Cleanroom automotive

Plug & play indoor cleanroom facilities as-a-service, the key for succes for companies in rapid evolving markets

Category: Blog
Date: October 14, 2021

As a cleanroom manufacturer, we notice a general trend that more and more production processes are subjected to increasing quality requirements to stay relevant within their industry segment. To keep up with these rapidly evolving market demands, the conventional cleanroom solutions who are generally known as substantial CAPEX projects are often too constringent in terms of “time to market”-readiness, assignment of resources and scalability over time. With INITIO, the first box-in-box Cleanroom-as-a-Service offering, ABN Cleanroom Technology is able to respond and offer a fit for purpose solution in these rapidly evolving market.

While serving the cleanroom market for more than 25 years, ABN Cleanroom Technology has developed a unique solution portfolio to serve a large variety of companies and applications. As being an innovative leader in our market, ABN has developed INITIO as the entry level indoor cleanroom solution with a complete as-a-Service offering. This enables the end-user to solely finance the facility per operational utilization and enable enterprises to utilize their financial resources on their core activities without having to take the burden of long-term CAPEX expenditures. Particularly for novel markets, as-a-Service exchange of value provides the required flexibility and risk-mitigation over time.

How INITIO, circularity and business model innovation are interrelated

Besides the financial aspect of the solution, an as-a-Service offering is the best suitable way forward. As end-to-end cleanroom solution provider, ABN Cleanroom Technology wants to take full responsibility to maintain, repair, reuse and upgrade the provided resources who provide contained air quality. As Jan Jonker (Dutch Specialist in Sustainable Entrepreneurship) states: circularity is not about more or better recycling, but focuses on designing products for reuse, repair and ultimately lifetime extension.

Our cleanroom portfolio, ranging from indoor to outdoor cleanroom facilities, has evolved over time with Design for Sustainability and Design for Circularity as central value proposition. The focal starting point has diverted towards design and deployment of a cleanroom as a whole where the ability of repair and upgrade of cleanroom assets results in ultimate lifecycle expansion. Only by transforming the business model towards an as-a-Service exchange of capital, we enable our company to deliver value in a sustainable and durable manner.

Let’s zoom in on the technical capabilities of INITIO. This off-the-shelf indoor cleanroom serves as an ISO8/ISO7 environment for a wide range of manufacturing and processing activities requiring ISO8/ISO7 cleanliness classification, with or without humidity control. Being a pre-engineered cleanroom facility, based on certified building blocks, INITIO is designed with sustainability and circularity as starting point and marketed with an as-a-Service approach in order to extend the lifetime.

INITIO: an answer to increasing production demand and evolving quality regulations

In the next part, we will further elaborate on two use-cases. The first use-case concerns a rapidly expanding high-tech market, while the second use case concerns INITIO for a novel and rapidly growing CBD market. Both market segments require a renewed OPEX or as-a-Service business model approach with a focus on sustainability and circularity.

USE-CASE 1 – Transition from basic to high-end cleanroom in high-tech sector

Driven by digitalisation and the continuous increasing demand for computing power, semiconductors are inevitable components in our world. They support technologies that improve the lives of consumers and make businesses run smarter, faster and more efficiently. This promising sector faces the challenge and opportunity of meeting the fast-growing product demand in the immediate future. In order to meet this increasing demand, easy expandable and upgradeable cleanrooms are needed.

What’s the challenge? The semiconductor industry faces the challenges and opportunities of increased product demand. The growth of artificial intelligence (AI) and the Internet of Things (IoT) and the ongoing demands from high-tech industries exerts high pressure on the semiconductor supply chain. In order to reduce that pressure and meet urgently increasing customer demands for additional manufacturing lines, cleanroom projects with very strict timelines are needed.

INITIO has been developed to start as a basic cleanroom with integrated temperature and pressure control, and can be optionally equipped with humidity control. This indoor cleanroom facility is designed to support high-tech start-ups or companies starting on a small scale in their transition to a more high-end cleanroom to meet increasing demand production demand within the high-tech market. From an as-a-Service business model and Design for Circularity, INITIO allows to be fully recycled for reuse at some new destination once it has proven its worth for a high-tech start-up.

Pre-engineering gives us the advantage of being able to work with building blocks. Our approach considers the Design Qualification, Installation Qualification and Operational Qualification of a cleanroom to ensure smooth production start-up. Solid project management according to our model does not only lead to efficient project execution, but also to efficient cleanroom use without overlooking its demolition phase.

We can smoothly incorporate various building blocks into an INITIO cleanroom project:

  • Requirements Initiation
  • Design & BIM modelling
  • Equipment & contractor supply
  • Use and data acquisition
  • Circular lifecycle planning: condition based maintenance & repair and upgrades, reuse of area, assets, data and knowledge

USE-CASE 2 – As-A-Service business model for premature CBD market

The CBD sector of the hemp industry is one of the fastest growing segments in the world of pharmaceutical products. Over time, the regulations surrounding the production of medicinal marijuana and medicinal CBD will also be put on a par with those that apply in the pharmaceutical industry. Producers who are not prepared for rapidly changing measures may encounter challenges which result in halting or even suspending production. With ABN Cleanroom Technology, we are helping multiple companies within this industry to guarantee the continuity while rapidly expanding their production processes with INITIO, our unique cleanroom-as-a-service formula.

Since recent legal regulation and recognition of the medicinal properties of CBD’s, we are witnessing an increasing demand for specific cleanroom solutions and facilities. As with other pharmaceutical products, the FDA currently regulates sterile drug products produced by aseptic processing with a set of standards in accordance with cGMP. The cleanroom is an integral part of the manufacturing process required to produce sterile drug products. While many of the advances in cleanroom design have been the result of similar challenges and requirements found at the semiconductor industry, the pharmaceutical industry has many unique and challenging circumstances to deal with. CBD cleanroom environments are becoming the norm for medical grade cannabis and CBD producers. Complying with those standards will ensure that your production environments meet the standards for quality and safety, increasing your product value and safeguarding the employees and end-users from non-compliances and eventual safety issues.

The focus of sterile drug product cleanrooms is the removal of particles classified as viable organisms, which can reproduce under the proper environmental conditions. Sterile drug products typically require cleanroom classifications of ISO8 to ISO7, which are far less stringent than the average cleanroom utilizing industry. Activities conducted in such areas include manipulations of sterile materials prior to and during filling and closing operations. Unlike most pharmaceutical cleanrooms, these cannabis cleanrooms also have to control pollen contamination between mites as well as strains and other microbial contamination. Cleanliness standards from ISO8 to ISO7 are requested as producers want to develop their own value proposition through cleaner, safer handling of the product throughout its lifecycle. Since many biotech products are heat sensitive, product stability requirements may also need specific temperature and humidity levels during processing and storage.

Due to its modular design, each module of INITIO can be decommissioned and deployed for other purposes. Since each cleanroom module is pre-engineered, it is obvious that each module comes with the required documentation in order to execute pre-commissioning and factory acceptance tests. Once arrived at the end-user’s site and the facility is operational, a site acceptance test and site validation is executed by a certified validation engineer in order to provide the required quality management and validation to certify the cleanroom zoning according the specification requirements. Our off-the-shelf cleanroom solutions such as INITIO connect strongly with the changing requirements and the diversity of today's products that require ISO8/ISO7 cleanliness classification. We’re more than happy to support you with INITIO for your cleanroom application.

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