TURNKEY CLEANROOM & LABORATORY DESIGN & INSTALLATION
Pharmacy
USP 797-800 Cleanrooms
Pacific Environmental Technologies, Inc. (PETI), a California Corporation, is a specialty contractor and manufacturer that designs, constructs, builds, and installs controlled environment rooms (CERs), which include cleanrooms, laboratories, and other types of CERs.
One of the specialized CERs is the pharmacy clean room designed and built to meet the US Pharmacopeia (USP) requirements for compounded sterile preparations (CSP). These are used by hospitals, outpatient treatment clinics, pharmacies, and physicians’ practices. The USP <797> pharmacy clean room is for non-hazardous CSPs, and the USP <800> pharmacy clean room is for handling hazardous and toxic CSP drugs.
Types of Facilities We Design & Build
Construction types of cleanrooms and laboratories
modular cleanrooms
Modular rooms using metal clad modular wall panels and ceiling components that can be well sealed. Finishes will be based on your budget, preferences and process needs. Floors are typically epoxy-coated or use welded seam vinyl flooring.
Conventionally constructed “stick-built” fabs
Conventional stick-built rooms using metal studs and drywall and other standard construction components along with specialized components where necessary. Many of the other aspects of the room will be common with modular construction.
softwall cleanrooms
Softwall Isolator rooms using vinyl plastic curtains on a portable cleanroom framework to form the enclosure. The rooms can be positively or negatively pressured.
mobile cleanrooms
Mobile transportable rooms utilizing trailers, containers or large vans.
dry cleanrooms
Most dry rooms are built within an existing building. However, smaller R &D or pilot operations could be built within containers.
Why Choose PETI for Your Laboratory or Pharmacy Cleanroom Construction Project?
Our Strengths Promote Your Success
- Over 35 years of experience designing and engineering, constructing and manufacturing cleanrooms, laboratories, including medical industry cleanrooms of all types and sizes.
- We have designed and built cleanroom laboratories in most of the industries listed above.
- We can provide programming services.
- We work with specialty consultants when and where required.
- We can provide collaborative development of your basis of design.
- We take the drawing package through the building department
- We can provide turnkey solutions covering all aspects of your project, including process piping, control-monitoring systems, and special environmental conditions.
- Our experience enables us to design and construct small to large R & D cleanroom and laboratory facilities.
- 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 our 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 mechanical 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.
USP 797-800 Pharmacy Cleanrooms
have special requirements
The USP 797-800 covers a large spectrum of issues related to the supply of safe, quality medicines, including operator training, healthcare and safety training, education, compounding standards, and construction guidelines for the actual pharmacy clean room.
These include:
- Materials, surfaces, and finishes
- Sealing
- Accessory furniture
- Air quality and classification
- Environmental conditions
- Workflow and ergonomics
Regulations Affecting the Design & Build
cleanrooms, laboratories, and medical industry cleanrooms
In the USA, PETI designs and engineers cleanrooms and laboratories subject to various government regulations and industry standards organizations such as:
- Occupational Safety and Health Administration (OSHA) (safe working conditions)
- Environmental Protection Agency (EPA) (protecting the environment)
- DOE (setting energy conservation standards)
- State and local regulations (e.g. building codes and specialized agencies)
- International Standards Organization (ISO 14644)
- Center for Disease Control and Prevention (CDC)
- National Institutes of Health (NIH): Design guidance for biosafety levels
- American National Standards Institute (ANSI): Laboratory ventilation
- American Industrial Hygiene Association (AIHA): Laboratory ventilation
- National Research Council (NRC): handling hazardous chemicals
- College of American Pathologists (CAP): Sets quality and safety levels in medical industry cleanrooms and laboratories.
Options & Additional Design & Construction Scope
we can provide for your low cleanroom & laboratory requirements
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
- Suspended T-bar ceiling options
- Lighting options
- Floor covering options
- Lighting 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
- Hydronic hot and chilled water 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
Plan Check & 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
Starting with the assumption that you have a building and a space for the cleanroom or laboratory: A least a general basis of design, a general space planning layout accounting for product-people flow and raw materials and finished product storage, a list of equipment with required utilities (power, gases, water, ventilation, drains, sizes and weights) and an idea of where mechanical equipment (HVAC)and process support equipment can be placed. The more well developed these are the quicker your project can proceed. If you don’t have this information or the staff to develop this, PETI can provide assistance.
Maybe, if they have the experience and know how, but how many contractors have the experience and know how. Its definitely not the majority of contractors. In the case of cleanrooms, cleanroom construction and laboratory construction is a specialty market in which someone in the chain has to understand cleanroom design and cleanroom construction so that the finished product performs according to the agreed-upon design parameters. Is serviceable, maintainable and reliable.
Yes, PETI is willing to handle this aspect of your project.
No, it is not required in many cases, However, some building departments will require it depending on their perception of the complexity. PETI can handle most architectural requirements for the cleanroom laboratory facility and if the building department or 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.
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.