Pharma Newsletter-April 2024

Ardmac Fit-Out & Refurbishments Quarterly Newsletter July 2021

We’ve got News

Ardmac Pharma Solutions Newsletter April 2024



Hello from Ardmac,

Reach out to Enda Murphy Managing Director Cleanrooms & Pre-Construction +353 (0) 85 888 8340


Welcome to our newsletter, where we will keep you up to date with current developments and thinking within our Pharma Business Unit. In this issue we are proud to share some recent case studies we have been working on, including an API Project, Blast Wall Solution and Cleanroom. We will also share a blog surrounding the new ISO 14644-4 guidelines. Finally we take a look at a number of campaigns we are working on, including our goal to become net zero by 2030, our women in construction focus and our new plans around pollination for 2024, signaling our commitment to biodiversity conservation. We hope you enjoy reading and if there is anything you’d like to see in future issues, please let us know.



Reach out to Dermot McKenna Associate Director Business Development +353 (0) 86 813 5475

Reach out to Mark McCullagh Construction Director +353 (0) 86 812 7170






API Project Design & Build Turnkey Package for a Quality Control Laboratory

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

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. 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 This comprehensive 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.



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. Client: Confidential Location: Ireland Project Size: 1450 sqm



Blast Wall Turnkey Design & Build of the Cleanroom Facility Including Blast Walls

Blast Wall Solution:

Blast Wall Product Components

Ardmac were awarded the Turnkey Design & Build of the cleanroom facility including Blast Walls for an international pharmaceutical client in Ireland. A critical component of the API facility was 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 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. This project included many innovative and challenging designs. The project team worked closely to ensure the ‘first of a kind’ installations were successfully achieved. The required Blast Resistance of 50kN/m² meant Ardmac had to co- ordinate and design the various elements of the blast wall system as required to build the walls, bulkhead and linings required for the space. The Ardmac Architectural Design Team worked to provide solutions for any challenges that arose during the project design phase of this prestigious pharmaceutical project. An integrated approach was taken to provide clarity and confidence in the design and subsequent installation of the Blast Wall system by Ardmac. Our team was available onsite to support all parties involved with answers to questions arising during the construction to avoid unnecessary delays.

20mm Corex A1 Board was used to provide 120 minutes fire protection to the structural steel members. This was installed before external walls were erected. This meant that the product needed to be suitable for exposure to the elements. Corex A1 Board can be left fully exposed for up to 6 months prior to the building becoming weathertight. 9.5mm thick Impact Board is tested to provide fire and blast resistance. Impact Board was used in this project to form fire and blast resistant barriers with fire performance of 120 minutes and blast resistance of up to 50kN/m² on all walls. The design, construction and independent body certification of the blast wall demonstrates our commitment to safety and quality.



turnkey CLEANROOM Design & Build Turnkey Cleanroom in an Existing Facility

Ardmac were contracted to provide a Design & Build Turnkey Cleanroom in an existing facility, consisting of approximately 3500 square meters of ISO 8 Cleanroom, non-classified White Room, fit out of offices, meeting rooms and staff facilities for one of our global Medical Device clients in Waterford. Our architectural and structural scope involved the design and construction of a new mezzanine floor for the offices and new gantry cranes to service the cleanroom areas. Our design prioritised safety by implementing robust fire safety measures throughout the facility. The dividing firewalls, including all fire rated windows and doors along the firewall, compartmentalised the two cleanrooms and office areas, allowing suppression systems to protect neighbouring rooms, effectively enhancing overall safety. Our mechanical scope involved the design, supply, and installation of all mechanical services within the Cleanroom and offices areas, including HVAC systems, a compressed air system with strategically located live tap-ins throughout the Cleanroom facility, a central vacuum system with conveniently located inlets, cold and potable water supplies, drainage and sprinkler. Our electrical scope of work encompassed the design, supply, and installation of all electrical services within the Cleanroom and offices areas, including distribution boards, distribution systems, HVAC control cabling, general services, specialist cleanroom light fittings controlled through ceiling-mounted Passive Infrared Sensors (PIRs),

and equipped with a Central Battery-backed Emergency Lighting System. Ardmac demonstrated ingenuity on the project by incorporating specifically designed service plates. These plates provide the critical services needed for the client’s equipment, in a flexible solution allowing for the seamless movement of equipment in and out of the facility. This flexibility is crucial for the client, allowing them to adapt to changing technological needs, providing the ability to replace outdated machinery with new equipment without disruption. For this project, Ardmac used the latest technologies such as BIM to generate a clash free model, LEAN processes to bring value to the client and the use of integrated scheduling coupled with strong Project Management. The Ardmac PM on this site tells us ‘It is as important as anything else in the project to ensure that the client has trust in what we are doing’. Ardmac earns that trust by consistently delivering high-quality results that meet and exceed expectations. Our approach adds value to any cleanroom construction project and that is why Ardmac has become a trusted partner in the industry.

Project: Medical Device Cleanroom Client: Confidential Location: Waterford Project Size: 3500 square meters



The Ardmac approach to applying the new ISO 14644-4 In our Annex 1 blog #4 we concluded that the key takeaway from the new ISO 14644-4 guidelines was the importance of science-based cleanroom design around the “surrounding” airflow patterns and contamination removal effectiveness, rather than a “rule of thumb” table of Air Change rates. Right now, our challenge in GMP Cleanrooms is to move focus away from the air change rate table. Instead, we need to understand the science around contamination control and change our narrative from a table of Air Change Rates to air volume flow rates with new metrics of Air Change Effectiveness (ACE) and Contamination Removal Effectiveness (CRE). Effective airflow design, verified through airflow visualisation studies and local airborne particle counts in cleanroom grades without unidirectional air flow (UDAF), promotes: Improved behaviour Enhanced cleaning and disinfection practices Confirmation of these benefits should be obtained through traditional viable Environmental Monitoring (EM) data.

processes, and activities, for effective contamination removal, i.e. the HVAC design. The good news is that this is a particular area of Ardmac’s technical expertise. We have advanced HVAC design tools, along with integrated BIM and CFD (Computational Fluid Dynamics). These tools, that were expensive in the past are now routinely used in an integrated cleanroom design approach. HVAC technology has moved forward significantly since the late 90’s when the original ISO 14644-4 was being developed. If we go back to the traditional table of air change rates again; the air change rate metric should not be discarded, it is still a useful reference. The recommended approach in Cleanroom design and adherence to Good Engineering Practice (GEP) suggests that the air change rate is an outcome of effective design. It should be calculated after establishing the supply air volume flow rate, rather than being the initial consideration. The more precise term introduced in the recent ISO 14644-4 is Air Change Effectiveness (ACE) Evolution and Application of ISO 14644-4:2022 The new ISO 14644-4:2002 recognises that cleanroom technology has matured since the standard was developed in the mid 1990’s, before the internet was freely available. As a result, the new standard is not a ‘cook book’, rather it contains the relevant “things to be considered” as best practice in cleanroom design. The new -ISO14644 Part 4 has an extensive bibliography as reference material for more detailed design guidance on

HVAC, utilities, material, and component selection, etc.

The downside of the new ISO 14644-4:2022 is that we need to understand the process and the contamination risks to carry out an effective cleanroom design. We’re back again to QRM (Quality Risk Management) and a CCS (Contamination Control Strategy) in the new Annex 1. When we apply the new ISO 14644-4:2022 standard in the context of the new Annex 1 then we design our GMP cleanroom, based on understanding the process(es) and risks to the product, with a focus on the user requirements and contamination removal effectiveness, considering energy efficiency (ISO 14644-16:2019). We apply the principles of QRM and develop a CCS taking into account the URS (User Requirements Specification) from Annex 15 (Q&V) and data integrity from Annex 11(DI), resulting in the most effective and efficient GMP Cleanroom design, all with a laser sharp focus on contamination removal effectiveness. The new ISO 14644-4:2022 presents several different formulas for calculating the correct supply air volume flow rates based on the process and expected emissions rates from the activities, including people movements and interventions, equipment processes and material handling. In addition, the new ISO 14644-4:2022 standard offers 2 types of ventilation effectiveness, called indices. These are Air Change Effectiveness (ACE), and Contamination Removal Effectiveness (CRE).

The Importance of assessing Air Change Rate Tables It’s probable that the Air Change Rate table has been quoted and misused for over 2 decades. To enhance energy efficiency without compromising product quality or patient well-being, it is advisable to implement best practices outlined in ISO 14644-4 and -16 within the context of the new Annex 1. By leveraging the clauses in Annex 1, users can address routine compliance challenges while simultaneously decreasing air volume flow rates, contributing to a more sustainable and efficient system. The airborne concentration in a non-UDAF cleanroom is determined by the airflow patterns created by the dilution of HEPA filtered air with room air and varies considerably depending on

the emission rates from the people, activities, the process, and material movements. The air change rate, which is the total air volume flow rate divided by room volume, is purely a mathematical formula. Therefore this simplistic formula should not be used as the starting point in the design of a cleanroom. This can lead to higher airborne concentrations than expected in small rooms. It can also lead to lower airborne concentrations than necessary in larger rooms, with associated high capital and energy costs. Contamination Control Strategy in HVAC Design A key element of the CCS (Contamination Control Strategy), required by the new Annex 1 is to understand the process, the hazards and impact of possible contamination, and then design the airflow patterns around the Cleanroom, the

Click here to continue reading article



What is your GMP Cleanroom Contamination Control Strategy (CCS)?

Imagine a scenario where your organisation is gearing up for a regulatory audit and you have been tasked with supporting their preparation of a Cleanroom Contamination Control Strategy (CCS).

The CCS outlines the key decisions and scientific rationales for contamination control, and is based on a detailed understanding of the process, contamination risks/hazards and contamination source strengths, i.e. the application of QRM. The CCS is focused on where the product or process is exposed and at risk, critical control points (CCPs) and mitigation controls, applying the best available technologies and in an integrated and holistic manner. The CCS will address all aspects of the control measures, (Physical, Organisational and Procedural) under the following fundamental categories:

There are many views of what a CCS should look like. It could be a separate document file, like a Site Master File (SMF) OR Quality Management System (QMS), while others take the view that the CCS is a high-level document, is not expected to be a Bible but does reference other parts of the SMF and QMS, thereby avoiding unnecessary duplication. It is important to demonstrate to the auditor that you understand the critical quality attributes (CQAs), the critical process parameters (CPPs), the critical control points (CCPs) in the environment, the hazards at each risk, the consequences and what we need to do to protect our patient.

Engineering Controls

• People and Material controls, Gowning and Behaviour • Ongoing Cleaning & Disinfection

Click here to continue reading article



#ArdmacEvents Ulster University

#ArdmacEvents Advanced Therapies Karen O’Hara, Head of Sales and Marketing and David Higgins, Project Manager in attendance. Germfree’s self-contained, cGMP BioPharma Cleanroom trailers are deployed for a range of applications where a dedicated or limited-scale cGMP-compliant facility is required, bringing advanced capabilities when existing infrastructure is insufficient or unavailable. Learn more about our mobile and modular offerings here: THE ANNUAL KICKSTART EUROPE CONFERENCE Ardmac’s Jason Casey, Managing Director of Operations and Peter Lonergan, Associate Director Pre-Construction, were in attendance at the Kickstart Europe Conference in Amsterdam on February 26th and 27th. ​KickStart Europe is the Annual Strategy & Networking conference on trends and investments in tech and digital infrastructure. By bringing together an array of industry professionals at the start of the year, Kickstart Europe helps to explore the emerging trends and technology shaping the digital industry and digital infrastructure of cloud, connectivity and data centers. #ArdmacEvents

Ardmac’s Architectural Manager, Ciaran McMahon was guest speaker to the Architectural Technology and Management students at Ulster University. Ciaran informed the class of best practices in managing larger projects using BIM and collaborative working practices. He discussed the importance of setting up projects in a cloud-based location, enabling seamless work sharing and collaboration amongst team members.


CIF Women in Construction

Catherine Greene, Senior Quantity Surveyor at Ardmac, represented Ardmac as a panellist at the International Women’s Day event on 7th March at Castleknock Hotel, Dublin, hosted by the Construction Industry Federation (CIF). We are grateful to have such a diverse and talented group of individuals driving our company forward. Thank you to all the amazing women at Ardmac for being a driving force behind our success. #InspiringInclusion

April 16-18 ISPE Europe Annual Conference 2024 Ronan Quinn, Mark McCullagh & Karen O’Hara

April 16-18 Interphex Conference 2024 Enda Murphy

April 23-24 Lab 2 Cleanroom Dermot McKenna

#ArdmacEvents Upcoming events

Schedule a meet up with one of the Ardmac team. Contact us directly or through Linkedin. We would be delighted to see you at any of the following events



Bulbs Out Bees In






Schools & Colleges 222 Community Groups 171 Pledger Companies 73

year being part of this wonderful initiative building awareness, advo- cacy and most of all taking action. Pollinator Plan: Introducing a groundbreaking initiative, the first colaboration with the All-Ireland Pollinator Plan, it offers a com- prehensive toolkit comprising 42 pollinator-friendly actions. As partners of Host in Ireland, we will be participating in this vital en- deavour, signaling our commitment to environmental stewardship and biodiversity conservation.

As the world becomes increasingly aware of the crucial role bees play in our ecosystem, gardeners are seeking ways to support these vital pollinators. One simple and effective method is planting bulbs specifically chosen to attract and nourish bees. From vibrant tulips to delicate crocuses, these floral delights not only add beauty to our gardens but also provide essential food sources for bees. By 2050, we could lose 90% of the bumblebee population in Ireland. In 2019, they were down 24% year on year. 1/3 of our 101 wild bee spe- cies are under threat of extinction. DCs for Bees Purpose Ardmac are members of the initia- tive “DCs for Bees” who’s purpose is to halt the decline of bees in Ireland and beyond.This is our 4th

3,587 Orchards =

Why Bulbs in the Community This is an extension of the Orchards in the Community project. Bulbs bloom early in the Spring, providing an essential source of nectar and pollen for pollinators that emerge from hibernation or overwintering.They are hardy and adaptable, making them suitable for various garden settings, including rock gardens, borders, and meadows.

Recommended Bulbs



Grape Hyacinth (Muscari)


250 Bulbs per Orchard =



WOMEN IN CONSTRUCTION International Women’s Day 2024 and beyond, let’s #InspireInclusion.

We reached out to some of our staff members, Caoimhe Matthews, Recruitment Manager in HR and Lisa Donnegan, Design Lead in Engineering to share their experiences. To see their videos please click on the below links

WIC AWARDS It is the first year of the WIC awards and we are excited to have entered 2 of our women in construction for excellence in their areas.The judges will be looking for experienced professionals who are making significant contributions to their company, projects and to the industry. Keep your fingers crossed for Justine and Thays!

Click here for Lisa Donnegan’s video

Click here for Caoimhe Matthew’s video S ee also the interviews we conducted

When women are discriminated against, we must call out poor practice. When the treatment of women is not equitable, we must take action. And we must do this each time, every time. When women aren’t present, we must ask: “If not, why not?” As a business, we recognise the valuable contributions that women bring to the construction industry and are proud to champion their skills and expertise. Together, we are #inspiringinclusion and shaping a more diverse and dynamic future for construction. gender equality and strive to build a supportive community where women can thrive and succeed.

In honour of International Women’s Day, we were delighted to celebrate the inspiring women within our workforce. This year’s theme was #InspiringInclusion, which is a reminder of the importance of representation and empowering all employees to reach their full potential. When we inspire others to understand and value women’s inclusion, we forge a better world. We are committed to supporting and empowering women in the construction industry. Our Women in Construction initiative aims to encourage and inspire more women to pursue careers in this traditionally male-dominated field. We believe that diversity drives innovation and creativity, and we are dedicated to creating a more inclusive workplace for all. At Ardmac it is of high importance for us to provide mentorship, networking op- portunities, and professional development resources for women at all stages of their construction careers. We actively promote

with our female graduates Lauren O’Shea Click here Helen Davies Click here Oana Duta Click here

“In Ardmac, we have a split 79% male to 21% female , which may not seem like a lot, but in general in construction according to the CSO it is on average 91% male to 9% female”

Thays Brito SHEQ Advisor Best Health & Safety Leadership

Justine Geminiani Pre Construction Lead Excellence in Senior Leadership Excellence in Project Management



Net Zero by 2030 Ardmac’s goal is to become Net Zero by 2030, and carbon negative thereafter.

Ardmac recognises the importance of environmental matters and is committed to promoting sustainability. Through our Sky Blue programme, we ensure that environmental protection is part of our daily operations and business decisions. We follow and promote good sustainability practices and work consistently to reduce the environmental impact of all our business activities. Ardmac are fully committed to ethically and responsibly managing all aspects of our operations, every day. We continue to work to reduce our carbon footprint, having implemented measures like the use of low-emission vehicles in our fleet and educating employees on sustainable commuting options. We also incorporate carbon reduction measures into project planning, including the selection of sustainable materials and construction techniques. At Ardmac, we’re as passionate as ever about this journey and we look forward to achieving our Net Zero goal. Link to our ESG Programme view/37771622/



Ardmac Dublin Swords Business Campus, Swords, Co. Dublin, K67 D8H0, Ireland. E: T: +353 (0) 1 894 8800 Ardmac Manchester 4 Scholar Green Road , Cobra Court,Trafford Park, Manchester M32 0TR, England. E: T: +44 (0) 161 8668086

Page 1 Page 2-3 Page 4-5 Page 6-7 Page 8-9 Page 10-11 Page 12-13 Page 14-15 Page 16-17 Page 18-19 Page 20-21 Page 22-23 Page 24

Made with FlippingBook - professional solution for displaying marketing and sales documents online