (the above yellow part of the font), you can derive 100,000 purification workshop corresponding parameters are as follows
Five, 100,000 purification workshop validation standards for referencePurification workshop overview
The company's purification workshop is located in the heart of the city of Beijing. p>
The company's clean room level of 100,000, local level 100, is located in the company's production area of the first floor, floor area of 160 square meters, the main purpose is to produce Class III medical device products silicone ophthalmic implants, soft tissue expanders. According to the production process and flow of our products, the clean room is divided into flat plate vulcanization room, extrusion vulcanization room, oven room, impregnation vulcanization room, inspection and packaging room, and so on.
Verification Purpose
Check and confirm whether the clean room is in line with the requirements of medical device GMP and related national standards, whether the purification capacity of the air-conditioning purification system can comply with the design requirements, and whether it can meet the requirements of the production process. Whether the information and documents meet the requirements of medical device GMP management.
Verification of the basis
3.1. "Quality Management Standard for Medical Device Manufacturing Enterprises"
3.2. YY0033 "Management Standard for the Manufacture of Sterile Medical Apparatus"
3.3. GB 50073 "Purification Workshop Design Specification"
3.4. GB 50457 "Purification Workshop for Pharmaceutical Industry"
3.5. 50457 "Pharmaceutical Industry Cleanroom Design Code"
3.5. GB 50591 "Cleanroom Construction and Acceptance Code"
3.6. GB/T 16292 "Pharmaceutical Industry Cleanroom (Area) Suspended Particle Test Methods"
3.7. GB/T 16294 "Pharmaceutical Industry Cleanroom (Area) Sedimentation of Bacteria Test Methods"
3.8.
Documents and Records Required for Verification
4.1 General Layout Plan of the Company
4.2 Layout Plan of 100,000 Class Cleanroom
4.3 Layout Plan of Air Ducts
4.4 Layout Plan of Air Supply and Return Outlets
4.5 Layout Plan of Exhaust Ducts
4.6 Layout Plan of the Clean Room
3.7 GB/T 16294 "Test Methods for Sedimentation Bacteria in Pharmaceutical Industry"
4.6. Distribution of air filters
4.7. Lamps and lanterns plan
4.8. Instruction manual of air-conditioning unit
4.9. Acceptance report of the clean room project
4.10. Record of environmental monitoring of the clean area
4.11. Third-party environmental monitoring report
4.12. Clean room management system
Verification methods and procedures
5.1. Measuring instruments and equipment required for testing
5.1.1. Temperature and humidity meter
5.1.2. Thermal ball anemometer
5.1.3. Counter
5.1.5 portable stainless steel pressure steam sterilizer
5.1.6 constant-temperature incubator
5.1.7. The above apparatus and equipment to be functional, need to be tested should have a valid certificate of verification.
5.2. Purification workshop building decoration verification
5.2.1. verification requirements
5.2.1.1. plant structure requirements
a) purification workshop of the inner wall surface is flat, smooth, no particles off, can withstand cleaning and disinfection. The junction is decorated with round arc.
b) The floor of the purification workshop should be flat, no cracks, no defects, easy to clean.
c) the sealing of the security door, easy to open in case of emergency, the security channel should be free of obstacles.
d) the roof of the clean room and into the clean area of the pipeline, the air outlet and the wall or roof parts should be well sealed. Purification workshop door closure should be completely sealed, and open to the direction of high cleanliness.
5.2.1.2. Power distribution, lighting facilities requirements
a) power supply system lines, distribution cabinets, sockets and other electrical equipment in line with the installation requirements.
b) The power supply lines are laid in a concealed manner. Electrical pipeline orifice, installed on the wall of the various electrical equipment and wall joints should be reliably sealed.
c) lighting fixtures should be simple external modeling, not easy to accumulate dust, easy to wipe. Lighting fixtures using ceiling mounted, lamps and lanterns and ceiling seams should be used for reliable sealing measures.
5.2.1.3. water supply and drainage pipe requirements
a) water supply and drainage pipe materials should be corrosion-resistant, easy to install and connect.
b) water pipeline line leakage test qualified
5.2.1.4. Other ancillary facilities
Purification workshop at the entrance to the rodent-proof facilities; purification workshop and non-clean area should be installed between the differential pressure gauge; equipped with personnel hand-washing, shoe change, disinfection facilities; transfer window between different rooms; safety door next to the hand hammer, clean room passage with emergency lighting.
5.2.2. Verification methods
Purification workshop construction process, the construction site of the plant's architectural decoration to verify the validation of the results of the project should be filled out the corresponding intermediate acceptance form or equipment opening inspection records. After the completion of the plant, the plant should be site acceptance and fill in the completion of the acceptance form.
5.2.3. Determination of standards
In the purification plant construction process, the intermediate project through the acceptance, before the construction of the next process. Purification workshop completion and acceptance is completed, all items are in line with the content of the verification requirements, then the building decoration of the plant is in line with the provisions of the verification.
5.3 Purification and air-conditioning system verification
5.3.1 Purification and air-conditioning system overview
100,000 purification workshop adopts the all-air duct central air-conditioning system, duct material using galvanized sheet steel, purification and air-conditioning system ducts using polyethylene insulation materials, fire grade B2, purification workshop outside the new air through the primary, medium and high-efficiency air filters The fresh air outside the clean room is sent into the clean area after three-stage filtration. The high-efficiency filter is set in the air supply outlet at the end of the air supply system. The lower side is the return air outlet, which is equipped with a primary filter, and the return air from all rooms is sent back to the air-conditioning unit through the return air duct. Since the production process of molding vulcanization, extrusion vulcanization and secondary vulcanization will produce trace dust and irritating gases, the extrusion vulcanization room, plate vulcanization room, and the oven room are equipped with a local exhaust system, with a stainless steel exhaust hood at the end, which is connected to the exhaust fan by galvanized sheet steel, and with check valves installed in the air ducts to prevent the backflow of the air from the outdoor airflow.
5.3.2 Confirmation of purification and air-conditioning system installation
5.3.2.1 Requirements for equipment installation
5.3.2.2 Requirements for installation of high-efficiency air filters
According to the diagram of the air supply system and the high-efficiency filters design and installation regulations, the installation of high-efficiency air filters is confirmed to comply with the specifications through the inspection of the following items The inspection items are:
a) Installation steps: end of air-conditioner assembly→internal cleaning→installation of primary and secondary filters→fan after 24 hours of continuous operation→installation of the end of the high-efficiency filter.
b) According to the air supply system diagram in the specified location, the installation of the specified type of filter.
c) Each high-efficiency filter should have a certificate of conformity.
d) The filter and the air supply piping should be softly connected and installed with a regulating valve.
e) The connection between the filter and the ceiling is firm and tightly sealed.
5.3.2.3. purification air-conditioning system installation verification method
a) in each component and equipment should be checked before installation and fill in the equipment out of the box inspection records, ducts should be blown before installation degreasing to ensure that the ducts are clean. After cleaning should fill in the piping system blowing (degreasing) records, air supply, return air duct installation is completed, should be used 200W light leakage detection, verification of whether the interface is sealed without air leakage. After the inspection, should fill in the duct leakage inspection records.
b) in the purification of air conditioning system all equipment and components installed after construction, should be purified air conditioning system for intermediate engineering acceptance, acceptance includes: structural parts, ventilation and electrical parts. Fill in the intermediate acceptance form after acceptance.
5.3.3. Air conditioning system operation confirmation
a) air conditioning purification unit operation confirmation
Air conditioning unit and air duct installation is completed, after checking to confirm compliance with the requirements, in accordance with the operating instructions to open the air conditioning system for operation. Checks include: power self-control system: should be started off normal, sensitive control; air supply and return ducts: connected in accordance with the provisions of the air supply pipeline valves regulating normal. Conveyor fan: normal operation, no abnormal vibration; box: sealing tight, no leakage. After checking the equipment should be filled out single test run records.
b) purified air conveying pipeline operation confirmation
Check: airtight: no leakage; terminal valve: adjustable, close tight. After checking should be filled out: purification air conditioning system joint test run record
c) air conditioning system debugging
To be stable after the air conditioning system operation, the air conditioning system should be debugging, debugging results should meet the following requirements.
d) the debugging results will be recorded
the corresponding records are: environmental monitoring records - temperature, humidity (No.: JL-6.4-01a); environmental monitoring records - the number of air changes (No.: JL-6.4-01b ); environmental monitoring records - static pressure difference (No.: JL-6.4-01d); environmental monitoring records -dust count (No.: JL-6.4-01e)
5.3.4. air-conditioning system performance confirmation
a) in the case of air-conditioning purification system is working normally, the purification of the workshop static measurement of various indicators, in order to confirm the purification of the workshop environment to meet the requirements.
b) purification and air conditioning system performance confirmation time for one month, every working day for static testing, the frequency of testing projects in accordance with the provisions of YY0033 "Sterile Medical Apparatus Production Management Specification" in the test, the test should be filled out after the completion of the corresponding environmental monitoring records.