CGMP CLEANING SERVICES
Critical environments require the highest level of cleaning and verification. Every aspect if a cGMP space requires analysis and attention to perform at it's highest level. Mistakes made within a critical environment can be extremely costly and produce long lasting residual effects.
Nx2 has been partnered with cGMP manufacturing customers for years producing beneficial relationships that allow our customers to continue thriving in their fields without the worry of contamination in their spaces.
Management of Nx2 maintains multiple certification that endorse our knowledge of the requirements in the most critical of environments.
24/7 SUPPORT. EXPERIENCE TECHNICIANS. COMMITTED PARTNERS.
THE NX2 PROCESS
Nx2 understands the importance of our customer's industry and supporting it with a highly trained team of technicians ready to support ongoing processes as well as unexpected events.
Through a deep understanding of the purpose, process and goal, we train our technicians to perform the steps that allow a facility to be free of contaminates. Through reviews with our team of customer's SOP to ensure they are comprehensive as well as functional, we perform the required daily, weekly, monthly and further periodic services.
Ensuring that both equipment and chemistry used within the controlled space is adequate the Nx2 team ensures that the elimination of contaminates gives our customers the cleanest and most sterile environment possible.
Through our own internal auditing systems, that include electronic and duplicate paper checklists and periodic inspection, verification of processes becomes simple. A comprehensive library of completed processes and audits allows our clients to be overly prepared for auditing events from outside government regulatory agencies.
Due to the fact that most facilities only have shutdowns on weekends, or holidays, our team of technicians and auditors are ready to perform the periodic cleaning necessary to maintaining a contaminant free space, 24/7.
cGMP CONSULTING
As a partner to your facility, Nx2 provides consulting services for established and new GMP spaces.
With over 40 years of experience in critical environments, including medical device manufacturing and pharmaceutical manufacturing, our team has been a part of the certification of many facilities that go on to produce the life savings tools that are used throughout hospitals all over the world.
Our understanding of the compliance needed for domestic and international auditing agencies, such as the FDA and TUV, allow us to give valuable insight to our customer's processes within their Standard Operating Procedures (SOP's).
Through viewing the process from the lens of a cleaning technician, we are well suites to provide valuable feedback on SOP's and see any deficiencies that may exist within the process.
When time is critical and manufacturing has to stop due to contamination, Nx2 provides all of the services necessary to get your suite back up and running. Along with triple cleanings, using different chemistries, Nx2 offers VHP disinfection cleaning as the final step in the process.
Being a local company, Nx2 is able to provide emergency services to our customers typically same-day or next day. Being able to provide remediation services on a short timeline, allows our customers to get back to manufacturing and prevent costly shut-downs.
When clean suites have to be shut down, either due to emergencies, planned maintenance or new suite qualifications, Nx2 can provide comprehensive solutions to quickly and effectively decontaminate your facility. Our GMP crews are trained to the highest levels, allowing us to work in ISO 1-10 suites.
Nx2 will perform a site evaluation, risk assessment, method statements prior to commencing work. Once work is completed, a bio-decontamination report is produced for auditing purposes.