Solution Of Consulting And Design Services For Pharmaceutical Engineering

I. Introduction:

The solution of consulting and design services for pharmaceutical engineering targets pharmaceutical projects at home and abroad, which aims to provide high-level engineering design services for customers in the fields of process equipment, civil work engineering, clean room engineering, utilities, engineering cost and others based on advanced design philosophy and rich design experience. Standardized project design service procedures and quality control can guarantee compliance with predetermined functionality and advancement under the premise of design compliance. In the design process, attention are paid to such key problems as safety, environmental protection and energy saving, thus risks are avoided and economy, manipuility and enforceability of project are realized to the maximum extent.

II. Detailed introduction:

1. Pharmaceutical consulting services include:

★ Pharmaceutical consulting services aim to provide efficient and high quality full life cycle management for pharmaceutical engineering projects based on customers’ requirements, design drawings, general codes of construction industry, GMP and ISPE implementation guidelines and related standards of pharmaceutical industry, thus guarantee conformance of engineering quality, progress, cost, EHS and other aspects to requirements of final user/project investor;

★ The consulting services during construction of a pharmaceutical factory contain design optimization, equipment supply, equipment validation, and integrated solutions dominated by technical service, aiming to save costs for customers and ensure efficient operation of customers’ compliance laboratory.

2. Pharmaceutical process design services include:

★ Project purpose, product types, production scale, technological processes, GMP standards of workshops, labor capacity, main process equipment list, selection of process equipment and common facilities, process plan, building structure, utilities, project budget, project schedule, etc.

★ Overall project design, design of process layout, main technological processes, equipment selection and installation, estimation of civil work quantities and cost.

★ Integration of technical resources to provide pharmaceutical enterprises with advanced fluid process system meeting requirements of Chinese GMP, European Union GMP and American CGMP, such as pharmaceutical water system, liquid preparation system, CIP/SIP system, biological upstream and downstream process system. The application scope of products covers API's, oral solid preparation, iv solutions, powder injections, sterile preparation and non-sterile preparation, biological preparation and other preparations.

★ Customized design of specific non-standard equipment and equipment design.

3. Main consulting and design services for clean room engineering of pharmaceutical workshop are as follows:

★ Technical consulting and construction drawing design of air-conditioning purification plant and clean dust-free laboratories with different cleanliness degree, process requirements and floor plans;

★ Design and construction of clean food workshops and assistance in GMP certification;

★ Special requirements of clean workshops such as relatively negative pressure, high temperature, fire and explosion protection, noise elimination, efficient self-purification, oder suppression and anti-static;

★ Supporting lighting, electrical facilities, power and electric appliance control system and AC automatic control system of clean workshops;

★ Constant temperature and humidity system, AC room and chiller room of clean workshops;

★ Supporting water supply &drainage, water and air handling systems of clean workshops;

★ Engineering consulting, commissioning and testing assistance of clean AC system.