EM · Utilities · Cleaning Validation · Mobile
Contamination Control
Built for a holistic Annex 1 contamination control strategy
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.
Modular by design. Take one product or all three, with the option of integrating LIMS and Nova-QMS .
Capabilities
Everything contamination control requires, in one platform
Annex 1 CCS alignment
Every element of the contamination control strategy in one platform, documented the way regulators expect to see it.
Viable & non-viable monitoring
Surface, active air, settle and contact plates, personnel and compressed gas, plus non-viable particle counts.
Continuous monitoring
Continuous particle and viable data through aseptic processing, alarmed against limits as it is captured.
Batch release EM records
Environmental data compiled per batch, so the EM evidence is ready when the batch is dispositioned.
Quarterly reports
Periodic trend reports generated from live data instead of rebuilt in a spreadsheet every quarter.
Data integrity by design
ALCOA+ from the point of capture: contemporaneous entry, time-stamped audit trails and electronic signatures to 21 CFR Part 11.
Paperless mobile capture
A touchscreen built for a gowned user — no keyboard, no mouse, no route sheets to transcribe.
Water & utility systems
Purified water, WFI, clean steam and compressed gases sampled, trended and alarmed against system limits.
HBEL, MACO & worst case
Health-based limits and MACO calculated and versioned, with worst-case product and equipment matrices maintained automatically.
Electronic cleaning log
Every cleaning event tied to the equipment, product and limits it applies to, replacing the paper logbook.
Excursion & trend management
Alert and action limit breaches route straight to investigation, with trending by area, organism and shift.
Integrated, process-specific solutions
Three products, one contamination control strategy
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.
Viable and non-viable monitoring
The full EM program across aseptic and non-aseptic areas, with continuous monitoring where Annex 1 requires it.
Includes EM Mobile- Sampling plans by area, shift and frequency
- Surface, active air, settle and contact plates
- Personnel, gowning and compressed gas monitoring
- Continuous particle monitoring in aseptic processing
- Organism ID, alert and action limits, excursion routing
- Batch release records and quarterly trend reports
Water and utility monitoring
Purified water, WFI, clean steam and compressed gases held to the same discipline as the areas they serve.
Includes UM Mobile- Sample point mapping across generation, loops and distribution
- Scheduled chemical and microbial sampling with overdue alerts
- Conductivity, TOC, bioburden and endotoxin against system limits
- Trending by loop and sample point
Compliant cleaning validation, faster changeovers
Defensible HBEL-based limits and automated worst-case selection, out of spreadsheets and into a validated system.
Includes Cleaning Log- HBEL-based limits and MACO calculations, versioned
- Automated worst-case product and equipment evaluation
- Swab and rinse plans mapped to equipment trains
- Live cleaning status for equipment release
- Electronic cleaning log replacing the paper logbook
Paperless in the cleanroom
Paperless from sampling to quarterly report
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.
- The day’s sampling plan arrives on the tablet, already scheduled
- Barcode scan of pre-labeled media — no labels to print
- The scan blocks expired media and reconciles inventory automatically
- Interactive facility dispersion map on the tablet confirms the sample location
- Sampling and incubation reads recorded contemporaneously, as performed
- Out of calibration instruments can’t generate a result
What replacing paper removes
- Transcription steps
- → 0
- Labels to print
- None
- Expired media
- Blocked at scan
- Media inventory
- Auto-reconciled
- Data review
- By exception
Why quality teams choose Novatek
Built for the strategy, not just the sample
Extend the system
Connect it to the rest of quality
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
Contamination control software: frequently asked 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
Works with the rest of the Novatek quality suite
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 →See contamination control running in your facility
A walkthrough using your areas, your sample points and your equipment trains — not a generic demo script.