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Trusted in regulated manufacturing
EM · Utilities · Cleaning Validation · Mobile
Under Annex 1, regulators expect contamination control to be demonstrated holistically. Novatek covers the full strategy with solutions built for a holistic contamination control — viable and non-viable monitoring, water and utility monitoring, and cleaning validation — in one paperless platform.
Capabilities
Every element of the contamination control strategy in one platform, documented the way regulators expect to see it.
Surface, active air, settle and contact plates, personnel and compressed gas, plus non-viable particle counts.
Continuous particle and viable data through aseptic processing, alarmed against limits as it is captured.
Integrated, process-specific solutions
Under Annex 1, EU regulators expect control demonstrated across the facility rather than product by product. These modules share interactive facility dispersion maps and one limits library — available together or on their own.
The full EM program across aseptic and non-aseptic areas, with continuous monitoring where Annex 1 requires it.
Includes EM MobilePaperless in the cleanroom
The record starts on a touchscreen in the cleanroom and ends in a signed report, with no paper step in between. EM Mobile and UM Mobile are built for a gowned user: no keyboard, no mouse, minimal interaction.
Extend the system
Add Nova-LIMS and Nova-QMS and product testing, deviations and CAPA sit alongside your EM data, MACO calculations and worst case product evaluations — one vendor, one platform. Already have a LIMS or QMS? Each contamination control product stands on its own.
Common questions
A CCS is a facility-wide documented plan showing how microbial, particulate and endotoxin contamination is prevented, monitored and controlled. The 2022 Annex 1 revision requires it to be holistic — premises, utilities, personnel, cleaning and monitoring addressed together, with the links between them documented.
It plans, schedules and records the monitoring that demonstrates contamination control: environmental monitoring, water and utility monitoring, and cleaning validation. Most vendors cover one of the three. Novatek covers all three in one platform, sharing interactive facility dispersion maps and a limits library.
The emphasis moved from passing individual samples to demonstrating a holistic strategy: sampling locations and frequencies justified by risk assessment, continuous monitoring through aseptic processing, trended rather than isolated data, and documented links between monitoring, utilities, cleaning and investigations.
Sampling plans by area, shift and frequency; surface, active air, settle and contact plate monitoring; personnel, gowning and compressed gas monitoring; continuous particle monitoring; organism identification; alert and action limit management; and batch release records and quarterly trend reports. EM Mobile captures results in the cleanroom.
Data is recorded contemporaneously at the point of work rather than transcribed from paper, under ALCOA+ principles. Time-stamped audit trails, role-based access and electronic signatures meet 21 CFR Part 11 and EU GMP Annex 11, and scanning pre-labeled media prevents expired media being used.
Yes. Nova-UM manages purified water, WFI, clean steam and compressed gas systems — sample point mapping, scheduled chemical and microbial testing, conductivity, TOC, bioburden and endotoxin against system limits, and trending by loop and sample point.
MACO is the largest quantity of residue that may carry over into the next product without posing a risk. Current expectation is that it derives from health-based exposure limits (HBEL/PDE) rather than dose or 10ppm rules alone. Nova-CVM calculates and versions HBEL-based limits and checks swab and rinse results against them.
Yes, optionally. Each product stands alone, so an organization with an existing LIMS or QMS can take environmental monitoring, utility monitoring or cleaning validation on its own. Where Nova-LIMS and Nova-QMS are added, product testing, deviations and CAPA sit alongside contamination control data from one vendor.
Related solutions
Raw material, in-process, finished product and stability testing from the same vendor.
Pharmaceutical LIMS software →Deviations, CAPA, change control and document control raised from an excursion.
Quality management software →Calibration and preventive maintenance, so out of calibration instruments can’t generate a result.
Calibration management software →Controlled inventory for media, plates, reagents and standards.
Inventory management software →A walkthrough using your areas, your sample points and your equipment trains — not a generic demo script.
Modular by design. Take one product or all three, with the option of integrating LIMS and Nova-QMS .
Environmental data compiled per batch, so the EM evidence is ready when the batch is dispositioned.
Periodic trend reports generated from live data instead of rebuilt in a spreadsheet every quarter.
ALCOA+ from the point of capture: contemporaneous entry, time-stamped audit trails and electronic signatures to 21 CFR Part 11.
A touchscreen built for a gowned user — no keyboard, no mouse, no route sheets to transcribe.
Purified water, WFI, clean steam and compressed gases sampled, trended and alarmed against system limits.
Health-based limits and MACO calculated and versioned, with worst-case product and equipment matrices maintained automatically.
Every cleaning event tied to the equipment, product and limits it applies to, replacing the paper logbook.
Alert and action limit breaches route straight to investigation, with trending by area, organism and shift.
Purified water, WFI, clean steam and compressed gases held to the same discipline as the areas they serve.
Includes UM MobileWhy quality teams choose Novatek