API Project

Ardmac were entrusted with a Design Build Turnkey Package for a Quality Control Laboratory associated with a new API (Active Pharmaceutical Ingredient) facility in Ireland. In addition to this scope, Ardmac were awarded the Architectural envelope of the cleanroom facility and a critical containment facility blast wall.

This comprehensive undertaking encompassed various crucial components, including a Quality Control (QC) Laboratory, Filter Drier, Scrubber, Solution Preparation area, and a spacious multi-level Process Ballroom, complete with numerous supporting rooms across three floors. Ardmac played a pivotal role in the initial design and subsequent construction phases, addressing structural, architectural, mechanical, and electrical aspects of the cleanroom and laboratory package. Collaborating with specialist trade partners and under the supervision of Jacobs Engineering as Project Integrator, Ardmac ensured the seamless execution of the project.

Integrated Approach:
Ardmac adopted an integrated approach to instil clarity and confidence in the design and subsequent installation of the Blast Wall system. Identifying secondary steel requirements at an early stage (BOD) optimised constructability and ensured compliance with the necessary blast and fire ratings. Potential future services and facility adaptation needed to be considered and accounted for in the design with more than 250 service penetration points for current and future process requirements.

Blast Wall Solution:
One of the critical components of the API facility is its blast wall. Ardmac successfully designed and supplied an extensive multi-storey blast wall solution, standing at an impressive 18 meters in height and encompassing 1000sqm. This
50Kn/M2 blast wall design was instrumental in meeting the client’s stringent blast resistance requirements for the project and for providing future process development and adaption requirements. The design, construction and independent body certification of the blast wall demonstrates our commitment to safety and quality.

Coordination of Service Penetrations:
The project presented numerous challenges related to service penetrations, which Ardmac adeptly coordinated with our trade partners. The Ardmac Design Team played a crucial role in providing innovative solutions to these challenges, ensuring a smooth project design and construction process. Due to the nature of the blast wall construction all service penetrations had to be fully co-ordinated in advance of construction.

HVAC System:
Ardmac was responsible for the design, supply, and installation of the complete HVAC system associated with the QC Laboratory area and its associated support rooms. Our scope included Air Handling Units (AHU), primary and process extract systems, associated ductwork distribution systems, and the CAV and VAV system associated with the safe operation of the facility. The full lab HVAC system was controlled using a system of CAV’s and VAV’s which integrated to both the HVAC and the fumehood and process extract systems with additional BMS integration.

Electrical Scope:
Our electrical scope of work encompassed the supply and installation of all electrical services within the QC laboratory and its support areas including distribution boards, distribution systems, general services, lighting and HVAC control cabling. Our scope also extended to the cleanroom area where we provided general services and specialist cleanroom light fittings, featuring top access for maintenance, controlled through ceiling-mounted Passive Infrared Sensors (PIRs), and equipped with a Central Battery-backed Emergency Lighting System.

Bespoke Door Interlock System:
A fully bespoke door interlock system was provided for the facility. The interlock system included the integration into a number of Decontamination Misting Showers and Automated Door Closers, this was meticulously developed to cater to the specific requirements of the project. Additionally, Ardmac provided a pneumatic door automation system for high-containment ATEX areas and offered seamless integration into the site security system.

Containment Safety:
The QC Laboratory saw Ardmac’s expertise in action, with the supply and installation of lab furniture, specialised fume hoods, and chemical storage units. The installation of a resin flooring system, Dagard walls, ceilings, and doors were seamlessly integrated. The facility in question is used in the production of API materials handling OEB 5 material, a critical safety element in the ability to contain any future leak of API to allow decontamination. With this in mind, the facility was constructed using Dagard walls, ceiling and doors from one of our key supply chain partners, the cleanroom and laboratory areas were constructed to achieve permeability in accordance with VDI 2083 Part 19. To achieve this, all penetration details to the facility were reviewed and detailed by Ardmac to ensure minimal leakage and a comprehensive book of penetration details were developed as part of the project to ensure compliance.

Commissioning and Certification:
Ardmac ensured that all areas were not only constructed but also commissioned to meet the client’s stringent safety standards. Through our continuous review of the client user requirement specifications, Ardmac developed an attributes assessment at an early stage in the design which was used to confirm compliance in design. Subsequently we developed SAT’s (Site Acceptance Tests) which were leveraged by the client into their qualification process. This included rigorous testing of the facility to ensure compliance with the end users requirements. Special attention was given to the independent testing of the containment under VDI 2083 which was the critical safety requirement for the facility. Ardmac also provided commissioning and certification to ensure the safe use of fume hoods and the overall functionality of the HVAC system.

Conclusion:
The API Project for our International Pharma Client based in Ireland was a testament to Ardmac’s commitment to excellence, safety, and innovation. Our integrated approach, collaborative efforts with trade partners, and dedication to meeting client requirements ensured the successful completion of this complex and vital project. The resulting facilities are built to facilitate OEB 5 product use and adhere to global safety standards, demonstrating our capability to deliver exceptional solutions in the pharmaceutical industry.