DIGA PHARMACEUTICAL GROUP SHARESLimited Company
Announcement on Invitation for Bids for New Oscillating Screen for Sodium in A5 Workshop
Basic information of 1. project
1. Project (Material) Name: New Oscillating Screen for Sodium in A5 Workshop
2. Location of demand: 268 Tianrun Road, Wendeng Economic and Technological Development Zone, Weihai
3. Demand Overview: See URS for details
4. Quality requirements: Comply with national mandatory standards and requirements of Party A
5. Time limit requirement: 30 days
6. Other requirements: quotation includes invoice
2. Supplier Qualification Requirements
1. A valid business license shall be provided for a legal person or other organization registered in the People's Republic of China.
2, must have the ability to independently bear civil liability.
3, must have a good business reputation and sound financial accounting system, and can issue special VAT invoices.
4. It must have a good record of paying taxes and social security funds in accordance with the law within 3 years, and there is no record of major violations in business activities.
5, must have the necessary equipment and professional and technical capabilities to perform the project. Relevant supporting materials (including but not limited to professional qualifications, past successful cases and contracts) shall be provided.
6. Other conditions stipulated by laws and regulations.
3. Registration Instructions
1. This tender invitation announcement shall end on [July] [15] of [2024] and will not be accepted within the time limit.
2. If you are interested in participating, please sort out the above information (seal) before the deadline for announcement,Send to dijiazbb@163.com in the form of mail；
Note: Please unify the mailNamed after "preliminary quotation of project name bidding unit name", please leave "contact person, position and contact information of the unit" (not less than two) in the body of the email.
3. Telephone number for consultation: [Li Wei 15106314392]]
4. After examination of qualified registration units, our staff will send detailed bidding documents by mail. Please check the mailbox in time. If you receive any, please reply and confirm by mail.
4. supervision and reporting methods
1. Reporting telephone number: 0631-3855888
2. Reporting Mailbox: zhengquanbu@dijiagroup.com
5. Other
The final interpretation of this tender belongs to our company. Please pay attention to the feedback information received by phone or email.
 
 
 
 
 
 
 


 
 
 
 
 
 
 
 
DIGA PHARMACEUTICAL GROUP LIMITED
Edit Pharmaceutical GroupCo., Ltd.
 
 
 
Oscillating sieveURS
 
 
 
 
 
 
Scheme No:URS-A05.30.00
 
 
 
 
 
 
 
Directory
 
1.0 Protocol Approval 3
2.0 Introduction 4
3.0 Regulations and guidelines 4
4.0 Terminology 5
5.0 User and system requirements 6
6.0 Parameter Change Description 9
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

1.0 Scheme Approval

 

Development Department	Signature of the formulator	Date
Equipment Department

 
 
 
 
 

Audit Department	Signature of Reviewer	Date
Equipment Department
Production Department
Quality Assurance Department

 
 
 
 
 

Approver	Signature	Date
Production Director
Quality Director
Effective Date		Number of prints	1

 
 
 
 

2.0 Introduction

This user requirement statement (URS) is to specify the technical requirements for the oscillating screen in Wendeng A5 workshop of Dijia Pharmaceutical Group Co., Ltd., to provide technical basis for the bidding of the equipment, and to serve as the basis for subsequent verification work.
2.1 Overview
The equipment is mainly used for the production needs of the A5 workshop in the Wendeng plant.
2.2 Purpose
The purpose of this user demand is to put forward the specific content of the user demand of the oscillating screen to the equipment manufacturing supplier. After confirmation, the equipment manufacturing supplier will carry out the preliminary specification selection, functional design and final detailed design of the oscillating screen based on the control standards proposed by our company, so as to provide sufficient basis for future equipment confirmation. The equipment provided by the equipment manufacturing supplier shall meet the requirements of relevant Chinese regulations, codes and mandatory standards for design, manufacturing, safety and environmental protection, and shall also be the basis for acceptable standards for system design and verification.

Scope of 2.3

The scope of this plan involves the oscillating screen of Wendeng A5 workshop, including vacuum feeder, oscillating screen equipment main body, feeder, pipeline, controller, cleaning accessories and other parts, and is designed according to explosion-proof requirements. URS is used as the basis for detailed design and quotation by equipment manufacturing suppliers. The manufacturing supplier must design, manufacture and assemble the equipment in strict accordance with the URS to ensure that the equipment is environmentally friendly, safe and reliable, and meets the requirements of the production process.

2.4 responsibility

The supplier is responsible for providing all equipment, software and devices necessary for the normal operation of the vibrating screen and related ancillary facilities. The supplier shall provide relevant equipment, facilities and services in strict accordance with the regulations, standards, technical requirements and service requirements specified in this URS, and the supplier shall be responsible for the confidentiality of the URS provided by the demander. Deviations shall be notified to the user in writing.

3.0 regulations and guidelines

The systems within the scope of this URS shall meet the requirements of the following regulations and guidelines:
1) China GMP(2010 Revision) and its Appendices
2) Safety of GB52261-2002 machinery-Mechanical electrical equipment-Part 1: General technical conditions
3)JBT20049-2014 "Medicinal Vacuum Feeder"
 

4.0 terminology

Term Terminology	Definition 定义
GMP	Good Manufacturing Practices 药品生产质量管理规范
DQ	Design Qualification 设计确认
ISO	International Standards Organization 国际标准组织
IQ	Installation Qualification 安装确认
OQ	Operational Qualification 运行确认
SOP	Standard Operating Procedures 标准操作规程
URS	User Requirement Specification 用户需求标准
PQ	Performance Qualification 性能确认
cGMP	Current Good Manufacturing Practice 现行药品生产质量管理规范

 

5.0 User and system requirements

编号	Equipment Name	Model	Quantity	Equipment number	主要介质
URS001	Oscillating sieve	1200	1	/	洛纳

 

5.1 Oscillating sieve整体要求

编号	要求	Remarks
URS002	316L不锈钢1200型超声波振荡筛一套，使用物料名称：洛纳（堆密度约0.35，过筛前粒度D90 200-300），批量400kg，产能要求150-200kg/h，筛分精度60-80目，使用区域D级洁净区，物料接触材质316L,其它304或碳钢外包304，所有密封垫片选用硅胶或四氟材质。该设备为成套设备，包括但不仅限于喂料器、真空上料机、振荡筛、机架及管道控制系统等
URS003	待筛分物料采用间歇式上料方式，通过喂料器转入真空上料机，真空上料机通过定时开关料仓气动放料阀，将物料输送到振荡筛料仓，经筛分后物料装入底部纸板桶。要求振荡筛整体要按照GMP标准进行设计制作，所有接触物料部分氩弧满焊镜面抛光，表面光滑平整，设备外表面镜面抛光，其他部位无法镜面抛光部分Ra≤0.6µm，不得出现电气焊或其它清洁死角
URS004	真空上料机：采用真空驱动源，输送能力≥200kg/h，配备φ51洁净管道喂料器、DN200出料气动阀+手动洁净蝶阀、震动气锤及控制器等，要求主体厚度2mm以上（甲方自配真空，需要设备厂家提供所需真空度及抽气量），整机密封良好，用于粉体输送过程，实现物料的密闭输送，输送距离：水平距离1.5米，垂直距离2.5米。
URS005	真空过滤器：304不锈钢材质，要求孔径5μm，应能满足避免最小直径的物料进入真空系统的要求。可采用钛金属或四氟滤芯，通量根据所用真空耗气量选择，配有压缩空气反吹系统，易于过滤器的自动清理，设备外表面拉丝或镜面抛光处理。
URS006	振荡筛：有效筛分直径不低于1100mm，有效筛分面积0.95㎡以上，配备60目/80目不锈钢筛网各2张，可单层独立使用，也可上下两层配合筛分（，配备不锈钢超声波发生器（必须牢固固定于筛网架，使用过程中不得产生震动杂质）及高效防爆震动电机。 振荡筛入口配备半透明软连接配2个，一个用于单层使用，1个用于双层使用）用于与真空上料机连接，底部出料口高度不低于800mm。
URS007	整套设备配备304不锈钢支架,各设备连接、焊接部位平滑、牢固，焊接部位均应采用氩弧抛光处理。设备整体高度≤2600mm，出厂前整体测试，分体发货
URS008	物料进料管：采用导静电软管，吸料软管与设备及喂料器的连接均采用快卡联接。吸料软管必须带金属骨架，易导出静电
URS009	喂料器：无死角易清洗，可调整物料输送相密度，防止堵管，直径供应商可根据输送能力自行合理选型。
URS010	电器与控制系统：上料机及振荡筛 整体控制，可一键设置进料、出料、振荡程序，真空上料机进料料位能实现自动启停、反吹时间可调，智能自控运行。（设备除振荡筛电机选用防爆电机外，超声波发生器等优先选用防爆型号 ，若无法满足，需将相关控制统一放置于304不锈钢配电箱内 ）

5.2 安装Requirements

编号	要求	Remarks
URS011	在启动订单和安装设备之前，设备供应商应提供一份设备安装图纸，以便于公司做好相关准备工作。
URS012	设备上的连接管线应通过不锈钢穿线管连接。
URS013	设备与压缩空气、水等管路系统的连接接头使用法兰或快拆（装）接头。水、电、气接头不外露，应设置在围护板内。设备快装接头采用ASME BPE或ISO 2037标准。
URS014	供应商应提供设备所需全部公共系统的参数和连接方式，如：电压、功率，压缩空气压力、用量、管径等。

5.3 特殊功能Requirements

编号	要求	Remarks
URS015	上料机能够根据料位信号自动启动或停止，上料机出料口大于仓桶直径的1/2，并配备2台震动气锤，防止架桥

5.4 润滑密封要求 

编号	要求	Remarks
URS016	设备在任何状态下无渗液、漏油现象，润滑用油要采用食用级别或其它相同级别，不得对药品产生污染
URS017	所有密封垫片选用硅胶或四氟材质，筛分过程中不得出颗粒脱落现象

5.5 EHSRequirements

编号	要求	Remarks
URS018	设备符合国家环境保护的法规、法律、符合GMP的有关要求。
URS019	设备使用、操作、维修等方面结构设计合理、方便，考虑设备的日常维护，并确保设备使用的安全可靠
URS020	设备边缘应该平整，没有潜在尖角伤及操作员工。
URS021	所有紧固件能够做到拆卸自如，方便快捷，没有维护操作死角
URS022	当外部公共系统发生故障或达不到要求或设备本身震动超过阈值时，设备不能启动或自动停机。整机过载保护

5.6 文件Requirements

编号	要求	Remarks
URS023	说明书、合格证、外形图、安装图纸
URS024	产品质量证明书、材质单
URS025	验证方案

5.9 服务Requirements
5.9.1 包装运输要求

Serial Number	Requirements	Remarks
URS026	包装满足运输和装卸要求，防潮干、防磕碰、防振动，由于包装不良而造成的任何锈损，卖方承担全部损失和费用。
URS027	运输时间包含在供货周期内，供方负责运输，并承担运输费用。
URS028	包装箱应清晰标出发货及运输作业标志。
URS029	设备到货清单必须详列每装箱内容物并加盖公章

5.9.2 备品零件要求

Serial Number	Requirements	Remarks
URS030	卖方应提供设备所需易耗、易损件清单及更换周期。

5.10 维修Requirements

Serial Number	Requirements	Remarks
URS031	设备的建造、安装方便快速简洁的维修保养活动。
URS032	设备供应商为用户提供长期有效的维护保养服务及计划。
URS033	如因设备故障导致停止生产时，需要延长保修期限。同时故障备件供应商需无条件负责免费更换

5.11 培训Requirements

Serial Number	Requirements	Remarks
URS034	供应商对用户操作、技术人员提供原理、操作、维修保养等全方位的培训，使其能够对系统进行操作和日常维修保养、常见故障解决。

5.12 质量控制Requirements

Serial Number	Requirements	Remarks
URS035	为了确保需方的要求，供应商应在设计、制造和测试的所有阶段执行质量确认项目计划，包括对伙伴供货商提供的零部件的质量检测和控制。
URS036	乙方保证设计、采购、安装、检测和调试的安全可靠性、规范性和合理性并负全部责任。
URS037	文件是乙方工作范围内的不可分割的一部分，延时提供文件或提供文件不完全乙方支付违约金。若不能提供文件，即使是部分的不能提供，也会被认为未能完全履行合同并且是不可被接受的。乙方提供的货物和文件必须满足甲方的要求并且必须满足现行GMP认证的要求。

5.13 其它要求补充说明

Serial Number	Requirements	Remarks
URS038	该设备货期10-15日，请注明实际交货期

6.0 参数变更说明

在具体实施过程中，如本文件有不妥之处，可以对本文件进行相应的修改，但对本文件及其附件中的任何内容进行任何修改都必须通过已制定的变更程序，经审核和取得有关部门批准后才能修改和执行。

Serial Number	执行日期		变更原因		变更详细描述
1
2
汇报人/日期				批准人/日期