Class 100 cleanroom
Cleanroom Construction
Cleanroom ISO 8

Modular Cleanroom Design

Class One Cleanroom Systems are experts in cleanroom design and have extensive experience designing, manufacturing and installing modular cleanrooms for leading pharmaceutical, medical device companies. Class One Cleanrooms is the engineering, manufacturing, and construction leader in the modular cleanroom industry. We would like to be your cleanroom design source for your cleanroom from start to completion.

Modular Cleanroom Design

Modular Cleanrooms, Designed for ISO 14644-1 compliance

Our design team has over 30 years of experience in Cleanroom design. Class One Cleanrooms designs cleanrooms to meet your exact requirements, ISO 14644 compliant clean room. Experienced with proven results, the CLASS ONE CLEANROOMS Design Team works within your budget to Design- Build your next cleanroom.

Cleanroom Questions we ask

What cleanliness level is required.
What floor plan works best for your clean room.
What temperature and humidity are required in the cleanroom space.
Are pass thru units or air showers required?
Materials of construction for walls, ceiling, and floor.
Fire protection system required.
Light level needs.
What pressure controls, monitors and network connections are required for the clean room.
Best floor plan for the process being conducted.
Heat loads due to the number of people and equipment loads in the space.
Is there any HVAC design needs to meet the tight temperature, humidity, and pressure of a cleanroom.

Our preferred design is negative plenum cleanroom using Fan Filter Units FFU’s, this design allows future upgrades to the clean room while saving the cost of ducting along with less possibility of leeks through the ceiling.

The lowest cost cleanroom is a one pass cleanroom normally used when the space the cleanroom is within is currently air-conditioned space.

Class One Cleanrooms designers work together with our construction cleanroom installers to deliver a design within your budget and meet your cleanroom needs. This works best when Class One Cleanrooms is brought on at the beginning of the project. This allows our staff to design the cleanroom space. This early cleanroom design integration saves design costs and speeds up the schedule, and eliminates duplication of services.

CLASS ONE CLEANROOMS uses Good Engineering Practices

ISO 14644 guidelines, cleanroom engineering and design methods intended to design, construction cleanroom facilities, Clean room specifications, are the key to a successful cleanroom installation. Building Codes and city building codes are review during the building permit process. Design-Build Modular cleanrooms are our specialty.

Our Approach to Your Cleanroom Project

Cleanroom Pre-Construction Phase

  • Class One Cleanrooms will develop plans to meet your local building code and along with our installers held eliminate gaps in responsibility that are addressed in the pre-construction phase of the cleanroom planning.
  • Class One Cleanrooms helps to maximize the details of the modular cleanroom system.
  • Class One Cleanrooms helps the coordination of structural engineering, HVAC design integrated with modular return air walls, electrical systems.
  • Focus during the engineering phase on the construction to ensure that the facility drawings can be built in a cost-effective,
  • Class One Cleanrooms design and construction teams work together to ensure the cleanroom meets your needs.
  • This phase of the project includes shop drawings used for approval, fabrication, and construction.
  • Basic cleanroom designs, and the implementation of company policies and procedures that work inside the cleanroom are critical for the production of safe products.
  • The review and approval process for medical devices in the USA many other manufacturers to provide evidence that their production and manufacturing facilities are designed and operated to ensure that products meet the manufacturer’s specifications. The integrity of the manufacturing process is especially important for any medical device that comes in direct or indirect contact with a patient since they can be easily contaminated with microbiological or chemical residues produced within the cleanroom manufacturing environment.

We design for following ISO class cleanrooms

  • ISO 8 cleanrooms class 100,000 cleanrooms
  • ISO class 7 cleanrooms. class 10,000 cleanroom
  • ISO class 6 cleanroom, class 1,000 cleanroom
  • ISO class 5 cleanroom, class 100 cleanroom
  • ISO class 4 cleanroom, class 10 cleanroom

 

Industrial Cleanroom Classes
Application Classification
Aerospace ISO Class 5-7
Assembly of Touch Screen ISO Class 7
General Materials ISO Class 8
General Industrial ISO Class 8
Injection Molding ISO Class 7-8
Optical ISO Class 5-7
Electronics Cleanroom classes
Application Classification
Semiconductor ISO Class 5
SMT Assembly ISO Class 7-8
Solar ISO Class 5-7
Wafer Fab ISO Class 5
Cleanroom Pharmaceutical Classes
Application Classification
E-Liquid ISO Class 7-8
Food Packaging No Classification
Nutraceutical ISO Class 7-8
Pharmaceutical Compounding ISO Class 7
Pharmaceutical Packaging ISO Class 8
Sterile Packing ISO Class 5
Medical Device Cleanrooms
Application Classification
Device Reprocessing ISO Class 7
Implantable devises ISO Class 5
Medical Device Packaging ISO Class 7-8