Purification workshop testing, purification workshop standards

First of all, you don't know what to ask. Is it a test or an audit?

If it is an audit: first of all, it is necessary to find out which industry your factory belongs to and which competent department manages it. For example, if a pharmaceutical company is a pharmaceutical company, it should submit the design drawings to the NMPA for review in advance, because there is an industry pre-review.

Then before the construction, the drawings will be sent to the local fire department for preliminary review, and he will send you a report on the commencement of construction if it is passed. The inspection is carried out after the construction is completed.

Testing: 1. Purification testing, after the completion of construction, the owner shall contact a qualified purification testing department, such as a pharmaceutical packaging testing institute; He will conduct the test according to the requirements of your competent authority, and he will issue a test report. It is generally in quadruplicate.

2. For fire inspection, first contact the qualified fire inspection department for testing and issue an inspection report; Then contact the fire department for an on-site inspection.

As for the cost, it is not clear, it has to do with your design, size, how much function is between you and the relationship with the relevant local authorities.

After completing the above work, you can go to the competent department to apply for the production license, health license, etc. of the workshop! If it is a pharmaceutical company or health care product industry, it has also passed GMP certification.

The purification workshop generally audits itself, and the quality department will have regular personnel to test it every month, if the dust content is less than 10,000 levels, it will pass, if not, it will be necessary to strengthen the environmental finishing of the purification workshop.

The design of the purification workshop is now widely used in the market, almost all pharmaceutical factories, cosmetics, mechanical science and technology, will use the purification workshop, because the production of some parts needs to achieve a dust-free environment, so the requirements for the purification workshop will be relatively high, so what is the national standard of the purification workshop?

Decoration of the purification workshop.

1.The purification workshop must maintain a certain relative positive pressure, and the pressure between different levels of clean workshops is not less than 5Pa; The pressure between the clean workshop and the non-clean workshop should not be less than 10Pa to prevent the air from the low-level clean workshop from backflowing to the high-level clean workshop.

2.The temperature should be maintained at 18 26, and the cleanliness level is the maximum allowable number of latent particles and the maximum allowable number of microorganisms is 5 m plankton cubic meters and sedimentation bacteria cubic meters.

Level 100 3,500 0 5 1

10,000 350,000 2,000 100 3

100,000 3,500,000 20,000 500 10

300,000 level 10,500,000 60,000 1,000 15

3.Class 10,000 purification workshop standard (defined by the number of dust particles and microorganisms): Maximum allowable number of dust particles (per cubic meter):

The number of particles large or equal to microns shall not exceed 350,000, and the number of particles large or equal to 5 microns shall not exceed 2,000; The maximum allowable number of microorganisms: the number of planktonic bacteria shall not exceed 100 per cubic meter, and the number of sedimentation bacteria shall not exceed 3 per petri dish.

4.Class 100,000 clean workshop standard (defined by the number of dust particles and microorganisms): Maximum allowable number of dust particles (per cubic meter):

The number of particles large or equal to microns shall not exceed 3,500,000, and the number of particles large or equal to 5 microns shall not exceed 20,000; The maximum allowable number of microorganisms: the number of planktonic bacteria shall not exceed 500 per cubic meter, and the number of sedimentation bacteria shall not exceed 10 per petri dish.

5.Class 300,000 clean workshop standard (defined by the number of dust particles and microorganisms): Maximum allowable number of dust particles (per cubic meter):

The number of particles large or equal to microns shall not exceed 10,500,000, and the number of particles large or equal to 5 microns shall not exceed 60,000; The maximum allowable number of microorganisms: the number of planktonic bacteria shall not exceed 1000 per cubic meter, and the number of sedimentation bacteria shall not exceed 15 per petri dish.

The standard of the 100,000-level purification workshop is the number of air changes in the clean room.

1. The number of air changes in the 100,000-level clean room is not less than 15 times.

2. The number of air changes in the 10,000-level clean room is not less than 25 times.

3. The number of air changes in the thousand-level clean room is not less than 50 times.

10,000-level purification mainly relies on clean airflow to continuously dilute the indoor air and gradually discharge the indoor pollution to achieve the cleaning effect.

1. The material of the purification workshop is the wall and roof of the purification plant, which are generally made of 50mm thick sandwich color steel plate, which is characterized by beautiful appearance, strong rigidity, good thermal insulation performance and easy construction.

2. The floor of the purification workshop can be epoxy artesian floor or high-grade wear-resistant plastic floor, and the anti-static type can be selected if there are anti-static requirements. The high-efficiency air supply outlet is made of stainless steel frame, which is beautiful and clean, and the perforated mesh plate is made of painted aluminum plate.

3. The indoor airflow is an uneven speed of non-parallel flow, mixed with backflow or vortex, different levels of clean room, mainly rely on the difference in the amount of air supplied per unit time. At present, there are two standards: 100,000 and 300,000.

4. The main function of the clean room is to control the cleanliness and temperature and humidity of the atmosphere that the product (such as silicon chips, etc.) is exposed to, so that the product can be produced and manufactured in a good environmental space, which we call the clean room.

4. The outlet of the workshop and the drainage and ventilation connected to the outside world are equipped with rodent-proof, fly-proof and insect-proof facilities. 5. The building enclosure boundary area and interior decoration of the food purification workshop should be made of materials with good air tightness and basically no deformation under the condition of temperature and humidity changes. The surface of the walls and ceilings in the clean workshop should be smooth, smooth, no cracks, and tight interfaces.

6. The walls, ceilings, doors and windows in the food purification workshop are built with non-toxic, light-colored, waterproof, mildew-proof, non-falling and easy-to-clean materials. The corners, corners, and corners of the wall should have arcs. 7. When the technical mezzanine is a lightweight ceiling, an overhaul channel should be set.

The interior surface decoration standards of building air ducts and return air trenches should be suitable for the entire return air system and easy to dust removal. 8. The operating table, conveyor belt, transport vehicle and tools in the purification workshop should be made of non-toxic, corrosion-resistant, non-rusty, easy to clean and disinfect, and sturdy materials. 9. The floor and wall of the purification workshop of the food factory should be laid with light-colored materials that are non-absorbent, impermeable, easy to clean and disinfect, and do not hide dirt and dirt, and the surface should be flat and smooth.

Pipes, lamps, and tuyeres should be made of products that are easy to scrub and disinfect, and there should be no parts that are not easy to clean.

1. The construction of food purification workshop involves many aspects, including factory layout, environmental parameters, process design, ventilation and purification air conditioning, clean room grade, electrical, building, water supply, drainage and a series of others. Among them, the building plays a key role in the food purification workshop to meet the safety and hygiene requirements of food production. 2. In addition to meeting the needs of the production process, the architectural design of the purification workshop in the food factory should also meet the requirements of no dust production, no dust accumulation, corrosion resistance, moisture-proof, mildew-proof, easy to clean, and should meet the requirements of fire prevention and environmental protection.

3. The room of the food workshop should be convenient for the installation of air conditioning purification equipment, air ducts and tuyeres, and the indoor net height should meet the requirements of the production process.

Do the exhaust vents.

The test items in the clean workshop are: wind speed, air volume, air exchange times, temperature and humidity, pressure difference, and suspended particles.

1. Wind speed and air volume ventilation times

The cleanliness of clean rooms and clean areas is mainly achieved by feeding a sufficient amount of clean air to replace and dilute the particulate pollutants generated in the room. For this reason, it is necessary to measure the air supply volume, average air speed, air supply uniformity, air flow direction and flow pattern of clean rooms or clean facilities.

2. Temperature and humidity.

The temperature and humidity determination of clean rooms or clean facilities is usually divided into two grades: general test and comprehensive test. The first grade is suitable for the completion acceptance test in the empty state, and the second grade is suitable for static or dynamic comprehensive performance testing.

This type of test is suitable for occasions with strict requirements for temperature and humidity performance.

3. Differential pressure.

The purpose of this test is to verify the ability to maintain a defined differential pressure between the completed facility and its surroundings, as well as between spaces within the facility. This test applies to all 3 occupancy states. This test needs to be done regularly.

The differential pressure test should be carried out with all doors closed, starting from high pressure to low pressure, and from the inner room furthest from the outside world in the floor plan.

4. Suspended particles

Indoor testers must wear clean clothing, no more than 2 people, should be located downwind of the test point and away from the test point, and should remain stationary. When changing points, the action should be light, and the interference of personnel to the cleanliness of the room should be reduced.

In the unidirectional flow area, the selected sampling probe should be close to isodynamic sampling, and the deviation between the wind speed entering the sampling probe and the wind speed of the collected air should not exceed 20. If this is not possible, the port is directed in the main direction of the airflow. For sampling points that are not unidirectional flows, the sampling port should be vertically upward.

The sampling points are generally left and right from the ground, and should be evenly and scientifically distributed, and the return air outlet should be avoided. For any small clean room or local air purification area, the number of sampling points shall not be less than 2, and the total number of samples can be calculated according to the area of 2 roots.

5. Plankton

The minimum number of sampling points corresponds to the number of suspended particle sampling points, the position of the measurement point in the work area is about 30cm from the ground, the position of the measurement point of the air supply outlet is about 30cm away from the air supply surface, and the measurement point can be increased at the key equipment or key work activity range, and each sampling point is generally sampled once.

1. The purification workshop must maintain a certain relative positive pressure, the pressure between different levels of clean workshops is not less than 5Pa, and the pressure between the clean workshop and the non-clean workshop is not less than 10Pa, so as to prevent the air of the low-level clean workshop from flowing backward to the senior clean workshop, and the temperature should be kept at 18 to 26 degrees Celsius for pure socks to crack.

3. The maximum allowable number of dust particles, the number of particles large or equal to microns shall not exceed 10,500,000, the number of particles large or equal to 5 microns shall not exceed 60,000, the maximum allowable number of microorganisms, and the number of planktonic bacteria shall not exceed 1,000 per cubic meter.

Purification workshop erection standard for judging:

1. The purification workshop must maintain a certain relative positive pressure, the pressure between the different levels of clean and poor workshops is not less than 5Pa, and the pressure between the clean workshop and the non-clean workshop is not less than 10Pa, so as to prevent the air of the low-level clean workshop from backflow to the senior clean workshop, and the temperature should be maintained at 18 to 26 degrees Celsius.

3. The maximum allowable number of dust particles, the number of particles large or equal to microns shall not exceed 10,500,000, the number of particles large or equal to 5 microns shall not exceed 60,000, and the maximum allowable number of microorganisms and the number of planktonic bacteria shall not exceed 1,000 per cubic meter.

How to test whether the workshop meets the standard of 100,000-level purification workshop? People and purification are your answers.

Escherichia coli and salmonella in the air will cause food contamination, and a particle of dust can destroy computer chips, therefore, the purification workshop has been as common as a household air purifier, and enterprises use the purification workshop to effectively reduce dust, bacteria, viruses, etc. in the air, and achieve constant temperature, constant pressure and constant noise, and provide a good production environment. Among them, the 100,000-level purification workshop standard is the most common, and during the production process, the workshop must be dynamically monitored in real time to ensure that the 100,000-level purification standard is reached.

To determine whether the cleanliness is up to standard, it is necessary to start from many aspects, including indoor air supply volume, total fresh air volume of the system, static pressure difference, average cross-section wind speed, uneven cross-section wind speed, air cleanliness level, plankton bacteria and sedimentation bacteria, indoor temperature and relative humidity, indoor noise level, etc., taking the detection of a beverage workshop as an example. The main cleanliness criteria monitored by food establishments are the number of sedimentation bacteria and planktonic bacteria, which have the greatest impact on food production. The beverage and food workshop adopts the sedimentation bacteria determination method:

Detaposition bacteria are bacteria carried in dust that falls on the ground or on the surface of objects. In the state of the aseptic operation table open, take a number of sterile petri dishes with an inner diameter of 90 mm, inject more than 15 ml of nutrient agar medium melted and cooled to 45 respectively in aseptic operation, and invert it in a 30-35 incubator for 48 hours to prove sterility and set aside.

Place the petri dish that has been covered with nutrient agar medium in the designated area about 1 meter from the ground (generally a flat dish is placed every 10 square meters), expose it to the air for 30 minutes, collect sedimentation bacteria, change the lid of the plate, and incubate it in a 30-35 incubator for 48 hours, take out and count, and the workshop should be in an operating state. The number of sedimentation bacteria is detected, and each dish is less than or equal to 10, which is a qualified 100,000-level production area.

In general, sedimentation monitoring is sufficient once a month. The commonly used instruments in the purification workshop include temperature and humidity meter, temperature and humidity meter, digital display anemometer, infrared thermometer, differential pressure meter, multi-function sound level meter, particle counter, air volume, etc., which are conventional real-time detection equipment.

The purification workshop constantly needs continuous monitoring, as well as strict use specifications, and high-quality purification workshop engineering is indispensable, so that the purification space has many advantages such as safety, energy saving, and humanization, better operation, and create a good living and working environment.

The above is "how to test whether the workshop meets the standard of 100,000-level purification workshop?" If you have any questions, you can consult Anhui people and purification.