Pharma Newsletter Nov 2022
We’ve got News Ardmac Pharma Solutions Quarterly Newsletter Nov 2022
04 ANNEX ! IS FINALLY OUT
Hello from Ardmac,
Welcome to our quarterly newsletter, where we will keep you up to date with current developments and thinking within our Pharma Business Unit. The new Annex 1 has been published, after 7 years. We look at the updated guidelines and summarise the key highlights and takeaways. With this issue, we are celebrating 45 years in business. Colm Casey, Operations Director at Ardmac discusses our plan to take Ardmac to the next level and how our people will facilitate that journey. In other good news, Ardmac raised €68,000 for Pieta House at this year’s Cycle for Hope. Our head of innovation Chris Fitzpatrick featured in Chain Magazine’s cover story. We look at sustainable project delivery and highlight our achievements so far along with other news. We hope you enjoy reading and if there is anything you’d like to see in future issues, please let us know.
06 ARDMAC 45 YEARS
07 ARDMAC CYCLE FOR HOPE
08 GERMFREE SOLUTIONS
10 LCI ANNUAL CONFERENCE
12 SUSTAINABLE PROJECT DELIVERY
14 CHAIN MAGAZINE COVER STORY
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Chat to George Walker Business Development Director george.walker@ardmac.com 353868051723
Chat to Enda Murphy MD Cleanrooms
enda.murphy@ardmac.com 35385 8888340
Chat to Dermot McKenna Associate Director Business Development
Chat to Mark McCullagh Director Cleanrooms mark.mccullagh@ardmac.com 35386 8127170
dermot.mckenna @ardmac.com 353868135475
Chat to Mark Seymour Regional Manager UK mark.seymour@ardmac.com 00447785 324599
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Annex 1 is finally out! Finally the new Annex 1 is published, after 7 years. The challenge is how best to apply good science and GEP (good engineering practice), as the goal is to improve product quality and ultimately patient safety and wellbeing. The deadline for coming into operation of Annex 1 for both EMA and PIC/s documents is 25 August 2023, except for clause 8.123 which is postponed until 25 August 2024. New Annex 1 has 59 (58) pages Vs 16 in 2008 version The assessment of risks (hazards) across the entire manufacturing process (QRM), and having a coherent and comprehensive contamination control strategy (CCS) in in the new Annex 1 has been a core element of Ardmac’s best practice GMP cleanroom design and applications. For decades Ardmac’s engineers have been driven by the need for a detailed understanding of the process and hazards involved and the impact of contamination sources on client’s processes. The new Annex 1 is a culmination of a review and consultation process that started in 2015. The new EU-GMP Annex 1 is designed to encourage the use of new technologies in sterile manufacturing, the increased use of isolators and RABS designs as well as incorporating the changes in ISO Cleanroom Standards (ISO 14644 series of dashes).
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The fundamental approach in the new version is around a Pharmaceutical Quality System, with the application of QRM and risk assessment when developing a documented Contamination Control Strategy (CCS). This requires a thorough technical and process knowledge about potential sources of contamination.
The key highlights and takeaways include:
• Requirement to provide a formal contamination control strategy (CCS). This is a formal organisation-wide, risk- based strategy for minimising contamination and cross-contamination of medicinal products, based on QRM (ICH Q9 Quality Risk Management). • Importance of implementing the CCS across all departments and functions to define all critical control points and assess the effectiveness and monitoring of all the contamination control risks (design, procedural, technical, and organizational). • The CCS should not be treated as simply a document or a paper exercise created as a check box for compliance. It should be viewed as a living, breathing contamination control strategy of which all employees are aware and participate in. • The CCS must be updated as a routine, in order to drive continuous improvement of the manufacturing and control methods. • Of particular note in the cleanroom design for classification at ISO 5, clause 4.27 follows the guidance in ISO 14644-1:2015. Table 1 removes the requirement for classification at the ≥5.0µm particle size for Grade A and B, At Rest. However, note a) indicates “Classification including 5µm particles may be considered where indicated by the CCS or historical trends”. Other concentration limits are aligned with 14644-1:2015. There are also important clauses dealing with airflow visualisation and air velocity at the working position that require very careful consideration. Later blogs will address these specific requirements. In order to implement the new Annex 1 a high-level gap assessment is required to identify potential contamination hazards or risks. It’s important to update any previous risk assessments to ensure compliance with the new Annex 1. For newly identified contamination risks, appropriate control measures and monitoring systems should be designed and implemented. You can download a copy of the EMA here - https://health.ec.europa.eu/latest-updates/revision-manufacture-sterile-medicinal-products-2022-08-25_en
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Ardmac are proud to celebrate our 45th year anniversary. Our story has changed quite a bit since our establishment in 1977. We have grown from a small operation to the leading provider of manufacturing facilities across Europe. Colm Casey, Operations Director at Ardmac talks about our plan to take Ardmac to the next level and how our people will facilitate that journey.
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Team ardmac Cycled for Hope and raised almost €70,000 for pieta. This world Mental Health Day, we showed up, spoken loudly, and provided crucial support and services for people in need through Pieta House. A very big thank you especially to you to all who sponsored, domated, cycled, engaged with our social media and supported Ardmac in any small way. We are very proud of the Ardmac community for delivering a heart warming, successful event, looking forward to next year!
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germfree Global Cleanroom Solutions Germfree has manufactured innovative, compliant facilities and process equipment for six decades and delivered thousands of projects to experts across the globe. Our Biopharma Equipment and bioGO® Mobile and Modular Cleanrooms are Offsite-built, Process-ready and available in standard and custom configurations. It is the dedication of the Germfree team that enables rapid deployment of critical infrastructure both to cutting edge research facilities and the front lines of global health security
CASE STUDY Mobile Hospital
Compounding Pharmacy The remodeling of an I.V. pharmacy presents a range of potentially difficult or costly challenges. During building renovations it is imperative that compounding operations are not interrupted or otherwise negatively impacted
Client:
Undisclosed
Completion: Project Type Application:
September 2019
Mobile
Pharmacy
Location:
USA
Click here for more case studies
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lC I Annual CONFERENCE 2022 - CROKE PARK, DUBLIN - 2nd NOV Ardmac’s George Walker, with his wealth of knowledge around modular method of construction presented at the LCi annual conference on November 2nd at Croke Park. It was a wonderful event and Ardmac are very proud to sponsor. Did you catch us at Stream G: Offsite and Modular Construction? It was a very engaging presentation and we enjoyed the Q&A.
Ardmacs Fergus Nugent chaired Stream F: Leadership and Communication
The LCi Annual Conference is one of the leading Lean Construction conferences in the world. This Conference brings together our national community of learning and practice along with welcoming friends from all around the world.
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Sustainable Project Delivery
Sky Blue is Ardmac’s CSR commitment. We work within the recognised pillars of CSR; Workplace, Marketplace, Environment and Community. When we succeed, our staff, community and society does too. By encouraging wellbeing, giving back to our community and working in sustainable ways, we not only improve people’s lives but also our business. Our Sky Blue program is our CSR framework guiding our responsible business approach and outlining our sustainability commitments. Ardmac operates and maintains a certified ISO 14001 : 2018 certified Environmental Management System, part of which contains procedures and tools to ensure all construction waste is managed in a controlled manner to minimise the potential environmental impact of our construction operations.
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ACHIEVEMENTS:
Environmental Management System certified to ISO 14001. Currently achieving 99.5% waste (max. achievable) diverted from landfill. Targeting waste reduction of 5% per annum. Engaging with vendors to minimise packaging. Purchasing departments tracking percentage by cost of materials sourced responsibly. Off-site prefabrication where practicable. Energy Management System certified to ISO 5000. Scope 1 & 2 Emissions measured and assessed. Targeting 3% per annum reduction in CO2e from offices.
Power to all company owned facilities from 100% renewable power generators. Targeting 10% reduction in CO2efrom LGV Fleet vehicles by end 2022. Transition to zero emissions vehicles for LGV fleet by 2030. Strategy for reducing scope 3 emissions from business travel (flights, grey fleet etc.) in development for roll out Q4 202.
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OCTOBER 2022 | The latest issue of CHAIN is LIVE!
CHAIN is a global digital supply chain magazine on a mission to uncover the most recent news stories and best practices impacting on the world’s ever-evolving supply chain industry. Each edition, we bring you exclusive interviews courtesy of the biggest names in the business, together with must-read stories to whet your appetite for the latest industry activities.
Driving performance, empowering people & delighting clients.
CHRIS FITZPATRICK, Head of Innovation and Technology at Ardmac, charts his company’s digital transformation journey
In the 45 years since its inception, Ardmac has earned itself a reputation not just for delivering results, but for exceeding client expectations. This has not gone unnoticed; what was once a small Irish operation is now the leading provider of high-tech cleanrooms, data centre solutions, fit-outs, specialised refurbishments, and turn-key manufacturing facilities across Europe. Group turnover within Ireland alone last year was €75million, while overall turnover was closer to €135million. The past 12 to 18 months have seen Ardmac complete a whole range of significant projects across Ireland, the UK and Europe; these included a 15,000 square metre cleanroom facility for WuXi Biologics in Dundalk, a large microelectronic project in Kildare, several data centre projects in Europe, and several high-end commercial fit-outs in Ireland and the UK. Key recent wins have included large pharma facilities in Limerick, Cork and Finland, data centre projects in Denmark, Germany and Austria, and battery facilities in the UK. Modular construction is fast becoming a key part of the group’s activity. Having already delivered several such projects across Europe, its first modular project in Africa is on track to be delivered by the end of 2022. So far this year, the company has been working on several large campus sites, securing further phases.
Click here to read full article
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Ardmac Dublin Swords Business Campus, Swords, Co. Dublin, K67 D8H0, Ireland. E: info@ardmac.com T: +353 (0) 1 894 8800 Ardmac Manchester 4 Scholar Green Road , Cobra Court,Trafford Park, Manchester M32 0TR, England. E: info@ardmac.com T: +44 (0) 161 8668086
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