Since their first inception at Sandi National Laboratories in 1960, cleanrooms have become an essential part of industrial production and scientific research. Designed to minimize the levels of particulates and organisms, they traditionally require a lot of planning, lead time and sufficient real estate that limits many would-be users.
Mobile cleanroom rentals (MCRs) were first developed in the 1980s and have kept pace in parallel with the technology improvements of cleanroom design. ICS (Instant Cleanroom Solutions) has built its own fleet of portable facilities, ready for customization and use by clients. These 53-foot trailers are game changers for many situations while bringing cleanliness standards that often exceed those of larger, first class facilities. These mobile facilities have applications for a wide range of industries including aerospace, pharmaceuticals, medical devices and more. While this article will focus on benefits specific to the life sciences industry, the ability to have expedient access to state-of-the-art cleanroom facilities to optimize control of the research, development and production process, applies to other industries as well.
If a company does not own its own cleanroom facilities, it has to resort to hiring a Contract Manufacturer Organization (CMO). Frequently, this means “getting in line” behind other clients or projects that have already booked the CMO’s people and facilities. This can result in wait times of 6 to 12 months before the first use is started. On the other hand, when renting a MCR, the customer is in control of the process from the moment the trailer is parked and connected to power. It is an on-site, customized facility that is a dedicated resource to meet their needs. MCR’s are typically at the customer location and ready for use in less than a month.
Because they are in control, customers utilizing an MCR can realize efficiencies in conducting research. For one thing, it is easier to ensure that clinical processes have higher repeatability. This allows for an enhanced control of the variables involved in performing research. The philosophy of “failing fast” to gain incremental advancement works best when the results can be communicated fully and quickly, such as among members of the same team. Ideally, the result is an accelerated timeline to achieve breakthrough and success.
Because the trailers housing the mobile cleanrooms can be easily placed in a parking lot immediately adjoining existing facilities, they offer the opportunity to rapidly surge testing along numerous promising lines of development without teams having to fight over limited space, or across the distance from facility to CMO.
ICS is able to rapidly customize the MCRs to fit the customer’s specific needs. Requirements for more power, anterooms, nitrogen, or specific humidity requirements are just some of the aspects that can be addressed. Depending upon configuration, the trailers are certified up to ISO4 (Class 10) which further reduces the risk of introducing bioburden that could contaminate the clinical batch. Their self-contained nature allows work to continue year-round in any environment.
2. Cost Savings
It has perhaps never been truer that “time is money” given today’s fast pace of development and the need to be first to market. On that basis alone, the mobile cleanroom’s ability to be on-site, customized to the specific need and staffed by the company’s own team within a month makes them a game changer. Beyond that, there are the obvious savings in capital costs from acquiring real estate, getting permits, building and certifying a dedicated structure. And even if such a bespoke facility isn’t utilized for an extended period afterwards, its ongoing costs are still showing up on the books. On the other hand, when the need for the capacity provided by the mobile cleanroom has been satisfied, the trailer is removed along with the continued related costs.
3. Speed to Clinic
Similarly, if a company is willing to make the long-term investment in its own facilities, it can take 12 to 16 months for a dedicated space to be made operational. That is a lot of capital being tied up at the beginning of a project with a delayed return on the investment measured in years. On the other hand, if it is time to update and upgrade an already existing facility, that down-time negatively affect a product’s timeline. In both of these scenarios, a mobile cleanroom serves as an interim solution, keeping the customer’s highly trained (and highly paid) personnel working efficiently with minimal disruption.
Within the mobile cleanroom industry, it typically takes three months for a mobile cleanroom to be made available and brought onto the customer’s site. ICS’s track record has customers working on their first clinical batches within a month of requesting an MCR.
4. IP Protection
Mobile cleanrooms help companies avoid another complication that comes with using a contract manufacture. When a CMO is hired, steps must be taken to ensure that the contract facility has needed proprietary equipment and processes, and that none of the customer’s Intellectual Property (IP) is compromised. By bringing in a mobile cleanroom and staffing it with the client’s own personnel, not only is the risk to IP mitigated , but since they are already familiar with the company’s processes, there is no delay due to having to train up outsiders to perform the work as desired.
5. Control Over Production
Going hand-in-hand with the flexibility advantage, the ability to use the company’s own personnel means that there is not a communication lag between the research and development staff and the production team. If new processes are developed or formula changes are required, then these are shared in real time among colleagues who are not only used to working together, but who are most likely located on the same campus. This is as opposed to contract personnel in an unfamiliar facility that may be out of town or even out of state, adding the delay of travel time before such changes can be implemented.
Another factor of production control is the proximity of the conveniently adjacent mobile cleanroom. This gives the customer a much higher degree of control of their production schedule. If production needs to ramp up, it is a simple matter of assigning additional personnel to the task, as opposed to having to request further assets from the contractor. If the contractor does happen to have those additional bodies available rather than working on other assignments, then they would have to be brought up to speed much like the original crew, and with the same lag time.
Having the control inherent in using their own staff gives companies more mastery of their budget and deadlines.
Renting a mobile cleanroom from ICS is an optimal option to help meet schedule, budget and control of your research, development, and production needs.