Vivarium — Biopharma & life sciences
Temperature, humidity, pressure, air changes and photoperiod.
Vivarium is a segment of Biopharma & life sciences. Below are the systems and equipment FacilityOS covers for it, filtered from the Biopharma & life sciences solution.
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).
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 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 room | Core | Room temp · Relative humidity · Pressure vs corridor · Air changes per hour · Light level · Photoperiod: lights on | |
| 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). |
| 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 |
|---|---|---|---|
| Autoclave | Core | Chamber temp · Chamber pressure · Cycle phase (0 idle … 5 dry) · Cycle aborted | |
| 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. |
| 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. |
| 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 | |
| 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.
Segments of Biopharma & life sciences
- Biologics (mAb / protein)
- Small-molecule API
- Sterile fill-finish
- Vaccines
- Cell & gene therapy
- QC laboratories
- Medical devices
Full Biopharma & life sciences solution →
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.