TURNKEY CLEANROOM & LABORATORY DESIGN & INSTALLATION
ISO Cleanrooms
PETI: A Design Build Contractor and Manufacturer of Cleanrooms and more
Pacific Environmental Technologies, Inc. (PETI), a California corporation, is positioned within a specialty industry of contractors and manufacturers that design and install controlled environmental rooms (CER), which include the ISO Cleanrooms. PETI is very application-oriented and therefore not limited to one or two design types.
What is an ISO Cleanroom?
controlled environmental rooms (CERs)
Cleanrooms are part of a group of controlled environmental rooms called CERs. The International Standards Organization (ISO) publishes standards for most industries that define and establishes criteria for design, construction, testing, monitoring, safety risk management and other topics in a wide variety of fields.
One of the sections or chapters (14644) in the standards is dedicated to cleanrooms where controlling particulate contamination is key to product quality and in some cases safety. It covers design, construction, testing monitoring and other key aspects of operating a cleanroom. It defines 9 levels of cleanliness or levels of airborne contamination e.g. dust or foreign object debris (FOD). ISO 1 cleanrooms are the cleanest thru ISO 8 cleanrooms and finally ISO 9 cleanrooms, the least clean.
It also covers testing procedures, design criteria and operational criteria. ISO 8 cleanrooms are probably the most common because of cost and low complexity. Very few ISO Class 9 cleanrooms are designed and built as the step up to an ISO 8 cleanroom is minor in cost and materials.
What Does the ISO 14644 Class Level Number Indicate?
Class level indicates the concentration of "dust"
- The class level indicates the concentration of “dust” particles measured in a cubic meter of air of certain sizes.
- The sizes measured are typically 0.5 micron and 5.0 micron average particle size.
For example, an ISO Class 1 cleanroom when measured and certified (typically certified annually or more often) should have no more than 35 particles at 0.5 microns and 0 particles at 5.0 microns.
In contrast, an ISO 8 cleanroom would be allowed up to 3,520,000 particles at 0.5 microns and 29,300 particles at 5 microns.
A statistical analysis is also part of the certification report to demonstrate the likelihood that all locations, measured and unmeasured, would meet the class definition. The more points in the clean room that are measure the higher the confidence level is that the measured values accurately represent the particulate level in the room
Following is an example of a printout from a particle test at one location.
How Are the Class-Particulate Levels Measured?
using a laser particle counter
Airborne particulates are typically measured using a laser particle counter. A sample of air is drawn through a clear counting tube and a laser light is passed through the tube perpendicular to the air flow.
The particles in the air scatter the light and a photodetector quantifies the number and size of particles. The particle counter then displays a list of sizes to be measured and the quantity of each size.
What Determines What Class Level the Room Will Certify To?
in general, air change rate using HEPA filtered air
- The air change rate using HEPA filtered air is the largest fixed contributor to Class level. HEPA filters (high efficiency particulate air filters remove 99.99% of particulates 0.3 microns or larger. The more filtered air supplied to the room, as measured in air changes per hour (ACH), the diluted contaminates will be and the faster they will be swept from the room. For even cleaner levels at smaller particle sizes, ULPA filters (ultra-low penetration air filters are used. These filters are usually rated to remove 99.999+% of all particles larger than 0.12 microns in size. Filter placement and location of exit air are finer nuances of the design.
- The next fixed design item to affect the performance are the materials of construction, the precleaning of the same and the proper sealing or gasketing of construction joints to prevent particulate shedding or infiltration of contaminants and facilitate cleaning.
- The next major impact on the performance is minimizing the introduction of contaminates from outside the cleanroom. Major sources of contamination and foreign object debris (FOD) are: a) People (skin shedding, hair, makeup, clothing and shoes); b), contamination brought in on raw materials, equipment, carts and paper products; and c), process equipment that generates particles.
- Many users of cleanrooms are under the impression that regular cleanroom cleaning is not necessary. If neglected the particle counts in the room may increase over time and could exceed the class limit.
- As mentioned above, people have a large impact on the contamination levels and therefore the ISO class level. Gown rooms (where operators don their cleanroom garments) are the first line of defense against contamination being brought in by people or carts. It may be that the air change rate must be increased for this area to offset the influx of contamination.
Is Airborne Contamination the Only Contamination Area that the ISO Standards Address?
ISO Standards Address Many Areas
The ISO standards address many other areas of contamination as it relates to manufacturing and other industries. The standards address contamination in water ISO 22519 as used by pharmaceutical mfr’s, Biological contamination ISO 14698 also critical in pharmaceutical manufacturing. A search of the ISO standards will show numerous other contamination related standards.
Get a Free Quote for Your Cleanroom, Laboratory or Specialty Room Needs
With over 35 years of experience in projects ranging from large turnkey facilities to portable modular cleanrooms and containerized solutions, we are your single-source solutions provider.
PETI ISO CLEANROOMS
some of our strengths: CONTROLLING AIR BORNE CONTAMINATION
- Over 35 years of experience designing and building cleanrooms and laboratories of all types and sizes including chemistry, physics, biology, microbiology and medical labs.
- We design laboratories using modular, conventional and specialized construction materials.
- We build a wide variety of Controlled Environment Rooms CERS and certify and/or pre-certify these cleanrooms. From experience in the field, we know the importance of attention to detail so that your cleanroom performs to its best.
- We can provide turnkey solutions covering all aspects of your project, including process piping, ventilation, control-monitoring systems and special environmental conditions.
- We design and install small QA laboratories to large R & D lab facilities and Biosafety labs.
- Most of the design and engineering is done in-house, we are responsible for all of the design. Of course, you, our customer, dictate the scope of work.
- We work domestically and internationally (see our who we have done work for page).
- Our designs are cost-effective and robust.
- We self-perform the critical parts of the installation such as controls, HVAC duct and equipment, HEPA filters, air balance and startup.
- We can generate the protocols and perform IQ, OQ and PQs on our scope of work if you require validated systems.
- We are experienced in all types of controls from stand alone to building automation systems.
Types of Laboratories & ISO Clean Rooms We Design & Build
turnkey design & installation
modular cleanrooms
Modular cleanrooms which use modular wall panels and ceiling components. Advantages are the ease of installation and the absence of drywall dust and mess found with conventional construction.
"Stick-Built" cleanrooms
Conventionally constructed “stick-built” cleanrooms which use metal studs and drywall to construct the walls, resulting in a more permanent installation. The cost per square foot of the stick-built walls is usually less than modular. They are more readily accepted by building departments. The walls have fewer joints making them easier to clean and sanitize.
mobile labs
Mobile labs, meaning that they can be transported and they can be designed in a couple of different flavors.
- They can be built inside of containers and custom enclosures such that they can be transported on a flatbed truck trailer and moved from site to site or shipped overseas on a container ship.
- They can be built into the trailer of a highway tractor-trailer and then towed from location to location.
- They can also be built inside of motorized vans such that they are driven from location to location.
Specifications of Labs
PETI DESIGNS & BUILDS
PETI designs and builds labs to meet the ISO standards, Federal standards and European standards. Our designs meet strict regulatory classifications and design standards such as those required by:
- CLIA
- cGMP
- BSL
- FDA
- CDC
- OSHA
- CMS
- ISO
- EN ISO
Options & Additional Scope for Your Lab to Consider
customized solutions to fit your needs
PETI is a turnkey solution provider. As such, we can and do get involved in many aspects of your facility. We offer the following and other ancillary support systems:
- Modular wall system options
- Drywall coverings
- Suspended T-bar ceiling options
- Lighting options
- Floor covering options
- Air filtrations options
- Electrical systems
- Standby emergency power systems
- Exhaust ventilation systems
- Life safety systems
- HVAC systems
- Process piping systems
- Specialty systems
- Dust collection systems
- Water (RO-DI, WIFI, USP) systems
- Certification & validation
- Startup test and balancing
- Commissioning
- Training
- Consulting services
- Preventative maintenance programs
Skilled Professionals &
Industry Experts for Over 35 Years
SOLUTIONS THAT WORK AND CONTINUE WORKING
PETI was borne of a problem wanting a solution: A fire destroyed a cleanroom fabrication facility and the experience started. Attention to detail, reliable solutions, managing the project, learning and solving problems and more as the new facility took shape and was commissioned.
Millions of square feet and hundreds of cleanrooms later, PETI can provide a solution to your problem, whether it’s fixing an existing cleanroom or planning for a new one. Start your journey today.
Extensive Capabilities
We're Application and results oriented,
not product oriented
Are you looking for someone who can provide more than just the cleanroom envelope with some HEPA filters? See what extensive capability looks like by giving us a call or sending us an email. Start your journey now!
With experience in most industries, we can help you with more than the envelope, see our capabilities page, project references, and see how we are application and results oriented, not product oriented.
Full Service Solutions
Providing design-build services for turnkey cleanroom and laboratory facilities
Design Engineering
Ancillary Support Systems
Plancheck & Permitting
Construction & Manufacturing
Consulting Services
Certification & Validation
schedule a Discussion
Let’s start your project quote together. Give us a call at (951) 582-9306 to get the conversation started and schedule a discussion today.
Frequently Asked Questions
Find helpful answers to the questions we hear most often
For the most part yes as most users of cleanrooms want or need them certified to some level. The ISO standards are the most common here in the USA.
No, Any of the above or following types of construction if properly designed can be an ISO cleanroom.
In most cases yes. In our experience, and we design using both systems, the cost of the materials and to prefab and ship the modular components is greater than the cost to have drywall and metal studs delivered and erected.
The other components and systems are essentially the same regardless of the wall system type.
In general, once on site, the modular wall system installs quicker and without the mess of stickbuilt (drywall metal stud) systems.
A real bonus if you have a current operation. It is more flexible in the sense of expanding or rearranging walls again without the standard mess of the stickbuilt system. Depending on the modular wall panel construction, the quantity of seams can vary widely. FDA regulated facilities generally like to have fewer seams as it makes cleaning easier and may reduce the number of sampling points for viables.
When a modular wall is damaged it is less likely to shed particles, however it can be more difficult to repair. Additionally, it could be disassembled and relocated, however, there is an additional cost to the disassembly, cleaning, labeling and freight which may reduce the benefit.
The materials and components of a stick-built systems can be readily purchased and delivered to a job site. The installation process can be begin when permits are close to being issued. There is not a lengthy manufacturing-delivery cycle.
Depending on the plan check-permit issuance duration this may or may not be an advantage. Plan checkers at your city building department will probably be more familiar with metal studs and drywall than a modular wall system. They may also ask less questions shortening the plan check process. When installed and finished, it can have seamless surfaces and inside/outside corners that are easy to clean and lack the joints and crevices that could harbor bacteria and molds-spores.
Return air paths are easier to create and may take less materials (read: cost) than a modular system. Having a hard-lid ceiling from metal studs and drywall is more easily achieved for laboratories. Metal stud systems usually can accommodate various R value, fire ratings and structural requirements easier than modular systems.
Yes, PETI is able to handle this aspect of your project. We have customers that ask us to certify their room as part of the performance of the construction contract, customers that do it in house, and others that use a third party service.
Yes, PETI is willing to handle this aspect of your project.
No, it is not required in most cases. PETI can handle most architectural requirements for the cleanroom facility and if you have requirements for other architectural services, we have Architects that we work with who can provide these services keeping the project as a single point of contact and responsibility. However, we do not provide architectural services for green-field and new buildings.
No, we will do the parts of the project that make sense from your perspective.
As an example, You may have an electrician you would like to use or a painting contractor. We can coordinate with them to bring about the successful conclusion of your project.
Give us a call or send us an e-mail. We will discuss or review your requirements and find out some information about your project. We will ask questions such as:
- Is it budgetary for planning or it has been approved for capital expenditure?
- What is the time line for getting a quote?
- What is your desired construction timeline?
- What ISO classes do your require?
- In general what process will occur in the cleanroom (we will sign an NDA when your are ready to give more detailed information)?
- Where is the project site located?
- What electrical power do you have available?
- What are the process heat loads from your equipment?
- What are your other performance requirements e.g. T/RH and +/- tolerances, room pressure monitoring-controls, lighting levels …?
- What other systems do you need us to look at to support your project such as water (domestic, DI/RO, USP, wifi), drains, exhaust systems, compressed air systems and process gases?
If your question isn’t covered here, contact us, and one of our experts will be happy to assist.
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Get a Free Quote for Your Cleanroom, Laboratory or Specialty Room Needs
With over 35 years of experience in projects ranging from large turnkey facilities to portable modular cleanrooms and containerized solutions, we are your single-source solutions provider.