Ardmac Pharma Solutions Bi-Monthly Newsletter Sept …

Ardmac Pharma Solutions Bi-Monthly Newsletter Sept …

We’ve got News Ardmac Pharma Solutions Bi-Monthly Newsletter Sept 2021

Hello from Ardmac, In this month’s issue of our bi-monthly newsletter, we feature our Associate Director of Business Development, Dermot McKenna. Anyone who has worked with Ardmac in the past is sure to have come across Dermot as he has worked with Ardmac for over 30 years. He has made a fantastic contribution to our success over the years, so it is a privilege to feature him here.

04 MEET DERMOT MCKENNA

We are excited to share with you some insights into one of our recent Germfree projects.

06 GERMFREE CASE STUDY

We have a new blog about Cleanrooms, highlighting the benefits and exploring how they work and what makes a cleanroom‘clean’. This month our feature focus is on Sustainable Development and we are proud to share with you some of our goals relating to the environment, climate change, responsible business, innovation and community. Finally we are delighted to be raising awareness of our Cycle for Hope charity fundraiser which takes place on the 10th of October in Dublin.

08 WHAT IS A CLEANROOM?

14 SUSTAINABILITY ACTION

16 CYCLE FOR HOPE 2021

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Chat to Dermot McKenna Associate Director Business Development

Chat to Enda Murphy MD Cleanrooms

[email protected] 35385 8888340 Ext. 858

dermot.mckenna@ardmac. com

Chat to George Walker Associate Director Business Development

Chat to Mark McCullagh Director Cleanrooms

[email protected] 35386 8127170

[email protected] 353868051723

Chat to Philippa King-Smith Business Development Manager

Chat to Mark Seymour Regional Manager UK

[email protected] 00447785 324599

Philippa.king-smith@ardmac. com

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Hi, I’m Dermot McKenna, Associate Director of Ardmac. I’ve worked for Ardmac longer than I can remember, but it’s over 30 years so far. I am Ardmac through and through, I can’t imagine being anywhere else. I enjoy the challenges my job brings, the great culture within Ardmac and the world class clients we service. Early Career When I joined Ardmac, I started in the design department and over the years have been responsible for engineering, regional operations, group technical and currently; business development. This wide-ranging level of experience combined with my MBA and mechanical engineering background has enabled me to develop a well-rounded view of the world of cleanroom solutions. My understanding cleanroom applications, architectural product and their strategic selection, the move towards sub-assemblies andmodularisation allowsme to support our customers providing them with the best solutions for their fast track projects.

Associate Director Business Development M E E T dermot McKenna

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My Learnings Looking back over my career, if there is anything I’ve learnt, it’s that when you’re starting your career, it doesn’t matter what it is, you shouldn’t think too linearly about where you should be going. Be able to adapt, go sideways or go in a totally different direction. To move forward in life, you need to evolve your abilities, which will require ongoing education and changing direction to develop those essential skills. At Ardmac we have people that joined us as designers and ended up becoming construction managers because they’ve allowed themselves to change their direction to develop their construction skills and be a more well-rounded individual at the end of it. There are many benefits to this because not only does the individual still progress with their career, but from a customer perspective, they get the benefit of someone with a broader range of experience that can deal with all the challenges a complex project will bring. It’s a win win in my book.

ISPE & Enterprise Ireland #Biopharma Construction & Engineering event

LEAN Business Ireland

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germfree expert environments

Germfree was recently commissioned to work with a client who sought to expand their process space to deliver novel therapies both faster and at scale. Time to market is very important for our clients. From the clients experience, traditionally constructed cleanrooms have lengthy timelines which delay and disrupt time to market. This in turn negatively impacts revenues and life of patent. Needing rapid delivery and flexibility, our client contacted Germfree to explore the modular off-site approach.

Solution Exploration

As part of the first phase of the process the ecosystem was investigated. This included the entire scope,

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The Outcome

to comprise the cleanroom function, from the laboratory itself, to the location, internal process flows and engineering controls, but most importantly equipment selection. At Germfreewe offermuchof the standard cleanroom equipment such as Isolators, Safety Cabinets, LAF units etc., providing a seamless integration into the cleanroom space. We can also integrate client preferred equipment. With standardised designs we offer competitive solutions, as well as enhanced ease of operation, warranties and aftersales service.

The project was a great success and delivered a solution that was tailored to the specific process and time-to-market needs of the client.

About Germfree

Germfree is a leading manufacturer of mobile and podular cleanroom facilities, with applications across Biopharma, Biocontainment, and Pharmacy. Decades of experience in equipment design led Germfree to integrate its product offerings into turnkey labs— with equipment and facilities built in-house, in a climate-controlled facility for delivery around the globe. Germfree delivers enhanced flexibility to meet the needs of their clients. Tailoring solutions in this way is what differentiates Germfree in the market, all while delivering robust cleanroom solutions that outperform traditional methods of fabrication.

The Solution

Germfree’s Podular solution was chosen by the client as it offered a flexible design, quick outfitting, and delivery to an on-site shell building. This offers parallel construction activities reducing the overall project timelines. Germfreeprovidedasingle, assignedprojectmanager to work alongside the client across the entire project. Transparency and efficient communication were paramount to ensuring that the client’s needs were adequately addressed, and the impact of any changes were made known early in order to avoid delays. Throughout the journey, Germfree consulted with multiple individuals on the client side to coordinate their needs specifically. With an ever-changing landscape, both from the customer and regulatory standpoint, Germfree used their experience to overcome any issues that were encountered.

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What is a cleanroom?

A cleanroom is a controlled environment where provisions are made to reduce particulate contamination (along with other environmental parameters such as temperature, humidity, and pressure) to levels appropriate for accomplishing contamination- sensitive activities. A cleanroom environment is typically specified in industries such as aerospace, microelectronics, optics, nuclear and life sciences (pharmaceuticals, medical devices, food and healthcare).

ISO Standards determine the controlled level of contamination based on the number of particles per cubic meter at a specified particle size. An ISO Level 3 cleanroom, or Class 1 cleanroom, contains the least number of particles per cubic meter and the smallest specified particle size going down to 0.1 micron. At ISO Level 9, the environment is equivalent to normal room air with no control over the particle count or size. The tablebelowshows thevarious ISOlevelsand their corresponding cleanroom classification.

iso 14644-1 cleanroom standards

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benefits of a cleanroom.

Cleanrooms with a number of key benefits, firstly zero contamination. Controlling the entire provide organisations environment where sensitive processes are carried out is the only way that contamination can be eliminated.

Secondly, the right environment to meet the highest manufacturing standards and facilitating the needs of various industries. a cleanroom provides The most notable benefit, however, is that a cleanroom ensures compliance with strict industry or governmental regulations. Often this is the key driving factor behind the specification of cleanrooms and cleanroom

Establishing cleanroom requirements.

If you have requirements for a cleanroom, early engagement with your supply chain is the key to establishing the best environment for your manufacturing process. Speaking to a cleanroom specialist early will ensure alignment on the understanding of your needs, environmental compliance and regulatory requirements. This enables you to collaborate with design resources and commercial teams to develop your scope, progress the design, evaluate risks and develop a cost plan and construction strategy.

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What makes a cleanroom ‘clean’? A key part of a cleanroom is the air filter that is used to trap particles and enable the circulation of clean air within the room.

Personnel undertake extensive training in the protective measures that are determined for each controlled area. This may vary depending on the level of contamination permissible. This could include things like airlock entry and exit protocols, air showers and specialist personal protective equipment designed to trap contaminants that come from the body. The higher the classification of cleanroom, the more restrictions you have in place to ensure adequate control of contamination.

There are two main filter types used within a cleanroom; High Efficiency Particulate Air (HEPA) filters, which should remove particles 0.3µm in diameter and above and Ultra Low Particulate Air (ULPA) filters, which should remove particles as small as 0.1µm in diameter. Other factors that affect the cleanliness within a cleanroom are the things that are introduced into the environment. For example, process equipment or personnel. Each introduction must be carefully considered, and risk managed from a point of view of becoming a potential source of contamination.

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Clean air Technology

Alongside the use of HEPA or ULPA filters, cleanrooms maintain clean air through the use of air flow principles. Using unidirectional air flow systems to direct filtered air downwards in a constant stream or turbulent flow principles which, as the name suggests, offers multi directional air flow.

By managing the air flow within the cleanroom in this way, it is possible to move particles away from the operator and operating area towards the filters positioned in either the ceiling or the walls of the cleanroom. The particles are then captured in the filters and clean air is recirculated into the cleanroom. The diagram below shows the air movement within a cleanroom.

Air flow patterns in Clean room

Turbulent dilution of dirty air Turbulent Diluati of dirty air

Uni-directional / laminar displacement of dirty air Uni-directional / Laminar Displacem nt of irty air

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Ardmac prides itself in a proven in-house technical ability to take a client brief and develop a concept for the front-end design of a cleanroom facility.

To speak to a member of our team for further help or advice, call us on +353 (0) 1 894 8800.

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building better for our future Ardmac are fully committed to ethically and responsibly managing all aspects of our operations, every day. We are committed to protecting our environment by embedding our LEAN practices on reducing waste and support sustainability. We monitor suppliers in line with our code of conduct and drive efficiencies and we source locally and ethically in the first instance to reduce our carbon footprint and reduce our impact on the environment. In 2015, a total of 193 countries committed to the UN Sustainability Development Goals. These goals (SDG’s), address global challenges such as poverty, inequality, climate change, and environmental degradation and stand as a blueprint for achieving a sustainable future for all; designed to promote prosperity while protecting the planet. For our part, Ardmac have identified where we can take action. Climate change, environment, communities, responsible business and innovation .

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Created by Wichai Wi from the Noun Project

Created by Kamin Ginkaew from the Noun Project

Created by Lima Studio from the Noun Project

Created by Carl Holderness from the Noun Project

C L I MAT E CHANG E

R E S PON S I B L E BU S I N E S S

E NV I RONME N T

I NNOVAT I ON

COMMUN I T I E S

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S U N D A Y O C T O B E R 1 0 T H

Ardmac are delighted to invite you to our Cycle for Hope charity fundraiser, in aid of Pieta House. The cycle will take place on the 10th of October and will start and finish at the site adjacent to the Ardmac office in Swords. The cycle will have three different routes to cater for different levels of cycling ability; Beginner 15k, Intermediate 60k & Advanced 100k. We have a corporate team package and you can also opt to Cycle from home on your own local route. Ardmac will match any donation made. Cycle for Hope is a guaranteed great day out in aid of a fantastic charity and we hope to see you there.

REGISTER HERE

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

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