Hydrogen peroxide steam sterilization system

Customer: Customer Name

Scenary number: SP20170712B

1. BDS-5000 hydrogen peroxide steam sterilization system

The BDS-5000-type hydrogen peroxide steam sterilizer is designed for spatial region such as rooms, completely domestic, gives a variety of rooms, closed space sterilizers to provide a low temperature, no residual efficient solution, friendly users Operating interface, easy to use: Removing the console is placed outside the door to be sorted, and the closed door prevents steam to leak. Once started, the disinfection process is fully automatically run until completion, and there is no need to monitor and participate.

1.1 main features

Ø Designed based on the "wet" sterilization theory, it is better to sterilize the sterilization of "dry method\\

Ø Domestic equipment, performance can be similar foreign similar equipment, and price is good, spare parts and service response

Ø Chinese user interface, easy to pick up, real-time graphical display sterilization process

Ø Fully automatic completion of the sterilization process, no operator monitoring and participation, can start the sterilization in the evening, and the production activities of the sterilization area can be restored during the morning.

Ø Multi-machine network sterilization, can meet the sterilization needs of large area regions

Ø The metering pump is accurate and reliable, the sterilization effect is stable and repeatable, reproducible process

Ø Algorithm is reliable, no special sterilization program development

Ø Print full sterilization process record, data can be saved

1.2 main advantages

2 Domestic analytical pure (Ar) levels, 30% (w / w) hydrogen peroxide solution can reach 6-log sterilization effect

2-liter hydrogen peroxide solution bottle, theoretically sterilized for the largest 500 cubic meters of room

2 Easy to move, easy to use, no complex installation

2 The program is simple, simply enter the size of the room to generate a suitable sterilization process; the sterilization process is fully operational, and there is no need to participate and monitor

2 Single spatial area only use BDS-5000 self-diffusion system for sterilization and built-in degradation system for decomposition of remaining hydrogen peroxide gases

2 Sterilization cycle time short, greatly improve the efficiency of the use of the area to be sterilized

2 Low maintenance requirements each year, and the maintenance cost is also low

 

2. Operation of the BDS-5000 system

 

2.1 illustrate the use of BDS-5000

The BDS-5000 operation is simple and convenient. After preliminary estimation of the size and environmental conditions to be sterilized, the BDS-5000 is initially estimated, and the sterilizer is pushed into the room, connect the main power supply, put the control panel outside the door, close the door and will All gaps can be started with the colloidal tape to start the sterilization process.

   

Figure 1, BDS-5000 system arrangement

Parameters such as long, width, high or volume are input to the console software interface, and the sterilization process can be initiated outside the room. The generator will automatically calculate the amount of hydrogen peroxide required to achieve saturation conditions based on the room size and environmental conditions, determine the runtime of each stage of the sterilization process, thereby defining the sterilization procedure.

    After starting the generator, the hydrogen peroxide liquid will be vaporized and spread through the built-in diffusion system to the entire room. The machine's self-bonded hydrogen peroxide gas concentration monitor monitors the concentration, temperature and humidity of hydrogen peroxide gas, maintains the vaporization process until the ideal sterilization conditions are reached, and this state is maintained until it is achieved to ensure sterilization. After reaching the sterilization purpose, the machine starts degradation channel, the catalyst efficiency and the ventilation unit will automatically open the residual hydrogen peroxide gas in the room into water vapor and oxygen. The hydrogen peroxide gas concentration monitor will continue to monitor until re-entering the safety conditions.

During the sterilization operation, the process measurement parameters are displayed on the touch screen in a chart. If you need this information, you can download it to your computer. The console also includes a thermal printer that prints the parameters of each cycle phase. All alarm process will also be printed. When the loop is coming, the operator can measure the concentration of the indoor residual hydrogen peroxide to ensure safe entering the room.

Figure 2, parameter input interface and graphics monitoring interface

2.2 Operation sequence:

1) Remove the console, push the generator host into the room, connect the power supply

2) Place the console in the room, connect the console and generator with the cable.

3) Place the bottle of hydrogen peroxide solution in the generator bottle

4) Seal the door of the room with tape

5) Close the room ventilation

6) Enter room size or volume size on the console touch screen, select the room load state

7) Start the sterilization process

8) Check whether there is hydrogen peroxide in the door using a hand-held hydrogen peroxide gas detector?

9) Sterilization, if the room HVAC system is straight, then restart the room ventilation after the start of the ventilation degradation phase, accelerate the decomposition of the remaining hydrogen peroxide gas in the room, speed up the recovery of the room

10) Sterilization cycle end stage (according to the prompts of the generator), open the door, measure the steam concentration of hydrogen peroxide by hand-held low-concentration hydrogen peroxide gas detector

11) If the hydrogen peroxide gas in the room is less than 1 ppm after the end of the sterilization cycle, the equipment is collected according to standard operating procedures (SOP), and the room is returned to the production.

Figure 3, machine operation schematic

2.3 Sterilization process

The entire sterilization cycle process is divided into four stages:

1, preparation stage

Preheating the flashboard, pipes, and nozzles to achieve a suitable operating temperature. It takes only 7 minutes this stage.

2, vaporization stage

After the hydrogen peroxide solution drops on the flash plate, quickly vapor into steam, spray into the sterilization space. Flash effect: The hydrogen peroxide steam diffuses through the nozzle to the respective corners of the separator until the saturation is reached. Saturated state we call "condensation points" - that is, the air cannot accommodate more hydrogen peroxide vapor in the air, and hydrogen peroxide steam becomes a microaceous state. This state is the best killing effect on the microorganism. This phase of time is different from the size of the short-range space, which can be set by machine intelligence, or program development (GCD) is defined.

3, maintenance stage

At this stage, there is constant hydrogen peroxide vapor to be injected into the space, maintain the saturation of the steam to achieve continuous coverage of the sterilization surface and the continuous killing of the microorganism. This phase of time is different from the size of the short-range space, which can be set by machine intelligence, or program development (GCD) is defined.

4, ventilation stage

The hydrogen peroxide vapor in the sterilization space is broken down into oxygen and water vapor by a catalytic filter, and the vapor is discharged out of the chamber, and the concentration of the monophydrogenation is less than 1 ppm. This stage is time consuming

2.4 Sterilizer Accessories

For convenience, the Kang Kang's generator is equipped with the following attachments in the console:

1) 3M long power cord (IEC C19 / 20)

2) 7.5M long winch control line

3) Hand-held low-concentration hydrogen peroxide gas concentration detector

4) Goggles

5) Disposable gloves

6) 2 volume printing paper

7) Operation manual can be equipped with an extended control line

3. BDS-5000 optional accessories

3.1 Mobile Catalytic Ventilation Degradation Unit

The mobile catalytic ventilation unit is specifically designed to meet the need for fast ventilation degradation, especially suitable for auxiliary ventilation degradation of larger spaces and regions without a room ventilation system. The device is placed in a sterilization zone and is automatically activated by the generator after completion of the vaporization phase. After sterilization, the concentration of hydrogen peroxide in the indoor air is high, and the air is recovered by a ventilated degradation system to degrade the hydrogen peroxide gas as water vapor and oxygen, and then efficiently filtered into the room. The gas discharged from the special ventilation degradation unit is very fast, which will produce a dramatic airflow, which avoids the gas flow angle in the room.

  

3.2 Floor-standing shaking fan

Falling shaking fans are mainly used for room sterilization to assist in hydrogen peroxide steam

Diffusion, users can prepare themselves.

3.3 Extended control cable

In the area where the area to be sterilized, the distance from the host to the console exceeds the machine

When using a 7.5-meter-long control cable, you can choose the extended control cable accessories.

Connect the BDS-5000 with a console.

serial number	describe description	Function function
TDL01-7500SPARE	Alternate control cable	Alternate control cable
TDL02-15000SPARE	Extended control cable	Extend cable, connect panel

3.4 Handheld high concentration hydrogen peroxide gas detector

(Part No.TDD-2000SERV)

Range range: 2000ppm;

Uses: Measuring the hydrogen peroxide gas concentration from the location of the generator in the sterilization areaFigure 5, hand-held detector

  

 

4. Generator control line crosswall layout

Figure 6, generator crosswall arrangement

5. Sterilization plan for corresponding regions

 

5.1 Definition of the area to be sterilized

 

A schematic diagram of a sterilized area is required. A total of three pieces:

1. Wash bottle area, with an area of about 275 square meters, with a volume of about 743 cubic meters (calculated by 2.7 meters high)

2. Configure the area, the area is about 276 square meters, with a volume of about 745 cubic meters (calculated by 2.7 meters high)

3. Filling area, with an area of about 224 square meters, with a volume of about 605 cubic meters (2.7 meters high by layer)

 

The following scheme design is carried out in three regions of the above area / volume.

 

 

 

5.2 Sterilization

The maximum sterilization range of the sterilizer is limited to the amount of hydrogen peroxide which is loaded. The BDS-5000 can load up to 5,000 ml of hydrogen peroxide solution, which is theoretically sure to have a maximum of 500 cubic meters, but we nominally sterilized to 250 cubic meters (this is sterilized according to its best performance Scope).

 

Since the volume of the above three regions is greater than 500 cubic meters, it is 2 to 3 times that nominally 250 cubic meters, so the sterilization of each area requires a minimum of 2 BDS-5000 machines to work. This solution design uses two, three, 6 BDS-5000 sterilifiers, respectively, for customers to choose from. The main difference between the three sets is different from the length of the total sterilization time. Please note: "Total Sterilization Time" said here refers to the total time to decompose the hydrogen peroxide gas in the room to decompose the hydrogen peroxide gas in the room. Time to account for most of the total sterilization time. If the air conditioning system (HVAC) can be activated during the degradation, the degradation time can be greatly shortened, but this program does not consider this shortened time.

 

5.2.1 Scenary 1. Use 2 solutions for 2

 

If the customer has only 2 BDS-5000 sterilizers, it can be sterilized by these 2 BDS-5000 sterilizers, and the total sterilization time is performed by each of the three regions. Time:

Total sterilization in the bottle area: 9 hours

Configuring a total sterilization time: 9 hours

Filling area total sterilization time: 8 hours

The time required for the three regions to complete the turntorming \\u003d 9 9 8 \\u003d 26 (hours).

 

 

 

 

 

 

Sterilization plan of the bottling area (2 killing programs):

1. The placement of the sterilizer BDS-5000 and the floor shaking fan is shown in Figure 8;

2. In the process, 19 assisted landing shaking fans (preferably the disc in which the original land supported by the original land is preferably replaced by a triangular frame, reducing the sterilization angle). The so-called "Number of landing fans required" is only estimated according to drawings, and the actual situation is not seen. This amount may be adjusted according to the actual situation (which can be reduced);

3. According to this program, the bactericidal time takes 3.5 hours; single by the machine itself, degradation time is about 5 hours. Then, the total measurement of the sterilization of the wash bottle is required to take about 9 hours (the specific actual time consumption will depend on the load in the field room, and whether the HVAC ventilation system can be enabled. If the HVAC can start, the degradation time can shorten 2 to 3 Hour).

 

See Figure 8:

 

Figure 8: Sterilization Solution 1 - Wash Bottle Area

A Sterilization Scheme of the Aquential Area (2 killing programs):

1. The placement of the sterilizer BDS-5000 and the ground moving head fan is shown in Figure 9;

2. A 28-auxiliary landing shaking fan is required during sterilization (it is best to replace the disc replacement of the discharged discs into triangular support to reduce sterilization angles). The so-called "number of landing fans that need to be used" is only estimated according to drawings;

3. According to this scenario, the sterilization time takes 4 hours; with the machine's own degradation capability, the degradation time is about 5 hours. Then, the total measurement of the sterilization of the wash bottle is required to take about 9 hours (the specific actual time consumption will depend on the load in the field room, and whether the HVAC ventilation system can be enabled. If the HVAC can start, the degradation time can shorten 2 to 3 Hour).

 

See Figure 9:

Figure 9: Sterilization plan 1-configuration area

Sterilization plan of the filling area (2 killing programs):

1. The placement of the sterilizer BDS-5000 and the floor shaking fan is shown in Figure 10;

2. Twenty-one-supported landing shaking fan (preferably the disc in which the original supported disc is used to replace the sterilized angle of the sterilization angle) during the sterilization process. The so-called "number of landing fans that need to be used" is only estimated according to drawings;

3. According to this program, the bactericidal time takes 3.5 hours (because one of the BDS-5000 has a larger area of filling, so the sterilization time is relatively long); the ability to degrade the machine, degradation time About 4 hours. Then, complete the sterilization of the wash bottle is required to take about 8 hours (the specific actual time consumption will depend on the on-site room load, and whether the HVAC ventilation system can be enabled. If the HVAC can start, the degradation time can shorten 2 to 3 Hour).

See Figure 10:

Figure 10: Sterilization plan 1-filling area

The advantages of this program:

1. The number of sterilized equipment required is the least, the highest in the pre-periods.

2. Implementation of layout equipment is shorter.

3. It can be used to use the evening time to sterilize.

 

Disadvantages of this program:

1. The number of sterilizers is less, resulting in a long time to be sterilized, and the total sterilization time is also longer. All three regions are completed for 28 hours, and it may take longer when practical.

2. If a machine failure occurs, the sterilization task may not be completed.

3. There is a small number of sterilizers, and thus, the region is large, the shape is more complicated, and if there is no auxiliary degradation device or the HVAC system in the room, the degradation time will be long.

 

5.2.2 Scenario 2, using 3 sterilizer

 

If the customer has 3 BDS-5000 sterilizers, 3 spectrosperms can be used to sterilize three regions, and the total sterilization time is also the sum of the time to complete the sterilization of the three regions:

Total sterilization in the bottle area: 6 hours

Configuring a total sterilization time: 6 hours

Filling area total sterilization time: 6 hours

The total time required for the three regions to complete the turntorming \\u003d 6 6 6 \\u003d 18 (hours).

 

Sterilization plan of the bottling area (3 dead fungi scheme):

1. The placement of the sterilizer BDS-5000 and the ground moving head fan is shown in Figure 11;

2. 19 auxiliary floor shaking fans are required during sterilization. The so-called "Number of landing fans required" is only estimated according to drawings, and the actual situation is not seen. This amount may be adjusted according to the actual situation (which can be reduced);

3. According to this scenario, the bactericidal time takes 2.5 hours; with the machine's own degradation capability, the degradation time is about 3.5 hours. Then, the total measurement of the sterilization of the washing bottle area takes about 6 hours. If the HVAC can start, the degradation time can be shortened by about 3 hours.

See Figure 11:

 

Figure 11: Sterilization Solution 2 - Wash Bottle Area

 

Sterilization plan of the area (3 dead stocks):

1. The placement of the sterilizer BDS-5000 and the floor shaking fan is shown in Figure 12;

2. During the sterilization process, 25 assisted landing shaking fans are required (preferably the disc in which the original land supported is replaced with triangular frame, reducing the sterilization angle). The so-called "number of landing fans that need to be used" is only estimated according to drawings;

3. According to this scenario, the bactericidal time takes 2.5 hours; with the machine's own degradation capability, the degradation time is about 3.5 hours. Then, the total measurement of the sterilization of the wash bottle area needs to be taken for about 6 hours (the specific actual time consumption will depend on the load situation in the live room, and whether the HVAC ventilation system can be enabled. If the HVAC can start, the degradation time can shorten 2 to 3 Hour).

 

See Figure 12:

Figure 12: Sterilization Scheme 2 - Configuration Zone

 

Sterilization plan of the filling area (3 sterilization programs):

1. The placement of the sterilizer BDS-5000 and the floor-to-ground fan is shown in Figure 13;

2. Twenty-one-supported landing shaking fan (preferably the disc in which the original supported disc is used to replace the sterilized angle of the sterilization angle) during the sterilization process. The so-called "number of landing fans that need to be used" is only estimated according to drawings;

3. According to this program, the bactericidal time takes 2.2 hours (because one of the BDS-5000 has a larger area of filling, the sterilization time is relatively long); single-by-machine self-degradation ability, degradation time About 3.5 hours. Then, the total measurement of the sterilization of the wash bottle area needs to be taken for about 6 hours (the specific actual time consumption will depend on the load situation in the live room, and whether the HVAC ventilation system can be enabled. If the HVAC can start, the degradation time can shorten 2 to 3 Hour).

See Figure 13:

Figure 13: Sterilization Solution 2 - Filling Area

The advantages of this program:

1. The number of sterilized equipment required is not a lot, but the sterilization time is relatively small, especially the reduction in the filling area is most obvious; the waiting time is also short.

2. Use 3 sterilized programs can be compatible with 2 solutions to use 2 sterilizers. That is to say: In the absence of a machine failure, it is entirely possible to take only 2 sterilizer to complete the sterilization task of all regions.

3. It can be used to use the evening time to sterilize.

Disadvantages of this program:

1. The number of fans is not significantly reduced. However, this is determined due to the large area and more complicated.

2. Implementing the layout device time slightly.

5.2.3 Solutions 3, using 6 sterilizer

 

If the customer has 6 BDS-5000 sterilizers, you can use 6 sterilizers at one time to sterilize 3 regions, and the sterilization of each region is as implemented as the above regional programs, but simultaneously start. Moreover, there is no need to wait. The total sterilization time is the longest time in the three regions to complete the sterilization time:

Total sterilization in the bottle area: 9 hours

Configuring a total sterilization time: 9 hours

Filling area total sterilization time: 8 hours

At the same time, the time required for three areas is sterilized \\u003d max {9, 9, 8} \\u003d 9 (hours).

 

The advantages of this program:

1. The sterilization time required is the shortest, there is no need to wait, and the sterilization task of all regions can be completed.

2. Solutions using 6 kills can be compatible with 2 or 3 sterilizers. That is to say: In the absence of one or more machine failures, it can be taken only 2 or 3 sterilizers to complete the sterilization task of all regions.

3. It is also possible to use the evening time to sterilize. Almost do not delay production time.

 

Disadvantages of this program:

1. The number of sterilizers used is large, and the previous investment is large.

2. Implement the layout time.

 

6. On-site service

The previous gas generator needs to conduct a professional analysis to obtain a related parameters that realize the room or area effective sterilization, but for the BDS-5000 generator, only the room size or volume data is required, and the device can utilize the conditions during the cycle. Feedback control. The special algorithm built by generator automatically calculates the parameters of the sterilization cycle process. This completely automatically controls the entire process and does not have to intervention. This simplifies the installation and use of the system.

For CGMP, the system's authentication is very important. Kang Kang also provides the following verification services:

l Installation and trial operation of the device

l Install Certification (IQ), Operation Certification (OQ)

l Sterilization program development (GCD)

l Performance certification (PQ)

l training

 

6.1 equipment trial operation

Contains the connection and assembly, calibration, physical inspection and control interface of the device, the feature of the function, ensuring all the functionality of the device is normal.

 

6.2 Installation and Operation Certification (IQ / OQ)

The device used by CGMP needs IQ / OQ authentication. The BDS-5000 steam generator requires IQ / OQ certification for the stand-alone before entering the room. Our engineers use standard process protocols and equipment for related tests. The results of the test are recorded according to the protocol and is tracked.

 

6.3 Sterilization Procedure Development (GCD)

Establishing a suitable sterilization program parameter variable (hydrogen peroxide injection rate, vaporization time, contact time, and ventilation phase) is necessary, which guarantees sterilization of each region. Kang Kang has developed and optimizes the relevant technical protocol documents to ensure effective process. During the development of sterilization procedures, including surface temperature measurement, gas diffusion measurement, and then correction of repetition and cyclic parameters of the process to determine when the biological indicator (Bacillus thermophilic fatty, GeoBacillus Stearothermophilus) is inactivated.

The sterilizer can operate according to the parameters, which simplifies the process of achieving sufficient concentrations. We use parameter control to establish a suitable loop condition. Such a suitable and safe factor ensures smooth and safe and just right in the circulation process. The test data protocol file is provided in writing.

 

6.4 Training

Users have a comprehensive understanding of the operational process because they will cause potential hazards without training. Kang Kang will give our customers a comprehensive training and retraining. The training process includes the classroom training of disinfection experts and one-on-one training. We offer a phased training program that there is also a practical practice.

 

The main contents of the training are:

l Operation technology and principles

l Security and safety work practice

l Ventilation system processing

l Preparation before sterilization

l Device arrangement and operation

l Device function test

l Sterilization cycle parameters

l emergency treatment

l equipment daily dimension