Biopharma & life sciences
Biologics, small-molecule API, sterile fill-finish, vaccines, cell and gene therapy, QC labs, vivaria and medical devices: clean utilities, GMP environmental monitoring and the cold chain.
How FacilityOS helps
- GMP cleanroom zones with pressure, particles, temperature and humidity, and compliance reports.
- Purified water, WFI, clean steam, cold rooms, isolators and biosafety cabinets.
- ISA-88 batch records and electronic signatures in the style of 21 CFR Part 11 (FacilityOS provides controls that support Part 11; validating the system remains the customer's responsibility).
Platform modules used
FMCS
Facility management and control
The whole cooling and power chain at a glance, with redundancy, shift handover, utility efficiency and first-out alarm analysis.
Learn more →BMSBuilding management system
Air-side equipment, setpoints with approval, schedules, holidays, optimal start, OpenADR demand response and automatic fault detection.
Learn more →PLC / DCSProcess control
PID loop faceplates, ISA-88 batch records, controller redundancy, EtherNet/IP and Siemens S7, and a soft-PLC IDE with simulation.
Learn more →EMSEnergy management system
Electricity, gas, water and steam metering by workshop and system, time-of-use cost, demand, carbon, PUE and tamper-evident report archives.
Learn more →CMMSMaintenance management
Asset register linked to live data, preventive maintenance by calendar, run hours or starts, signed work orders, QR/NFC inspection rounds, spares and MTBF/MTTR.
Learn more →Segments
Biologics (mAb / protein)
Cell culture and purification in single-use or stainless bioreactors.
Learn more →Small-molecule API
Reactors, solvents, classified areas and oxidizers.
Learn more →Sterile fill-finish
Grade A RABS or isolators, lyophilization and sterilization.
Learn more →Vaccines
Biocontainment, cold chain and filling.
Learn more →Cell & gene therapy
Small Grade B suites, biosafety cabinets, incubators and LN2 storage.
Learn more →QC laboratories
Fume hoods, incubators, refrigerators and stability chambers.
Learn more →Vivarium
Temperature, humidity, pressure, air changes and photoperiod.
Learn more →Medical devices
ISO 7–8 assembly cleanrooms and sterilization.
Learn more →Systems and equipment
Core: every site of this kind has it. Common: most sites have it. Optional: depends on the site.
Heating & cooling plant
GMP temperature and humidity depend on steady chilled water and steam.
| Equipment | Level | Points worth watching | Notes |
|---|---|---|---|
| Chiller | Core | CHW supply temp · CHW return temp · Load · Power draw · Efficiency · Fault | Mid-size plant chillers on BACnet/IP. |
| Cooling tower cell | Core | Tower leaving water · Tower entering water · Fan speed · Basin level · Water conductivity · Fan vibration | |
| Pump | Core | Running · Speed · Differential pressure | Chilled and condenser water pumps; drives usually on Modbus TCP. |
| Steam boiler | Common | Steam pressure · Firing rate · Drum water level · Low-water cutoff · Fault | |
| Hot-water boiler | Common | Hot water supply temp · Hot water return temp · Firing rate · Flue gas temp · Fault | |
| Heat-recovery chiller / heat pump | Optional | Hot water supply temp · Chilled water supply temp (recovery side) · Power draw · Combined COP | Heat recovery displacing boiler gas — one of the main decarbonization levers. |
| Absorption chiller | Optional | CHW supply temp · Crystallization alarm |
GMP HVAC & cleanrooms
Grade A/B/C/D cascades, particles and T/RH are recorded by the EMS.
| Equipment | Level | Points worth watching | Notes |
|---|---|---|---|
| Make-up air unit | Common | Supply air temp · Supply dew point · Outdoor airflow | |
| Recirculation air unit | Core | Supply air temp · Recirculation airflow · Filter pressure drop | GMP AHUs, duty/standby or N+1. |
| GMP cleanroomBiologics (mAb / protein) · Sterile fill-finish · Vaccines · Cell & gene therapy · Small-molecule API | Core | Pressure vs adjacent lower grade · Room temp · Relative humidity · Particles ≥ 0.5 µm · Particles ≥ 5.0 µm · Air changes per hour · Door held open | Typical cascade 10–15 Pa (0.04–0.06 inWC). |
| Grade A zone (RABS / isolator)Sterile fill-finish · Cell & gene therapy · Vaccines | Core | Particles ≥ 0.5 µm · Particles ≥ 5.0 µm · Unidirectional airflow velocity · Pressure vs background room · Glove breach | Annex 1 Grade A limit 3,520/m³ ≥ 0.5 µm (about 100/ft³); about 90 fpm (0.45 m/s) is the usual guidance for unidirectional flow. |
| Cleanroom zoneMedical devices | Core | Pressure vs adjacent · Room temp · Relative humidity · Target class (ISO 14644-1) | ISO 7–8 assembly cleanrooms. |
| GMP environmental monitoring system | Core | Open cleanroom excursions · Open cold-chain excursions · Sensors offline | A validated, independent EMS (e.g. Vaisala viewLinc, Rees) is the system of record. |
| Vivarium roomVivarium | Core | Room temp · Relative humidity · Pressure vs corridor · Air changes per hour · Light level · Photoperiod: lights on | |
| Biosafety cabinetCell & gene therapy · QC laboratories · Vaccines | Core | Inflow velocity · Downflow velocity · Airflow alarm · Sash out of position | |
| Fume hoodQC laboratories · Small-molecule API | Core | Face velocity · Sash opening · Low airflow | |
| Humidifier | Common | Controlled humidity · Cylinder / nozzle service | |
| Pass-through / airlock interlock | Common | Both doors open · UV lamp hours |
Clean utilities: PW, WFI, clean steam
Conductivity and TOC are release limits; cool WFI loses self-sanitization.
| Equipment | Level | Points worth watching | Notes |
|---|---|---|---|
| Reverse osmosis unit | Core | Permeate conductivity · Permeate flow | |
| Electrodeionization unit | Core | Product resistivity | |
| Purified water loop | Core | Conductivity (25°C comp.) · TOC · Loop temp · Loop ozone · Ozone-destruct UV on | USP <645> conductivity and USP <643> TOC (500 ppb typical limit). |
| Multi-effect WFI stillBiologics (mAb / protein) · Sterile fill-finish · Vaccines · Small-molecule API | Core | WFI output · Distillate conductivity · Heating steam pressure · Off-spec water diverted | |
| Water for injection loopBiologics (mAb / protein) · Sterile fill-finish · Vaccines · Small-molecule API | Core | Conductivity (25°C comp.) · TOC · Loop temp · Return flow | Hot loops typically run near 80°C (176°F). |
| Clean steam generatorBiologics (mAb / protein) · Sterile fill-finish · Vaccines · Cell & gene therapy · Small-molecule API | Core | Clean steam pressure · Clean steam temp · Condensate conductivity | |
| Clean-in-place skidBiologics (mAb / protein) · Vaccines · Small-molecule API | Common | CIP supply temp · Caustic concentration · Supply flow · CIP cycle failed | |
| pH neutralization system | Common | Effluent pH · Flow | Including bio-kill. |
| Domestic water booster | Common | Discharge pressure · Flow | |
| Steam trap monitoring | Optional | Traps failed · Estimated steam loss | |
| Condensate return unit | Optional | Conductivity |
Process equipment (monitor only)
The batch system runs the process; the platform confirms utilities keep up.
| Equipment | Level | Points worth watching | Notes |
|---|---|---|---|
| Bioreactor (utility monitoring)Biologics (mAb / protein) · Vaccines · Cell & gene therapy | Core | Vessel temp · pH · Dissolved oxygen (% sat.) · Agitation | |
| AutoclaveSterile fill-finish · Biologics (mAb / protein) · Vaccines · Cell & gene therapy · QC laboratories · Vivarium · Medical devices | Core | Chamber temp · Chamber pressure · Cycle phase (0 idle … 5 dry) · Cycle aborted | |
| CO2 incubatorCell & gene therapy · QC laboratories · Vaccines | Core | Chamber temp · CO2 · Chamber humidity · Door open | |
| Freeze dryer (lyophilizer) | Common | Chamber pressure · Batch alarm | |
| Isolator / RABS | Common | Pressure to room · Glove leak test failed | |
| Vial washer | Optional | WFI temp · WFI pressure | |
| Depyrogenation tunnel | Optional | Hot-zone temp | |
| Aseptic filling line | Common | Fill rate · Reject rate | |
| Chromatography skid | Common | UV absorbance · Over-pressure | |
| Ultrafiltration / TFF skid | Common | Transmembrane pressure | |
| Solution preparation system | Common | Tank level · Batch alarm |
Cold chain
2–8°C, −20°C, −80°C and LN2 vapor storage; excursions need QA review.
| Equipment | Level | Points worth watching | Notes |
|---|---|---|---|
| Cold room (2–8°C) | Core | Room temp · Door left open · Refrigeration power failure | |
| Freezer (−20°C) | Core | Cabinet temp · Door open · Power failure | |
| Ultra-low freezer (−80°C) | Core | Cabinet temp · Power failure · LN2/CO2 backup cooling on | −80°C (−112°F), often with LN2/CO2 backup. |
| LN2 vapor-phase freezerCell & gene therapy · Biologics (mAb / protein) · Vaccines | Core | Vapor-phase temp (top) · LN2 level · Filling · Lid open | |
| Medical refrigeratorQC laboratories · Cell & gene therapy | Common | Cabinet temp · Door open | Lab and stability refrigerators. |
| Temperature mapping set | Common | Coldest logger · Warmest logger · Mean kinetic temperature (MKT) · Loggers reporting | Warehouse and cold-room temperature mapping. |
| Stability chamber | Common | Chamber temp · Excursion |
Compressed air & process gases
Product-contact air must be oil-free and dry; CO2, O2 and N2 feed bioreactors and inerting.
| Equipment | Level | Points worth watching | Notes |
|---|---|---|---|
| Air compressor | Core | Discharge pressure · Load · Power draw · Fault | |
| Desiccant air dryer | Core | Pressure dew point · Pressure drop · Regeneration temp · Fault | Dew point usually specified as an ISO 8573-1 class, e.g. −40°F. |
| Compressed-air header | Common | Header pressure · Air demand · Receiver pressure | |
| Bulk gas supply | Core | Tank level · Supply pressure · Vaporizer outlet temp · Flow · Impurity · Reserve supply in use | N2, O2, Ar, H2, CO2; tank telemetry is usually the gas supplier's. |
| Oxygen deficiency monitor | Core | Oxygen · Alarm 1 (O2 below 19.5 %) · Alarm 2 (O2 below 18 %) | LN2 storage and CO2 areas. |
| Cryogenic vaporizer | Common | Outlet gas temp · Low outlet temp |
Exhaust
Lab and process exhaust; solvent oxidizers.
| Equipment | Level | Points worth watching | Notes |
|---|---|---|---|
| Process exhaust system | Core | Exhaust main static · Exhaust airflow · Fans running · Low exhaust static | Watch general, heat, solvent and acid exhaust separately; N+1 fans. |
| Regenerative thermal oxidizerSmall-molecule API | Common | Combustion chamber temp · Inlet solvent (LEL) · Bypass damper open | |
| Exhaust fan | Common | Running · Speed |
Power & sub-metering
The EMS, cold chain and Grade B HVAC must be on emergency power.
| Equipment | Level | Points worth watching | Notes |
|---|---|---|---|
| Medium-voltage switchgear | Core | Bus voltage · Incoming current · Real power · Breaker closed · Protective trip · Relay trouble | Monitor only — never operate breakers. |
| Low-voltage switchgear | Core | Bus voltage · Load current · Real power · Power factor · Current THD · Breaker trip | |
| Power transformer | Common | Top-oil temp · Winding temp · Load · Gas / sudden-pressure alarm · Over-temperature alarm | |
| Transformer | Common | Winding temp · Load · Over-temperature alarm | Dry-type transformers. |
| UPS | Core | Load · Battery runtime · On bypass | SNMP v3 (UPS-MIB). |
| UPS battery string monitor | Core | String voltage · Lowest jar voltage · Highest jar voltage · Highest jar internal resistance · Highest jar temp · State of charge | Per-jar resistance trending (one of the maintenance practices in IEEE 1188). |
| Generator | Core | Running · Output power · Fuel tank level · Starting battery voltage · Not in AUTO | |
| Branch transfer switch | Common | On emergency source · Normal source available · Emergency source available | |
| Power quality meter | Common | Voltage THD · Current THD · Voltage sags today · Sag / interruption event | Voltage sags are a common hidden cause of trips. |
| Site utility meter | Core | Site power · Site power (MW) · Energy today · Power factor | |
| Area energy meter | Core | Area power · Energy today · 15-min demand · Power factor | Sub-metering by workshop or system for energy analysis and cost allocation. |
| Natural gas meter | Common | Natural gas flow · Heat input (1,037 BTU/scf) · Gas today (scf) | Natural gas in scfh, converted to BTU/h by heating value. |
Life safety Monitor only
Fire, leaks and solvent vapour. Monitor only.
| Equipment | Level | Points worth watching | Notes |
|---|---|---|---|
| Fire alarm zone & linkage | Core | Fire alarm · Supervisory · Trouble · Linkage: air handlers stopped · Linkage: fire/smoke dampers closed · Linkage: smoke exhaust running · Linkage: elevators recalled | Linkage proofs verify the fire system did what it should. |
| Fire alarm panel | Core | Fire alarm · Supervisory signal · Trouble signal | Monitor only (NFPA 72). |
| Aspirating smoke detector | Common | Smoke obscuration (%/ft) · Alert · Action · Fire 1 · Airflow fault | |
| Leak detection cable | Core | Leak detected · Distance to leak · Leak zone · Cable break or contamination | |
| Sprinkler riser | Common | Riser pressure · Waterflow alarm · Valve tamper | |
| Combustible gas detectorSmall-molecule API | Core | Combustible gas (LEL) · Gas alarm | |
| Pre-action / dry-pipe valve | Common | Air pressure · Valve tripped · Low air |
Security & video Monitor only
Camera and door status, and video linkage: cameras are linked to areas, devices and alarm rules; on an alarm the gateway takes an ONVIF snapshot and attaches it to the alarm, with a live-view link to the NVR/VMS. Core never contacts a camera.
| Equipment | Level | Points worth watching | Notes |
|---|---|---|---|
| Video camera | Common | Online · Recording · Motion detected · Video analytics alarm · Tamper (blocked or moved) | Status via the VMS (Milestone, Genetec…); on an alarm the gateway takes an ONVIF snapshot and attaches it to the alarm — Core never contacts a camera. |
| Access-controlled door | Core | Door open · Door held open · Door forced | GMP suites and cell-bank access. |
Life-safety equipment (fire alarm, gas detection, emergency power transfer) and protection devices are monitored only. FacilityOS never sends them commands.
Standards and compliance
| Standards and compliance | Notes |
|---|---|
| EU GMP Annex 1 (2022) | Manufacture of sterile medicinal products: Grade A–D cleanrooms, environmental monitoring and contamination control strategy. Grade A ≥ 0.5 µm limit 3,520/m³. |
| 21 CFR Part 11 | Electronic records and electronic signatures. |
| 21 CFR 210/211 | Current good manufacturing practice for finished pharmaceuticals. |
| FDA Aseptic Processing Guidance (2004) | Guidance for sterile drug products produced by aseptic processing. |
| ISO 14644-1 / -2 | Cleanroom classification and ongoing monitoring. |
| USP <645> / <643> / <1231> | Water conductivity, total organic carbon and water for pharmaceutical purposes. |
| ISPE Baseline Guide Vol. 4 | Water and steam systems. |
| GAMP 5 | A risk-based approach to compliant GxP computerized systems. |
| WHO TRS 961 Annex 9 | Model guidance for storage and transport of time- and temperature-sensitive pharmaceutical products. |
| NSF/ANSI 49 | Biosafety cabinetry design, performance and field certification. |
| ISO 13485 | Medical devices quality management systems. |
| NFPA 72 | National Fire Alarm and Signaling Code. |
Standards are listed with what they cover; numeric values are typical figures, not requirements for every site. FacilityOS supports your compliance work; it does not certify a site.
KPIs the platform tracks
| KPIs the platform tracks | Notes |
|---|---|
| Grade B ΔP low point | Lowest pressure across Grade B rooms. |
| WFI TOC | WFI loop TOC (ppb) against alert and action levels. |
| Cold-chain excursions | Open cold-chain excursions in the EMS. |
| EM excursion rate | Monthly excursions ÷ monitoring points. |
| Utility availability | Share of time PW, WFI and clean steam were in spec. |
Reports
| Reports | Notes |
|---|---|
| Monthly environmental monitoring report | Per-grade pressure, particle and T/RH excursions and trends for QA product quality review. |
| Pharmaceutical water report | PW and WFI conductivity, TOC, temperature and excursions. |
| Cold-chain excursion report | Start, peak, duration and disposition of each excursion. |
| Audit-trail report | Setpoint changes, acknowledgements and signatures (21 CFR Part 11). |
How we deliver
We can take a Biopharma & life sciences project from survey and design through procurement, installation, commissioning and training — all of it, or only the stages you need.
- Site survey & needs assessment
- Solution design
- Procurement
- Installation
- Commissioning & acceptance
- Training
- Go-live & support
Demo site
Durham Biologics Plant
A monoclonal-antibody and aseptic fill-finish plant: PW, WFI and clean steam, a Grade A/B/C/D pressure cascade, single-use bioreactors and a 2–8°C to −80°C cold chain.
Open the Durham Biologics Plant demo site to see this industry with simulated live data: process graphics, video wall, alarm drills and remote adjustment.
Try the live demo