1. Project Overview

Tendering Entity: Beijing Minhai Biotechnology Co., Ltd.

Project Name: Minhai Biologics’ Internationalization Industrial Base Construction Project for Novel Vaccines

Project Name: Clean Piping Installation Project

Project Address: Simiao Road, Biomedical Industry Base, Daxing District, Beijing 35 Number

Project Overview: The Minhai Biologics International Vaccine Industrial Base Project, invested in and constructed by Beijing Minhai Biotechnology Co., Ltd., is located within the Daxing Biopharmaceutical Industry Base. 0503-039 、040、043、044 The site is bounded as follows: to the north by Simiao Road, to the south by the planned land‑use boundary (municipal green space), to the west by Xiangrui Avenue, and to the east by Tianfu Avenue. The project is primarily intended for the research, development, and production of human vaccines.

Total project land area 90013.218m² , the land use designation is M1 Class I industrial land, total floor area 189820.11m² , building height 33.3 Rice, underground 1 Layer, above ground 8 Layer. The construction scope includes 1 R&D pilot workshop, 2 R&D Technology Workshop, 3 Comprehensive Service Building, 4 Number of laboratory animal facilities, 5 Hazardous waste and dangerous goods warehouse, 6 sewage treatment plant, 7 Boiler Room No., 8 Vaccine Production Building No. , 9 Number packaging and warehouse building, 10 Bacterial vaccine production building, 12 Basement No. , 13 Gatehouse and carport, 14 Gatekeeper, 15 Gatehouse, etc.

II. Scope of Tender

1、 The overall scope of the clean pipeline installation project encompasses the clean pipeline systems of all buildings (specific interface details are provided in the tender documents).

1) Purified water piping distribution system and automatic control, 17 set

2) Water-for-injection piping distribution system and automatic control (including water production from the water machine into the storage tank), 14 set

3) Pure steam piping distribution system, 10 set

4) Process water system host computer (integrated preparation) + allocation system), 5 set

5) Compressed air generation and piping distribution system (excluding air compressors and aftertreatment equipment, but including piping connections between the generation system components), 3 set

6) Special gas system (nitrogen, carbon dioxide, oxygen, etc.), 1 item

7) Connection to other utility systems (including secondary piping connections for process equipment drainage, industrial steam, chilled water, softened water, and other utility pipelines). 5 item

The scope includes optimized design of all the aforementioned systems, supply of relevant equipment and materials, transportation and on-site delivery, installation and construction, testing and trial operation, inspection (including costs for submitting raw materials for testing and associated testing fees), validation, and other related matters. System design and installation shall comply with Chinese standards. GMP 、 FDA , the European Union, etc. GMP Regulatory requirements. Manufacturing standards shall comply with GAMP5、 ISPE 、 ASME BPE 、 ASTM and requirements.

2、 The cleanroom piping installation project shall provide piping layout plans and system diagrams, and coordinate with the MEP general contractor for drawing preparation. “ Deepen Integrated MEP Drawing ” “ BIM Pipeline diagram ” The clean pipeline installation contractor is responsible for integrating the three-dimensional drawings of equipment and piping in the water‑production room and providing them to the cleanroom MEP general contractor.

“ Integrated MEP Drawing ” “ BIM Pipeline diagram ” The content must include plan, elevation, and section drawings to show all… Comprehensive layout arrangements for equipment, piping, electrical wiring, and associated accessories, as well as integrated ceiling layouts, etc. The drawing depth must comply with the requirements of national drafting standards.

3、 The allocation system employs a modular design.

3. Quality Standards

This project is a key initiative of Beijing Municipality, and its design concept must meet the requirements of scientific rigor, human-centeredness, standardization, intelligence, and landscape integration, ensuring that it achieves… 5 Remain at the forefront throughout the year, 10 The overarching goal of not falling behind within the year.

The project must comply with the legal and regulatory requirements of China, the European Union, the United States, and the World Health Organization pertaining to laboratories, pharmaceutical pilot‑scale facilities, and production workshops; it must also meet fire safety standards and occupational health and safety requirements.

Including, but not limited to, the requirements of the following current editions of standards:

l Chinese Pharmacopoeia 2020 Edition

l European Union Guidelines on the Quality of Water for Pharmaceutical Use 2020 Edition

l China GMP ( 2010 (Revised in [Year]) and its appendices

l WHO GMP

l ISPE Pharmaceutical Engineering Benchmark Guide: Part 4 Volume “ Water and steam ”

l ISPE Pharmaceutical Engineering Benchmark Guide: Part 5 Volume “ Debugging and Verification ”

l WHO On the Guidelines for Water Treatment and the Guidelines for Inspecting Clean Piping Systems

l Basic Guidelines of the International Society for Pharmaceutical Engineering: Commissioning and Qualification Section

l Current Edition of the United States Pharmacopeia

l FDA Relevant provisions of federal regulations (cGMP)

l Current edition of the European Pharmacopoeia

l ASME BPE Current version

l GB-52261-5002 Machine Safety — Mechanical and Electrical Equipment — Part 1: General Technical Requirements

l United States 21 CFR Part 210 ，211

l United States 21CFR Part 11 Electronic Records and Electronic Signatures

l Basic Guidelines of the International Society for Pharmaceutical Engineering

l GEP Good Engineering Practice Standards

l GBZ 1-2010 Hygienic Design Standards for Industrial Enterprises

l Pressure vessel ( GB150-2011 )

l NB/T 47003.1-2009 (JB/T 4735.1) Steel welded atmospheric-pressure vessel

l Safety Technical Supervision Regulations for Stationary Pressure Vessels ( TSG 21-2016 )

l Nondestructive Testing of Pressure Equipment ( NB/T 47013-2015 )

l General Code for Construction and Acceptance of Mechanical Equipment Installation Projects ( GB50231-2009 )

l Code for Construction of Industrial Metallic Piping Projects ( GB50235-2010 )

l Code for Acceptance of Construction Quality of On-site Equipment and Industrial Pipeline Welding Works ( GB50236-2011 )

l Code for Construction and Acceptance of Earthing Systems in Electrical Installation Projects ( GB50169-2016 )

l Code for Construction and Acceptance of Installation of Electrical Equipment—Panels, Cabinets, and Secondary Circuit Wiring ( GB50171-2012 )

l GB/T 5226.1-2019 Mechanical and Electrical Safety—Mechanical and Electrical Equipment, Part 1 Section: General Technical Requirements

l All electromechanical equipment, wires, and cables must comply with the relevant national standards and IEC Standard

l Safety: Meets relevant domestic standards and CE Standard requirements

l Protection Rating: Mechanical protection rating for the motor, electrical components, instruments, and all control system parts (including the control panel) IP55 and above

l Software Standards: Computer and Electronic Systems Comply with 21CFRpart11 Standards, the control system complies with GAMP 5

4. Registration Instructions:

1 Units participating in the registration must submit the enterprise legal person’s business license, qualification certificates, a certificate of the legal representative or a letter of authorization from the legal entity, copies of identification documents, and other relevant materials (copies must be stamped with the official seal of the unit), and must indicate the company’s registered capital.

2、 Eligibility Requirements

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2.1 Qualification Requirements: GC3 Class-level pressure pipeline installation qualification, with at least… in the past three years. 3 The performance of vaccine‑industry‑related projects (either under construction or completed) is strong, with at least one project having passed… WHO 、 FDA or EU pre‑certification. The performance record must include at least the following information: project overview, workshop name, implementation period, contract value, certification standard, and the owner’s contact person and contact details.

2.2 Must pass through ASME Certification, GB /T19001-2016/ISO9001:2015 Quality management system, GB/T24001-2004 Environmental management system, GB/T28001-2001 Occupational Health and Safety Management System Certification.

2.3 The bidder undertakes to handle all procedures and acceptance inspections related to the clean piping installation project, as well as to manage day-to-day coordination and liaison activities, upon winning the bid.

2.4 In accordance with relevant national and Beijing municipal requirements, the organization is well‑structured, and key management personnel are certified and qualified to assume their duties. Specifically, the project manager is required to have experience in similar projects. 5 More than [X] years of experience, with at least three comparable project achievements; the project manager must be fully dedicated to this project and may not concurrently serve on other projects; the project manager shall be the on-site principal responsible party.

2.5 The project manager designated by the bidding entity and the project manager assigned to the project site upon award of the contract must be those nominated for review by the bidding entity. Project Manager. Otherwise, the procuring entity shall have the right to terminate the contract upon the successful bidder’s entry onto the site.

2.6 Other Project management personnel are designated by the contractor and in accordance with… The staffing shall be commensurate with the scale of the contracted project and the on-site management requirements. Relevant personnel must hold the qualification certificates required by the competent authorities at the national or municipal level in Beijing, and their numbers must comply with the requirements stipulated in applicable laws, regulations, and official documents.

3、 Registration requires providing the contact person and contact information of the submitting organization. The contact person must be the project leader or an designated business liaison, and must also provide… 12 Monthly social security certificate.

4 The tendering entity will review the qualification documents of all registered entities, giving priority to those with relevant project experience, and will conduct further discussions and on-site inspections with the shortlisted candidates.

5 , Beijing Minhai Biotechnology Co., Ltd. was established in 2004 Year is a wholly owned subsidiary of Shenzhen Kangtai Biological Products Co., Ltd. (a publicly listed company). For more information, please visit the company’s website.

5. Registration address:

Beijing Minhai Biotechnology Co., Ltd. (Simiao Road, Biomedical Industry Base, Daxing District, Beijing) 35 No.). Contact persons: Mr. Hao and Ms. Fang from the New Engineering Project Department; contact telephone: 010-57864910 、57864916 Email: mhzb@biominhai.com 。

VI. Registration Deadline: 2020 year 12 month 31 day 5:30 PM Time.

Hereby announced!

Tendering Entity: Beijing Minhai Biotechnology Co., Ltd.

                        2020 year 12 month 02 day