Aseptic Enclosures designs, manufactures, and delivers mobile cleanrooms built inside standard 40-foot high-cube shipping containers. Each unit leaves our St. Louis facility fully furnished, factory-tested, and ready for sterile compounding, pharmaceutical manufacturing, or laboratory work the moment it arrives at your site.

Our mobile cleanroom units are engineered to meet USP 797, USP 800, and ISO 7 (Class 10,000) cleanroom classification standards. Whether you need a temporary compliance bridge during a facility renovation, a rapid-deployment lab at a remote location, or a permanent expansion without the 12- to 18-month timeline of traditional construction, our container-based cleanrooms get you operational in days rather than months.

How Our Mobile Cleanrooms Are Built

Every Aseptic Enclosures mobile cleanroom starts with a new or certified 40-foot high-cube intermodal container. We selected this platform for three reasons: extreme structural durability, universal transport compatibility (sea, rail, road, air), and standardized dimensions that simplify logistics anywhere in the world.

Design and Engineering

Our project team includes architects, mechanical engineers, equipment planners, and compliance specialists who work directly with each client through a structured needs assessment. Within days of the initial consultation, we deliver a detailed 3D conceptual model for review. Most projects reach final design sign-off within two to three iterations, at which point we begin ordering long-lead components and producing construction documents.

The entire process from signed contract to on-site installation typically takes less than five months. Compare that to the 12 to 18 months required for a conventional cleanroom build, not including the time needed to obtain local building permits for facility expansion. In many jurisdictions, our container-based approach eliminates the need for building permits entirely, since the unit does not require external HVAC venting modifications to the host building.

Construction and Outfitting

Each container is built out to the client’s exact ISO classification, pressure cascade requirements, venting specifications, and biological safety needs. Standard features of our mobile cleanrooms include:

Integrated HVAC system with HEPA filtration (H14 grade) for ISO 7 or ISO 8 classification
Positive and/or negative pressure differential capability for sterile and hazardous compounding
Primary engineering controls including Compounding Aseptic Isolators (CAI) and Compounding Aseptic Containment Isolators (CACI)
Air-lock safety entrance with interlocking door system to maintain pressure integrity
Pass-through chambers for material transfer without breaking classification
Cleanroom-grade LED lighting, smooth-radius wall-to-ceiling junctions, and non-porous surfaces for simplified cleaning and decontamination
Environmental monitoring integration points for temperature, humidity, differential pressure, and particle counting
Standard power outlet and water supply connectivity for true plug-and-play operation

Units can be stacked, combined side-by-side, craned onto elevated platforms, forklifted into interior spaces, or mounted on a self-leveling chassis for placement flexibility on uneven terrain.

Compact Size

Fit into standard 40′ shipping container
Standard Sea/Air/Land transportable
Can be moved into position with the use of a forklift
Extreme durability from the custom shipping containers

Fully Furnished

Comes pre-equipped with all client needs and specs
Prefabricated and configured
Primary engineering controls
Compounding Aseptic Isolators (CAI & CACI)
Pass-through
Air-Lock safety entrance

Quick and Easy Setup and Installation

Minimal site prep needed
Plug and Play connectivity
Connects to standard power outlet and water supply
Can be placed indoors and outdoors

Mobile Cleanroom Rental vs. Purchase

Aseptic Enclosures offers both rental and purchase options for our mobile cleanroom fleet. The right choice depends on your operational timeline, capital budget, and long-term facility plans.

When Renting Makes Sense

Interim compliance during a permanent cleanroom construction or renovation project
Surge capacity to meet short-term demand increases without long-term capital commitment
Emergency deployment when an existing cleanroom fails inspection or requires unplanned maintenance
Pilot programs or clinical trial phases where the duration of need is uncertain

When Purchasing Makes Sense

Long-term or permanent cleanroom capacity at a fraction of traditional construction cost
Multi-site operations that may need to relocate cleanroom capacity between facilities
Remote or international deployments where the container format simplifies shipping logistics
Organizations that prefer asset ownership over ongoing rental expense

Both rental and purchased units are delivered factory-tested, fully furnished, and backed by Aseptic Enclosures’ warranty to meet the specified ISO classification and USP compliance standards.

Industries and Applications

Our mobile cleanrooms serve a diverse range of industries where contamination control, regulatory compliance, and rapid deployment matter. Common applications include:

Pharmacy Compounding (503A and 503B): Hospital pharmacies and outsourcing facilities use our mobile units to maintain sterile and hazardous drug compounding operations during facility upgrades, or to add permanent capacity without traditional construction.

Pharmaceutical Manufacturing: cGMP-compliant mobile cleanrooms support drug manufacturing, fill-finish operations, and packaging in environments that meet FDA and ISO 14644 requirements.

Biotechnology and Cell & Gene Therapy: Advanced therapy manufacturing often requires rapid scale-up in classified environments. Mobile cleanrooms provide ISO 7 workspace that can be deployed and validated in a fraction of the time required for permanent facilities.

Military and Defense: Field-deployable cleanrooms for equipment maintenance, munitions handling, and mobile laboratory operations in austere environments.

Medical and Clinical Research: Mobile cleanrooms provide controlled environments for clinical trial support, diagnostic laboratory operations, and medical device assembly at locations where permanent infrastructure is unavailable.

Disaster Response and Emergency Healthcare: When natural disasters or public health emergencies disrupt existing pharmacy or laboratory infrastructure, mobile cleanrooms can be deployed rapidly to restore compounding and testing capabilities.

Setup, Installation, and Site Requirements

One of the most common questions we receive is how much site preparation is needed. The answer is: very little. Our mobile cleanrooms are designed for minimal site prep and rapid deployment.

What You Need at Your Site

A level, load-bearing surface capable of supporting the container weight (typically a paved lot, loading dock, or reinforced concrete pad)
Standard electrical power connection (specifications provided during project planning)
Water supply connection if the cleanroom includes sink or decontamination stations
Truck access for delivery and a crane or heavy-duty forklift for positioning

Delivery, installation, utility connection, system startup, and environmental certification can all be completed within a few days of the unit arriving on site. Compare that to the months of on-site construction, ductwork installation, and commissioning required for a conventional cleanroom.

Units can be placed indoors (inside a warehouse or manufacturing facility) or outdoors. For outdoor placement, the shipping container’s inherent weather resistance provides full protection against rain, wind, and temperature extremes. The self-contained HVAC system maintains classification regardless of external conditions.

The Design Process of Mobile Cleanrooms At Aseptic Enclosrues

The design process is crucial for a successful build. Our team of architects, engineers, equipment planners and representatives work with our clients in the initial needs assessment process.

After the assessment is complete, we work on submission of our first sign-off document, the conceptual design. Usually, within just a few days, we are able to submit an exceptionally detailed 3d model for evaluation and comment.

Typically, after just a few iterations we have “sign off” and begin ordering long lead items and producing detailed construction documents for final approvals.

They are built in less than 5 months from design to final on site installation. This is quicker than the time needed to get the permits from your local government for the facility expansion.

We build the configurations in shipping containers which yields an impressively durable installation. Units can be of various sizes. They can be stacked, combined, craned, forklifted or supplied on a leveling chassis for placement flexibility.

Each module is built to meet your specific ISO classification, pressure, venting requirements and biological safety. Additionally, they are delivered factory tested and fully furnished and site prep requirements are minimal. Delivery, installation, startup and certification can all occur in just a few days. HVAC is included. These modules are made for the long haul and provide exceptional durability and mobility.

Compliance

Aseptic Enclosures’ USP 800 Compliant mobile cleanrooms can be customized to meet your specific needs and after production, they can be delivered to anywhere in the world and can be set up to be used in days.

Clients have signed contracts for :

Test lab at a remote location.
Extra capacity quickly and on short notice.
No need for permits for operating cleanroom with external HVAC vents.
A temporary solution to the increased strain on the healthcare system.
Becoming compliant with USP regulations.

These portable versions are built into standard 40’ HC containers that have standard attachment points, facilitating easy shipping by boat or on the road. Moreover, only an adequate source of power is needed at the installation site.

Design of the mobile cleanrooms complies with the requirements of biology, military or medical labs. To add more, the installed equipment is highly customizable as the interior design is always made according to the requirements of our customers and the appropriate regulations and standards.

Specifications

We custom design specific to your application in a very short period of time, and we also install all the components faster than you ever thought possible. Additionally, we take pride in the fact that we have the highest quality available, and best of all, we offer rock bottom cleanroom pricing that absolutely can’t be beat.

We care about design, shipping, fabrication, and customer service efficiencies that save us money – savings. Furthermore, that we pass on to you. You’re looking for a reliable company that will ship your cleanroom to you on time, arrange for professional installation on your site, and back it all up with customer service that will make you smile.

configurable parameters:

Parameter	Options / Details
Container Size	Standard 40’ HC (custom sizes available); units can be combined or stacked
ISO Classification	ISO 7 (Class 10,000) standard; ISO 5, ISO 6, ISO 8 available
USP Compliance	USP 797, USP 800, and USP 825 configurations
Pressure Control	Positive pressure, negative pressure, or multi-zone cascade
HVAC & Filtration	Integrated system with H14 HEPA filters; temperature and humidity control
Primary Engineering Controls	CAI, CACI, laminar airflow workbench, biological safety cabinet
Entry System	Air-lock with interlocking doors; gowning/ante area
Material Transfer	Pass-through chambers; HAZMAT unpacking area (USP 800)
Environmental Monitoring	Integration points for differential pressure, particle counting, temperature, humidity
Transport	Sea, rail, road, air; standard ISO container attachment points
Placement	Indoor or outdoor; forklift, crane, or self-leveling chassis
Power	Standard electrical connection; specifications determined during design

MOBILE CLEANROOMS