Cleanroom design and construction:
- Architectural, mechanical, electrical and structural engineering
- Process Evaluation
- Regulatory review and consultation
- Complete construction
- Validation Protocol Development and execution
- Final report of data with clear pass/fail criteria and result.
Controlled environments have evolved and diversified in a very short period of time. The design, construction, validation and maintenance requirements needed to successfully commission and operate today’s controlled environment draw from multidisciplinary resources. Monitronics has provided consultation services ranging from design and engineering support to the development of operational controls and procedures. With regulatory experience in meeting the statutory requirements set forth by FDA, ISO, DHS, CDC, CCR Title 22, JACHO, USP and many other agencies, Monitronics strives to effectively supplement the QA/RA position of a client facility when requested.
Monitronics is experienced in the installation of Biological Safety Cabinets, Fume Hoods, Laminar Flow Hoods and all clean air devices. Field service can be promptly scheduled for the initial installation of a piece of equipment, the move of a hood from one location to a new location, or the upgrade of a hood installation to meet current industry standards. Installation services include repair or servicing of duct and blower systems, as well as all utilities common to hood work stations including vacuum, gas, water and electrical outlets as applicable.