卫生级管子管件培训

卫生级管子管件培训

卫生级管子管件培训

卫生级管子管件培训

卫生级管子管件的应用范围Increasing Quality RequirementFood, Dairy & BeveragePersonal Care BioTech / PharmaceuticalStandard Sanitary industry “HighClean” industry

Pharmaceutical & biotech industry

卫生级管子管件培训

What is

Sanitary Standard 卫生级，要求使用的材料是304L或者316L,表 面需要进行表面处理或抛光。 HighClean Standard 高洁净，要求使用的材料是316L。表面粗糙度 等级达到Ra0.8。 Pharm Standard 生物医药级，材料使用316L。符合ASME BPE 标准，抛光等级为SFF1或SFF2以上。

卫生级管子管件培训

Sanitary Standard Connections

ISO SMS DS DIN BS RJT IDF JIS Clamp

卫生级管子管件培训

SMS, DS, BS, IDF/ISO, DIN and ISO-ClampBS 4825 Part 5 RJT DS 722 SMS 1145

ISO 2853

DIN 11851

ISO-Clamp 2852 DIN-Clamp 32676

卫生级管子管件培训

HighClean & Pharma standardsDIN Range

DIN DIN DIN DIN DIN DIN

11850 Tubes 11864-1 Unions form A 11864-2 Flanges form A 11864-3 Draft Clamp form A 11865 Tees, Bends, Reducers 11866 General requirements

ASME BPE Range

ASME BPE 2005

卫生级管子管件培训

ISO标准ISO:the International Organization for Standardization 我们常用到的标准主要有： ISO 2037: Stainless steel tubes for the food industry ISO 2852: Stainless steel clamp pipe couplings for the food industry

卫生级管子管件培训

ISO 2037: Stainless steel tubes for the food industry Dimensions:

卫生级管子管件培训

DIN 11850 1mm thickness recommended for expanding. 1.5 and 2mm recommended for welding. Fixed I.D.

Different standards as ISO 2037.Wall thickness from 1.2 - 1.6 - 2mm. Fixed O.D.

卫生级管子管件培训

Tolerance on outside diameter:

O.D.O.D.≤101.6m m O.D.>101.6m m

ToleranceIn ISO 5252, class D4 (±0.5% with ±0.1mm min. ) In ISO 5252, class D3 (±0.75% with ±0.1mm min. )

卫生级管子管件培训

Surface roughness: Finely finished surface: Ra≤1μm Other surface: Ra≤2.5μm

Materials(材料):

Austenitic stainless steels.(奥氏体不 锈钢)

卫生级管子管件培训

ISO 2852: Stainless steel clamp pipe couplings for the food industry

Definitions: Clamp pipe coupling: Coupling with two liners intended for joining pipe ends together by means of a clamp. 卡箍连接：用卡箍将连接管道的两个平接头夹紧连接方式； Clamp liner: Flanged pipe coupling part, with one conical face to provide means for connecting mating liners. 平接头：带有圆锥面的一种管道连接件。 Welded-type clamp liner: Clamp liner intended to be joined to a pipe end by butt welding. 焊接式平接头：与管道是对接焊的连接方式。 Expanded-type clamp liner: Clamp liner intended to be attached to a pipe end by expansion. 胀接式平接头：与管道是胀接的链接方式。 Gasket: Ring-shaped pipe coupling part intended to make a hygienic liquid-tight joint between the flanges of two clamp liners. 即垫片。 Clamp: Ring-shaped pipe coupling part with a taper-sided channel section. 卡箍、卡钳：环形的内部带有锥形通道的夹紧件。

卫生级管子管件培训

Expanded-

type clamp liner(胀接卡箍):

卫生级管子管件培训

Expanded-type clamp liner(胀接卡箍):

卫生级管子管件培训

Welded-type clamp liner(焊接卡箍):

卫生级管子管件培训

Welded-type clamp liner(焊接卡箍):

卫生级管子管件培训

卫生级要求：表面要易于清洗(CIP或者拆卸清洗) 焊接式平接头的内表面清洁光滑，没有表面缺陷。 在工艺操作条件下，垫片的材料应该合适。例如： 垫片本身不能产生任何味道等。(主要指垫片的 成分不能在物料中有溶解、挥发或发生反应)。

卫生级管子管件培训

Surface roughness(表面平整度):

The surface roughness of expanded- and weldedtype clamp liners, in accordance with the specifications of ISO 468, shall be, for finely finished surfaces, Ra≤1μm 根据ISO 468,平接头表面应该达到Ra≤1μm

卫生级管子管件培训

Materials(材料):

Clamp liners: Austenitic stainless steel奥氏体不锈钢 Gasket: 具有一定硬度的天然或合成橡胶，材料应符合卫生级要求 并有一定的使用寿命； 常用的垫片材料：PTFE,EPDM,无色硅橡胶,PTFE包覆EPDM

卫生级管子管件培训

ASME BPE

GR-1 INTRODUCTION This Standard provides the requirements applicable to the design of equipment used in the bioprocessing, pharmaceutical, and personal care product industries, including aspects related to sterility and cleanability, materials, dimensions and tolerances, surface finish, material joining, and seals. These apply to: GR-1 简介 此标准所规定的要求，适用于生物工程 ﹑制药和个人保健品行业设备的设计。所涉 及的方面包括灭菌﹑清洁﹑材质﹑尺寸﹑公 差﹑表面抛光﹑材料的连接和密封等。这些 应用于：

卫生级管子管件培训

(a) components that are in contact with the product, raw materials, or product intermediates during manufacturing, development, or scale-up; (b) systems that are a critical part of product manufacture [e.g., water-for-injection (WFI), clean steam, filtration, and intermediate product storage]. (a)在制造﹑改进和生产过程中与产品﹑原料﹑产品介 质直接接触的元件； (b)产品制造中主要部件系统(如WFI,洁净蒸汽，过 滤和半成品贮存等)。

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