Pharma Manufacturing Design & Installation of New Line
Integrated Life Science Group (ILSG) successfully executed a turnkey £5.5M upgrade for LEO Pharma to enhance their semi-solids manufacturing and filling capabilities at their manufacturing facility in Crumlin, Dublin.
The project was the result of a strategic decision by LEO Pharma to expand their portfolio of semi-solid products and involved the design and construction of a 200m2 class7 clean room equipped with a 6-tonne main mixing vessel, a 1-tonne side vessel, two 6-tonne storage vessels, and an 80 upm filling line.
ILSG's scope of work was comprehensive and included project and cost management, equipment design overview, equipment selection, vendor management, full validation documentation, and installation and commissioning.
Working collaboratively with LEO Pharma, the ILSG team developed and qualified all elements of the project. The use of a dynamic validation solution during the works played a significant role in ensuring the success of the project. This innovative approach made it possible for LEO Pharma to supply finished product into the market sooner than anticipated.
The project was completed in line with the agreed budget and original timeline. This highlights ILSG's ability to efficiently manage complex projects without compromising on quality.
By effectively managing the project from design to commissioning, ILSG ensured that LEO Pharma could expand their product range without any delays or unexpected costs.
The success of this project underscores the value of a collaborative approach.
By working closely with LEO Pharma, ILSG was able to fully understand the client's needs and deliver a solution that exceeded expectations.
LEO Pharma expressed their satisfaction with the project, stating:
"We are delighted with Integrated Life Science Group's exceptional execution of our £5.5M semi-solids manufacturing upgrade in Crumlin, Dublin. Their precise planning, expert construction, and innovative validation approach enabled us to enter the market promptly, surpassing our projections. We highly endorse ILG for their unparalleled professionalism and expertise."
ILSG's handling of the £5.5M upgrade for LEO Pharma's semi-solids manufacturing facility in Crumlin, Dublin, is an excellent example of how integrated project management, combined with industry-specific expertise, can deliver outstanding results and serves as an important benchmark for similar projects in the future.
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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.
