Is modular for me?
Skip The Cleanroom Queue: Rapid Operational Readiness Explained.
Skip The Cleanroom Queue: Market Drivers
Many of our customers have found themselves in a queue of between 18 to 24 months when commissioning a new manufacturing space. With long lead times due to a shortage of facilities for C> and this has caused a significant delay to market. We are seeing some customers experiencing a 400%-500% shortfall in manufacturing capacity, leading to requirements for a more global delivery model and global reach. In addition, our customers are seeking repeatable and scalable solutions that can quickly grow and shrink to meet demand. They demonstrate significant uncertainty around the costs involved and are concerned about the impact on the programme length. With the ever-increasing challenges around speed to market we have found that our clients are looking to provide the finishing process inhouse due to lack of availability in the market. This added complexity is driving them to look at modular off-site as an option to meet this demand.
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Skip The Cleanroom Queue: Customer Needs
Focusing attention towards customer needs, we find that many of them consider the following to be important in the decision making process;
Speed to market Risk Management Cost certainty Transparency Single point of contact
Speed to market is the single most important driving factor impacted significantly by the patent lifespan for a customer product. With a shorter timespan for rolling out a new product, it is imperative that the manufacturer can get into production as soon as possible. That said they want all the assurances of quality, safety, cost certainty, minimal disruption and that their programme will be able to go ahead within the time they have to work with.
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Skip The Cleanroom Queue: ....the solution
Off-site building of modular cleanroom facilities allows for the following factors.
• Adaptive facilities that can expand and contract with rapid changes in business strategy. • Access to facilities that support commercialisation ensuring improved ROI. • Speed of delivery allowing for companies to rapidly progress towards commercialisation. • Multi-modal and agile facilities than can meet the technical challenges facing gene and cell therapies. Looking at a comparison between off-site construction versus tradition onsite construction, we can show a distinct time saving of approximately 8-10 months in duration since certain elements of offsite build can be done concurrently.
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Skip The Cleanroom Queue: Timeline : Offsite versus Traditional Construction
bioGO TM Offsite Build 10-12 Months (standard Layout)
Design / Engineering Building
Permits and Approval
bioGoTM Build
Pre-Commissioning
Site Construction Concrete Shell Building
Design Engineering Civil and Site Foundation
Permits and Approval
Traditional Brick and Mortar - Approx 22 Months
Site Development Concrete, Structural
Design / Engineering
Permits and Approval
Qualification Commissioning Validation
8-10 Months Time Savings
Install
Let’s Explore how this is achieved.....
Building Construction MEP + Fit and Finish
Qualification Commissioning Validation
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Skip The Cleanroom Queue: The benefits of modular off-site cleanroom construction
Manpower Not only does the reduction of labour onsite improve the overall safety of a construction project, but it allows skilled labour to be maximised through-out a project. Resources don’t have to be spread so thinly as they are working from one site instead of multiple sites. Speed The delivery of modular off-site cleanroom builds is up to 40% faster than traditional builds. You can be operationally ready in a lot less time and beat the queue on early product trials.
Increased quality Off-site manufacturing offers greater control over your manufacturing environment which will allow you to optimise your manufacturing processes and add some significant value the impact of which will be seen in your quality output.
Minimal disruption Without the onsite labour tooing and froing, there is a lot less disruption to your existing manufacturing site.
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Skip The Cleanroom Queue: Case Study for Modular Cleanroom Construction
It is clear the capabilities that modular brings to the construction process, allowing a cleanroom facility which looks like more than just a temporary building, adding value to the organisation on a whole other level.
Ardmac were commissioned to build a two- storey cleanroom with a production space of 87m2 on each floor. The ground floor was to be used for production and the first floor was a plant area. The challenge was delivering the Class 7 & 8 (BSL2) cleanroom building just 5 months with 95% completed and tested. Key deliverables were for it to have a flexible HVAC system, be scalable to grow, suitable for construction inside a building or externally to the building and a replicable design which enabled future growth.
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Skip The Cleanroom Queue: Design Considerations
We have highlighted below some of the key design considerations to be aware of when modular pod cleanroom design is your chosen option. • Consider your configurations: Multi-module or single pods. • What is your structural height to accommodate large scale processes and equipment. • MEP/HVAC placement, will it be on top, inside or adjacent to the facility? • Will they be external to the building or internal (a box within a box). • What flexibility needs to be built in from the outset.
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Skip The Cleanroom Queue: What are your options when it comes to cleanroom facilities?
Mobile Facilities As official partners of Germfree, Ardmac provide mobile facilities that are rapidly deployable, available for sale or lease, with multi model HVAC designs and are BSL 2/3 and cleanroom ready.
Standard Single Module Modular facilities are engineered and constructed to meet or exceed the quality of brick and mortar construction while reducing risk and accelerating time to market.
The Internal Option Where you have an open area designated for cleanroom or laboratory modules, the Standard Pods can be used inside a building to offer a scalable solution depending on the size of the building.
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Skip The Cleanroom Queue: Is modular for me?
In order to make a decision, here are some key factors which may be present when modular isn’t going to be the right solution for you. • It has been considered too late in the design process. • Standard modular sizing is not achievable within your landscape. • Global standards which may be preventing adoption of standard solutions. • Existing facility doesn’t accommodate the easy installation of modules. To ensure that you can eliminate any factors which may limit your potential for the optimum solution, we would make the following recommendations: • Engage with an off-site modular construction company as early as possible in your process. • Consider the structure of your units for plant locations. • Standardise the solution as much as possible in order to increase speed of delivery and reduce cost. If you would like to speak to a professional regarding your modular cleanroom options, please get in touch with a member of the Ardmac team. Ardmac are specialists in cleanroom construction and, as Germfree partners are well equipped to provide further advice regarding your modular options.
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