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高效过滤器检漏流程
来源:本站时间:2014/11/6 16:52:43

检漏的目的:
1.高效空气过滤器的材料无破损;
2.安装恰当。

   高效过滤器本身的过滤效率一般由生产厂家检测,出厂时附有滤器过滤效率报告单和合格证明。对制药企业来说,高效过滤器检漏是指高效过滤器及其系统安装后的现场检漏,主要是检查过滤器滤材中的小针孔和其他损坏,如框架密封、垫圈密封以及过滤器构架上的漏缝等。检漏的目的是通过检查高效过滤器及其与安装框架连接部位等处的密封性,及时发现高效过滤器本身及安装中存在的缺陷,采取相应的补救措施,保证区域的洁净度。


高效过滤器检漏的方法
   高效空气过滤器泄漏测试基本上是把挑战微粒施放在高效空气过滤器上游,然后在高效空气过滤器表面与边框用微粒探测仪器搜寻有无泄漏。泄漏测试有几种不同的方式,适用在不同的场合。

测试方式有:

1.气胶光度计测试法
2. 微粒计数器测试法
3.全效率测试法
4.外气测试法

说明如下。

PAO检漏属于气溶胶光度计测试法
气溶胶光度计:
   气胶光度计测试法是最早期的测试方式,但是因为效果非常好,到今天仍旧沿用。
   气胶光度计(Aerosol Photometer)是微粒计数器的一种,也是使用雷射科技,但是它在扫描空气样本的微粒之后,所给的是微粒的总体强度,不是微粒数目。DOP是一种油性化学物质,加压或加热雾化之后,可以产生次微米等级的微粒,可用来仿真无尘室的微粒,因此被当成验证微粒。 泄漏的定义是泄漏出上游浓度万分之一,由于气胶光度计可以直接显示上下游微粒浓度的比值,因此扫描高效空气过滤器非常方便。也正因其准确、可靠,美国食品与药品管制局(FDA)规定,在其管辖范围内(食品加工场所与医疗制药场所),所有的高效空气过滤器泄漏测试必须使用DOP与气胶光度计。


    一段时间以来,因被怀疑对人有致癌作用,现常以 DOS ( Dioctylsebaeate 癸二酸二辛脂)亦称 DEHS[di(2-ethylexyl)sebacate] 及 PAO(polyaphaolefin 聚 a 烯烃)等代替,但实验方法仍称“ DOP 法”。

   大气尘由于其浓度随地点及时间等变化,有时较大,有时较低,一般不用来作为检漏用。 FDA 指出在进行检漏时,选用的气溶胶应符合一定的理化要求,不应使用会引起微生物污染、造成微生物滋生的气溶胶。

   DOP 发生器可分为热发生和冷发生两种,热发生器是利用蒸发冷凝的原理,被雾化的气溶胶粒子用加热器蒸发,并在特定条件下冷凝成微小液滴,去掉过大和过小的液滴后留下 0.3um 左右的雾状 DOP 进入风道,粒径分布在 0.1 ~ 0.3um 。冷发生器是指利用压缩空气在液体中鼓气泡,经 laskin 喷管飞溅产生物态的多分散相 DOP 气溶胶,最大分布粒径在 0.65um 左右 。目前常用的热DOP比较多,所以过滤器的效率要有保证。

 

测试仪器:
   使用仪器为气胶光度计(Aerosol Photometer)与微粒产生器(Aerosol Generator)。气胶光度计的显示版有模拟与数字两种,每年必须校正一次。微粒产生器有两种,一种是普通的微粒产生器,只要求高压空气,另一种是加热型微粒产生器,要高压空气和电源,微粒产生器不需要校正。

工具/原料

  • 气胶光度计(Aerosol Photometer)

  • 微粒产生器(Aerosol Generator)

  • 高效空气过滤器

  • 无尘服

方法/步骤

  1. 1

    .在图面上记录高效空气过滤器数量并编号。

    高效过滤器检漏测试步骤
  2. 2

    确定空调系统正常运转并可供测试,风速与风量必需调整平衡完毕。  

  3. 3

    使用气胶产生器在上游施放挑战微粒,将PAO打入高效空气过滤器上游,微粒浓度是大约每公升空气含有10到20微克的PAO。微粒愈多愈容易找出泄漏,但是超过50微克以后差别不大,少于10则很难使用。微粒浓度可用风量粗略计算,再用气胶光度计确认。

  4. 4

    上游微粒浓度确认后,就可以在高效空气过滤器表面扫描,寻找泄漏,必要时高效空气过滤器四周可用塑料帘覆盖以确保测试之准确。

  5. 5

    在高效空气过滤器表面扫描,扫描之路径可由外而内或沿长/短边迂回检测,其方式如下:

    a.每一高效空气过滤器和其边框均需测试。

    b.高效空气过滤器之表面时,将探漏器摆设如图 (b),用短边方向前进, 覆盖全高效空气过滤器。

    c.扫描高效空气过滤器边框时,尤其高效空气过滤器与Ceiling Grid之间,探漏器摆设可以如上图(a)或(b),涵盖全部接缝。

    d.利用微粒计数器之方锥形(10mm*60mm)采样器置于高效空气过滤器下 25mm左右,以50mm/sec速度仪动。

    e.气胶光度计上的读数是上下游百分比值,因此若是数值大于0.01,即可怀疑为泄漏,可退回约100mm反复再测,如果没有持续高读数,则可继续测试,反之即为有泄漏,需作记录且日后修补或更换。

     

  6. 6

    高效空气过滤器若有破损则应修补或更新,然后重新再测。

  7. 7

    边框若有泄漏,应重新安装、调整,直到无泄漏为止。

  8. 8

    记录时必须登记扫描结果,泄漏状况与处理方式。

    说明:对于 HVAC 系统中的 HEPA, 为使气溶胶到达 HEPA 时 时的浓度均匀,可将气溶胶直接从系统风机的负压一侧引入,如要从风管中引入,则应在距 HEPA 至少 10 倍风管直径处引入,并尽量减少拐弯(美国环境科学和技术学会)。一般情况下,保持上游气溶胶达到要求浓度,且浓度波动在一定范围即可。对于层流罩、超净台上的 HEPA ,气溶胶直接从系统风机的负压一侧引入。 

     

    END

注意事项

  • 验收基准 
    1.凡是连续性读值超过 0.01﹪视为泄漏,每一片高效空气过滤器测试及修换后均不得有泄漏,边框也不得有泄漏。 
    2.每一片高效空气过滤器的修补面积不得大于高效空气过滤器面积的3%。 
    3.任何修补长度不得大于38㎜。  

1.4 Air-Con & Ventilation System
  1.4
空调及通风系统

Refer to hot-water system
 
参照热水系统

 

Centrifugal Air Duct
  Fan/Centrifugal Blower
 
离心式通风机/离心式鼓风机

Common ventilation,
  dust content in air ≯150mg/m3, temperature ≤60℃, no corrosion. Body shell of
  fan use galvanized steel plate; its thickness must stand the weight of motor
  and other drive equipment. Examine and repair doors are at both sides. The
  fan is centrifugal fan; the air inlet of impeller must be arc to insure that
  the transition is fluent between air inlet and Venturi tube. Antisepsis and
  had passed the test of dynamic balance and static balance. The strap must
  selec according to 1.5 times of drive power, trap can be adjust in locale to
  make the test of balance. The axis is permanent airproof, and can be
  lubricated. Motor shall be concert with the load of fan,380V, IP54,
  insulation grade F. Must show its working noise (DB(A)).Fan must be with absorber,
  and show its numerical value of absorb. Each fan shall be provided with the
  isolation switch and connection point with BAS system. The spring shock
  absorber shall be applied as the centrifugal fan above 6#; the rubber pad
  shock absorber shall be applied as the centrifugal below 6#. The inlet and
  outlet of the fan shall be provided with flexible joints
 
普通通风、气流含尘量150mg/m3、温度≤60℃,无腐蚀性。外壳应采取镀锌钢板,钢板厚度应足以承受驱动机构和电机的重量;风机两侧应设有检修门,风机类型应为离心风机,叶轮进口文丘里管截面应成圆弧形确保与风机进口文丘里管过渡顺畅;风机轴应经过热处理达到硬度HB370等级;表面应进行防腐处理,并连同叶轮一起进行动静平衡测试;皮带应按照驱动功率的150%选型,且可以调节以便进行现场的系统平衡;轴承应是永久密封,并可润滑;电机应与风机负载紧密配合,380VIP54,绝缘等级F;应明确标明风机运行噪音值(dB(A));应配有减振器,并标明减振量。每一风机应带有就地控制开关,并可连接信号至BAS系统。6#以上的离心风机应采用弹簧减震器,6#以下的离心风机可采用橡胶垫减震器,风机进出口应设有柔性接头

WOLTER, TWIN-CITY,
  Greenheck, Kruger        

沃特、双城、格林瀚克、科禄格、

AHU(Air Handling
  Unit with Heat Recovery) & PAU(Pre-Cooling Air Handling Unit)
 
空气处理机组/预冷空调箱

Unit
  construction and unit assembly complies with DIN EN 1886 and VDI 6022. The
  thickness of the AHU panels is required more than 70mm and the specific
  volume of the insulation material are required more than 55kg/m3. Insulation
  material is required to use mineral fibre. The flame resistance shall be
  reached the A. Contractor shall supply, install, testing, and service in
  accordance strictly with drawings, criterion and specification
 
施工和装配按照德国标准DINEN1886VDI6022AHU Panels厚度大于70mm,绝热材料容重大于55kg/m3,绝热材料选用矿棉纤维,A级阻燃。承包商应严格按照图纸、规范及本项目技术文件供应、安装、调试及服务

AL-KO, Robatherm,
  Carrier, Klingenburg (heat recovery)
 
爱科、罗百特、开利

克林根堡(用于能量回收段)

Constant temp &
  humidity air conditioner
 
机房精密空调

Precision
  air-conditioning for IT& computer room, Indoor units shall be provided
  with the isolation switch and connection point with BAS system. Contractor shall
  provide all air-cons intact and effective documents and test records in
  accordance with Specification.
 
用于空调和IT房间,每一室内机应带有就地控制开关,并可连接信号至BAS系统。所有空调设备需要提供技术规范说明书中所有完整有效的资料和测试记录

Caros, Emerson,
  HAIRF/HiRef, Stulz
 
卡洛斯、艾默生、海瑞弗、史图斯

Outdoor split air
  conditioners
 
分体空调

Used for cooling for
  general offices in summer. In order to correctly install the split air
  conditioner, the Contractor must provide all necessary units, materials and
  cabling. The protection class of outdoor unit must be suitable for outdoor
  use and shall be no lower than IP55, 220V. All materials to be used for
  silence and heat insulation must conform to the latest requirements of local
  fire department. The appropriate units shall be provided according to the
  requirements specified in the drawing and equipment list to satisfy maximum
  cooling amount in summer. The air conditioner shall have single cooling
  functions according to the design requirements; the coolant of air
  conditioning shall be no harm to environmental protection. All outdoor units
  shall be installed on the channel-steel foundation and have protection for
  rain-proof. The units shall include compressor, condenser coil, fan, engine,
  access opening of control box and control desk control panel for use and
  maintenance. The position and layout of condenser must be free from space
  constraint and avoid to circuit for hot air. Cabling from indoor units to the
  control panels shall also be the contractor’s works scope, the operation
  signal and disturbance signal of each outdoor air-conditioner must have the
  function accessing the BAS. Indoor units shall be provided with the isolation
  switch and connection point with BAS system
 
普通办公室夏季制冷,为了正确地安装分体式空调机组,承包商须供应所有必需的装置,材料及配线。室外机组防护等级必须适合室外使用,且不得低于IP55220V。所有用作消音及保温的材料必须符合当地消防局的最新要求。须按照图纸设备表内所示要求提供合适的机组设备以满足夏季的最大冷冻量的要求。空调器应按设计要求具备单冷功能,冷媒必须对环境无害。所有室外机组应装配在整体型钢基础上并有防雨措施。机组应包括压缩机、冷凝盘管、风扇、发动机、控制箱检查口和使用维修控制面板。冷凝器的位置和布置必须避免空间限制和热空气的二次流通。包括室内机与控制器间的电线,每一室外机组的状态信号及故障信号具备可接入BAS系统功能;每一室内机应带有就地控制开关,并可连接信号至BAS系统

DAIKIN, YORK,
  MITSUBISH, TRANE, CARRIER
 
大金、约克、三菱、特灵、开利
  National famous brand: Haier, Gree, Midea
 
海尔、格力、美的

Multi-split Air
  Conditioning System    
 
空调多联机

 

DAKIN, YORK,
  MITSUBISH
 
大金、约克、三菱
  National famous brand: Haier, Gree, Midea
 
海尔、格力、美的

Fan coil
 
风机盘管

 

DAIKIN, YORK,
  MITSUBISH
 
大金、约克、三菱
  National famous brand: Haier, Gree, Midea
 
海尔、格力、美的

Air duct
  heater/Cooler
 
风管加热器/冷却器

 

Trox, Halton,
  Zehnder,
 
妥思、霍尔顿、森德

Noise
  silencer/Muffler

消音器

Common
  ventilation, dust content in air ≯150mg/m3, air supply temperature in winter
  23℃, outdoor natural wind in summer, no corrosion. Including the mufflers for
  square and round pipes. The shell shall be made by the galvanized steel sheet
  and the joints shall be sealed. The over-sized muffler shell shall be fixed
  with strips. The silent pad shall be made by the non-textile glass fiber
  material. Before formal installation, the contractor shall submit specific
  muffler selection and technical parameter sheets. The data in the technical
  parameter sheet shall cover each-muffler manufacturer, brand, model, size,
  weight, quantity of silent pad, resistance loss and noise parameter. The
  above parameters shall be given based on the muffler flow and length
  appointed in the drawings
 
普通通风,气流含尘量150mg/m3,送风温度冬季为23℃,夏季为室外自然风,气流无腐蚀性。外形为方形或圆形。外壳镀锌钢板制作,接缝处做密封处理,超大尺寸外壳需做加固处理,消声片由非织物玻璃纤维材料制作。正式安装前,承包商应提交详细的消声器选型及技术参数表,数据应包含每台消声器的制造商、品牌、型号、尺寸、重量、每台消声器的消声片数量、阻力损失、消声参数等,这些参数应基于图纸给定的消声器流量及长度

Trox, Halton, shinelong
 
妥思、霍尔顿、显隆

All kinds
  Damper(incl. electrical damper) grille
 
各种风阀(包括电动风阀)

General
  ventilation system, dust content in air
150mg/m3, temperature ≤60, humidity 85%. De-smoke system, in case of fire: temperature
  ≤280
; normal: dust
  content in air
150mg/m3,
  temperature ≤60
,
  humidity
85%. The
  dampers must opposed multi-blade dampers. Case, shall not produce vibration
  or sound. The air leakage volume is not higher than 5% when the dampers
  closed. There is excellent seal between body and shaft. Fire damper shall
  conform to the requirements of local fire department and relevant Chinese
  regulation or code. Fire damper shall also be provided with one fusible sheet
  with operating temperature of 70
. In case
  the air temperature is higher than 70
, the fire damper shall be closed. Besides it can only
  be reset manually. All dampers are made by carbon steel
 
普通通风系统,气流含尘量150mg/m3,温度≤60,排风湿度>85%;排烟系统:火灾温度≤280,平时:气流含尘量150mg/m3,温度≤60,排风湿度>85%。风量调节阀须为多叶对开叶片型,所有调节阀在任何情况下,都不能产生震动或声响,调节阀紧闭时其漏风程度不能大于5%。调节阀体和转轴须有良好密封;防火阀须符合当地消防局及有关中国国家标,防火阀应同时配有一易熔片,其操作温度为70,当排经的烟气温度大于70时,将防火阀关闭。并只能以手动复位。所有的风阀均由碳钢制作

Trox, Halton, shinelong
 
妥思、霍尔顿、显隆
  Electric driver: BELIMO, SIEMENS, HONEYWELL, Trox


 
风阀电动驱动器:博力谋、西门子、霍尼韦尔、妥思

Constant Air Volume
  Regulator(CAV)
 
定风量调节器

The
  constant air volume regulator shall be the pressure-independent type. The
  automatic mechanical regulator with the air volume through the constant air
  volume regulator can strictly supply or exhaust air according to the dial
  scale without impact of pipe static pressure and air volume change. The valve
  body structure of the constant air volume regulator shall be the single-
  plate throttle and can automatically adjust the opening of the valve position
  according to the static pressure before the valve, so the constant air volume
  can be ensured. The square-shape constant air volume regulator shall be
  equipped with flanges on both ends. The both ends of the round-shape constant
  air volume regulator shall be the sockets with actuators. The constant air
  volume regulator can work at the static pipe pressure of 50-1000Pa and not be
  limited by the installation position which can be horizontal or vertical. The
  air volume calibration of each-set end unit shall be carried out in plant and
  the accuracy shall be ensured. It is made by carbon steel hot- galvanized
 
定风量调节器应是压力无关型,机械式自动调节装置,经过定风量调节器的风量,可严格按照刻度盘标定的风量送风或排风,不受管道干管静压以及风量变化的影响。其阀体结构应为单阀板节流形式,并根据阀前静压的变化自动调整阀位的开度,从而保证送风量的恒定。方形的两端应带法兰,圆形定的两端为插接口,并可附带执行器。定风量调节器可在管道静压压差501000Pa范围内正常工作,并且不受安装位置的限制,可水平或垂直安装。每台末端装置的风量标定工作应在工厂进行,并保证标定的准确性,同时应能在现场进行额定风量的二次标定,以适应项目情况的变化,由热镀锌材料制作

Trox, Halton, shinelong
 
妥思、霍尔顿、显隆
  Electric driver: BELIMO, SIEMENS, HONEYWELL
 
风阀电动驱动器:博力谋、西门子、霍尼韦尔

G.I. steel board air
  duct with accessory 

镀锌铁皮风管

For
  the rectangle air duct which is ≥800mm, the support bracket inside the pipe shall
  be used for reinforcement (see the assembly sequence). Combination flange
  rectangle air duct which is 1250mm≤ air duct edge length (A) ≤2250mm, the rib
  line and inner-duct support shall be used and the inner support part is 1
  piece. >2250mm, 2 pieces
All the ducts for air supply and
  return, air exhaust and exhaust smoke duct shall be generally made of
  galvanized sheets. The fabrication of all ducts sheets shall conform to
  Unless
  additional specified, all the ducts shall be made of galvanized steel sheet, Ducts
  thickness shall conform to the minimum thickness as specified by the above
  standard. Galvanized steel sheets shall meet the requirements of
  GB50243-2002. Rubber seal joint gaskets or suitable adhesive shall be used as
  air-tight seal for all flange joints
 
对边长≥800mm的矩形风管,采用管内支撑架方式加固,对于1250mm≤风管边长 (A) ≤2250mm的风管,采用楞线和管内支撑加固方式,管内支撑为1个,大于22502个。所有一般空调送回风、排风和排烟风管道由镀锌钢板制成。所有金属板的风管道的制作须按照中国标准GB50243—2002。除特别说明外,所有风管须为镀锌钢板风管,板厚须同时符合上述标准内所规定的最小厚度而制造。镀锌钢板能满足GB50243-2002之板材要求,所有法兰接驳位须采用橡胶密封接合垫片或合适的胶粘剂作为气密封

China national
  standard high quality products: WuSteel, AnSteel, BaoSteel, BenSteel
TongSteel
 
国标优质产品:武钢、鞍钢、宝钢、本钢、通钢

Diffuser (Incl. Round
  diffuser with air volume adjust, Displacement air port, Swirl diffuser)
 
风口(包括:带风量调节圆形散流器、置换风口、旋流风口)

Round
  exhausts and supply diffuser with air volume adjustment: It shall be made of
  prefabricated aluminum alloy, corrosion by oxidation treatment; surface
  painted by the architect requires recognition of color. Center separate
  diffuser blades to be equipped with square or round neck. Each diffuser shall
  be equipped with a steel plate made of aluminum or more leaf off the air flow
  control valve, shall be painted black blade hidden by a built-in spacious
  style adjustable rod for adjustment
 
带风量调节圆形排风和进风散流器:由预制铝合金材料制作,经氧化防蚀处理后,表面按建筑师要求涂上认可的颜色。中心叶片分离式散流器须配有方形或圆形颈,每个散流器须配有一个由铝合金或钢板制成的对开多叶式风量调节阀,叶片须涂上黑色由一内置隐敝式调校杆作调校

Trox, Halton, shinelong
 
妥思、霍尔顿、显隆

Displacement air
  port

置换风口

Displacement
  air port: The shell and the support grid shall be made by galvanized plate
  which can be sprayed as RAL standard. The noise parameter must be the sound
  power level tested in the standard echo chamber. The supplier must provide
  the selection reports based on the actual project condition
 
置换风口:外壳和支撑格栅由镀锌钢板制成,可根据RAL标准进行喷涂。噪声参数必须在标准回响室内测得的声功率噪声,供货厂家必须能提供针对本项目实际情况得出的选型报告

Trox, Halton, shinelong
 
妥思、霍尔顿、显隆

Diffuser
散流器

Swirl
  exhaust and supply diffuser with air volume adjustment: Swirl vanes can be
  independently adjusted to meet the different swirl air supply in different
  rooms. The panel shall be made of galvanized steel sheet and the surface shall
  be painted with powder as the project required. The swirl vane material shall
  be polystyrene. The color shall be white or black. The supplier must provide
  the selection reports based on the actual project condition
 
带风量调节旋流排风和进风散流器:旋流叶片具有单个可调节特点,以满足不同房间的不同旋流送风特点。面板材料为镀锌钢板,表面需根据工程要求粉末喷涂颜色,旋流叶片材料为聚苯乙烯,颜色为白色或黑色。噪声参数必须在标准回响室内测得的声功率噪声,供货厂家必须能提供针对本项目实际情况得出的选型报告

Trox, Halton, shinelong
 
妥思、霍尔顿、显隆

Door Hot Air Curtain
 
风幕

Wall
  mounted type heater, Horizontal Flow Q: refer to drawings, water temperature 90/40
, noise level67dB(A)
 
顶吹大门热风幕,水平安装,配中间出风喷嘴,流量见图纸,水温90/40,噪音67.0dB(A)

Zehnder, Kampmann,
  TTL
 
森德、卡普曼、TTL

Wall Mounted Type
  Heater

墙装加热器

Horizontal
  installation, Flow Q: refer to drawings, water temperature 90/40
, noise level67dB(A) ), indoor temperature:
  19

 
水平安装,流量见图纸,水温90/40,噪音67.0dB(A),室温19

Trox, Halton,
  Zehnder,
 
妥思、霍尔顿、森德

Warm air blower
暖风机

Flow
  Q: refer to drawings, water temperature 90/40
, noise level61dB(A),
  indoor temperature: 10

 
流量见图纸,水温90/40,噪音61.0dB(A)
 
,室温10

Trox, Halton,
  Zehnder,
 
妥思、霍尔顿、森德

Exhaust Heads
 
风帽

Installed
  the end of upper wind outlet dust, round type, cylinder type, square type,
  size see construction drawings, and vertical installation normally. It has
  fixed mechanical strength, can resist
  violent typhoon
 
安装于风道上出口终端,有圆伞形,筒形和方形,尺寸按照施工图,垂直安装,具有一定机械强度,可抵抗强台风

IMOS,
  BeijingHangtian Taizhou pipe equipment CO.LTD
  IMOS
、北京航天、台州管业

Supports
 
支吊架

Meet
  drawing and specification

按照图纸和规范

Golkin, Shanghai
  Xinqi, Walraven
 
固多金、上海新奇、
 
沃雷文

Anchor Bolt
 
锚栓

 

Hilti, Simpson, Fisher
 
喜利得、辛普森、慧鱼

Fire-stopping
 
防火封堵

Refer
  to hot-water system
 
参照热水系统

STI, 3M, Hilti
  STI
3M、喜利得

Strainer
 
水过滤器

Refer
  to hot-water system
 
参照热水系统

Watts, Danfoss, THT
 
沃茨、丹佛斯、津滨瓦特斯

Pressure Gauge,
  Temperature Gauge
 
压力表、温度计

Range
  and precision, see bidding document Chapter 7

量程、精度参见招标文件第七章规范

GF, Honeywell,
  Dwyer, 
 
乔治.费歇尔、霍尼韦尔、德维尔

Insulation
 
橡塑保温

Meet
  drawing and specification

按照图纸和规范

Armacell,3M,Yingsheng
 

阿乐斯、3M、赢胜,

Rock Wool insulation
 
保温岩棉

Meet
  drawing and specification

按照图纸和规范

Saint-Gobain, Owens Corning,
  CSR
 
圣戈班、欧文斯科宁、西斯尔

Shock absorber                                          减震器

The
  spring shock absorber shall be applied as the centrifugal fan above 6#, the
  rubber pad shock absorber shall be applied as the centrifugal below 6#. Meet
  design and equipment manufacturer installation instruction at the same time
  6#
以上的离心风机应采用弹簧减震器,6#以下的离心风机可采用橡胶垫减震器;同时符合设计和设备制造商按照说明

Mason, EHASE-FLEX,
  JSC, Liaoning Tongze

梅森、通力、兆山辰、辽宁同泽

Flexible Joints
 
柔性接头

Flexible
  duct shall be made of flexible metallic bellows using stainless steel,
  aluminum, galvanized steel or aluminum steel. Flexible joint shall meet the
  requirement of air-tightness and be suitable for specified air pressure and
  temperature conditions. Relevant material shall be fire-proofing material and
  shall conform to the regulations of local fire department
 
柔性通风管道应由不锈钢、铝、镀锌或铝钢所制成的柔性金属波纹管,柔性软接头的材料须满足气密性要求,适用于指定的风压和温度条件。有关材料须为防火材料,防火程度须符合当地消防局要求

1:高效过滤器检漏流程  
     1.1 在待测HEPA上游一侧引入PAO气溶胶
     对于HVAC系统中的HEPA, 为使气溶胶到达HEPA时时的浓度均匀,可将气溶胶直接从系统风机的负压一侧引入,如要从风管中引入,则应在距HEPA至少10倍风管直径处引入,并尽量减少拐弯(美国环境科学和技术学会)。一般情况下,保持上游气溶胶达到要求浓度,且浓度波动在一定范围即可。对于层流罩、超净台上的HEPA,气溶胶直接从系统风机的负压一侧引入。
 
     1.2 气溶胶光度计初始化、设定100%、0%参比标准值
按照气溶胶光度计操作要求进行初始化、设定报警值。将UPSTREAM采样管与上游采样口相连,测量上游气溶胶的浓度。按照气溶胶发生器操作要求调节发生的气溶胶浓度,使上游气溶胶浓度达到10~20ug/mL。  
     1.3 扫描检漏      
     
     卸下HEPA的散流板,对整个滤器面、滤器与边框之间、边框与边框之间以及边框与静压箱之间的密封进行扫描。扫描时采样头距滤器面约1英寸(约2.54cm),扫描速度不超过5cm/s。扫描按直线来回往复地进行,线条间应重叠。检测过程中,若有报警声(即%LEAKAGE(泄漏率)超过0.01%),表明有泄漏。泄漏处经用硅胶堵漏或紧固以后再进行扫描巡检。检查一个过滤器约为5min 左右,在测试的过程中,应经常确认上游气溶胶的浓度,注意在检测过程中应带防护面罩和防护眼罩。      

     2 结果判定及处理   
     高效过滤器泄漏率应小于等于0.01%。若HEPA在检测过程中, 所有点的%LEAKAGE( 泄漏率%)都不超过0.01%,则判该HEPA合格,若有一处%超过0.01%,则判为不合格,并将该点标记出来,需修补或更换。高效过滤器滤料泄漏处允许用专用胶水修补,但是单个泄漏处的面积不能大于总面积的1%,全部泄漏处的面积不能大于总面积的5%,否则必须更换。  
      3 高效过滤器检漏周期  
     FDA在无菌药品生产指南中建议对于无菌制剂生产车间每半年进行一次检漏,我国在GMP 检查指南中建议通常一年一次。ISO14644 对已安装HEPA的泄漏检测,建议的最长时间间隔为24个月。DOP检漏在HEPA 安装或更换后都应进行。当环境监测显示空气质量恶化、或当产品无菌试验不合格、培养基模拟灌装试验失败时,都可作为偏差调查的一部分进行检漏。需进行检漏试验的滤器还包括烘干隧道和干烤箱所使用的HEPA。