Gerbig Cleanrooms does more than provide modular cleanroom solutions — our company has set standards for cleanroom certification and engineered new models that have set the bar in the cleanroom industry. When providing equipment to new clients, whether it be for a workstation, pass-thru, storage cabinet, partition wall or structural ceiling, we consult our clients on the best solutions for their area of expertise.
Learn the details of the cleanroom industry with insights backed by experience and discover the ins and outs of cleanrooms as we answer our most frequently asked questions.
What is a cleanroom?
A cleanroom is a space where environmental pollutants are controlled to a specific level. These rooms are commonly utilized in manufacturing, scientific research, and medical applications when even the tiniest of contaminants will compromise a project.
Contaminants include things like dust, airborne microbes, aerosol particles and chemical vapors. They can come from facilities, people, tools, fluids, and products. While it is impossible to completely eliminate all contaminants, the levels of acceptable contaminants vary by the cleanroom.
What materials can be used in a cleanroom?
The individual classes of cleanrooms will dictate many specifics regarding the types of materials allowed in a controlled environment.
For example, required garments and acceptable garment materials vary by class. The same is true for solvents. Then, there are everyday items that are generally prohibited in any cleanroom. Some of these items are available in a cleanroom-approved form. It is imperative that these approved items are used and never substituted with everyday items.
Many cleanroom suppliers offer cleanroom-safe objects that include:
• Paper and notebooks
• Pens and pencils
• Adhesives or tape
• Plastic containers
• Cleaning materials, including containers, mops, buckets, vacuum cleaners, wipes, detergents and more
Many cleanroom prohibited materials include:
• Food, gum, or drink
• Makeup or jewelry
• Wood products
• Regular writing utensils, paper or notebooks
• Greases, oils, lubricants
• Any unapproved tape or adhesive
• Unapproved plastic
What is cleanroom testing?
Cleanroom testing is a process used for the certification and documentation of evidence that proves a system will produce a product that meets all specifications and standards.
Each cleanroom needs to meet a certain level of class standards, set by The National Environmental Balancing Bureau (NEBB) to be considered compliant and qualified for use.
Validation is FDA-mandated for the pharmaceutical, biopharmaceutical, medical device, and food manufacturing industries. Although cleanroom certification is required, there are many reasons to have your cleanroom certified.
The cleanroom testing procedure ensures that the facility, equipment and environment:
1. Are fit for the cleanroom’s intended purpose
2. Meet User Requirement Specifications (URS)
3. Meet defined regulatory requirements
4. Function together as a system to meet standards
Maintaining a low contaminant environment is imperative to cleanroom use. Learn more about cleanroom certification and how Gerbig Cleanrooms can consult you through, perform and approve the certification process.
What are some tips and best practices to reduce contaminant levels?
Particulate control is not only dependent on the materials used in the cleanroom. People create more particles than anything else. Using proper garments as well as appropriate hygiene and behavior will all significantly affect cleanroom integrity.
Here are some tips on cleanroom behavior that will help keep contaminant levels down:
- Work in slow, calm movements
- Keep talking to a minimum
- Do not enter a cleanroom immediately after smoking
- Wash hands before and after you’ve been in a cleanroom
- Don’t bring unnecessary items into a cleanroom
- Put clothes on and take them off in the correct order. For most environments, you’d follow the order cap, gown/full dress, shoes, and gloves. You would remove each in reverse order
- Ensure that your clothing fits properly before entering the cleanroom
- Use hairnets and beard covers