Cleanrooms for IV Compounding
The CE Cleanroom team has developed unrivaled expertise in designing and constructing multi-location IV-compounding cleanrooms. Our clients include many of the country’s leading retail pharmacies, hospitals and hospital systems as well as regional brands that demand the highest level of construction excellence.
Types of IV-Compounding Cleanrooms
Types of IV-Compounding Cleanrooms
Our facilities are used for the compounding and mixing of customized prescriptions, bulk IV-compound manufacturing and the production of hazardous drugs such as radiopharmaceuticals that contain radioactive isotopes, antineoplastic drugs and other medications on the NIOSH list.
FDA Validated Pharmaceutical and Therapeutics Manufacturing Cleanrooms
CE Cleanrooms builds highly specialized cleanrooms that provide contamination-free laboratories and manufacturing plants for the safe and effective production of drugs, vaccines and other medical products.
Below are some of the types of pharmaceutical and therapeutics environments we build:
OSD (Oral Solid Dose)
Sterile facilities designed to accommodate the workflow, machinery and personnel needed to manufacture a wide variety of pills and tablets, including everything from controlled substances to nutrients to over-the-counter vitamins.
Blow Fill Seal
Aseptic manufacturing environments designed to meet injection molding process requirements where ultra-clean plastic bottles get filled with sterile drugs or solutions and are then sealed to prevent contamination.
Pharmaceutical Injectable
Germ-free industrial manufacturing plants where precision equipment fills vials with injectable drugs.
APIs
Controlled environment spaces for the chemical synthesis, manufacturing and formulation of active pharmaceutical ingredients (APIs) that are needed for pharmaceutical drug manufacturing.
Biopharmaceuticals
Antiseptic research and development labs and manufacturing environments where biopharmaceuticals such as bone, tissue, vaccines, blood components and other products are grown using biological processes rather than chemical synthesis.
Medical Devices
This is a broad category of cleanrooms with features and regulations that vary depending on the device manufactured and its medical use.
Products include everything from plastics, catheters and surgical tools to hoses, silicone breast implants and items transplanted into the body.
Cleanrooms for Manufacturing
Controlled manufacturing environments provide ideal conditions for making products with sensitive components or strict industry regulations.
CE Cleanrooms Experience with Controlled Environments for Manufacturing
We design and build facilities that minimize contaminants such as dust particles, germs, chemical vapors and other pollutants entering, circulating and escaping from the cleanroom enclosure. Depending on the application, we may also install equipment to control air pressure, temperature and humidity.
Most manufacturing facilities are ISO classes 7-8. However, food processing facilities are usually IOS 5-7.
Below are some of the different types of manufacturing facilities we build:
Automotive
These cleanrooms are generally for manufacturing electronics and precision parts and providing enclosures for finishing processes such as spray painting.
Aerospace
These are facilities where delicate parts, hardware, electronics and optics are built. They must meet ISO class 7 and comply with the American Society for Testing and Materials (ASTM) and National Aeronautics and Space Administration (NASA) standards relating to air filtration and procedures.
Food
These environments are designed to minimize exposure to germs and fungi and increase shelf life. They must meet ISO5-7 and include temperature, humidity and air filtration systems.
Injection Molding
Cleanrooms are needed to eliminate the danger of particle contamination during the production of plastic parts. However, ISO compliance varies depending on the industry, with health care applications requiring the most stringent standards.
Medical Cannabis
Typically, cannabis grow rooms are ISO5-7 and comply with FDA’s cGMP regulations. Primary concerns include reducing the risk of pollen contamination between strands and limiting mites and other microbial contamination.
Positive & Negative PSI Rooms
Positive PSI rooms prevent contaminants from entering, while negative PSI spaces keep contaminants contained within the work environment.
White Rooms
We offer spaces for tasks such as packaging and assembly that don't require certification.
Electronics Cleanrooms
From semiconductors to microchips and nanotechnology to optics, the electronics industry uses cleanrooms to limit pollutants and control humidity, temperature and airflow within production, assembly and research spaces.
CE Cleanrooms Experience with Electronic Cleanrooms
The CE Cleanrooms team has the advanced skills to design and build cleanrooms for the electronics industry.
Here are some of the projects we’ve worked on in the past.
Optics
Manufacturing spaces for the lenses used in cameras, telescopes and other optical equipment require contamination, humidity and vibration isolation controls. Spaces are typically ISO 5-7 cleanrooms, with the critical work performed under Laminar Flow ISO 4 Benches.
Semiconductors
Even the tiniest speck of dust can damage delicate semiconductors and chips used in cell phones, computers and other electronic devices.
Semiconductor cleanrooms are sterile and enclosed environments located within semiconductor foundries or fabs[DB1] . We use state-of-the-art cleanroom technology to tightly control airborne particulates, air pressure, airflow, static, vibration, lighting, temperature and humidity.
Nanotechnology
Nanotechnology cleanrooms require environments free from particles, gasses and other contaminants that could adhere to components during manufacturing and impact product quality and performance. Nanotech is used in the semiconductor, optics, medical device, pharmaceutical delivery systems and other industries
Fuel Cell Battery Dry Rooms
[Jenn, interesting diagram of battery dry room on this page if you are looking for a graphic element https://www.cotes.com/faq/what-is-a-battery-dry-room]
These cleanrooms feature highly specialized dehumidification equipment to prevent chemical reactions, corrosion and a reduction in the performance and lifespan of lithium batteries. Relative humidity levels may be as low as one percent in these facilities.
We have completed a number of these projects specifically designed to meet the needs of research and development teams as well as component manufacturing and assembly.
Controlled Environments for Life Science & Biotechnology
Cleanrooms in this category facilitate the study of living organisms in the fields of biology, biochemistry, genetics and microbiology. They typically feature one- or two-person suites with strict controls for cross-contamination and separation that allow the science to be the only variable.
CE Cleanrooms Expertise in Cleanrooms for Life Science and Biotech
The specifications for life science and biotech cleanrooms vary considerably from one application to the next. We generally design and build these cleanrooms using pre-engineered wall components. We customize the electrical, HVAC, air filtration, lighting and control systems for the room’s type, size and use.
Below are some of the life science and biotech cleanrooms in our portfolio.
Bioprinting
Bioprinting is a technology in which bio-inks, mixed with living cells, are printed in 3D to construct natural tissue-like three-dimensional structures. This technology is currently used in various research areas, such as tissue engineering and new drug development. Environments are rigorously controlled for temperature, contaminants and airflow.
Environmental Testing Rooms
Also called an environmental chamber, a climatic chamber or a climate chamber, an environmental testing room is an enclosure in which temperature, humidity and other variables are managed. This allows scientists to test the effects of different conditions on industrial and biological products, materials, electronic devices, food and more.
In addition, testing in an environmental chamber may include chemical, bacteriological and radiological analyses of water, soil, animals, air and hazardous waste.
Some chambers can also test the effects of corrosion by simulating it with salt spray. Testing rooms must comply with ISO/IEC 17025 standards and maintain a cleanroom classification of ISO Class 5/Federal Standard 209 Class 100.
Laboratory, Research & Development
This category comprises a wide range of cleanroom types across many industries. They are isolated spaces focused on maintaining a low concentration of contaminants such as dust, vaporized particles and other organisms.
We have built several highly specific controlled environments for research and development teams and laboratory applications.
Consulting
Every CE Cleanrooms project begins with a guided discussion about what you want and the best way to approach the project.
We developed this collaborative process to uncover the scope of your cleanroom project, from the major requirements to the critical details.
- Timeline
- Layout and workflow
- Temperature, pressure, humidity and other environmental needs
- Standards and compliance requirements such as cGMP, ISO, USP and FDA-mandated septic standards
We leverage our experience building cleanrooms for health care, manufacturing and other applications to explore whether pre-engineered and modular cleanroom construction suits your project.
While our consulting services begin during this requirement-gathering phase, our teams will continue to provide guidance and present options and recommendations at every stage of your project to help you make informed decisions.
Every CE Cleanrooms project begins with a guided discussion about what you want and the best way to approach the project.
We developed this collaborative process to uncover the scope of your cleanroom project, from the major requirements to the critical details.
- Timeline
- Layout and workflow
- Temperature, pressure, humidity and other environmental needs
- Standards and compliance requirements such as cGMP, ISO, USP and FDA-mandated septic standards
We leverage our experience building cleanrooms for health care, manufacturing and other applications to explore whether pre-engineered and modular cleanroom construction suits your project.
While our consulting services begin during this requirement-gathering phase, our teams will continue to provide guidance and present options and recommendations at every stage of your project to help you make informed decisions.
DESIGN & ENGINEERING
CE’s design, architectural and engineering teams clarify the program details, select the most appropriate pre-engineered materials and develop the construction drawing according to your operational, workflow and compliance requirements.
We provide comprehensive and specialized engineering services that prioritize efficient and durable construction products and the importance of workflow- and people-centered space planning because they enhance productivity and boost quality control.
Our cleanroom design and engineering services include all of the following and much more:
Structural calculations for permits
Professional review and professional engineering (PE) stamp
AutoCAD electronic design files and shop drawings
Control and monitoring systems including:
Airflow rate and direction
Air pressurization
Temperature and humidity
Contamination
Lighting and electrical requirements
Energy conservation
Construction scheduling
Bill of Materials (BOM) list
Final as-built certification
CONSTRUCTION, INSTALLATION, & PROJECT MANAGEMENT
Construction is messy and requires careful planning to ensure the correct materials and crews are precisely where they need to be. As a turnkey design/build contractor, we handle it all - project management, construction and installation - and update you regularly.
Accountability is one of our Core Values at CE Cleanrooms
We have detailed processes in place to ensure the smooth running of every project. Our team is accountable for everything from materials deliveries to scheduling to managing our in-house construction workers, specialized subcontractors and partners.
With CE Cleanroom, you’ll have a single point of contact and an established team of specialists who are used to working together on precision construction projects. For your project, this means less time and money lost to problems and miscommunications.
Your CE project manager is an experienced, hands-on professional who pays attention to the details and takes personal responsibility for your project.
Construction Services
CE Cleanrooms uses the most appropriate construction methods for your application and protocols, including:
Conventional onsite construction
Factory-built pre-engineered buildings
Panelized modular-building systems
CE’s construction crews and qualified and approved subcontractors understand the unique requirements of these specialized buildings.
COMMISSIONING
CE Cleanrooms executes a systematic and multistep commissioning process before we turn your facility over to you and your team. We:
Verify the cleanroom meets all design, systems, engineering and procedure specifications.
Validate components, mechanical hardware and equipment are in place and function within the desired parameters.
Tune systems and balance airflow for quality and effectiveness.
Provide comprehensive documentation.
CERTIFICATION
At CE Cleanrooms, we guarantee your new critical environments will pass certification by a third-party agent, whether you must meet ISO or cGMP manufacturing standards or comply with stringent FDA and USP requirements for controlled sterile environments.
We can offer this guarantee because we’ve:
Designed and built your facility around the standards you need from the get-go.
Done rigorous balancing and validation tests before the building is certified to iron out any issues.
Built-in contingency to correct any issues identified during the certification process.
Your project team can recommend an independent third-party certification company.
AFTER-SALES SUPPORT
CE Cleanrooms will support you for the life of your new cleanroom environment.
We are available to answer questions and assist with repairs and upgrades if your certification requirements change or you want to remodel, relocate or expand.