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.
The Project
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 organised 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 Approach
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 could control airborne particulate contamination at an acceptable level. This level of control is essential for the safe and efficient production of SpectrumX’s non-pharma product line.
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 begin 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 Results
The client was highly satisfied with the work 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.” Damien Hancox, 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.
