We have developed turnkey advancements in the sterile environment and cleanroom space for a multitude of industries. Explore some of our case studies and then contact us to request a consultation to discuss your cleanroom needs today.
Cleanetics recently built approximately 1,200 sq/ft collection of ISO 7 Laboratory suites, with Bio-Gard wall and epoxy floors. The project included a critically-controlled clean air system supplied by a 50-ton TRANE Horizon unit.
RJ Lee Group is an industrial forensics analytical laboratory and scientific consulting firm located in the Greater Pittsburgh area. We partner with our clients to deal with problems encountered during the manufacturing process, to ensure regulatory compliance, and to uncover and understand the root cause of product failure. Our network of technical experts provides you with customized solutions that are flexible, scalable, and best-suited to your application. For more than 30 years, we have worked toward one goal: to solve the technical challenges you face every day.
Cleanetics specializes in new construction and retrofits of USP797 cleanroom compliant compounding facilities. In as little as 3 weeks, Cleanetics turned a non-compliant sterile compounding pharmacy into a state-of-the-art fully-compliant facility.
Considering the recent outbreak of Meningitis being attributed to deficient sterile compounding practices, we advise all of our clients to take the necessary steps to ensure that their production facilities are in compliance with the federal mandate.
Operating within a Cleanetics environment will be your company’s first step in preserving the public’s safety, lessening the risk of contamination of the end product and reducing your long-term liabilities.
Cleanetics specializes in new construction and retrofits of USP <797> compliant compounding facilities.
Here at the Sheikh Khalifa Medical City (SKMC) in Abu Dhabi, UAE, Cleanetics turned a non-compliant sterile compounding pharmacy space into a state-of-the-art fully-compliant facility.
The project, completed in two phases, consisted of the design and construction of a 20,000 sq/ft aseptic renovation of the parental bay and chases for client AstraZeneca at their Westborough, Massachusetts facility.
Phase 1 took place over a 14-day Christmas shutdown. The eventual Phase 2 scope can be seen in the distance.
The project showcases Bio-Gard Germicidal Wall & Ceiling System. The project consisted of removing the existing, corroded epoxy floor coves and creating a seamless transition with the new wall laminate.
On April 10, 2020, Cleanetics was awarded this challenging project–to design, engineer and designed a 1,200 sq/ft high-bay ISO 8 (Class 100,000) Clean Room at Comau, LLC USA, an industrial automation company taking on the noble task of implementing a medical-grade mask production line to support the growing demand of the current Covid-19 crisis.
This project will be completed by April 30, 2020–a 3-week timeline–and includes the complete retro-fit of a new HVAC system (recirculation HEPA system), as well as a sterile interior renovation using Cleanetics’ proprietary Bio-Gard Wall System and Custom Cart Pass-Through.
Cleanetics completed a 1,000 sq/ft 503a Sterile Compounding Pharmacy–a Hazardous and non-Hazardous CSP production line (USP <797> and USP <800>). A “Turnkey” Design-Build Construction, the project retro-fits an existing open warehouse space into a state-of-the-art clean manufacturing facility.
The project includes a Custom 40-ton Trane RTU with CRC controls and a Real-Time Particle Monitoring, enabling the system to “spin down” during off-shift hours for significant energy consumption savings, while validating the room stays in compliance. This project utilizes Cleanetics’ proprietary Bio-Gard Wall & Ceiling System–an encapsulated, homogenous finish–which transitions seamlessly into a 4″ trowel cove epoxy flooring.
Cleanetics has completed the Design & Engineering of a 900 sq/ft 503b Compounding Pharmacy–a Hazardous Pharmaceutical production line (cGMP). A “Turnkey” Design-Build Construction, the project retro-fits an existing open warehouse space into a state-of-the-art clean manufacturing facility.
The project includes a Custom 30-ton Trane RTU with CRC controls and a Real-Time Particle Monitoring, enabling the system to “spin down” during off-shift hours for significant energy consumption savings, while validating the room stays in compliance. This project utilizes Cleanetics’ proprietary Bio-Gard Wall & Ceiling System–an encapsulated, homogenous finish. Construction is set to begin in the summer of 2020.
Cleanetics is in the process of constructing of 1,500 sq/ft ISO 6 (Class 1,000) Microlab, utilizing a 2″ thick, Studless Modular Wall System with Aluminum Honeycomb composite panels, as well as a 2″ rod-hung gasketed ceiling grid system.
Cleanetics is in the final stages of construction of a 250 sq/ft of Hazardous Compounding Room (USP<800>) with an adjacent Negative Pressure Hazardous Drug Storage Room.
Cleanetics is custom manufacturing two (2) Custom ISO 5 Air Shower Purging Pass-Throughs for the hospital’s satellite Hazardous Compounding Rooms (USP<800>).
Cleanetics completed an ISO 6 (Class 1,000) Clean Room Ceiling system–a 2″ rod-hung gasketed grid system utilizing SAM24 MICROSOUND Room-Side Replaceable (RSR) Fan Filter Modules with Local Modbus Control and Zephyr 2 Color Touchscreens.
Cleanetics is in the 2nd phase of a Multi-Suite Sterile Compounding Consultative Review & Design Build Cost Assessment. Cleanetics provided a USP <797/800> Gap Analysis and Comprehensive Budget review for an upcoming Capital project.
Cleanetics recently provided Clean Room Consultation Services and Engineering Review of an 8,000 sq/ft ISO 7 Aerospace-Grade Clean Room. The project included a full Performance Specification Evaluation as well consultation in respect to Environmental Monitoring.
Cleanetics custom manufactured a list of custom Sterile Casework, including our Air Shower Purging Pass-Throughs for the hospital’s Hazardous & non-Hazardous Sterile Compounding Renovation (USP<797/800>).
