Views: 393 Author: HOWCOOL Publish Time: 2024-11-22 Origin: Site
Beijing HOWCOOL has completed the construction of the antibody drug R&D manufacturing plant cold storage project for a well-known pharmaceutical company and has successfully passed the acceptance and delivery
Client Background:
The pharmaceutical company is an innovative biopharmaceutical enterprise with comprehensive capabilities in research and development, production, and commercialization. The company focuses on the field of immunology, with a strategic layout covering autoimmune diseases through a collaborative department approach, and tumor immunology with a focus on different cell types as targets. The company offers a wide and diverse range of products and solutions for patients.
Project Description:
This cold storage project is primarily designed for the research and production of antibody drugs. It includes nearly 20 cold storage rooms, such as raw and auxiliary materials cold storage, finished products cold storage, turnover storage, and low-temperature freezing rooms. The project follows various standards and regulations, including the Pharmaceutical Production Quality Management Standards, the Chinese Pharmacopoeia, GSP Drug Distribution Management Quality Standards, FDA guidelines, GMP, Pharmaceutical Cold Chain Logistics Temperature Control Equipment Performance Verification Technical Specifications, and more than 20 national and international standards.
The entire project was implemented and completed in strict accordance with the detailed requirements of the international and domestic biopharmaceutical fields. It underwent rigorous design and testing validation processes, including DQ (Design Qualification), IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification), FAT (Factory Acceptance Test), and SAT (Site Acceptance Test). The validation results demonstrate that the cold storage project meets the design requirements in terms of insulation performance, equipment operation, power failure testing, door-opening temperature excursions, refrigeration efficiency, and response time. Specifically, the -40°C low-temperature freezer maintains a temperature deviation of 5°C, and the power failure insulation time is up to 1 hour and 33 minutes. The 2-8°C refrigerated storage room maintains insulation for 2 hours and 38 minutes after a power failure.
This project was successfully completed by first thoroughly understanding the client's needs and the standards to be achieved. The company's technical team, through professional design optimization, precise on-site quality control management, and comprehensive construction progress monitoring, worked diligently to ensure the successful delivery of the project. After six months of use, the system's performance and functionality have received high recognition from the user. Below are some on-site images from the execution of the project.
Medical cold storage cooling units
Temperature-controlled storage for pharmaceuticals
ultra-low temperature cold storage
Cold storage design and construction
Refrigeration equipment electronic control system
Medical cold storage design Howcool
Temperature-controlled storage online
