The maximum allowable number of dust particles: the number of particles larger or equal to 0.5 micron can not exceed 3500000, the number of particles larger or equal to 5 micron can not exceed 20000;
The maximum allowable number of microorganisms: the number of planktonic bacteria can not exceed 500; the number of bacteria can not exceed 10 per petri dish.
Differential pressure: the same cleanliness level of the clean room pressure difference to maintain the same, for different cleanliness levels of the pressure difference between neighboring clean rooms should be ≥ 5Pa, clean room and non-clean room to be ≥ 10Pa.
Expanded
GMP requires that food production enterprises should have good production equipment, reasonable production process, perfect quality management and strict testing system to ensure that the quality of the final product meets the regulatory requirements.
So a GMP workshop is a workshop that meets the requirements of GMP quality and safety management system.
The production workshop has been tested by the Drug Administration, and the cleanliness reaches 100,000 level of pharmaceutical production standards.
GMP plant generally have 10,000, 100,000 and 300,000 level, of which 100,000 and 300,000 level is the most, 100,000 level than 300,000 level of cleanliness and health to be much more stringent.
Reference:
Baidu Encyclopedia - 100,000 GMP production plant100,000 clean room what standards?
There are different levels of purification room, ten, one hundred, one thousand, ten thousand, one hundred thousand levels at all levels of workshop design requirements are also different.
Where is the difference between class 100, class 1,000 and class 10,000? Mainly in the air of each particle size class allowable particle concentration is not the same.
1, 100-class clean room 0.5 micron allowable particle concentration is less than 3520, 5 micron allowable particle concentration is less than 293.
2, 1000-class clean room 0.5 micron allowable particle concentration is less than 35200, 5 micron allowable particle concentration is less than 2930.
3, 10,000-class clean room 0.5 micron allowable particle concentration is less than 352000, 5 micron allowable particle concentration is less than 2930. 352000, 5 microns of the allowable particle concentration of 29300.
Each industry requires different levels of purification room, Shuangjia purification for you to explain the pharmaceutical plant 100,000 purification room
Pharmaceutical plant production workshop by the Drug Administration testing, cleanliness to reach the 100,000 level of pharmaceutical production standards, 100,000 level of dust purification workshop standards for the number of particles of dust in the air cubic meter not more than Thirty-five point two times one hundred thousand, the number of air changes generally in accordance with the hour 15-20 times, more suitable for air cleanliness level of lower production occasions. One hundred thousand dust-free clean room using technology processing measures are as follows:
1, the air conditioning system must be after the primary, intermediate and high efficiency of the three filtration purification air conditioning system. Ensure that the air sent into the room is clean air, can dilute indoor polluted air.
2, indoor to ensure a certain pressure, to prevent dust-free indoor air from outside air interference. General purification project clean room requirements for indoor and outdoor pressure difference of 5-10Pa.
3, the building envelope must ensure that the airtightness of the good, smooth building surfaces, do not produce dust, do not accumulate dust, do not leak.
Shuangjia purification services: hospital operating rooms, laboratories, wards, laboratory purification equipment, purification system design, planning and construction and maintenance of construction
Hospital blood, reagents, pharmaceutical cold storage, pharmaceutical acceptance of cold storage, cold storage at ultra-low temperatures; support for remote control of cold storage.
Equipment supporting: purification board, PVC floor, floor paint, gas-tight lamps, etc.
Purification engineering: purification design, purification construction, third-party testing, laminar flow, vertical flow, 100,000 purification of how much money, etc.
Engineering services: free design, free survey, lifelong maintenance of the after-sales service without worry!
Application: pharmaceutical, hospital, food, electronics, biology, science and technology, pure water, sterilization, etc.
What is the standard of 100,000 purification workshop?
100,000 clean room standard is the number of clean room air change.
1, 100,000 clean room air change times not less than 15 times / h.
2, 10,000 clean room air change times not less than 25 times / h.
3, 1,000 clean room air change times not less than 50 times / h.
10,000 purification, mainly by the clean air flow constantly dilute the indoor air, the indoor pollution gradually discharged, to achieve the effect of cleanliness.
Physical
Physical purification:
1, adsorptive filtration-activated carbonActivated carbon is a kind of porous charcoal-containing material, which has a highly developed pore structure, the porous structure of the activated carbon provides a large amount of surface area, which is able to make full contact with the gas, thus giving the activated carbon a unique adsorption performance, making it very easy to achieve the purpose of absorbing the collected impurities. Like magnetism, all molecules have a mutual gravitational attraction to each other.
2, mechanical filtration - HEPA mesh?HEPA, meaning high-efficiency air filter, to achieve the HEPA standard filter, for 0.3 micron efficiency of 99.998%, HEPA mesh is characterized by the air can be passed, but fine particles can not be passed.HEPA filters are composed of a stack of continuous before and after the folding of the sub-glass fiber membrane to form a wave-shaped Gaskets are used to place and support the filter boundary mass.
New version of the cleanroom class 100,000 purification standards
2018 new version of the class 100,000 cleanroom purification workshop standards
A, class 100,000 cleanroom standards are:
Maximum allowable number of dust particles;
The number of particles larger or equal to 0.5 micron shall not exceed 3,500,000 particles, and the number of particles larger or equal to 5 micron 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 sinking clones shall not exceed 10 per petri dish.
Differential pressure: the same cleanliness level of 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 exchange:
100,000 clean room requirements per hour 18-25 times of air exchange, complete air exchange after air purification Time not more than 40 minutes.
Ten thousand clean room requirements per hour 25-30 times, complete ventilation after air purification time of not more than 30 minutes.
Thousands of clean rooms require 40-60 air changes per hour, complete air changes after air purification time of no more than 20 minutes.
Three, "GB50073-2013 clean plant design specification" 100,000 and purification workshop standards for reference:
Four, air cleanliness classification standards
Air cleanliness classification standards: ISO14644-1
Air cleanliness classification standards: GB/T16292-1996
British 5295 standard clean room and air purification device classification
Comparison of various international cleanliness standards
In summary, the above standards, you can derive 100,000 purification workshop corresponding to the following parameters
Five, 100,000 purification workshop validation standards case reference
Purification plant overview
The company's purification plant level of 100,000, the local level 100, is located in the company's production area, the production area, the production area, the production area, the production area, the production area, the production area, the production area, the production area, the production area, the production area and the production area. Local class 100, located in the company's production area of the first floor, construction 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 meets the requirements of medical device GMP and related national standards, whether the purification capacity of the air-conditioning purification system meets 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 "Medical Device Manufacturing Enterprises Quality Management Standard"
3.2 YY0033 "Sterile Medical Apparatus Manufacturing Management Specification"
3.3 GB50073 "Purification Workshop Design Specification"
3.4 GB50457 "Design Specification of Purification Workshop for Pharmaceutical Industry" < /p>
3.5 GB50591 Cleanroom Construction and Acceptance Code
3.6 GB/T16292 Testing Methods for Suspended Particles in Pharmaceutical Industry Cleanrooms
3.7 GB/T16294 Testing Methods for Sedimentation of Bacteria in Pharmaceutical Industry Cleanrooms
Verification of Required Documents and Records
4.1 General layout plan of the company
4.2. Layout plan of 100,000-class clean room
4.3. Layout plan of air ducts
4.4. Layout plan of air supply and return vents
4.5. Layout plan of exhaust ducts
4.6. Distribution plan of air filters
4.7. Lamps and fixtures
4.8. 4.8 Air-conditioning unit instruction manual
4.9 Clean room project acceptance report
4.10 Clean area environmental monitoring records
4.11 Third-party environmental monitoring report
4.12 Clean room management system
Verification methods and steps
5.1 Measuring instruments and equipment required for testing
5.2 Measuring instruments and equipment required for testing
5.3 Measuring instruments and equipment required for testing
5.4 Measuring instruments and equipment required for testing
5.1.1 Temperature and humidity meter
5.1.2 Thermal bulb anemometer
5.1.3 Differential pressure meter
5.1.4 Dust particle counter
5.1.5 Portable stainless steel pressure steam sterilizer
5.1.6 Constant-temperature incubator
5.1.7 The above equipment must be fully functional. The above apparatus should be equipped with functionally sound, need to check 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) purification workshop roof 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 works through the acceptance, before the construction of the next process. Purification workshop completion and acceptance is completed, all projects 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, the return air outlet 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 methods
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 records, air supply, return air ducts after installation, 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
Corresponding records are: environmental monitoring records - temperature, humidity; environmental monitoring records - the number of air changes; environmental monitoring records - static pressure difference; environmental monitoring records - the number of dust
5.3.4. air-conditioning system performance confirmation
a) In the case of air-conditioning purification system is working normally, the purification workshop should be carried out. Under the condition of working, carry out the measurement of static indexes of the purification workshop to confirm whether the environment of the purification workshop meets the requirements.
b) purification and air conditioning system performance confirmation time for one month, every working day for static testing, the frequency of the test items in accordance with the provisions of YY0033 "Sterile Medical Apparatus Manufacturing Management Specification" in the test, the test should be filled out after the completion of the corresponding environmental monitoring records.
What is the meaning of class 100,000 clean room standard?
100,000 clean room standard is the number of clean room ventilation, 100,000 clean room ventilation is not less than 15 times / h. 10,000 clean room ventilation is not less than 25 times / h. 1,000 clean room ventilation is not less than 50 times / h.
Purification of clean room cleanliness level: 100,000 1,000,000 100,000 300,000 that is to say that the value of the smaller the higher the level of purification. The higher the cleanliness, the higher the cost.
100,000 clean room notes
100,000 clean room equipment, instruments, etc. should be regularly inspected, some special equipment required to achieve dust-free processing, to prevent the use of reduced efficiency.
100,000 clean room requirements cleanliness should always be maintained in a clean state, in addition to the requirements of the relevant staff in and out, other personnel shall not enter.
Before entering the clean area of the 100,000 clean room, can not be fast and large walk, to avoid causing secondary pollution, and regular cleaning and sanitation.