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杭州吉沃科技有限公司Hangzhou Geevo Technology Co., Ltd.
地址: Add: 浙江省杭州市余杭经济技术开发区红丰路509号No.509 Hongfeng Road, Yuhang Economic & Technical Development Area, Yuhang District, Hangzhou, Zhejiang, China
电话: Tel: 0571-8993805186 571 89938051
传真: Fax: 0571-8993709386 571 89937093
Q  Q: QQ: 2276956915
邮箱: Email: geevosusan@126.com,
geevotech@126.com
www.geevo.net
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微生物检测
Microbial Test
无菌检查系统
Sterility Test System
SM86 无菌检查系统
Closed Canister & SM86 Sterility Test Device

 

无菌检查系统

SM86


工作原理

SM86型无菌检查系统是基于薄膜过滤法的原理,通过定向加压作用,将液体样品加至集菌培养器内并正压过滤,过滤后冲洗滤膜除去产品的抑菌剂,然后在滤器内灌装培养基进行培养,以检验供试品是否含菌。该产品可广泛适用于无菌制剂的无菌检测,包括抗生素类及含有抑菌成分的药品、大输液、水针剂、灭菌医疗器具、无菌注射用水等。

2015年版《中国兽药典》《中国药典》无菌检查的首选方法




技术性能特点

1. 吉沃创新培养器标签打印功能。与打印机连接,可直接将实验的相关信息打印到不干胶标签上,贴于培养器上,避免传统在培养器上手写的方法,提高实验数据标注的标准化。打印信息有:样品名称、样品批号、操作员、实验时间及相应的厌氧菌、真菌、阳性对照等标识

2. 超大尺寸(7英寸)工业级IPS防眩防紫外电容触摸屏,数据录入更方便,操作更灵敏

3. 仪器采用全不锈钢镜面外壳设计,便于表面的卫生清洁,提高仪器的使用寿命

4. 无菌检查操作管理软件有2个操作模式:可储存操作程序模式和临时操作模式

5. 配有医用防水脚踏控制开关,间断运行和连续运行2种模式选择,方便操作,避免样品污染

6. 仪器启动快,转速稳定

7. 排液槽的培养器托板和底槽可分离设计,并可180度旋转或台面放置

8. 侧装带亮灯按钮式电源开关

9. 样品放置篮可同时满足样瓶放置和袋装样品钩挂

10. 可选择简体中文和英文操作语言


技术参数 

电源

220V\110V±10%,50/60Hz

总功率

230W

电源开关

防水按钮式开关,带亮灯

打印机插口

5芯防水航空插口

脚踏开关插口

3芯防水航空插口

转速范围

最高转速240转/分钟

预存样品SOP信息

20个

显示屏

7英寸工业级IPS防眩防紫外电容触摸屏

操作语言

简体中文、英文

机箱

304不锈钢镜面抛光

培养器托板

316L不锈钢镜面抛光

排液槽底槽

聚苯砜(PPSU)

主机总量

14.8Kg

主机尺寸(mm)

610×380×420 (W×D×H)

打印机尺寸(mm)

133×186×128 (W×D×H)

标签尺寸(mm)

50×25 (W×L)


      

Sterility Test System

Compliance with regulatory requirements in ChP, USP, EP and JP.


Sterility Test Closed Canister

Sterility Test Closed Canister is used for pharmaceutical product sterility test by the membrane filter method Which produced in very strict condition. Working together with sterility test device. 
 
Sterilization
EtO Sterilization
Gamma irradiated sterilization
 
 Feature 
*Adopt all imported original pharmaceutical grade material, without chemical releasing.
*Ultrasonic welding process, avoiding side leakage accident.
*Chosen membrane avoiding adsorption of drugs.
*Designed wrench style clasp, easy to control the flow rate.
*Connected single use sealing lock clasp in the tube, easy to control.
*Sealing stopper for top and bottom designed with two wings of ergonomics.
*Imported adhesive paper of sealing package, avoiding false positive result by sterilization and false negative result by EtO.
*Double package including certain negative pressure,  eliminating the risk of false positive and false negative.
*Each set of closed canister package all have sterilization indicator card inside, giving visual clearly instruction of its sterilization result.
*Having 50ml cycle scale abd 100ml alarm line in the canister body.
*The color of wrench style clasp is same as single use sealing clasp in one tube which easy discriminate different tubes.
 
 



Sterility Test Device  

SM86

 
  

SM86 sterility test system is used for sterility test in sterile product.It can work with all kinds of closed canister. Many types of sterile products can be tested with the SM86 sterility test system, including:
◆ LVP(Large Volume Parenteral) in Glass bottle, plastic bottle, soft pouch, etc.
◆ Injection in Ampoule and vial, and freeze-dried powder
◆ Insoluble powder
◆ Medical devices
◆ Preloaded syringe


It is to test whether testing sample contains microorganisms. The microorganisms present in the sample are captured on the microporous membrane in the closed canister by the action of directional peristaltic pressure from the SM86 pump device. Rinsing membrane to remove the bacteriostatic ingredient if samples included. Appropriate medium is pumped into each canister separately to promote the growth of the captured organisms. The canisters are incubated and examined for contamination in accordance with the relevant pharmacopoeia.


Feature

1. The unique label print function, connect with the printer, can print the relevant information of the experiment to the sticker and stick it on the canister body directly, which avoids the traditional method of hand-writing on the canister body and improves the standardization of the labeling of experimental data.

2. 7inch capacitive touch screen, supply good user experiences for information display and input.

3. Whole mirror polished stainless steel process, easy to clean and disinfection.

4. Two operation mode: Program operation and Direct operation.

5. Equipped with medical waterproof footswitch, intermittent operation and continuous operation of 2 modes.

6. Run is quickly and speed is stable.

7. Drain tray can be hang on and lay on the table.When it is hanged on, more than 180  angle for choice.

8. Side installed with pushbutton power switch with light.

9. Bottle holder can meet the demand on hanging for the pouch.

10. English and Chinese operation language for choice


      

 Technical Parameter 

Voltage

220V\110V±10%50/60Hz

Total power

230W

Pushbutton power switch 

Waterproof button switch with light

Printer inlet

5 core waterproof aerial plugt

Footswitch inlet

 3 core waterproof aerial plug

Rotation speed

Up to 240rpm

Prestore SOP information

20pcs

Touch screen

7inch Industrial touch capacitive screen

Operating language

Chinese  \  English

Pump housing

 304 stainless steel mirror polished 

Drain tray support

 316L stainless steel mirror polished 

Drain tray container

PPSU 

Weight of pump device

14.8Kg

Pump device size (mm) 

610×380×420 W×D×H

Printer device size (mm) 

133×186×128 W×D×H

Print paper size (mm)

50×25 W×L


Application
—sterility test for pharmaceutical drug
—sterility test for medical apparatus
—sterility test for supplementary material and packing material.