A[ 2016-05-19 ]What operating room construction design requirements?

Q

Construction design requirements according to the operating room environment and customer requirements vary, the general requirements are as follows:

First, the seven-storey 3 m net operating rooms renovated, with room decoration net floor 2.8 meters.

Second, the operating room panels made of stainless steel plate modules. Attached room and other areas of inorganic coating clean plate finishes.

Third, each operating room power supply design, with a socket with three walls, one with a 380V socket with universal socket, one 16A universal socket, 3 10A universal socket, a network socket, and with grounding device. The other two with a 16A socket with universal socket, four 10A universal socket, a network socket, and with grounding device. Not designed to outlet (electric plug hanging bed tower).

Fourth, the use of cold light LED lamps, LED cold light film viewer. Film viewer cable 2-way switch points.

Fifth, the air-conditioning system: dual system (four pipe system), the solenoid valve with three-way valve, water-cooled, heat pump with the host, put a certain leeway. Each unit is equipped with a humidifier, electric heating (dehumidification), air-conditioning cycle unit one hundred, one thousand uses a drag system, 10,000 Three dragged.

Sixth, with 2 sets (with rooms, surgery) new air unit, specifically fans, motors origin, brand.

Seven, each operating room is equipped with writing desk, supplies warehouse with network cable, control panel with intercom calls.

VIII, No. 6 according to the operating room digital integrated design (brand Olympus, Stryker, Storz), construction units with construction. 1,2,3,4 renovated operating room by radiation (radiation operating room four weeks stereotype 2mm, height of three meters, the top, to 3cm barium cement), operating room 1,2,4 number one thousand, one hundred 3 class, number 5,6,7 ten thousand.

Nine, crane, shadowless lamp base for an apparatus construction unit installation, crane cable distribution network.

Ten, the operating room to attract, oxygen, compressed air systems. Wherein the suction system operating room alone.

XI, one hundred theater with insulation, freezer.

Twelve, carbon dioxide, anesthetic gas cylinder storage position in the operating room clean staircase on the north side. Adoption bus. Through seven operating room anesthetic gas, carbon dioxide through No. 5,6,7 operating room.

XIII device layer between 3,4 floors. All configuration, timber, cabinets, etc., a clear origin, specifications, models, materials, sheet thickness, quantity.

Fourth, between the northeast corner of disinfection installation with a separate outlet with a 380V universal socket, one 16A universal socket, 3 10A universal socket, and with grounding device.

XV pipeline anti-static design, emissions design.

A[ 2016-05-19 ]What supply chamber construction design requirements?

Q

Construction supply chamber design requirements:

First, the supply room decoration net floor 2.8 meters.

Second, the electrical system was designed by construction units themselves.

Third, the use of cold light LED lamps.

Fourth, the regional clean air conditioning system: a single system (2 pipe system), the solenoid valve with three-way valve, water-cooled, heat pump host, put a certain leeway. Heating air conditioning units and distribution. Auxiliary office area access 1-4 central air conditioning system.

Fifth, with the new air unit, specifically fans, motors origin, brand.

Six regional cable networks with (director office, the duty room, conference room, cleaning area, clean packing area, clean area).

Seven automatic washing machine: with four (with three, 1 placeholder), dimensions, power when available.

Eight, pulsating vacuum sterilizer: with four (with three, 1 placeholder), dimensions, power when available.

Nine, drying cabinet 1, dimensions, power when available.

Ten, using Caigangyanmian sandwich wall.

XI, ethylene oxide, plasma sterilizer to the provision of power, size.

XII dirt cleaning tank (with high-pressure steam gun, water gun), ultrasonic 

A[ 2016-05-19 ]GMP pharmaceutical production environment, regional requirements?

Q

Drug manufacturers must have a clean production environment, a certain green area; the factory floor to be hardened, roads and transport, which do not respond to drug manufacturing pollution; the overall layout of the production, administration, living and support areas should be reasonable, mutually separately, may not interfere with each other.

A[ 2016-05-19 ]Cleanroom disinfection methods are there? How to disinfect thoroughly?

Q

one. UV sterilization

Ultraviolet rays can kill a variety of microorganisms, including bacteria body, spores, viruses, fungi, mycoplasma, ultraviolet disinfection using 200 ~ 275nm of C-wave ultraviolet light, the strongest sterilization band is 250 ~ 270nm. Ultraviolet germicidal effect of ultraviolet radiation intensity is directly related to the use of ultraviolet light disinfection must be able to produce radiation reaches the national standard (voltage 220V, 60% relative humidity, temperature 20 ℃, UV intensity not less than 70μW / cm2) of UV germicidal lamp. In order to obtain a satisfactory strength of ultraviolet radiation, it is necessary for the glass of the UV lamp, reflector and service life make any such request. UV disinfection prior to other disinfection methods are not used as commonly used pharmaceutical manufacturers. Common form: On the clean room ceiling uniform UV germicidal lamp, which produces ultraviolet radiation sterilization of air and surfaces.

Advantages: simple operation, easy management, flexible, can be sterilized individual needs at any time according to the production room.

Disadvantages:

1. Ultraviolet light emitted UV intensity, with the increase in the use of time and weakened, thus diminishing the ability of disinfection and sterilization.

2. UV penetration is weak, easily blocked production equipment, appeared dead, the impact of sterilization effect.

3. Ultraviolet disinfection influenced by the relative humidity, when the clean indoor relative humidity> 60%, the sterilizing effect significantly reduced relative humidity> 80%, should not be used.

4. UV radiation energy is low, only direct exposure to kill microorganisms, therefore, necessary to disinfect the site fully exposed to UV light.

5. Ultraviolet radiation from the surface of an object should not be> 1.50m.

two. Chemicals fumigation and disinfectant spray method

Chemicals fumigation and disinfectant spray method can be to kill all microorganisms, including bacteria body, spores, viruses, fungi, mycoplasma, reliable sterilization effect. Chemicals commonly used disinfectant fumigation are: formaldehyde, ethylene oxide, peracetic acid, commonly used disinfectant spray disinfectant Act are: formalin, 75% ethanol, the new Jill off, potassium permanganate Wait.

Chemicals fumigation and disinfectant spray method has common properties:

1. Antiseptic long time, affecting production. Such as formaldehyde fumigation: disinfection time 12h, allowed to stand for 4 h, exhaust 8h, disinfected once a minimum of 24 h. Disinfected once discontinued 2 to 5 days.

2. To rule out a pungent odor, long open after sterilization ventilation system, non-productive running time is too long, energy waste.

3. You need to set the ventilation system or facility.

4. Easy to produce secondary pollution. Such as formaldehyde fumigation appears paraformaldehyde polymer (white powder), with maintenance work on the structure and equipment of the pipe surface clean room, and in a few days after disinfection, the suspension will increase the number of ions, formaldehyde polymer gradually depolymerized to formaldehyde for production operators great harm.

5. Because each time interval length disinfection chemical reagents fumigation sterilization time required a minimum of 24 hours can not be every day, so now most of the manufacturers use large monthly disinfection and microbial contamination - people, goods, materials, fresh outdoor air but every day and so out of the clean room to which microorganisms can not be brought promptly kill, there will be micro-organisms with time increasing phenomenon.

6. Chemicals has a strong pungent odor, long remain in the environment after sterilization chamber to remove residual odor for a long time, the production operator is hazardous to health, especially formaldehyde, a carcinogenic effect.

three. Ozone fumigation sterilization

    Ozone (also known as the third son of oxygen), formula O3, MW: 48, is an allotrope of oxygen, consisting of three oxygen atoms, ozone is unstable at room temperature and atmospheric pressure at the molecular structure, quickly broken down into individual oxygen and oxygen atom, which has a very strong. Activity, redox potential after fluorine, ranking second. Because of their physical and chemical properties of ozone is a strong oxidant, to determine that it is a broad spectrum fungicide, has a strong sterilization effect, he can kill vegetative bacteria, spores, hepatitis A and B viruses, fungi, protozoa cells bladder and other viruses can destroy the botulism toxin and Rickettsia like. Its sterilization mechanism and process category is biochemical oxidation. Ozone oxidation and decomposition of bacteria necessary for internal oxidation of glucose, glucose oxidase, deoxy oxidase, can also occur directly with the role of bacteria and viruses, which damage cells and RNA, decomposition of DNA, RNA, proteins lipids and polysaccharides and other large polymer molecule, so that the metabolism of bacteria growth and reproduction process material destruction. It can also penetrate the cell membrane tissue, cell invasion, the role of the outer membrane lipoprotein and internal LPS, the cell permeability distortion occurs, leading to the dissolution of cell death, and the death of bacteria in vivo genetic parasitic bacteria, parasitic virus particles, phage, mycoplasma and heat, dissolved degeneration and death. Therefore, ozone can achieve complete eradication within the body permanently outside all the microorganisms.

Throughout the ozone sterilization mechanism and process that can be summarized in the following characteristics:

1. Efficient chemical properties of ozone, an unstable three oxygen atoms, easy decomposition characteristics, determine its strong oxidation and disinfection of microorganisms such as viruses and bacteria kill rate is extremely high, therefore, ozone is a highly effective sterilizing agent .

2. Environmental protection (or cleanliness) ozone half-life of about 20 minutes, after the ozone oxidation sterilization, the excess oxygen atoms in 30 to 40 minutes, then combined into oxygen molecules, does not produce any toxic residue left without there is no secondary pollution after sterilization; the same time, increasing the oxygen content of the indoor air, but also has a strong addition to mold, organic smell function wake up, smell and so on, Chinese herbal medicines and other raw materials and other anti-moth mildew significant role in improving the environment clean indoor air quality, which is called clean disinfectant.

3. Broad spectrum of ozone in the air when the concentration of 2 ~ 15ppm, the internal structure of microorganisms such as bacteria and viruses have a strong destructive oxidation, so he and formaldehyde, ethylene oxide, peracetic acid and other chemical reagents belong broad-spectrum sterilant.

4. Thoroughness Since ozone is a broad-spectrum sterilizing agent, at certain concentrations, in a relatively closed environment, spread evenly, and only 30 to 60 minutes, you can kill the bacteria in the clean room, to overcome the ultraviolet sterilization, there are many dead drawback can achieve a full range of sterilization purposes.

5. Economic ozone is circulated through the air conditioning system disinfection of air purification equipment, filtration systems, filter material having a dielectric mildew, anti-clogging effects, can reduce the aerosol particles suspended in the air, improve the cleanliness of the air, extended purification equipment life, reduce operating costs, that other methods can not. At the same time, because it does not produce secondary pollution ozone disinfection, ventilation measures do not need to set up a second clean, reducing the initial investment in air conditioning facilities do not need to set the fan duty, saving operating costs.

6. Operation is simple disinfection, ozone directly introduced into the clean room or air conditioning system, according to the characteristics of the clean room, to determine the sterilization time, setting the timer, automatic shutdown after the end of sterilization, the operation is extremely simple to use.

7. Short run time using ozone disinfection, sterilization time is generally 30 to 60 minutes, after sterilization, excess oxygen atoms in 30 minutes, then combined into oxygen molecules, just before and after a total of 60 to 90 minutes to complete a sterilization, both save time and safety. Through the above analysis and comparison, we can easily come: Ozone is commonly used in a variety of disinfection and sterilization agents, the most suitable for biological clean room indoor environment sterilization agent. It should be widely used in engineering practice.

four. Fumigation

Fumigation is the use of potassium permanganate is reacted with formalin, formaldehyde gas, after a certain time to kill pathogenic microorganisms. Poultry house is a common and effective method of disinfection. Its biggest advantage is the fumigation of drug can be evenly distributed to every corner of the poultry house, thorough disinfection save effort, especially for disinfection of air pollution inside the poultry house. Formaldehyde can make bacterial protein denaturation coagulation and dissolution of lipid cells, can kill surface and airborne bacteria propagules, spores and fungi, viruses, in order to give full play to the role of fumigation to ensure disinfection.

Poultry house fumigation should pay attention to the following eight areas:

1, the poultry house to be closed intact: the higher the content of formaldehyde gas disinfection better. In order to prevent the gas from escaping outside the house, poultry house before the fumigation, be sure to check the tightness of the poultry house, no glass windows and doors fitted with glass or insufficiency, if the gap should be labeled plastic sheeting, newspaper or tape, to prevent air leakage.

2, in full bloom liquid containers to corrosion, bulky: potassium permanganate and formalin corrosive mixture reacts violently, releasing heat, typically last 10 to 30 minutes, so the full bloom of drugs container should be large enough, and corrosion resistance.

3, in conjunction with other disinfection methods: Formaldehyde can disinfect the surface of the object, so before fumigation should be carried out mechanical cleaning and spray disinfectant, such sterilization would be better.

4, to provide higher temperature and humidity: Usually Sherwin not less than 18 ℃, relative humidity of 60% to 80%, more preferably not less than 60%. When Sherwin at 26 ℃, relative humidity above 80%, the best disinfection.

5, the dose of the drug, to the right concentrations and ratios: ratio of number of milliliters of formalin and potassium permanganate number of grams of 2: 1. Usually by formalin 30 ml / m, potassium permanganate, 15 g / m and often water 15 ml / cubic meter usage.

6, appropriate disinfection methods to ensure human and animal safety: During operation, the first water poured into the ceramic or enamel container, then add potassium permanganate, stir, then add formalin person is left, closed poultry houses. A container for fumigation should be as close to the door, so that the operator can quickly evacuated. Operators should avoid skin contact with formaldehyde, disinfection must empty homes.

7, to maintain a certain disinfection time: Requires fumigated more than 24 hours, if not urgently be closed for two weeks.

8, escaping gas after fumigation: formaldehyde after disinfection of the poultry house smell thick, irritating, therefore, to turn the poultry house doors and windows, ventilation more than 2 days, formaldehyde and other gases escape completely before use. Such as the urgent need to use the available ammonia and formaldehyde, according to space with ammonium chloride 5 g / cubic meter, lime 10 g / cubic meter, 75 ℃ hot water 10 ml / m, after mixing into the container, you can release ammonia (ammonia can also be used in place of, the amount of 25% aqueous ammonia 15 ml / cubic meter). 30 minutes after the doors open birdhouse, birds can carry 30 to 60 minutes after ventilation.

Summary: cleanroom use of different disinfection methods will be different. According to business needs to select some of the above clean room disinfection disinfect.

A[ 2016-05-19 ]Laboratory and operating room air cleaner main purpose is?

Q 1. Exhaust air within each workplace;

2, to ensure that the workplace required amount of fresh air;

3, removal of dust and microorganisms;

4, the amount of ventilation to keep indoor positive pressure necessary laboratory and operating room according to the following formula:

V = 100M / K-Ko

Where: V Where: V-- necessary ventilation [m3 / - necessary ventilation [m3 / (h · person)] (h · person)];

M; M - the occurrence of CO2 [m3 / - CO2 occurs quantity [m3 / (h · (h · person)];

K people)]; K-- under normal indoor CO2 allowable concentration (% allowable concentration (%) indoor CO2-- normal state; Ko);

Ko-- outdoor air CO2 concentration (generally in standard air volume ratio of 0.03%). CO2 concentrations of the different intensity of human labor excluded CO2-- outdoor air (in the general standard air volume ratio of 0.03%).

A[ 2016-05-19 ]What is the close relationship between the number of clean room ventilation and cleanliness are?

Q

In the clean room practical range, close air changes and cleanliness, the greater the number of ventilators, the higher the level of cleanliness. Relationship between ventilation rate and indoor dust concentration in the double logarithm linear (assuming that particles uniformly distributed in the room) and line (actual particles indoors as unevenly distributed) case. Both under static and dynamic conditions, turbulence clean room ventilation frequency and level of cleanliness of the curve.

ACH according to the clean room air cleanliness level, the number of indoor, indoor area, indoor dust production and fresh air than by seeking out the formula, especially under dynamic conditions more needs to be calculated for specific conditions.

92 GMP clean room design specifications specify the minimum number of air changes dynamically both 20 10000, 100 000 five times since the acceptance testing in the static state, so cleanliness is very easy to achieve compliance. And now GMP cleanliness level required to achieve the static state, at 20 times / h ventilation rate, indoor dust concentration of 33 / L, both to achieve 1Dc0 level; 15 times / h ventilation rate, indoor dust concentration 40 / L, both reached 10,000. Less than 10 times / h ventilation rate can reach 100,000. So you can see, under static achieve ACH levels can vary a lot, the absolute value can be very low. ACH actual use than the specification value has improved a lot. So deal with the most important parameters to ensure the cleanliness - eleven the number of ventilators, Shaopian to give a reasonable safety, as such do basically can achieve the required value.

Single flow clean room by room sectional low wind speed, turbulence type clean room is a more adequate factor of safety recommendations. Vertical unidirectional flow ≥ 0.25m / s, the level of individual flow ≥ 0.35m / s, the detection cleanliness in the empty state or static state, although they would meet the requirements, but poor anti-pollution ability, once the indoor enter the work state, to cleanliness may fail to meet requirements, such examples are not part of the individual.

In the preparation of clean room air cleaning technology measures the investigation had determined the country more than 100 clean room, clean room still many under the dynamic test results show that the number of ventilators can be according to the above standards compliance.

A[ 2016-05-19 ]Decontamination clean room construction to civil engineering practices and what requirements?

Q

Shenzhen Yu Jin and electrical engineering at the time of purification civil construction clean room cleanliness level should be based on the following practices to meet the requirements and demands:
(1) clean air door shall ensure trouble retaining structures, doors, windows with good sealing performance;
(2) interior walls, ceiling surface should be flat, smooth surface can not afford to ash, scrub. Ground smooth, wear-resistant, easy to clean, the yin and yang angle indoor walls preferably made of arc-shaped, rectangular-shaped made to avoid plastering plastering standards for advanced;
(3) When using ceiling air vertically downward, provided static ceiling of the original sandwich structure. The need for a senior plaster layer;
(4) requirements for indoor drainage using sealed floor drain;
Color (5) indoor surface layer should be soft, light reflection coefficient should meet the specification;
(6) Building materials should have good moisture, corrosion and fire performance;
Civil budget system knowledge
1, the construction industry profiles, project cost control process and constitute a project cost;
2, construction and installation engineering cost composition and cost valuation basis;
3, the area of engineering calculation rules and measurement methods;
4, project valuation and set the price fixed;
5, the construction budget computerization;
6, construction budget review and completion of final accounts settlement;
7, Jiangsu quotas to explain;
8, Bill of Quantities;
Decontamination do not just interior cleanliness, but also to do the work at clean room to avoid the possibility of secondary pollution. Only by understanding the structure of civil engineering, master civil construction materials, clean room to a reasonable arrangement, selection of construction materials and design drawings, so clean room reaches a certain cleanliness while indoor staff make convenient use and operation, to avoid secondary pollution.

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