Service Competitiveness - Service Objectives

What Wellthinic Technology delivers to clients is not just a well-prepared validation document, but also a commitment to helping clients establish a comprehensive management system to ensure the system operates stably and continuously until its decommissioning.

Service Introduction - Service Principles

We provide you with the most high-quality CSV services in a comprehensive and detailed manner, gradually delving deeper.

Service advantages

• We provide efficient, cost-effective, and compliant validation solutions that adhere to regulations and cater to customer needs.

• Provide efficient, cost-effective, and compliant validation solutions.

• Strictly adhere to the results of system risk assessment.

• Fully customize CSV validation strategies and content.

• Professional CSV Engineer Team.

• All members possess a pharmaceutical industry background with extensive experience and a deep understanding of GxP regulations.

• Extensive experience in CSV validation within the GxP field.

• Able to accurately identify the risks associated with various systems.

• Mature project management system.

• Ensure minimal impact on the customer's existing business operations and maximize project execution efficiency.

• Exceptional cost-effectiveness.

• Provide a one-stop service for highly cost-effective system consulting and CSV validation.

• Customized validation.

• We can provide you with various types of CSV validation services, including customized validation (systems classified as Category 5 by GAMP 5) and compliance documentation.

Reference Cases

01：SIEMENS  Assists Chengdu Rongsheng Pharmaceutical in Building a MES Digital Factory

A Brief Introduction：

In June 2011, Siemens signed a contract with Chengdu Rongsheng Pharmaceutical Co., Ltd. (hereinafter referred to as "Rongsheng") for the MES project at its Chengdu factory (hereinafter referred to as the "project"). Phase I of the project was successfully launched and operated in parallel in December 2012, and Phase II was successfully launched and operated in parallel at the end of September 2013. The entire MES system is expected to officially achieve independent electronic operation in August 2014 (compliant with the regulatory requirements of 21 CFR Part 11 for electronic records and electronic signatures), marking the entry of Rongsheng's production management into the digital era.

Core Needs/Pain Points of the Project:

The project covers the entire blood product factory of Rongsheng, encompassing various stages from production planning, parameter standards, quality clearance, equipment status, process monitoring, to finished product warehousing. It fulfills the requirements of standardized and meticulous management in the GMP production process, supporting the company's strict control over effective production processes under GMP regulations.

Solution：

To ensure the smooth implementation of the project, it is divided into two stages. Phase I mainly focuses on the weighing, distribution and buffer preparation of materials; Phase II covers the entire production process of Rongsheng factory, including plasma input, separation, purification, ultrafiltration, semi-finished and finished product preparation, subpackaging and packaging. In addition, the project has completed the data integration and real-time communication of the underlying PCS and the upper ERP, realizing the digital factory with three-tier structure of automation, MES and ERP. The project manages more than 250 trained users, more than 50 customer terminals, more than 200 types of materials, more than 250 pieces of equipment, more than 50 work orders per day, and more than 1,000 work tasks being executed.

The project was strictly implemented in accordance with GMP requirements, and the entire implementation and verification process followed the guidance of GAMP5. It was jointly completed by Rongsheng's QA, productor, and IT, as well as the Siemens Industrial Software implementation and validation team. The implementation and verification of each step, from URS, FS, DS, FAT, SAT, to IQ, OQ, were all meticulously carried out.

Benefits:

With the objectives of safeguarding patient safety, improving drug quality, and ensuring data integrity, the project has fully realized electronic batch records, electronic signatures, and real-time audits. It ensures the use of sterilized, cleaned, and validated equipment that meets requirements, controls the release of production quality parameters, issues production scheduling and planning tasks, and manages and controls material batches, expiration dates, weighing accuracy, and pedigree tracking and tracing. Through strict control of the technological process, computer guidance, barcode technology, and other methods, the project has greatly reduced the risk of human operation in the production process and improved production compliance.

02：PCS7 Shenlian Biopharmaceutical Lanzhou Project Automated Production Control System

The automated production control system for the newly built Foot-and-Mouth Disease inactivated vaccine production line in Lanzhou of Shenlian Biopharmaceutical is the first fully automatic animal vaccine production line in China. The project adopts advanced process automation systems to achieve automation in production and operation, and provides comprehensive and open data information for operational management.

The newly built automated production control system for Foot-and-Mouth Disease inactivated vaccine in Lanzhou of Shenlian Biopharmaceutical is the first fully automatic animal vaccine production line in China. This project utilizes an advanced process automation system to achieve automation in production and operation, while providing comprehensive and open data information for operational management. The automation system directly controls modules such as media preparation, buffer preparation, inactivation and purification, emulsification, bioreactor, wastewater collection and treatment, centrifuge, and related auxiliary equipment. It also interacts with devices such as CIP stations for data exchange.

The project adopts DCS and fieldbus technology, configures the software platform and implements engineering design in accordance with ISA S88 requirements. The production process involves biopharmaceutical fermentation and purification, and all validation support documents are completed under the guidance of GAMP5. The total number of PO points for the entire project is around 2,500.

In addition to the conventional requirements for the reliability, functional completeness, maintainability, user-friendliness of the human-machine interface, and analyzability of data of the control system, this project also requires targeted design solutions for the following application characteristics.

• Implementation and documentation system that meets regulatory validation requirements

• Standardization and flexibility based on ISA S88

• Customized automation for complex process equipment

• Electronic batch reports and records

• Monitoring and management of process equipment status

• Monitoring equipment suitable for clean areas

Based on the above requirements, Wellthinic has selected PCS7 as the DCS platform for this project. PCS7 is an automation control system developed by Siemens. It is a fully integrated, structurally complete, and functionally comprehensive system oriented towards the entire production process and equipment management. It features high reliability and stability, utilizing high-speed, high-capacity controllers and employing an efficient client/server architecture that supports centralized, top-down configuration. Additionally, it boasts a sophisticated and user-friendly human-machine interface, as well as a fully open architecture that enables communication with management levels and seamless integration with fieldbus technology.

In addition, PCS7 has the following features that make it a suitable process control platform for this project:

The product design fully complies with electronic signatures and electronic records, supporting development in accordance with GAMP requirements.

Simatic Batch software fully meets ISA S88 standards and seamlessly integrates with the PCS7 system.

Supports customized development for various process objects.

Using Simatic Batch can automatically generate complete electronic batch reports.

Automated production process

• The whole process flow is monitored and controlled in real-time by the DCS. For the inactivation, purification, and formulation stages of the vaccine, the DCS system designs different control logics based on varying process requirements, thereby enhancing the overall automation level of the factory.

Standardized, traceable, and reusable software design documentation

• All programming and hardware equipment are accompanied by corresponding documentation support and comply with the requirements of the FDA in the United States and the GMP in the European Union, providing documentation support for customers' subsequent upgrades and modifications.

Formula Control Based on ISA S88 Standards

• In response to the formula control requirements of the project, technical documentation that complies with ANSI/ISA S88 standards has been compiled. The standard formula program for the batch control system provides customized batch reports after the completion of each batch. This not only reduces the workload of personnel but also improves the accuracy of data, while ensuring its traceability.

• Evolution from the conventional CM/EM/UNIT structure to the CM/CG/EM/UNIT structure: The newly added CG is used to resolve the limit on the number of valves called by SFC programs, thus avoiding logical confusion caused by repeated calls to equipment. At the same time, it simplifies the program structure, greatly enhancing the readability of the code and design documentation.

Effectively interact and control signals with third-party PLCs

• Network communication with third-party equipment ensures the real-time and reliability of data on the DCS. Data acquisition from reaction tanks and CIP cleaning systems allows for the output of reports, while coordination between the water system, large centrifuges, and reaction tanks ensures smooth operation. The DCS's control over the entire system guarantees the automated operation of the factory.

• Through the system, automatic control of the process flow, analysis of equipment operating status, and real-time data management are achieved, comprehensively enhancing the factory's automation and quality control levels, providing robust support for vaccine quality and safety.