Clean Pipeline System
The Process Engineering Department of Shandong Zhongda Engineering Technology Co., Ltd. takes the customer’s URS as its starting point, relies on the design institute’s construction drawings as its foundation, and uses drawing optimization as its entry point. In accordance with applicable GMP regulations—including U.S. FDA cGMP, EU GMP, WHO GMP, PIC/S GMP, EDQM CoS, TGA GMP, NMPA GMP, and others—as well as relevant pharmacopoeial standards (such as ChP, USP, EP) and EHS requirements, and guided by the Quality by Design (QbD) approach coupled with risk‑based quality management (RA), the department conducts GMP and EHS compliance audits and verifies the conformity of process and product characteristics for the client’s clean‑pipe engineering projects. Emphasizing “process‑based quality control” throughout the project execution, it prepares formal QPP documentation and validation deliverables (including DQ, IQ, OQ, RA, etc.), thereby ensuring that the constructed project meets the quality requirements specified in the customer’s URS.
We specialize in integrated services encompassing the detailed design, construction and installation, commissioning and acceptance, as well as validation support for purification water storage, distribution, and usage systems; water for injection storage, distribution, and usage systems; pure steam distribution and usage systems; clean gas distribution and usage systems; various liquid preparation systems; CIP systems; and pipeline systems for traditional Chinese medicine extraction and concentration processes.
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1. Utility piping systems for Purified Water (PW), Water for Injection (WFI), Pure Steam (PS), and Clean Gases (CA, N2, etc.)
Based on the customer’s production process, product characteristics, and URS requirements, we provide customized design, installation, and validation services.
2. Cleaning-in-Place (CIP) and Sterilization-in-Place (SIP) systems
Based on the customer’s production processes, product characteristics, and URS requirements, we provide customized design, installation, commissioning, and validation services for online cleaning and online sterilization systems.
3. Pharmaceutical Solution Preparation Process Piping System
Based on the customer’s manufacturing processes, product characteristics, and URS requirements, we provide design, installation, commissioning, and validation services for liquid‑handling systems across various dosage forms, covering material dissolution, formulation, filtration, storage and transfer, as well as in‑line CIP and SIP.
4. Pipeline System for Traditional Chinese Medicine Extraction Processes
Based on the customer’s production processes for traditional Chinese medicine—such as extraction and concentration—as well as product characteristics and the customer’s URS requirements, we provide design, installation, commissioning, and validation services for system piping at each stage of TCM extraction. These include piping systems for extraction and concentration, filtration and storage, water precipitation and alcohol precipitation, drying (including spray drying and vacuum belt drying), granulation, and solvent recovery, among others.
5. Validation of the Clean Piping System
Validation of clean piping systems is conducted according to the following validation cycle. Each phase is performed in accordance with ISPE’s “V”‑model validation lifecycle, which begins with a formally documented and validated User Requirements Specification (URS) and proceeds through the Design Qualification (DQ), Engineering Construction Phase (QPP), Installation Qualification (IQ), Operational Qualification (OQ), and finally Performance Qualification (PQ), thereby confirming the user requirements over a complete cycle.
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Shandong Zhongda Engineering Technology Co., Ltd. adheres to the business philosophy of “integrity as the foundation, quality first, technological innovation, and service above all,” and is committed to providing attentive, customer‑centric services to clients both at home and abroad.
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