Validation & Certification
Cleanetics technicians are will ensure that your environment complies will all of the ISO standards and requirements.
Cleanetics has been consulting on cleanroom projects for decades. Our specialty is working closely with the architects and GC to ensure your project is completed to federal and state standards. Staying up to date on the latest regulations, Cleanetics knows what your cleanroom project needs to be compliant and certified. Our first step is to identify the processes of your facility, the quantity of production, and access that is acceptable and or/needs restrictions. The next phase of the project is to identify the location of the cleanroom, determine the electrical, plumbing, and HVAC tie ins that will be needed to complete the project. At this point, it is the co-ordination of the construction and bringing in our specialty certified PVC welders to complete the lamination of your cleanroom walls. All items for cleanroom fit up will be custom built to meet your facilities needs-material pass throughs, material transfer carts, laminated workstations, etc… The last phase of the cleanroom project will be the certification. Cleanetics will guarantee your room will meet the ISO standards required to meet your regulations.
USP Cleanroom anteroom. Auto slider doors, handsfree handwashing sink, and aseptic protocol.
Cleanetics provides Consultations and construction for new and renovation cleanroom projects. With expert experience in renovating existing conditions to create a sterile compounding cleanroom, Cleanetics works directly with the customer to ensure they receive the ergonomic flow and cleanroom components that ensure certification and state inspections. Our specialties include the USP<797>/<800> mandates and 503b Facilities. We stay up to date on all regulations and ensure our clients receive a state of the art sterile compounding cleanroom. Contact Cleantetics to ensure your cleanroom is completed with regulations and time frames in mind. We pride ourselves in completing on time/on budget/regulated/state passed cleanrooms.
Bio-Gard Wall & Ceiling Laminate achieves a superior finish for aseptic environments.
Cleanetics’ Utility Grid offers a heavy-duty walkable ceiling with the ability to integrate lights when ceiling space is tight.
Cleanetics is your custom pass-through specialist
Cleanetics designs and manufactures a unique line of custom sterile interlocked pass-throughs. From standard 2’ x 2’ material units to larger cart pass-throughs, combination units, or distinctly smaller letter and document pass-through, Cleanetics provides custom solutions for most conditions. The Cleanetics pass-through line is manufactured from LEED-approved substances and clad with Bio-Gard for high performance, as well as an aesthetically pleasing integration with the clean room walls.
Custom Cleanroom Casework for Any Application
Cleanetics UV-Tech offers the world’s only air sterilization units that give measurable performance and guaranteed results.
It delivers the most powerful, efficient, and economical air sterilization units on the market today in live HVAC applications. Cleanetics UV-Tech removes airborne pathogens that include bacteria and viruses from indoor environments, providing ultra clean air.
The design and installation of a sterile compounding pharmacy cleanroom at Sheikh Khalifa Medical City consisted of a 850 sf (79 m2) suite which included an Editing Room, Ante Room, IV Prep Room, and a Chemo Room, as well as custom fabricated casework including counter-tops, cabinets, check tables, and pass-throughs to provide a functional work environment.
The coordination and installation of a sterile compounding pharmacy cleanroom at Cleveland Clinic Abu Dhabi included a 1700 sf (154 m2) suite with rooms for Gowning, Editing, Wipedown, IV Prep, and Hazardous Drug compounding. Custom casework was provided throughout the project including countertops, cabinets, and pass-throughs.
The installation of a modular construction advanced research facility located in Long Island, NY involved two separate facilities in the same building, totaling 2500 sf. Phase 1 consisted of a gowning room, clean room support, and the clean room. Phase 2 featured two cleanrooms with a shared gowning room. The construction of the rooms used modular wall systems, and a modular furring system to provide an environment free of electrostatic discharge.
In as little as 3 weeks, Cleanetics completed a site visit to perform Feasibility Analysis and USP 797 Consultation studies, developed the design and engineering plans, and completed the construction build out, renovating a non-complaint sterile compounding pharmacy into a state-of-the-art fully-compliant facility.
Cleanetics designed and engineered a 6100 sf (565 m2) high-bay aerospace cleanroom including an airlock, loading bay, air shower, AIT, viewing gallery, and the cleanroom with a 3-ton rail guided crane system. The project will utilize FANWALL technology to create a HEPA filtered laminar airflow over the critical work zone.
Construction is scheduled to begin Q1-15
Cleanetics: Cleanroom ServicesCleanroom specialists that are advancing clean technology worldwide. How can we help you?
Cleanetics a leader in cleanroom design-engineering and construction, servicing clients in the Life Sciences, Health Sciences, Nanotechnology, Microelectronics, and Aerospace industries and has effectively constructed classified facilities for R&D, food & beverage, contract manufacturers, and OEM providers. Cleanetics assess your facilities production and determines the cleanroom requirements that are needed to meet your regulations. Cleanetics understands regulatory compliance and can accommodate your cleanroom requirements.Don’t just trust anyone to design or build your cleanroom. Trust Cleanetics-a global leader in cleanroom design, build, and technology for the Sciences.
From big pharmaceutical manufacturing facilities, to the growing list of bio-tech upstarts or the compounding suites in community hospitals in accordance with USP <797>/<800> and 503b, Cleanetics cleanroom services have developed a volume of products and services that aid its clientele in reducing the risk of contamination by designing environments that create the ideal state for sterile production—that is, exposed surface materials and finishes which are easy to clean. Facilities that require ergonomic work flows to increase productivity and performance. Cleanetics will provide your establishment with a cleanroom that meets and exceeds state and FDA regulations.
We are the one stop business that will make your project run smoothly. On time. On budget.
Give us a call at our HQ | 1.412.405.8374