240m² Multi-Room Cleanroom Facility For Medicinal Cannabis Production
Curaleaf operates an MHRA-licensed facility, specialising in the production of tailor-made medicines for patients when standard options are either unsuitable or unavailable. Curaleaf appointed Angstrom Technology to build a 240m2 mezzanine cleanroom extension to a pre-existing ground floor cleanroom, which included many different areas to meet the needs of Curaleaf’s production processes.
GMP Classified Manufacturing Facility
10 Rooms
Materials Airlock Lift
Mezzanine Floor
Temperature & Humidity Control
Gallery
The Client
With a facility based in Sunderland, Curaleaf’s MHRA-licensed premises produces and distributes unlicensed medicines, commonly referred to as ‘specials’. A key area of growth for Curaleaf is in medicinal cannabis, where there is a requirement to scale up production to meet the demands for various dosage forms.
Given the focus on medicinal cannabis production, Curaleaf required a cleanroom that would meet strict regulatory requirements for medicinal manufacturing and provide scalability for future growth.
The Project
Angstrom Technology was appointed to create a large mezzanine cleanroom with several different areas, above a pre-existing cleanroom. Classified to GMP standards, the cleanroom is essential for the segregation of tasks, ensuring cross-contamination risks are minimised and maintaining the integrity of Curaleaf’s production environment.
Curaleaf had a User Requirement Specification (URS) in place from the outset, which included a variety of must-have features. Our team worked closely with Curaleaf to ensure these requirements were not just met, but exceeded, particularly in the areas of air handling and environmental controls.
The build for this project included:
- Change Area – GMP grade C
- Manufacturing office – GMP C
- 5 x Manufacturing Rooms – GMP Grade C
- Wash Room – GMP Grade C
- Materials Airlock Lift
Planning and constructing a cleanroom on a mezzanine above an existing cleanroom presented unique challenges. The onsite team had to penetrate the roof of the below area and place steel supports in to hold the mezzanine, and then lift the duct work off the area underneath, to allow the space for the mezzanine itself. All duct work for both the ground floor and mezzanine level now run along the ceiling of the mezzanine, meaning all space below can be utilised efficiently.
Angstrom’s ability to install a new air handling unit (AHU), utilise almost all available space, and manage the complexities without disrupting ongoing regulated activities was crucial. The whole process was managed carefully to avoid downtime, ensuring Curaleaf’s facility remained fully operational throughout.
The material airlock lift (MAL), connects the first and ground floors, allowing material to flow seamlessly between production stages.
The temperature and humidity controlled dry room is vital for the stability and quality of Curaleaf’s medicinal cannabis products.
Once the cleanroom had been completed, the team had to complete remedial works to the existing production area below, as the construction of the mezzanine created a dirty area. As the below cleanroom also has a GMP compliance requirement, the Angstrom Technology team completed validation to ensure compliance again.
Scaled-up Production
The new cleanroom has allowed Curaleaf to improve workflow through appropriate segregation of tasks and ample space for their operations, reducing downtime and the risk of errors, and enabling the team to considerably scale up production efficiently. The increased room sizes also support future expansions, and the temperature and humidity-controlled dry room allows Curaleaf to develop new products and expand their offerings in the future, opening up new revenue streams.
Operational efficiency has also improved, with better task segregation and improved workflows, leading to cost savings in production as well as a reduced risk of regulatory non-compliance, which can be costly to address.
Curaleaf have also now hired new team members, creating unique employment opportunities within a rapidly growing sector.
Testimonial
We appointed Angstrom Technology after reviewing their previous case studies and undergoing a tender process. The relational approach really stood out in this process, with Angstrom offering a dedicated project manager onsite throughout the build. The entire team were highly responsive to our needs and kept us informed every step of the way; this level of communication and commitment was key to the success of this project for Curaleaf.
Our new cleanroom has been a pivotal part of our ability to maintain supply to an ever-expanding patient base; while ensuring we meet all regulatory requirements. Ultimately, the cleanroom has positioned us to grow our business more sustainably, meeting the needs of our customers, and providing a clear path for long-term financial returns, thank you Angstrom Technology!
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