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API and Bulk Drugs · CMMS & EAM

Maintenance Software for API and Bulk Drug Plants

API plants run reactors, centrifuges, dryers and solvent systems in multi-step campaigns. PlantOps360 keeps the maintenance, calibration and cleaning records that ICH Q7 and customer audits expect.

Sample view · API and Bulk Drugs · Live
PlantOps360
Equipment health
90%
Open work orders
20
PM compliance
97%
Availability
94.8%
Downtime trend · 12 wks▼ improving
AI alert: Centrifuge bearing vibration above its alert limit during a campaign
THE PROBLEM

Common maintenance challenges in API and Bulk Drugs

An API plant has the compliance load of pharma and the process hazards of a chemical plant, in the same building.

Campaign-based production

Equipment is shared across products, so a breakdown mid-campaign delays batches and risks cross-contamination controls.

Solvents and hazardous operations

Flammable solvents, pressure and reactive chemistry make equipment integrity a safety matter.

Records for regulators and customers

Regulatory inspections and customer audits both examine equipment maintenance and calibration records.

Many instruments to calibrate

Balances, gauges, temperature probes and pH meters each have their own calibration interval.

Effluent and environmental conditions

Scrubbers, effluent treatment and evaporation systems must run to consent conditions.

Cleaning and changeover between products

Equipment is cleaned and released between campaigns, with maintenance coordinated around it.

PURPOSE-BUILT

Critical equipment managed with PlantOps360

Pre-configured preventive schedules, inspection checklists and condition parameters for the equipment that runs an API plant. Hover any card to see failure modes, checklists and sensors.

Healthy

Glass-lined and stainless steel reactors

Production
Critical30-Day PM
Hover for details
Common failures
Mechanical seal failure
Glass lining damage
Agitator bearing wear
Jacket leaks
Monitor
TemperaturePressureAgitator currentVibration
Recommended maintenance
Weekly seal and leak check
Monthly agitator inspection
Scheduled glass-lining inspection
Healthy

Centrifuges and agitated nutsche filter dryers

Production
Critical15-Day PM
Hover for details
Common failures
Bearing failure
Seal leakage
Basket or plate damage
Imbalance
Monitor
VibrationMotor currentTemperature
Recommended maintenance
Pre-campaign inspection
Monthly lubrication
Scheduled overhaul
Maintenance Due

Dryers (tray, rotary vacuum)

Production
High30-Day PM
Hover for details
Common failures
Vacuum loss
Seal and gasket leaks
Heater failure
Bearing wear
Monitor
Vacuum levelTemperatureRotation speed
Recommended maintenance
Weekly vacuum test
Monthly gasket check
Quarterly calibration
Healthy

Vacuum systems and chillers

Utilities
Critical15-Day PM
Hover for details
Common failures
Pump wear
Seal oil contamination
Refrigerant leaks
Condenser fouling
Monitor
Vacuum levelChilled brine temperatureMotor current
Recommended maintenance
Weekly round
Monthly oil check
Annual service
Healthy

Scrubbers and effluent treatment

Environment
High15-Day PM
Hover for details
Common failures
Pump blockage
Packing fouling
Dosing faults
Evaporator scale
Monitor
pHFlowDifferential pressure
Recommended maintenance
Daily round
Weekly pump check
Scheduled cleaning
Healthy

Process instruments and balances

Quality and control
CriticalCalibration interval
Hover for details
Common failures
Out-of-tolerance drift
Probe damage
Display faults
Cable faults
Monitor
As-found resultAs-left result
Recommended maintenance
Calibration at due date
Daily balance check
Healthy

DG sets and power systems

Utilities
High30-Day PM
Hover for details
Common failures
Fuel system faults
Battery failure
Cooling faults
Alternator problems
Monitor
Oil pressureCoolant temperatureBattery voltage
Recommended maintenance
Weekly test run
Monthly load test
Annual service
Equipment Health Dashboard
Sample view of a api and bulk drugs plant in PlantOps360 (illustrative figures)
● Live data
Healthy assets
184
Critical assets
6
Running
142
Idle
28
Maintenance due
12
Open work orders
14
Upcoming PM
23
Availability
97.8%
Downtime trend▼ illustrative
Asset health score
92of 100
DAY-TO-DAY

What changes in your api plant

Four everyday situations in an API plant, before and after PlantOps360.

Equipment logs are electronic and attributable

Before

Equipment usage and maintenance logs are filled in by hand and signed later. During audits, someone searches cabinets.

With PlantOps360

Work is recorded as it is done, by a named user, with a time. Records are searched by equipment, date or work order.

Document management →

Maintenance fits around campaigns

Before

Maintenance is squeezed between batches, and nobody sees which equipment is due before the next campaign.

With PlantOps360

PM tasks due before a campaign start are listed by equipment, so they can be done in the gap between products.

Preventive maintenance →

Calibration status is visible for every instrument

Before

Instrument calibration sits in a separate register, and an instrument can be used a day past its due date.

With PlantOps360

Due dates are shown with the asset. Out-of-tolerance results create a work order and a record for review.

Calibration management →

Solvent-area equipment is inspected on a plan

Before

Inspection of pumps, hoses and earthing in solvent areas depends on a safety officer's checklist on paper.

With PlantOps360

Inspections are recurring checklists with results recorded, and failures raise work orders.

Work orders →

Rules and standards that touch API plant maintenance

A plain-language summary of what each one asks of maintenance, and where PlantOps360 fits.

Standard or regulationWhat it expects from maintenanceHow PlantOps360 helps
ICH Q7GMP for active pharmaceutical ingredients
ExpectsEquipment maintained on a schedule with written procedures, calibration of measuring devices, and records of cleaning and use.
PlantOps360PM schedules, calibration records and equipment history in one system. Preventive maintenance →
Schedule M (revised GMP)Drugs Rules, 1945 (India)
ExpectsPremises and equipment kept in good repair, with planned maintenance and calibration, and records of the work.
PlantOps360Completion records and calibration due dates for every asset. Calibration management →
WHO GMPGood manufacturing practices for pharmaceutical products
ExpectsEquipment maintained, cleaned and calibrated to a written schedule, with logs.
PlantOps360A full history per asset: what was done, by whom, when and with which parts. Asset management →
21 CFR Part 11 / EU GMP Annex 11Electronic records and computerised systems
ExpectsAccess control, audit trails of changes and electronic signatures tied to the record.
PlantOps360User roles, change history and e-signatures on approvals. Validation stays under your quality system. Document management →
ICH Q9Quality risk management
ExpectsRisk-based decisions on maintenance and calibration intervals.
PlantOps360Criticality on each asset to support risk-based intervals. Asset management →
Factories Act hazardous-process provisionsSafety in chemical processes (India)
ExpectsSafety equipment and plant in hazardous process units maintained and tested, with records.
PlantOps360Test and inspection tasks for safety equipment, with results recorded. Preventive maintenance →

This is a plain-language summary for orientation. Always follow the current text of each law and standard, and the rules of your own site and licence.

Key workflows in a api plant

Three real situations, step by step, and where each step happens in PlantOps360.

Centrifuge vibration rises during a campaign

A shared asset with a batch waiting.

  1. A vibration reading crosses its alert limit. Predictive maintenance
  2. A work order opens with the inspection checklist and the product schedule visible. Work orders
  3. The technician repairs or replaces the bearing with a reserved spare. Spare parts
  4. The repair, readings and release for use are recorded and signed. Document management
The event is recorded for the batch file.

Pre-campaign equipment readiness

Equipment checked before a product starts.

  1. Tasks due before the campaign date are listed per train. Preventive maintenance
  2. Instruments due for calibration are included. Calibration management
  3. Technicians complete the checks on phones and record readings. Mobile app
  4. The completed list is stored with the campaign. Document management
Readiness is shown to be complete, not assumed.

Reactor seal leak mid-campaign

A breakdown on a high-value batch.

  1. The operator scans the reactor QR code and reports the leak. Mobile app
  2. The supervisor approves and a work order opens with the seal kit reserved. Spare parts
  3. The job follows the job plan, including safety steps, and the findings are recorded. Work orders
  4. The seal inspection interval is reviewed. Preventive maintenance
Cause, parts and downtime stay in the reactor history.

API and Bulk Drugs maintenance software: questions

API plants run chemical processing equipment in campaigns, with solvents and pressure, under ICH Q7. The compliance load is similar, but there is more process-safety equipment and more shared trains between products.
It provides the controls that ICH Q7 looks for in maintenance records: schedules, calibration, attributable entries and history per equipment. Compliance depends on how you use and validate it within your own quality system.
PM tasks can be listed by due date and equipment, so tasks due before a campaign can be completed in the gap between products.
Yes. Calibration tasks, certificates and results sit beside PMs and work orders on the same asset.
They are assets like any other, with rounds, PMs and a history, so consent-related equipment is kept up.
Yes. The offline-first mobile app lets technicians create and close work orders, run inspections and open documents with no connection. Everything syncs when the device is back online.
PlantOps360 offers integration with SAP, Oracle and other ERPs, and REST APIs to sync assets, materials and financials. The scope of an integration is agreed during the demo and planning.

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