Packaging Works at Vaccination Facility
In response to the growing demand for flu vaccines, CSL Sequirus, the largest biotechnology site in the UK, were required to expand their vaccine production capabilities.
CSL Sequirus enlisted the expertise of Integrated Life Science Group (ILSG) to develop and qualify all elements of the project.
The project involved the design and overall installation management of a new 19,000 square foot secondary packaging works within their new vaccination production unit at their manufacturing facility in Liverpool.
From the initial stages of the project, ILSG worked closely with CSL Sequirus to develop and qualify all aspects of the new expansion.
The collaboration was built on mutual understanding and a shared goal: expanding vaccine production capacity to meet the demands of global flu campaigns.
The ILSG team managed the project with a meticulous approach to ensure that all elements were designed, selected, and installed seamlessly.
The scope of work covered Project & Cost Management, Equipment Design Overview, Equipment Selection, Vendor Management, Full Validation Documentation, and Installation and Commissioning. Each of these elements was crucial in ensuring that the project met its objectives and was completed within the set timeline and budget.
The project was a success. The new 19,000 square foot secondary packaging works enabled CSL Sequirus to significantly increase their vaccine production capacity. This expansion facilitated improved distribution and accessibility of flu vaccines, ultimately contributing to better public health outcomes.
The project's success can be attributed to ILSG's proven expertise and professionalism.
Their project and cost management skills ensured that the project was completed within budget without compromising on quality. Their equipment selection and vendor management capabilities ensured that the best equipment and supplies were used for the project.
Furthermore, ILSG's full validation documentation and commissioning ensured that the project met all quality standards and requirements. This was integral in ensuring that the project not only met CSL Sequirus's needs but also complied with all relevant industry regulations and standards.
"Collaborating with Integrated Life Science Group on our vaccination production unit expansion was a testament to their professionalism and expertise. Their meticulous approach to design and installation management seamlessly addressed our need for increased vaccine production capacity. ILG's dedication to excellence significantly contributed to our ability to meet the demand for flu vaccines, ultimately improving public health outcomes."
CSL Sequirus.
ILSG's work on the CSL Sequirus project is a testament to their expertise in managing and executing large-scale projects. Their meticulous approach to project management, their dedication to excellence, and their commitment to delivering quality results significantly contributed to the success of the CSL Sequirus project.
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The Integrated Life Science Group (ILSG) recently undertook a significant project with SpectrumX, a leading pharmaceutical company. The project involved the design, procurement, installation, commissioning, and qualification of a new 16,000 sq. ft manufacturing facility. The facility was set up at SpectrumX’s production unit in Knutsford, paving the way for the launch of a non-pharma product line.
One of the primary objectives for SpectrumX was to introduce a non-pharma product line ahead of their respective pharmaceutical products. The new facility was not just a significant addition to SpectrumX’s infrastructure but also a strategic move aimed at diversifying the company’s product portfolio.
The ILSG team worked diligently on SpectrumX’s behalf to ensure a phased approach was implemented for the facility. This approach ensured that all the stages of the project were carried out in a structured and organized manner, mitigating potential risks and addressing challenges promptly.
The scope of work covered by ILSG was comprehensive. It included the overall manufacturing facility design, HVAC Specification, and validation to ISO8, equipment installation and qualification, validation to allow GMP ‘drug substance’ manufacturing, and development of an Aspectic Fill Finish Suite.
The HVAC Specification and validation to ISO8 were especially critical. The HVAC system plays a crucial role in maintaining a controlled environment within a pharmaceutical manufacturing facility. By aligning the new facility to the ISO8 standard, ILSG ensured that the HVAC system was capable of controlling airborne particulate contamination to an acceptable level. This level of control is essential for the safe and efficient production of SpectrumX’s non-pharma product line.
Additionally, ILSG also worked on the equipment installation and qualification. This process involved assessing the equipment to ensure they meet the specific operational requirements. With the equipment correctly installed and qualified, the new facility was ready to commence GMP ‘drug substance’ manufacturing.
The development of an Aspectic Fill Finish Suite was another crucial part of the project. This suite is a highly controlled area where the final stages of pharmaceutical manufacturing are carried out. By developing this suite, ILSG has provided SpectrumX with the capability to carry out the fill-finish process in-house, further enhancing their operational efficiency.
The client was highly satisfied with the work done by ILSG. “SpectrumX commends I.L.S. Group for their exceptional service in designing, procuring, and commissioning our 16,000 sq. ft manufacturing facility. Their unwavering commitment, meticulous attention to detail, and innovative solutions exceeded our expectations. I.L.S. Group is highly recommended for their professionalism and outstanding results in complex projects.” Joe Bloggs SpectrumX.
This project demonstrates the proficiency and expertise of ILSG in managing complex projects in the pharmaceutical industry. It also highlights the importance of a phased approach in achieving project goals and objectives.
References:
- International Organization for Standardization. (2019). ISO14644-1:2015 Cleanrooms and associated controlled environments — Part1: Classification of air cleanliness by particle concentration.
- U.S. Food and Drug Administration. (2018). Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice.
- World Health Organization. (2014). WHO guidelines on good manufacturing practices (GMP) for pharmaceutical products.
