Clean Room Supplier Value Propos

Here is an example of how the Productivity Hub can help cleanroom purchasers make the crucial decision as to who should be responsible for the systems to insure cleanliness and containment. This hub can be used by the supplier to present value propositions to best help the purchaser meet these goals in each niche.

The specific question is “How much of this responsibility should be that of the Cleanroom supplier. This is the company which furnishes walls, ceilings and HVAC’s.

Let’s start with the buyer’s perspective. We asked Barry Garfinkle for his thoughts. Barry was formerly VP of biological sciences and strategy at Merck. Previously he had roles relative to technology and quality and long experience as a cleanroom buyer. Here are his thoughts.

The buyers of clean rooms are changing from the large pharma clients to more and more of the Contract Manufacturers and Startup Companies. goes from large facilities to smaller flexible facilities where the manufacturing processes and platforms are changing every month we need to consider adapting. The knowledge base of the NEW and future clients is less and less from experience and the demand for HELP is more and more likely to continue. Examples are mRNA which suddenly during COVID emerged as a dominant technology. The value of a BATCH changed from millions of $ to perhaps a billion (example KEYTRUDA batch over 100K vials X $10,000/vial list price). This has demanded companies reduce risk and utilize technology which before was too expensive. Cell and Gene therapy often means a customized product which is only good for one patient (batch size 1) and high cost, which then means the companies need to figure out how to pivot from making 50 large batches/year to hundreds! The cell and gene therapy products need to use VIRUSES to alter genes in cells and viruses. Clean rooms now require new attributes (containment, once through air, rapid turnover between products, etc. The regulatory agencies are changing their expectations and requirements. The players don’t have the expertise and want to CONTRACT for everything other than discovery which they understand. Oh Yes, and Money is Expensive and Tight.

Barry has submitted a detailed listing of the tasks and concerns. It is linked below.

He starts with regulatory concerns. Most of them affect the design of the HVAC system and air quantity either directly or indirectly.

He then points out the unique needs of CDMO/CMOs. The need to avoid cross contamination between suites, to change from one batch to another and flexibility to change out equipment are high priorities.

Cell and gene therapies have their own unique challenges and require extensive mapping and monitoring of contaminants on surfaces as well as those which are airborne. The full analysis is liked below.

Garfinkle, Barry - August 2023 the Cell and Gene operator Concerns and Needs

Contractor: The value proposition is that the components and construction will meet all specifications and the quality and delivery time will both be reasons to pay more than to a competitor. Due to the high premium placed on fast-track completions this differential can lead to 30% EBITDA.

But it is hard to consistently achieve this level in cell and gene therapy where the rooms are relatively small and there are many variables impacting cleanliness. So, the purchasers are inclined to pay the most to the providers of solutions. As Barry points out, the CDMOs are seeking flexibility as well as ease of modification. So pre-designed modules such as AES Faciliflex are an answer.

Solutions Collaborator: The room supplier can collaborate with the purchaser and equipment suppliers to ensure the design will meet the performance goals. The maximum EBITDA is for the room supplier to take responsibility for the tasks he can do best. A strong case can be made that the most capable entity to make decisions about air quantity, purity, and distribution is the room supplier. He also needs to be involved in decisions relative to decontamination, isolation, particle measurement and other aspects which affect the room design and operation.

Solutions Provider: Total responsibility can be taken by a large A/E firm. But when it comes to rapidly evolving technologies such as variable airflow and continuous viable particulate measurement, the cell and gene room provider has the opportunity to be the most knowledgeable.

So what are the specific technologies which allow a cleanroom contractor to become the alpha solutions collaborator?

The starting point is the basic contracting function. The Hub has value propositions for AES Clean. One is based on a turnkey approach where AES has its own wall and ceiling manufacturing facility and its own construction force. Another is a modular predesigned room.

1109	AES	cell and gene	Cleanroom	Complete Solutions from design through operation
1110	AES	cell and gene	Cleanroom	Facililfex standardized modules increase flexibility and reduce cost

Cell and gene technology is rapidly evolving. The cleanroom firms which are best able to incorporate the latest technology improvements will generate the highest EBITA and provide the most value to the purchasers.

One rapidly developing technology is variable air flow with continuous particle monitors. The air flow to a zone is varied to keep particulate levels below a specified number. The advantages are better contaminant control at peak periods, energy savings in low periods, and faster recovery from events. Here is the initial Hub coverage.

Another developing technology is particle removal. The truth is that there are only rules of thumb when it comes to air changes per hour to meet the particle limits of a given class of cleanroom. There is controversy over the most penetrating particle size and therefore the selection of HEPA or ULPA filters. Coverage of this is provided at

The selection of filters will vary as explained in this analysis. So, it requires the knowledge of the cleanroom supplier to make sure the best decision is made.

As Barry points out the customers are very concerned about viable particles. There is now a way to measure them continuously.

1105	TSI	cell and gene	air monitoring	real time viable particle monitor provides critical measurement
1155	TSI	cell and gene	particle monitors	viable particle counter in real time

Since the air flow rates and particle concentrations are directly related, it makes sense for the room supplier to be at least collaborating on the monitoring system.

Isolators and RABS involve changes in HVAC air flow patterns in addition to the local air flows.

1107	Comecer	cell and gene	isolator	offers more processing options including robotics
1150	Ecolab	cell and gene	isolator	Isolator with integrated Vaporized H202 system
1154	Extract Technology	cell and gene	Isolator	Dec is combining isolators and rabs with the acquisition frm Wabash National
1130	Skan	cell and gene	isolator	isolators provide protection and efficient production aided by robots
1148	Envair	cell and gene	isolators	isolators and clean air cabinets to European pharmaceuticals since 1970s
1153	Telstar	cell and gene	isolators	range of isolators to complete fill lines

The use of isolators not only impacts the air quantity for the HVAC system but also the cleanroom class. So the cleanroom contractor should be involved in isolator decisions.

Barry cites flexibility as one of the needs of CDMOs. Not only is there a need to add equipment but in some cases to move equipment out for cleaning while a duplicate has been moved in for current operation

If a large piece of equipment such as a filter press is moved in and out of a room, the room designer will have to supply additional space.

Cleanroom suppliers are tasked with removing the particles from the room. A parallel activity is killing any viable organisms still remaining. One of the options is the dry method which uses airborne H2O2 and therefore depends on the HVAC system to some extent. The cleanroom supplier can have a proactive role and optimize the VHP use. He can also provide air locks with VHP.

Particle monitors can be placed in strategic locations and air quality measured continuously. Changes in equipment function, clothing protocols, traffic patterns and other variables can be immediately identified, and remediation action taken.

1120	Met One	cell and gene	instruments	air particle counters are reliable, durable and easy to use
1149	PMS	cell and gene	particle monitors	monitors and support to meet Annex 1

The room designer should be a major collaborator and instrumental in determining monitor locations. Periodic offsite monitoring can be performed simultaneous to checking filter pressure drop, humidity, temperature and other parameters.

In summary the Cleanroom supplier is best equipped to keep up with the rapidly changing technology. These changes can have a significant effect on cell and gene operations. So, a supplier who can provide them can maximize EBITDA.

Magazine	Date	Title
Cleanrooms Magazine	August 2023	Variable Air Flow has Advantages in Contamination Control and Energy Loss