Phase I of every clean room project begins with a Consultative Review by Cleanetics' Engineering Team, the first step in understanding our clients historical processes, or Means & Methods, a way to identify any noticeable gaps or inefficiencies in the flow of production that could be mitigated or improved prior to the onset of the Clean Room Design.
Most importantly, Cleanetics helps our clients to formally specify their Performance Criteria (environmental) and Operational Standards (SOPs & GMPs) to ensure that each clean room project has a clear direction from kick-off to certification.
Cleanroom Environmental Monitoring
The primary function of every Design-Build Clean Room project is to engineer and construct an ISO-CLASSIFIED environment that either adheres to a specific Code of the Federal Regulations (CFR) or a set of criteria that meets the internal standards set forth by the end user.
And, the only way to VALIDATE that one's room is in COMPLIANCE with those standards is through a routine ISO-Certification program.
Cleanetics' Environmental Monitoring & Certification Program provides both periodic ISO-Testing & Sampling (non-viable and viable) as well as Real-Time Remote Monitoring & Data-Logging.
Phase II of a clean room project--the Design-Build phase--brings together Cleanetics' team of Subject Matter Experts (SME)--Architects & Engineers--to develop the Construction Documents.
When completion deadlines are vital--or, when an accelerated Construction Schedule is required--Cleanetics will select and procure the long-lead equipment (HVAC) early stages of the engineering process to shorten the timeline of construction.
Cleanetics manages and constructs our projects to completion using our Certified Clean Room Technicians and experienced, licensed MEP contractors, sourcing vendors who are local and familiar to our clients.
Cleanroom Sterile Casework Manufacturing
For fifteen years, Cleanetics has designed and manufactured a high-performance line of Sterile Casework for the Hospital Pharmacy sector (USP <797>). Using our proprietary Bio-Gard surface finish and durable (high-capacity) mechanical interlocking system, we've custom built STERILE PASS-THROUGHS for some of the nation's foremost Healthcare networks.
In 2019, in response to USP <800>, Cleanetics launched its new ISO-5 Air Shower Purging Pass-Through as a buffer between Hazardous environments and non-classified zones--and recently, in response to the Covid-19 crisis, we've introduced our innovative Intubation Isolation Shroud, a portable, fully-contained negative pressure barrier to protect healthcare providers from the potential contagion of the intubating process.