"Whilst the business is relatively new, my partners and I have been involved in the cleanroom consumable space for 20 to 30 years, so there’s quite a bit of experience to go around," says Stephen Morgan, co-founder, and Managing Director of cleanroom consumables newcomer, Isofield.
I know this sounds quite cliché but it is good for business to open yourself to scrutiny around these areas
Morgan began his journey in the industry in 2006, an opportunity provided by his long-time mentor Derek Watts at specialist cleanroom consumable Nitritex. This relationship continues to this day, as Watts founded the business with both Morgan and sales specialist Richard Bryant.
Start of a new era
Originally from Ireland, Morgan has lived in Malaysia for almost 15 years. This geographic location and global connection are perfect for the company’s operations. "Our factory is located just outside Malaysia’s capital Kuala Lumpur, where we have our new purpose-built facility housing our ISO Class 5, 6, and 7 cleanrooms," Morgan explains. "From Kuala Lumpur, the product is shipped to our Isofield warehouse in Dublin, Ireland ready to be distributed to channel partners across Europe. We serve our Asian customers directly from the Kuala Lumpur facility."
These ISO Class cleanrooms are very important to the cleanliness standards of Isofield’s products. Morgan explains that the company has a "simple focused mission". This mission is to make clean and sterile PPE for life-science manufacturers. He goes on to elaborate that these are high-spec clean and sterile single-use consumables for cleanroom Grade A / B (ISO Class 5), as well as C & D (ISO Class 7 & 8) encompassing cleanroom gloves, facemasks, goggles, and garments.
We are only now starting to see this overstocking normalise
Morgan admits that the team had a very ambitious plan in the beginning. "[But we] stuck to it and the team has delivered beyond my expectations. In the space of 10 months, we went from a standing start, during COVID, to a fully fledged manufacturing operation, with all our cleanrooms NEBB Certified, our ISO 9001 in place, warehousing and distribution in Europe setup, and at last count 11 cleanroom products fully certified PPE CAT III and into the market."
The physical setup is just one aspect of getting a new company up and running, but the distribution is another. This is where Richard Bryant’s contribution shows its strength Morgan explains. "Bryant has put in a mountain of work onboarding specialised life science distribution partners in over 25 countries so far, and he’s not close to hanging up his bag yet!"
What is important in picking a supplier?
Morgan strikes an important note when talking about the company’s latest campaign, Isofield "Edge". "Ultimately, it’s all about the product and the journey it takes to get into the customer’s hands," he says.
The PPE expert saw the effect the pandemic had on the life sciences industry with regard to essential PPE and applied these hard-learned lessons to how they manage their operations. He explains that the edge campaign was developed to send a simple message that supplier selection is not just about the end product anymore. "It’s about supply chain integrity, ethical practices, continuous improvement, and knowing your manufacturer and the steps in their processes to ensure they stack up from a responsible sourcing and quality perspective. It’s really about information sharing and collaboration," he says.
"I know this sounds quite cliché but it is good for business to open yourself to scrutiny around these areas," he adds.
The location of all key functions under one roof at the Malaysian facility is one such function that helps with supply chain reliability, a pandemic buzzword! "This means that the product development, production, regulatory affairs, quality, supply chain, forecasting, finance, and marketing teams are interacting on a daily basis on new projects, products, and initiatives," Morgan says.
Unlike most of the competition we love customer audits at the facility
Post-COVID, there have certainly been some changes in and to the cleanroom industry from a single-use perspective. "During the pandemic there were massive concerns around supply chain with end-users and distributors understandably concerned with efficient inventory management," Morgan says. "At the time, not only were the manufacturing sites in Asia under pressure due to the rolling lockdowns, but as we all recall only too well, the shipping industry was also under tremendous pressure to move cargo around the world. This scarcity of containers, and product, led to overstocking in many of the channels. We are only now starting to see this overstocking normalise, after an extraordinary period of instability. The good news is that the underlying demand in the life science base remains quite robust."
On the back of this experience, Morgan says he observed three broad trends related to the challenges experienced during COVID-19.
Firstly he explains that distributors and end users have become even more focused on forecasting, minimal stock carrying levels, and just-in-time delivery. Secondly, end users are much more open to validating a second or third source for "critical to process" consumables such as sterile gloves. This approach further de-risks their own supply chain and creates a healthy level of competition for new entrants such as Isofield. Thirdly and finally, he saw that proximity of supply is another key trend after the shipping "fiasco". "Having our Warehouse inside the EU and being able to ship out small volumes same/next day, is something we have seen our channel partners gravitate towards and appreciate."
Morgan knows that as a new business, carrying stock is certainly a risk on the company’s part, as they need to determine what stock to carry, but expresses that it appears to be paying off!
A hard look at the products
As a man who has been part of the industry for a long time, Morgan knows the areas that need support and can support his company’s growth. "We want Isofield to focus on the differentiated cleanroom consumables (400mm and 600mm sterile cleanroom gloves), multi-cycle anti-fog autoclavable goggles, extra-wide validated cleanroom facemasks, aseptically presented cleanroom garments etc where there is a place for us in sales guys bags, and in the customers’ cleanroom," he explains. "The motto is simple, we believe contamination control in life science should not have to come at a high price."
Conversations have moved from off-setting and “greenwashing” to plans for more substantive, material outcomes
The other aspect that Morgan is particularly proud of in his new venture is an unexpected affinity for customer audit. "Unlike most of the competition we love customer audits at the facility, as it gives us a chance to showcase the factory, engage with top-class audit teams from around the world, and learn what is important to them," he says candidly. "I think for Isofield the key will be to develop products that are environmentally friendly, ethically made, easy to use, and competitive on the price front."
What are we working with?
In 2023, Isofield is having to work with a few overarching trends that define its everyday operations. Morgan explains that he is taking these challenges in stride with enthusiasm.
Annex 1, Annex 1 everywhere…
"One of the elements that we like about the new directive is that it advises practitioners what they should be doing in order to plan, build and implement their Contamination Control Strategy (CCS); but not exactly how to do it," Morgan explains. "This leaves plenty of scope for end-users, and subject matter experts such as Isofield to advise on areas of the CCS that cover their area of competence, whilst meeting their facilities requirements. Of course, of most interest to Isofield is section 7, covering (quite literally) personnel."
Morgan explains that a lot of the language and recommendations have been around for quite some time but some elements have benefitted from further clarification. "[For example, face mask selection] should now be validated for sterility in accordance with the ISO 11137 protocol, the nudge towards longer length sterile cleanroom gloves to ensure extra forearm coverage, and the need for eyewear that offers indirect ventilation instead of the often used open-top and base versions on the market today."
Solar is definitely one of the “low-hanging fruit” for us to study and prioritise
Packaging cleanliness was another aspect that Morgan has noticed is referenced a lot more in the document than previously. He even recalls that endotoxin control as well as particulates in the Grade A/B areas is mentioned 19 times!
The important part for Isofield is how they react to these new directives and language clarifications. Creating products that solve problems for the end-user before they have them, mitigating their risk.
As an example, in response to the 19 mentions of endotoxin testing, Isofield gloves now all come with endotoxin test reporting in line with the EN455 protocol, on all Certificates of Analysis (COA) related to each production lot.
Ethical supply chain and transparency
In addition to the need for supply chain reliability following the pandemic, consumers are also increasingly concerned about supply chain integrity from an ethical perspective. "Buyers are now rightly demanding supply chain transparency on the back of concerns raised during COVID to do with forced labour, ethical treatment of employees, and general levels of social compliance," Morgan explains.
Post-COVID, there have certainly been some changes in and to the cleanroom industry from a single-use perspective
"As a responsible manufacturer, Isofield invested heavily in this process early on as we understood the importance of giving our channel partners and end users the assurances they need to do business with us. I am proud to say that in May 2023, we successfully completed our first SMETA (Sedex Members Ethical Trade Audit), and are now registered on the SEDEX (Supplier Ethical Data Exchange) platform."
Environmental considerations
"Conversations have moved from off-setting and "greenwashing" to plans for more substantive, material outcomes," Morgan comments.
The co-founder explains his opinion that "what gets measured gets managed". So in 2024, he explains that Isofield will be embarking on its ISO 14000 (Environmental management system) certification.
In it Morgan and the team will be figuring out their baselines in terms of key consumption and carbon-heavy activities, and how the company can reduce consumption in these areas. "Being based in Malaysia, solar is definitely one of the ‘low-hanging fruit’ for us to study and prioritise."
The important part for Isofield is how they react to these new directives and language clarifications
"Additionally, as a cleanroom consumable manufacturer we plough through thousands and thousands of litres a week of pure DI (De-ionised) water, and we need to find a way to get back into the system for general use around the factory," Morgan says. He explains that on the product front to customers, it’s arguably a lot more impactful as there is an immediate, visible outcome. "We are looking at ways to minimise packing dimensions, loading patterns, and most recently we are working on an exciting project to add bioplastics into our cleanroom packaging which is far more sustainable than the existing configurations."
Morgan ends with a hopeful statement. "It’s a journey, and we are only at the beginning, but the great thing is that the team has fully bought into the idea of creating a carbon-neutral future for Isofield, and that’s half the battle."
Top image: Stephen Morgan, Managing Director of Isofield