Is the cleanliness of the perfusion room required to be 100,000 grades? Do you want to get tested on

It is clearly stated in the audit rules of QS, and there is also this provision in the annual inspection of QS certificate every year--- and provide a valid test report of the filling room.

1) The "Detailed Rules for the Review of Beverage Product Production License" (other beverages) stipulates that the clean operation area should be a clean workshop of more than 100,000 yuan for the hot filling process; In the post-sterilization and aseptic filling process, it is necessary to install coarse and medium air purification equipment to ensure that the air circulation times are more than 10 times;

2) The clause in the "Good Manufacturing Practices for Beverage Enterprises" (GB 12695) stipulates that the clean area shall formulate different air cleanliness requirements according to the characteristics and process requirements of different types of beverages, such as fruit juice and milk beverages and other products that need to be hot-filled, and the clean area shall be a 100,000-level clean workshop.

Anhui people and purification for you to answer! If you have any questions, please come to consult.

Depending on what type of product type is in the perfusion room, electronic products and drugs will be higher, and some food products will be less demanding.

10W--100W are available, and 10W is inspected every year. The higher the grade, the more frequent the inspection.

The clean operation area should be a clean workshop of more than 100,000 for the hot filling process; In the post-sterilization and aseptic filling process, it is necessary to install coarse and medium air purification equipment to ensure that the air circulation times are more than 10 times;

Medicines or foods? For hot infusion drinks, the cleanliness of the operation area should be 100,000 levels; Cold fill grade 1000. The annual inspection of food certification requires a valid filling room test report.

Educational technology in our country has largely gone through.

Three phases. a

Beginner, Intermediate, Advanced.

bEarly, intermediate, and high stages. c up.

10,000 grades: the maximum allowable number of microorganisms: 100 cubic meters of plankton; Applicable occasions:

Small-volume injectable filling workshop, final processing workshop for packaging materials that are in direct contact with pharmaceutical products.

Workshop cleanliness refers to the level of air purification in the workshop. The 100,000-level workshop of your customer refers to the maximum allowable number of microorganisms is 500 cubic meters of floating bacteria, which is generally an injection concentration workshop.

The specific definition is as follows:

10,000 level: the maximum allowable number of microorganisms: 100 plankton cubic meters; Applicable occasions: small-volume injection filling workshop, final processing workshop of packaging materials in direct contact with drugs.

10,000 level: the maximum allowable number of microorganisms: 500 plankton cubic meters; Applicable occasions: injection concentration workshop.

10,000 level: the maximum allowable number of microorganisms: 1000 plankton cubic meters; Applicable occasions: pill and granule packaging workshop.

Grade: Maximum allowable number of microorganisms: 5 cubic meters of plankton; Applicable occasions: filling workshops for large-volume injections.

Workshop cleanliness refers to the level of air purification in the workshop. The 100,000-level workshop of your customer refers to the maximum allowable number of microorganisms within 500 cubic meters of planktonic bacteria, and the general capacity is the injection concentration workshop.

The specific definition is as follows:

10,000 level; The maximum allowable number of microorganisms: 100 cubic meters of planktonic bacteria; Applicable occasions: small-volume injection filling workshop, final processing workshop of packaging materials in direct contact with drugs.

10,000 level; Maximum allowable number of microorganisms: 500 cubic meters of plankton; Applicable occasions: injection concentration workshop.

10,000 level; Maximum allowable number of microorganisms: 1000 microbial meters; Applicable occasions: pill and granule packaging workshop.

Level; Maximum allowable number of microorganisms: 5 cubic meters of plankton; Applicable occasions: filling workshops for large-volume injections.

Workshop air purification grade.

300,000 level; Maximum allowable number of microorganisms: 1000 microbial meters; Applicable occasions: pill and granule packaging workshop.

100,000 level; Maximum allowable number of microorganisms: 500 cubic meters of plankton; Applicable occasions: injection concentration workshop.

10,000 levels; The maximum allowable number of microorganisms: 100 cubic meters of planktonic bacteria; Applicable occasions: small-volume injection filling workshop, final processing workshop of packaging materials in direct contact with drugs.

Level 100; Maximum allowable number of microorganisms: 5 cubic meters of plankton; Applicable occasions: filling workshops for large-volume injections.

Refers to the level of air purification in the workshop. Cleanliness refers to the amount of dust contained in the air in an air environment. In general, it refers to the number of particles of a certain size per unit volume of air.

High dust content means low cleanliness, and low dust content means high cleanliness.

1. Workshop cleanliness level: 300,000 level; Maximum allowable number of microorganisms: 1000; The maximum allowable number of microorganisms: pill and granule packaging workshop.

2. Workshop cleanliness level: 100,000 level; Maximum allowable number of microorganisms: 500; The maximum allowable number of microorganisms: injection concentration workshop.

3. Workshop cleanliness level: 10,000 grades; Maximum allowable number of microorganisms: 100; Maximum allowable number of microorganisms: small-volume injection filling workshop, final processing workshop of packaging materials in direct contact with drugs.

4. Workshop cleanliness level: 100 grade; Maximum allowable number of microorganisms: 5; Maximum allowable number of microorganisms: Filling workshop for large-volume injections.

Workshop air purification level.

Workshop cleanliness level; Maximum allowable number of microorganisms ; Cubic meters of plankton; Applicable occasions:

300,000 level; 1000 ；Pill and granule packaging workshop.

100,000 level; 500；Injection concentration workshop.

10,000 levels; 100 ；Small-volume injectable filling workshop, final processing workshop for packaging materials that are in direct contact with pharmaceutical products.

Level 100; 5 ；Filling workshop for high-volume injections.

The cleanliness of the workshop reaches 100,000 levels, which refers to the number of micron dust particles per cubic meter (per liter) of air 35 100,000 (3,500).

per cubic meter (per liter.

genus) 5 micron dust particles in the air 250,000 (25).

The cleanliness level of 10,000 refers to the number of micron dust particles per cubic meter (per liter) of air of 35 10,000 (350), and the number of 5 micron dust particles per cubic meter (per liter) of air is 25,000 (pieces).

Airborne microorganisms are ubiquitous and often attach to dust particles, spreading with dust, hair, etc. The more dust particles in the air, the greater the chance that bacteria will attach to the dust particles and the chance of spreading. Similarly, viruses can attach to dust particles and spread.

Therefore, controlling the number of dust particles in the air can control the microorganisms that attach to it.

Class 100,000 is a clean room with low cleanliness requirements, only need to do a good job of dustproof treatment inside the workshop, maintain the positive pressure of the workshop, and install a high-efficiency filter at the end of the air conditioner. The specific parameters can be calculated for you if you find a mouth to make a clean air conditioner.

According to the concentration of suspended particles in the air, the air cleanliness level in the clean room and related controlled environment is divided into each cubic meter of air.

The maximum allowable particle volume in to determine its air cleanliness level.

1. Several levels of clean workshop: refers to the clean level, which can be understood as a clean room, but the clean room also needs to be ventilated, and the air changed in needs to be purified by the clean room and then sent to the clean room. Class (100,000) requires 15-19 air changes per hour, and the air purification time after complete ventilation does not exceed 40 minutes.

2. Purification parameters of 100,000-level, 10,000-level and 100-level clean workshops:

Number of air changes: 100,000 15 times; 10000 level 20 times; 1000 30 times; 100 500 times. Differential pressure: 5pa for the main workshop to the adjacent room

Nowadays, most of the workshops with the lowest requirements use 100,000-level purification workshops; The 300,000-level purified sedimentation bacteria (CFU, 100,000-level purified sedimentation bacteria (CFU dish) are 10:100,000-level air exchange parameters are 15 times.

Each cleanliness level has its own purpose, from the dust particles in the air to understand the difference between purification; In other words, the more air changes the better.

The standard of the clean workshop is: the number of fine dust particles per cubic meter = is 100,000And so on. 10,000 is: 10000Level 100 is: 100

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.

Cleanliness level of purification workshop: 100 level, 1000 level, 100,000 level, 100,000 level, 300,000 level, that is to say, the smaller the value, the higher the purification level. The higher the cleanliness, the higher the cost.

The cleanliness of the 100,000-level purification workshop is not too high, and the well-known purification workshop engineering company iwuchen usually does more 100,000-level purification workshops, including general electronics, food and beverage, medical equipment, cosmetics factories, etc.

Standard table of clean workshop (level 8 corresponds to level 100,000, and so on):

100,000 level cleanliness standard.

1. The maximum allowable number of dust particles shall not exceed 3,500,000 particles or equal to microns, and the number of particles greater than or equal to 5 microns shall not exceed 20,000. What is the concept of micron? The diameter of a hair is about 70 100 microns, the size of the bacteria is about 1 micron 2 microns, and the number of particles greater than or equal to 5 microns shall not exceed 20,000 through the air purification system, which is very clean.

2. The pressure difference between the clean rooms of the same cleanliness level is consistent, and the pressure difference between adjacent clean rooms of different cleanliness levels should be 5Pa, and the pressure difference between clean rooms and non-clean rooms should be 10Pa. This is mainly to ensure that the air flows from the clean area to the non-clean area and to avoid backflow of airflow.

3. The maximum allowable number of microorganisms, the number of planktonic bacteria shall not exceed 500 per cubic meter; The number of sedimentation bacteria should not exceed 10 per Petri dish. Microorganisms include bacteria, viruses, single-celled organisms, etc., and the purification workshop project focuses on the two indicators of plankton and sedimentation bacteria. When doing the sedimentation bacteria test, there must be a special petri dish, each petri dish is placed by specific nutrients in the workshop for a period of time, according to the number of bacteria growing in the nutrients, the number of sedimentation bacteria in the air can be measured.

The bottled water production workshop needs to meet the 100,000-level clean room standard, including air shower room, high-efficiency air supply outlet, transfer window, clean workbench, FFU fan filtration unit, laminar flow hood and other internal facilities.

What we are good at is to provide customers with all kinds of clean workshop projects that meet the requirements of international standards, and at the same time apply environmental solutions with new energy-saving technologies; We provide planning and design of purification workshops: 100-million purification schemes, clean air conditioning systems, and clean decoration systems; Installation and supporting services such as energy-saving renovation of the whole plant, hydropower, pure water pipelines, clean room monitoring, and maintenance systems;

First, first of all, let's talk about the cleanliness level of the dust-free purification workshop: 100 levels, 1000 levels, 100 thousand levels, 100,000 levels, and 300,000 levels.

This means that the lower the value, the higher the level of purification. The higher the cleanliness, the higher the cost. The purification and cleanliness of the dust-free workshop is suitable according to the requirements of the production process. The million-level doesn't seem to have this title, or it's a hundred-level, and more than 300,000 levels are basically not purified.

Manufacturers of manual purification boards.

Second, talk about the plate used in the dust-free purification workshop - manual purification board;

Because of its unique dust-proof, anti-static, antibacterial and other effects, it is widely used in electronics, pharmaceutical, food, biology, aerospace, precision instrument manufacturing and scientific research and other purification engineering fields with strict requirements for indoor environment.

The 100,000-level purification workshop refers to the control of particles per cubic meter in the workshop within 10W, which is generally used in electronics, food and beverage, medical equipment, cosmetics factories, etc.

1. The maximum allowable number of dust particles shall not exceed 3.5 million microns, and the number of particles of 5 microns shall not exceed 20,000.

2. The maximum allowable number of microorganisms, the number of planktonic bacteria does not exceed 500 m; The number of sedimentation bacteria does not exceed 10 Petri dishes.

3. Pressure difference: The pressure difference between the clean room of the same clean level is consistent, and the pressure difference between adjacent clean rooms of different clean grades should be 5Pa, and the pressure difference between the clean room and the non-clean room should be 10Pa (mainly to ensure the flow of air from the clean area to the non-clean area and avoid the backflow of airflow).

4. Temperature and humidity: the temperature is generally controlled in winter 20 22; Summer 24 26 ; Wave 2. The humidity of the clean room is controlled at 30-50% in winter and 50-70% in summer.

When there are no special requirements for temperature and humidity, it is advisable to wear clean work clothes without feeling comfortable.

Class 10,000 clean room standard refers to the special design of the room that excludes particles in the air within a certain space range, harmful air, bacteria and other pollutants, and controls the indoor temperature, cleanliness, indoor pressure, air velocity and air flow distribution, noise and vibration, lighting, and static electricity within a certain range of needs. That is to say, no matter how the external air conditions change, the interior can maintain the characteristics of cleanliness, temperature, humidity and pressure that were originally set.

Cleanroom standards can be divided into two categories: one is classified by application, and the other is classified by airflow pattern.

1. Classification by use:

1.The industrial clean room --- mainly controls the pollution of inanimate particles to the working object, and its internal pressure is generally maintained, which is suitable for precision industry, electronics industry, aerospace industry, chemical industry, printing industry and other departments. As long as the control parameters of the industrial dust-free workshop are temperature, humidity, wind speed, flow field, and cleanliness.

2.The biological clean room --- the control of living particles as the object, and can be divided into: general biological clean room, which mainly controls the pollution of living particles to the working object.

The biosafety dust-free workshop mainly controls the pollution of living particles to the outside world and people by the working object, but the difference is that the indoor static pressure is required to be a certain value lower than the surrounding environment, which is used for research experimental facilities, laboratories and bioengineering. The essence of the biological clean room is the same as that of the general industrial clean room, but the difference is that the biological clean room must control the content of bacteria.

2. Classification according to airflow flow pattern: airflow flow pattern is the form of airflow trajectory.

1.One-way flow clean room.

2.Non-unidirectional flow clean room.

3.Mixed-flow clean room.

4.Radial clean room.