URS-EN-201306 空压机组URS

1. PURPOSE 目的

Establish a URS for air compressor unit used in Jiangsu ***** Biopharmaceutical Co.,Ltd in

order to identify an acceptable specification for the system design and validation.

建立一个用于江苏***** 生物医药有限公司的空压机组的用户需要说明，旨在确定系统设计和验证的可接受标准的依据。 2. SCOPE 范围

2.1. This document applies to the user requirement specification of air compressor in

Jiangsu ***** Biopharmaceutical Co.,Ltd.

适应于江苏***生物医药有限公司空压机组的用户需求说明（URS）。 2.2. This document is written in both English and Chinese.

本规程为中英文版本。

3. DESCRIPTION 描述

3.1. Air compressor unit uses air as the gas source. The gas produced from the unit shall

meet the regulated specification of compressed air quality after the treatment of filtration and compression by the unit. The production capacity of the unit will be 2.0m/min（0.75MPa）. And it consists of air compressor, freezing dryer, precision filter and air tank.

空压机组以空气为进气源，经空压机组过滤、压缩处理后，达到规定的压缩空气质量。机组生产能力为2.0m/min（0.75MPa）。主要由空压机、冷冻式干燥机、精密过滤器、储气罐组成。

3.2. This URS describes the proper comprehensive requirements about the equipment.

本URS将描述设备的适当的综合化要求。

3.3. The supplier or vendor shall produce or supply the equipment according to this

document.

设备供应商或销售商应依照本文件概述进行生产和提供。

4. REGULATION AND GUIDLINE

法规和指南

4.1. Good Manufacture Practice (revised in 2010)

药品生产质量管理规范（2010年修订）

4.2. Validation Guideline on Pharmaceutical Manufacturing (2003)

药品生产验证指南（2003）。

5. TERMINOLOGY 术语

3

3

6. USER REQUIREMENT 用户要求

6.1. Production Capacity 生产能力

6.2. 工艺要求

6.3. 功能及技术参数

Jiangsu Biopharmaceutical Co.,Ltd 江苏**医药有限公司

Title: URS of Air Compressor Unit 文件名: 空压机组URS Document No.文件编号: Revision No.修订号: Effective Date生效日期: Page页码:

PRT-EN-012 02 2013-00-00 5 of 10 Necessary 必需

URS19

Motor control method: Power frequency control. 电机控制方式：工频控制。 The brand of electrical components shall be Schneider or other equivalent brand. Protection level of electric equipment: NEMAI

URS20

(IP23) 电气元器件品牌采用施耐德或者同等品牌，电器防护等级：NEMAI (IP23) High effective dust filter contains three groups. The filtration precision

Necessary 必需

URS21

is 5μm、 0.1μm 、0.01μm separately. 高效粉尘过滤器共3组，过滤精度分别为：5μm、0.1μm 、0.01μm. Start/stop function of the motor 电动启停功能 Automatic start/stop devices. Install the non-return device in the exhaust pipes of principal machine. 自动启停装置，在主机排气管路设有逆止装置 Air tank: select the brand of Shanghai Shenjiang or other equivalent

Necessary 必需 Necessary 必需 Necessary 必需 Necessary 必需 Expected 期望 Necessary 必需 Necessary 必需

URS22

URS23

URS24

brand. Material quality:SUS304 储气罐：品牌上海申江或同等品牌，材质：SUS304 Freezer dryer (brand of Jiamei or above or equivalent brands)

URS25 URS26 URS27

冷冻干燥机(台湾嘉美或同等及以上品质) Regeneration gas exhaust: 0 再生气耗：0 Electrical drainer (adjust by time and quantity) 电子排水器(定时、定量可调) Filter (Jiamei): multi-layer fiber filter at level A, filter precision : particle ≤0.01μm, oil content ≤0.001mg/m 油份≤0.001 mg/m3 3

URS28

Necessary 必需 Necessary 必需

过滤器(嘉美):A 级多层玻璃纤维滤芯，过滤精度：微粒≤0.01μm, Drainer: the brand of Netherlands JORC or other equivalent brand.

URS29

排水器：荷兰乔克或同等品牌

6.4. Utilities 公用系统

6.5. Environment and safety 环境与安全

6.6. Cleaning requirements 清洁要求

6.7. Documents文件

Jiangsu Biopharmaceutical Co.,Ltd 江苏**医药有限公司

Title: UR

S of Air Compressor Unit 文件名: 空压机组URS Document No.文件编号: Revision No.修订号: Effective Date生效日期: Page页码:

PRT-EN-012 02 2013-00-00 8 of 10 Necessary 必需 Necessary 必需 Necessary 必需 Necessary 必需 Necessary 必需 Necessary 必需 Necessary 必需 Necessary 必需 Necessary 必需 Necessary 必需

URS48

A flow chart of process control 工艺控制流程图(PID) Provide all the material quality certifications of the surface directly or indirectly contacting with the products. 所有直接或间接接触产品的表面的材质证明。 Provide instruments certification according to the national standard

URS49

URS50

calibration. 提供按照国家相关标准校验的仪器证明。 Provide actual test result and report which can be accepted by

URS51

Berkgen. 提供江苏伯克可以接收的实际的检测结果和报告。 Layout Drawing (including the location of pipe and equipment and

URS52

requirements of the joints). 布局图(包括管线、电器位置和接口要求) Technical and functional specification (equipment and control

URS53

system). 技术和功能规格(设备及控制系统) Hardware design specification (schematic diagram of electrical

URS54

system and pressure system) 硬件设计规范(电气系统原理图、气压系统原理图) Software design specification. 软件设计规范 Function logical introduction 功能逻辑说明 Wiring diagram 接线图 Operation, repair (detailed descript the cycle and items of heavy repair, medium repair, minor repair and daily maintenance),

URS55 URS56 URS57

URS58

installation and sanitation manual (equipment and control system) 操作，维修(详细说明大修、中修、小修以及日常维护的项目和周期), 安装及卫生手册(设备及控制系统)

Necessary 必需

URS59

SOP Documents along with the equipment 设备附带文件资料

Expected 期望

URS60

Official authentication literature 官方认证文献： All the instruments of outsourcing parts 所有外购部件说明 书；

Necessary 必需

6.8. Other requirements 其他要求

6.8.1.

N/A 无

7. CONSTRAINT CONDITION 约束条件

8. ATTACHMENT 附件

8.1. N/A 无。

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