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Learn More About Our Consulting Services
1. Where to begin when considering a cleanroom?
When working with our clients, the first thing we assess is the stage of the project. Are you building due to a new facility that is a concept or do you need to meet FDA/cGMP standards to conduct business? If you are in the concept phase of your business plan, Cleanetics can become an extension of your team to make this an operational cleanroom. Our Cleanroom Consulting division can survey properties and provide insight on the viability of the space. If you have the space to create or renovate an existing space, our cleanroom consulting team can assess the workspace and determine the best course of action to complete the project. After reviewing the site, our architects can complete the design or work with your contracted architect to bring your vision to life.
2. We have our design; can you help us?
Absolutely! We can gather our construction team and get your cleanroom built based on the design you furnish.
3. We have our design and would like to hire Cleanetics; will you provide all the materials needed for the cleanroom?
Cleanetics will procure the necessary materials needed to build your cleanroom. We can provide the modular cleanroom or bio-Gard wall laminate system, HVAC system, cleanroom interior components and can be negotiated/approved during our contracting phase.
4. Has Cleanetics ever received a customer's design that needed to be revised or adjusted?
Yes. We have had clients submit us architectural drawings and our team has identified issues that needed to be addressed. Normally, we see issues with the HVAC requirements that are missing components to assist the weather changes depending on your location. For example, in our high humid areas, we notice the conditioning capacity might not fulfill the levels that must be adhered to and make recommendations to fix this before being installed.
We have also identified possible issues with ergonomic flow in the interior of the cleanroom. Having pharmacists on our team, hands on knowledge can make suggestions the end user can appreciate.
1. We have a cleanroom. How do we validate that it meets ISO or USP797 Standards?
To validate that your cleanroom is in compliance with those standards, Cleanetics' certification team can conduct ISO-14644 validation services. Or team will perform ISO particle counts, air changes, pressure differential, relative humidity, HEPA filtration leak tests, and non-viable microbial testing. Our full report will be completed within a few days of testing services. Our team utilizes smoke testing to complete visual recordings for HEPA filters and LAFW/Bio-safety Cabinets.
We can complete monthly, quarterly, semi-annual or yearly certification contracts. Depending on your cleanroom regulations will determine the frequency for testing.
Regularly-Scheduled Maintenance ensures that your Cleanroom achieves ongoing sustainability. Your business and your reputation depend on the performance of your production lines, and a routine preventative maintenance program will keep your system functioning long after taking occupancy—a "best practice" that treats your cleanroom like a long term investment in the interest of your stakeholders.