点击图片查看原图
为您提供先进、稳定、方便的测试仪器
To provide you with advanced, stable and convenient test instrument
便携式BSQ-19全自动过滤器完整性测试仪
Portable BSQ - 19 automatic filter integrity tester
产品特点
Product features
高智能化：测试流程全自动控制，无需人工干预；
High intelligence: the testing process automatic control, without human intervention;
高可靠性：检测精度高，重现性好；
High reliability: high accuracy, good reproducibility;
高人性化：中文/英文操作环境，触摸屏输入，操作界面友好；
High human: Chinese/English operation environment, touch screen input, friendly operation interface;
多功能化：可用于测试单芯滤器、多芯滤器，多种测试功能；
Multiple function: filter can be used to test the single core and multicore filter, a variety of test functions;
高集成化：仪器采用便携设计，体积小，使用轻便；
High integration: instrument using portable design, small size, use the portable;
高科技化：采用ARM9控制器，Windows CE 6.0系统；
High-tech: the ARM9 controller, Windows CE 6.0 system;
高实用化：数据存储、实时打印检测结果，符合GMP的要求。
High practical: data storage, real-time print test results, in line with the requirements of GMP.
应用范围：
Scope of application:
圆片滤膜（Disc membrane）：Φ25mm至Φ300mm的各种滤膜
Wafer membrane filter (Disc be) : 25 mm to 300 mm Φ Φ various membrane filter
标准折叠式滤芯 (Standard cartridge)：2.5″至40″，1芯至9芯
Standard folding filter (Standard cartridge) : 2.5 to 40 "and" core core 1 to 9
囊式滤芯 (Capsule)
Capsule type filter (Capsule),
小型滤芯 (Mini cartridge)
Small filter (Mini cartridge)
空气过滤器的检测 2.5″至40″
Air filter to 40 test 2.5 ""
性能参数：
The performance parameters:
电源/功率
The power/power
170-240V AC, 50/60Hz；100W
170-240 - v AC, 50/60 hz; 100 w.
操作压力
The maximum operating pressure
7999 mbar
7999 mbar
进气压力
The minimum inlet pressure
3000 mbar
3000 mbar
外型尺寸
Installation dimensions
240(宽) x320（深）x 260(高)
240 x320 (wide) (deep) x 260 (high)
测试范围
Test range
测试压力：500-6900mbar
The test pressure: 500-6900 mbar
测试精度
Accuracy of the test
灵敏度：± 1.0 mbar ； 气泡点：±60 mbar ；
Sensitivity: + / - 1.0 mbar; Bubble point: plus or minus 60 mbar;
操作条件
Operating conditions
环境温度：0℃ ~ +50℃；相对湿度：10-80%
Ambient temperature: 0 ℃ to + 50 ℃; Relative humidity: 10-80%
测试耗时
The test time
基本泡点测试：2 min±2min； 扩散流测试7±2min；水浸入流量测试7±2min；系统气密性：3±1min；
Basic bubble point tests: 2 min plus or minus 2 min. Diffusion flow test 7 plus or minus 2 min; Water immersion flow test 7 plus or minus 2 min; The system tightness: 3 + 1 min;
打印功能
Print function
中文/英文打印，打印测试条件、测试结果、测试曲线；
Chinese/English print, print test conditions, test results, test curve;
历史记录功能
History function
32G存储空间，保存数据100万条
Article 32 gb storage space, save the data of 1 million
显示屏
display
尺寸：5.7-7寸；256色；触摸屏
Size: 5.7 to 7 inches; 256 color; Touch screen
语言选项
Language options
中文/英文
Chinese/English
完整性测试仪与国内其它品牌的仪器相比具有如下特点：
Integrity tester is compared with other brands of instrument in our country has the following features:
1、 自动进气控制
1, automatic admission control
完整性测试仪采用了国外通用的全自动数字进气控制子系统，抛弃了国内落后的机械式半自动进气方式（即采用手动调节单向节流阀的方法，来改变气体流速），使测试仪在不同的气源压力和测试条件下都能稳定可靠的工作，特别是当客户采用的气源压力波动比较大时，仪器自身所具有自动稳定和数字控制技术，保证了测试结果的精度和准确性。
Integrity tester adopt foreign general automatic digital intake control subsystem, abandoned the domestic backward mechanical semi-automatic air inlet (namely adopt the method of manual regulation one-way throttle valve, to change the gas velocity), the tester under different air pressure and test conditions can be stable and reliable work, especially when the customer USES air pressure fluctuation is bigger, the instrument itself has automatic stabilization and digital control technology, to ensure the precision and accuracy of test results.
2、 滤器合格，自动退出功能
2, filter unqualified, automatic exit function
滤膜 / 折叠滤芯作为一种耗材，它有自己的使用寿命，但是合理的使用会使它们的生命周期大大延长。出于对客户滤膜的保护和提高生产中的使用效率（即缩短测试时间），专门增加了“测试合格后，自动退出”功能，这也是国内家实现这项功能的仪器。
Membrane filter/folded filter, as a kind of material, it has its own life, but the reasonable usage will make greatly extend their life cycle. For the protection of the membrane filter to the customer and improve the production efficiency of the use of (i.e., shorten the test time), specifically to increase the function of "exit" automatic after testing qualified, this also is the domestic first to realize the function of the instrument.
3、 自动打印
3, automatic printing
有些用户在进行完整性检测时，可能还有别的事情要处理，需要离开测试现场，但是他希望在回来时，可以拿到打印出来的测试结果。不会因为测试结束后，其它不可预知的原因，而造成测试结果的丢失。 测试仪在用户启动了自动打印选项后，就可以实现测试结束后自动打印测试结果的功能，这也是国内实现这种功能的仪器。
Some users in the detection of integrity, there may be other things to deal with, need to leave the testing site, but when he wants to come back, you can get printed test results. Not because the end of the test, other unpredictable reason, and cause the loss of the test results. Tester after the user starts the automatic print options, can realize the function of automatic printing test results after the test, and this is the first domestic realizing the function of the instrument.
4、 用户分级控制
4, user hierarchical control
完整测试仪作为一种精密检测仪器，其中有很多参数需要设置，这些参数的改变有可能会影响测试结果的准确性和可靠性。 同时为了满足 GMP 的管理要求，普通操作人员和管理人员应该有各自不同的操作权限。 系列的所有版本都有用户分级管理功能，而 I V4.0 做了更人性化的处理，使用户可以根据使用情况更改仪器的登录密码，这也是国内实现这种功能的仪器。
Complete test instrument as a kind of precision testing instrument, many of them need to set parameters, these parameters change may influence the veracity and reliability of test results. At the same time in order to meet the management requirements of GMP, normal operation and management personnel should have different operating authority. Series with every version of the user classification management functions, and I did more humanized processing V4.0, allows a user to change the login password instrument according to the using situation, this is the first domestic implement the function of the instrument.
5、 数据存储量更大
5, and data storage
完整性测试仪是目前国内测试结果存储量的，它的标准配置是 500 组（包括测试条件，测试结果和测试曲线）历史记录，我们还可以根据客户要求定制更大容量的存储空间。并且当仪器与 PC 机相连接时，可以实现历史记录的无限制存储。
Integrity tester is the present domestic testing results of the largest storage capacity, it is the standard configuration of 500 sets (including test conditions, test results and test curve) history, we can also customize according to customer requirements more large capacity of storage space. And when the instrument is connected to the PC, can achieve unlimited storage for record.
6、 测试范围广
6, wide range of test
完整性测试仪的测量范围非常广泛，从平板过滤器到多芯的桶式过滤器，从囊式过滤器到呼吸器都能进行测试。而且仪器本身所具有的高分辨率信号分析处理模块，保证了在测量大过滤面积滤器的完整性时，能把误差减少到 小。与同类某些品牌在第三方做对比测试时， 测试仪器在重复测量 5 芯 20 寸、 PES 滤芯的完整性时，其测试速度和测试结果的一致性，远远优于对方仪器。
Integrity tester measuring range is very wide, from flat to multiple filter core barrel type filter, filter from sac to respirator can be tested. And the instrument has high resolution of the signal analysis processing module, to ensure the measuring, large filtering area of the integrity of the filter can reduce the error to a minimum. Compared with similar certain brand in the third party to do the test, the test equipment in the five core 20-inch, repeated measurement the integrity of the PES filter, the test speed and the consistency of the test results is much better than the other instruments.
7、 带有与上位机通信的数据接口
7, communication with the upper machine data interface
是国内目前家能实现远程操作，集中控制管理的完整性测试仪。仪器本身自带的通讯接口和随机附送的上位机软件，使管理人员可以在控制室内通过装在电脑中的应用软件完成过滤器的完整性检测。而且还能够把仪器中所有历史数据复制到电脑中，这样就实现了历史记录的无限制保存。
Is currently the only domestic can realize remote operation, centralized control the integrity of the tester. Instrument itself bring communication interface and attached with PC software, make managers can application in the control room through in a computer software to complete the integrity of the filter test. But also can put the instrument in all historical data is copied to the computer, thus realize the unlimited save for record.
8、 测试更方便，人机界面更友好
8, test more convenient, more friendly man-machine interface
在人机界面方面做了大量工作，首先每个工作界面的下边都有醒目的操作提示，用户可根据提示内容完成所有操作项目。其次，仪器设计了“ 后测试条件自动保存”功能，这样，如果用户每次测试的都是相同规格的滤器，就可以使用“一键到底”（即在选择某一项测试功能后，一直按下仪器面板上的确定键，仪器就能按照上次测试时输入的参数进行检测）实现过滤器完整性测试，大大简化了工作人员的操作程序。
Have done a lot of work in human-machine interface, each work first interface below are bold, prompt operation, the user can according to the prompt to complete the operation project content. Second, instrument design the function of "final test condition automatically save", in this way, if the user of each test is the same specifications of the filter, you can use the "keys" (namely in the choice after one test function, always press the identified key on the instrument panel, instrument can be carried out in accordance with the input during the last test parameters detection) implement the filter integrity testing, greatly simplifying the operation procedures of the staff.
9 、 是国内 早实现扩散流和水侵入测试功能的仪器，而且水浸入测试功能已经非常成熟了，其测试结果具有很高的可靠性。
9, is the earliest realize diffusion flow and water invasion test function of the instrument, and the water immersion test function has been very mature, the test result has the very high reliability.
10 、 安全性
10, security,
安全生产是所有企业 重要的一项指标，仪器设备的安全运行又是安全生产的基础， 从设计之初，就把仪器的安全性做为基础性能来考虑，无论是在加压测试过程中还是在待机状态下都做了安全性处理。例如：仪器在加电后进待机状态，其实一直在做系统的安全自检，当发现仪器内部的压力大于安全压力时，它就会自动开启放气功能，防止工作人员带压操作过滤器，消除安全隐患。
Production safety is one of the most important indexes of all enterprise equipment safe operation is the foundation of safety production, from the beginning of the design, the instrument performance security as a basis, both in the process of pressure testing and in standby mode all did security processing. Instrument, for example, the charging last in the standby mode, the safety of the system has been actually do self-checking, when your instrument internal pressure is greater than the security, it will automatically open the can qigong, prevent staff with pressurized filter operation, eliminate safety hidden trouble.
1 为什么要检测过滤器的完整性 ?
1 why do you want to test the integrity of the filter?
1 无菌工艺及验证的需要
1 the needs of the aseptic process and validation
a 、确认正确的过滤孔径
A, confirm the correct filter aperture
b 、检测 O 形圈、垫圈、密封垫的泄露
B, o-ring and gasket, seal leakage
c 、确认消毒灭菌后的完整性
C, confirm the integrity after disinfection
2 法规的要求及需要
2 regulatory requirements and needs
a 、国家 GMP 认证的要求
A, the national GMP certification requirements
b 、出口认证的要求（如 FDA ）
B, export certification requirements (such as the FDA)
c 、 SDA 检查
C, SDA to check
3 生产及成本控制的需要
The needs of the three production and cost control
a 、防止浪费
A, avoid waste
过滤前检测及过滤后检测，以过程保证结果有效，防止浪费药液
Filter test before and after the test, in order to process guarantee results effectively, avoid waste liquid
b 、节约生产成本
B, saving the cost of production
没有检测仪，大多数厂家滤芯是定期更换，使用检测仪后，可以准确判断滤芯情况，节约成本
No detector, most manufacturers filter is replacd periodically, after using the detector, can accurately judge the filter element, cost savings
C 、防止无用功
C, prevent useless
过滤前检测及过滤后检测，以过程保证结果有效，防止返工，节约人力成本，提高效率
Filter test before and after the test, in order to process guarantee results effectively, prevent rework, saving labor costs and improve efficiency
2 气泡点测试原理 : 取一定材质的滤膜或滤芯，用一定的溶液润湿后，在膜的一侧用气体加压，随着压力的增加，气体从滤膜另一侧释放，出现大小、数量不等的气泡，对应的压力值为泡点值。
2 bubble point test principle: take a certain material of membrane filter or filter element, with a certain solution after wetting, with gas pressure in the side of the membrane, with the increase of pressure, gas released from the other side of the membrane filter, ranging in size, quantity of air bubbles, the corresponding value for the bubble point pressure.
R = 2k ·δ·cosθ/ p
R = 2 k, delta, cosine theta as/delta p
其中：
Among them:
R —— 微孔半径； δ—— 液体表面张力系数；
R - pore radius; The delta - liquid surface tension coefficient;
θ—— 液体-滤膜材料的浸润角； p —— 气体作用在毛细管孔上的净压力；
Theta - liquid - membrane filter material infiltrates Angle; p - gas effect on capillary hole net pressure;
K —— 孔型修正系数 。
K - pass correction coefficient.
“空气优先穿透的孔 ”
"Priority to air through the largest hole"
3 扩散流测试： 指当气体压力在滤芯起泡点值的 80% 时 , 这时还没有出现大量的气体穿孔而过, 只是少量的气体先溶解到液相的隔膜中 , 然后从该液相扩散到另一面的气相中 , 这部分气体称之为扩散流。 ( 压缩空气每分钟通过膜孔液体的分子流 )
3 diffusion flow test: refers to when the gas pressure in the filter bubble point values of 80%, then there is no large amounts of gas hole, just a small amount of gas dissolved in the diaphragm of the liquid phase first, and then from the liquid spread to the other side of the gas phase, this part of the gas is called diffusion current. (compressed air molecules through the membrane pore fluid flow per minute)
N/t= D L D p F/ d ( 单独孔考虑 )
N/t = D L D p F/D (hole) alone
N/t : 单位时间内气体扩散的摩尔数 (mol/s)
N/t: unit time the number of moles of gas diffusion (mol/s)
D : 扩散系数 ( 气 - 液系统 ) L : 溶解度系数 ( 气 - 液系统 )
D: diffusion coefficient (gas-liquid system) L: solubility coefficient (gas-liquid systems)
D p : 压差 F : 气液接触面积 d : 液膜厚度 ( 过滤器 )
D p: differential pressure F: gas liquid contact area D: liquid film thickness (filter)
D = ( p ·V) / (T·Pa)（仪器测试）
As D = (delta p. V)/(T Pa) (instruments)
D —— 扩散流值； p —— 压力衰减值；
D - diffusion flow value; p - pressure attenuation values;
V —— 上游体积；T —— 测试时间； Pa —— 标准大气压；
V - upstream volume; T - test time. Pa - standard atmospheric pressure;
扩散流测试与微生物挑战结果相对应
Diffusion flow test results correspond with microbial challenge
4 为什么扩散流的方法更好？
4 why diffusion flow method is better?
起泡点值只是一个定性的值，从开始起泡到的群起泡是一个比较长的过程，不能准确的定量。而测量扩散流值是一个定量值 , 不但能准确的确定过滤器的完整性，而且还能反应出膜的孔隙率、流量和有效过滤面积等方面的问题，同时扩散流的测试压力要低于 小泡点的压力，能起到保护滤芯、延长滤芯使用寿命的目的，这也就是为什么现在国外滤芯厂家都只用扩散流法测试完整性的原因。
Bubble point value is only a qualitative, rose up from the blister at the end of the bubble is a relatively long process, not an accurate quantitative. And diffusion flow measurement value is a quantitative value, not only can accurately determine the integrity of the filter, but also can reflect a porosity of the membrane, flow and effective filter area, etc, at the same time, diffusion flow test pressure is lower than minimum bubble point pressure, can rise to protect filter, prolong the service life of filter element, which is why foreign filter manufacturers are now only diffusion flow method to test the integrity of reason.
5 水浸入法介绍
Five water immersion method is introduced
以前 : 疏水滤芯用溶液测试
Before: hydrohobic filter with organic solution test
由于疏水性的多孔滤膜不能被水相溶液润湿，必须使用异丙醇 / 水的混合溶液来润湿滤膜。
Due to the hydrohobic porous membrane filter can not be aqueous solution wetting, must use the isopropyl alcohol/water mixture to wetting membrane filter.
缺点：
Disadvantages:
1 过滤时疏水性是空气滤芯的特点但在测试时却需要将滤芯亲水化
1 when filtering hydrophobicity is the characteristic of air filter but need to filter hydrophilization during the test
2 通常滤芯必须从过滤滤壳中取出并在另一个独立的滤壳中测试，同时要求设备的防爆性能。
2 usually filter must be removed from the filter filter shell and test in another independent filter shell, also requires the equipment with the burst performance.
3 异丙醇测试只能在灭菌前进行
3 isopropyl alcohol test can only before sterilization
4 异丙醇作为气体污染物必须被彻底去除
4 isopropyl alcohol as gas pollutants must be completely removed
5 无法检测滤芯的疏水性 6 无法检测滤芯安装的正确性
5 didn't filter the hydrophobicity of 6 unable to test the correctness of the filter installation
水浸入法测试的介绍：
The introduction of water immersion method test:
在一定的压力下，测量挤入疏水性滤膜中的水的流量来判断滤芯的孔径。 孔越小，侵入就越少。的侵入发生在的孔。如果孔径 “ 太大 ”, 水就会穿透过去。 在小于临界压力的测试压力作用下，水不能通过膜而只能浸入到膜基体中，水优先浸入的膜孔。浸入膜基体的水不会与透过膜的水相混淆，浸入是一个极为缓慢的过程，为了在下游端得到水，需要保持很长时间的压力。
Under certain pressure, measured in hydrophobic membrane filter in the water flow to judge the filter aperture. The smaller the hole, the less they invade. The biggest invasion occurred in hole. If the aperture is "too big", water will penetrate the past. In less than the test pressure under the action of critical pressure, the water does not only through the membrane permeated the film substrate, water is preferred in the biggest film hole. Immersed membrane matrix of water won't be confused with the water through the membrane, is a very slow process, in order to get the water on the downstream side, the pressure of the need to keep for a long time.
优点：
Advantages:
1 在线测试 2 可以在蒸汽灭菌后进行
1 online quiz 2 after steam sterilization
3 只使用水，不含 DOP 或溶剂等污染物
3 use only water, do not contain pollutants such as DOP or solvents
4 同时检测滤芯的疏水性 5 同时检测滤芯安装的正确性
4 at the same time detection filter of hydrophobic 5 test the correctness of the filter is installed at the same time
6 测试压力在低于水穿透点的压力下进行
6 test pressure below penetrating point under the pressure of water
侵入速度 (ml/min) = D p (mbar) • 侵入体积 (ml)/ 测试时间 (min) • 大气压 (mbar)
Intrusion velocity (ml/min) = D p (mbar), intrusion volume (ml)/test time (min), atmospheric pressure (mbar)
水侵入的极限值与微生物挑战测试 (HIMA) 的结果直接相关。
Water invasion of limit and microbial challenge test (HIMA) is directly related to the results.