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Description

Product Detail

Turnkey Service for Biopharmaceutical Project

Strategy Consultancy & Feasibility Study

We determine the business opportunity and restrictions, carefully plan the cost and budget, evaluate the market and select the ideal financing way.

Master Plannning for the Site

We plan on the use of existing and reserved project sites, and visualize the site infrastructure, including existing and planning buildings.

We guarantee that all projects meet the requirements of logistics and regulations, including local and international requirements.

Concept Design

We define the objectives of the project and evaluate the location and cost of the project. Following that we determine what equipments are required and where it is positioned so as to provide smooth production and service. In this way we can ensure that the plant meets all the requirement in relation to output, quality, safety, and regulatory.

Concept design provides the best layout for your project, including master layout design, construction plan, process engineering, consumption balance calculation of utility and material, project estimation, etc.

Engineering Design

A team of senior architects and engineers (technique, mechanism, HVAC, electrical, automation and validation) are ready to provide their best service.

Basic Design

Tailor made design of facility layout based on specific needs. Provision of design package covers various drawing, files and specifications. In prior to an EPC start, an mutually agreed handover list, including technical details and total investment cost, shall be issued.

Detail Design

Our detail design package covers comprehensive deliverables: all drawings, specifications and documents. In the detailed design phase, we will prepare well all the necessary construction and production drawings, documentation and descriptive information to help you to carry out the procurement, construction, installation, commissioning, validation and qualification of project facilities.

Procurement (provide integrated service): utilizing our technical expertise and experience to provide tailor-made solution

Most of key process equipment and modules are produced by Shinva, by which we can better control the schedual and quality.

By means of rich procurement experience, we can provide the best solution fit for your needs.

Expert purchasing staff to provide comprehensive technical solution and efficient project management according to your URS.

Construction Management

From a start to the final handover, our project and construction manangement team will systematically plan the implementation of the project, promote and instruct the use of relative personnel and resource.

The whole process is based on agreed time arrangenment and budget milestone. Our goal is to guarantee the optimized and most transparent quality.

Work scope and team size to be determined with you in the form of project execuation plan (PEP).

Start-up

Final goal of EPC project is successful start-up. Contractor’s provision of start-up service plays a key role in the project. The start-up service goes through the whole process of project implementation, including all activities to attain successful start-up.

Contractor’s provision of start-up service can improve design quality and ensure the safety of start-up. All changes proposed for start-up are defined as mandatory changes.

Contractor’s provision of start-up service can greatly shorten the start-up cycle.

Successful start-up marks the completion of technology handover and basic establishment of complete operational team.

Consultancy In Term Of Quality Management System And GMP Conformity

Rich expertize and experience in GMP certification.

PIC/S GMP audit includes: quality management system gap, engineering, verification/qualification and operational conformity.

Audit report includes a detailed advice of trouble shooting and a GMP conformity risk assessment for each workshop and room.

Extensive experience in dealing with conformity of GMP, local and international regulation.