Single-sided Rigid Cabin Combined Sterility Isolation System

As a sealed system, thesterility inspection isolator is designed to realize safe air exchange through fan filter unit (high-efficiency particulate air(HEPA) filter) in a sealed environment, so as to continuously control the particles and microorganisms in the internal environment. When closed, the sterility inspection isolator undergoesbiological decontamination treatment for its interior surface. The fast transfer channel or airlock is utilized to carry out aseptic transfer of materials to ensure the protection fromoperators todrugs.

 

Product Features

1. It adopts a rigid-wall structure, madeof stainless steel and tempered glass, with dynamic A-level internal environment.

2. The gloves,in thickened and anti-breakage type, or in thin and comfortable type,are used in the operation.

3. It selects H14 high-efficiency particulate air filter and conducts scanning leak detection via PAO.

4. Hydrogen peroxide can kill 10⁶ spores on the air and exposed surface in the isolator.

5. The safe entry and exit of materials can be realized by various means, such as airlock and transfer cabin equipped with RTP system.

6. A built-in power supply is installed in the isolator, and compressed air connector provided with valve and cleaning water connector are equipped for the purpose of water and air intake.

7. This system is equipped with Siemens programmablelogic controller (PLC) for fully automatic control of pressure and air supply, and supports the alarm function for pressure loss.

8. The NetSCAD system of 10" touch screen/12.1" industrial tablet PC conforms to the verification requirements of GMP for computer system in 2010.

 

Technical Parameters

Supply voltage: 220V±22V, 50±1Hz

Maximum power: ≤3000W

Touch screen size: 12.1" industrial control screen

Pressure control range of cabin:-80~+80pa, to be adjusted.

Humidity resolution: 0.1%

Temperature resolution: 0.1 ℃

Pressure resolution: 0.1 Pa

Airflow model in isolator cabin: vertical unidirectional flow

Wind speed: 0.36~0.54m/s

Leakage rate of cabin: Conduct the testing of pressure maintaining at a positive pressure of 60Pa. The overall leakage rate of the isolator cabin is less than 0.5%vol/hour

Gas source: Filtered clean compressed air or nitrogen with a pressure of 0.4~0.6 MPa

Dimensions: 243×110×217.5cm

Operating space: 179×67×74cm

Airlock space: 60×58×74cm

 

Sterilization method of aseptic isolator

1. preparation of bacterial suspension

 

(1) fresh cultures of staphylococcus aureus, Pseudomonas aeruginosa and Bacillus subtilis are prepared into 15ml of bacterial suspension containing less than 100cfu per 1ml of sterile sodium chloride solution; The bacterial suspension is evenly packed in 3 small blue-capped bottles, the bottle mouth is sealed (the packaging form is the same as that of sterile test samples), and stored in the refrigerator at 2 ~ 8℃ for standby within 24h.

 

② The fresh culture of Candida albicans was prepared with 0.9% sterile sodium chloride solution into 15ml of bacterial suspension containing less than 100cfu per 1ml. The bacterial suspension and Staphylococcus aureus bacterial suspension were separately packed and stored by the same method.

 

③ take the fresh culture of Aspergillus niger and add 3 ~ 5ml of 0.9% sterile sodium chloride solution containing 0.05%(ml/ml) polysorbate 80 to elute the spores. Then take spore suspension to sterile test tube, and use 0.9% sterile sodium chloride solution containing 0.05%(ml/ml) polysorbate 80 to make 15ml spore suspension containing less than 100cfu per 1ml. The bacterial suspension and Staphylococcus aureus bacterial suspension are packed in the same way, and stored in refrigerator at 2 ~ 8℃ for later use within 2 months.

 

2. Preparation of sterile isolator

 

According to the requirements of Zda loading capacity of aseptic isolator, put the items required for aseptic inspection in the corresponding positions inside the aseptic isolator; Sterile isolation gloves and cabin sealing test are qualified; Operating parameters have been confirmed.

 

3. Confirm the concentration and distribution of hydrogen peroxide gas

 

Take 19 pieces of hydrogen peroxide vapor chemical indicator numbers, and put them into gloves, air inlet and outlet, back of fan, upper and lower corners of cabin and bottom of trash can of aseptic isolator. Observe discoloration after sterilization.

 

4. BI Challenge Experiment

 

Thirteen hydrogen peroxide sterilized biological indicators (Bacillus stearothermophilus pieces) were distributed in eight glove parts, left and right hatch doors, left and right operating table tops of cabin and bottom of garbage bins of sterile isolators. After sterilization, the bacterial pieces were taken out and inoculated in tryptone soy peptone liquid medium, cultured at 56℃ for 7 days, and the growth of the culture was observed. At the same time, three unsterilized biological indicators were inoculated in the same way as positive control.

 

5, sterile isolator open sterilization

 

Open the automatic operation program of aseptic isolator, and complete the operation program in five stages: "automatic dehumidification", "automatic adjustment", "automatic sterilization", "automatic ventilation" and "automatic pressure maintaining".

 

6. Detection of sedimentation bacteria

 

Take 15 tryptic soy peptone agar plates and put them on the operating table of isolator cabin, with 6 plates on both sides of the table, 1 plate on the left and right sides of the table, and 1 plate on the bottom of trash can. The plates were exposed and sampled for 4 hours, and three media were taken as blank control. After the collected media and blank control media were placed in an incubator at 20 ~ 25℃ for 72 hours, they were transferred to an incubator at 30 ~ 35℃ for 48 hours, and the number of colonies in the culture dish was recorded.

 

7. Detection of planktonic bacteria

 

The sampling points are one left point and one right point of the isolator operation platform. Using tryptic soy peptone agar plate, a sampler is placed near the working area of the sampling point for air sampling. The sampling amount of each sampling point is 1000 liters. At the same time, three culture media are taken as blank control. After the collected culture media and blank control culture media are placed in an incubator at 20 ~ 25℃ for 72 hours, they are transferred to an incubator at 30 ~ 35℃ for 48 hours and recorded in a Petri dish

 

8. Detection of surface microorganisms

 

Six tryptic soy peptone agar contact dish media were taken to contact the upper part, lower part, left part, right part, front part and rear part of the inner surface of the isolator cabin for 10 seconds; Trypsin soy peptone agar plate culture medium (TSA) was used to sample 8 glove fingerprinting plates respectively, and 3 culture media were used as blank control. The collected culture media and blank control culture media were cultured in an incubator at 20 ~ 25℃ for 72 hours, then transferred to an incubator at 30 ~ 35℃ for 48 hours, and the number of colonies in the culture dish was recorded.

 

9. Selective microbial challenge test

 

① Test group 1: selective microbial suspension, sealed and packed in small bottles, sterilized by hydrogen peroxide steam in sterile isolator, and inoculated and counted. 1ml of staphylococcus aureus, Pseudomonas aeruginosa and Bacillus subtilis suspension were inoculated on TSA, inoculated twice in parallel, cultured at 30 ~ 35℃ for 48 ~ 72 hours, counted colonies and averaged; 1ml suspension of Candida albicans and Aspergillus Niger was inoculated on the agar medium of Sarbanes-Oxley grape, inoculated twice in parallel, and cultured at 30 ~ 35℃ for 3 ~ 5 days. The colony count was taken and the average value was taken.

 

② test group 2: selective microbial suspension, which was sealed and packed in small bottles and sterilized by hydrogen peroxide vapor in sterile isolator. after sterilization, the bottle mouth of the suspension was opened to expose the contents in sterile isolator for 5min, and then inoculated and counted together with the test group.

 

Positive control group: the selective microbial suspension produced in the same batch in refrigerator, which is guaranteed to be inoculated with the test group.

 

Negative control group: 0.9% sterile sodium chloride was inoculated on TSA and Saskatchewan agar medium as negative control group

Optional Equipment