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§ Industry · 14

Pharmaceutical: reliability under cGMP.

Pharmaceutical manufacturers operate cleanroom-adjacent reliability programs under cGMP, batch-record discipline, and validated-system constraints. Droz applies vibration analysis, thermography, and ultrasound to the utilities, HVAC, and process equipment that support these lines — without compromising the validated boundary. Reference client: Apotex.

Request a plant-wide program → Capabilities
Asset focus
Cleanroom HVAC · Utilities · Process
Key disciplines
Vibration · Thermography · Ultrasound · Alignment
Standards
cGMP · ISO 9001 · ISO 10816
Reference client
Apotex
§ Operating context

Why downtime is brutal here.

Pharmaceutical plants combine high-value product with regulator-controlled processes; downtime is rarely just a production loss.

  • Batch invalidation. Excursions and unplanned stops can disqualify a batch worth six or seven figures.
  • Validated-system constraint. Reliability work must respect change-control on every validated instrument.
  • Cleanroom HVAC criticality. Particle counts and pressure cascades collapse on AHU trips.
  • Supply-chain commitments. Many products are sole-source or limited-supplier; a missed run cascades through national supply.
§ Disciplines

Disciplines we apply.

DSC · 01

Vibration analysis

Pumps, AHU fans, refrigeration compressors, mixers.
DSC · 02

Thermography

Switchgear, MCCs, transformer surveys, HVAC surveys.
DSC · 03

Ultrasound

Clean-utility leak detection; steam-trap audits.
DSC · 04

Laser alignment

Fan and pump train alignment.
§ Assets addressed

Assets we monitor.

DZ-A · Rotating equipment

Utility rotating fleet

AHU · pumps · refrigeration

  • AHU fansTrended
  • PumpsTrended
  • Refrigeration compressorsTrended
  • Mixers · blowersTrended
DZ-B · Static equipment

Process & utility boundaries

WFI · PW · HX

  • AutoclavesInsp.
  • WFI / PW systemsInsp.
  • Heat exchangersInsp.
  • Jacketed vesselsInsp.
DZ-C · Electrical & controls

Switchyard & BMS

Switchgear · BMS · MCCs

  • SwitchgearIR scan
  • MCCsIR scan
  • BMSIntegrated
  • PLCs · SCADAIntegrated
DZ-D · Production lines

Manufacturing lines

OSD · sterile · biologics

  • OSDTrained
  • Sterile fill / finishTrained
  • BiologicsTrained
  • PackagingTrained
§ Standards

Standards we operate under.

cGMP
Current Good Manufacturing Practice
ISO 9001
Quality system
ISO 10816
Vibration severity
Vibration Institute
Cat. I–IV
§ Software layer

Software services for this industry.

SW · 01

AI & Machine Learning Systems

HVAC and utility anomaly detection respecting validated-system change-control.
SW · 02

Reliability Data Platform

Audit-ready condition history with data-integrity controls.
SW · 03

Modern IT Infrastructure

SOC 2 Type II information security; data-integrity controls.
§ Engagements

Case studies.

CS · 01

Engagement case studies forthcoming

Apotex engagement summary will be published once cleared by marketing. Anonymized program outcomes appear in the case-studies index.

CS · 02

More engagements →

Browse the case-studies index for anonymized engagement summaries across other industrial sectors.
§ Plant-wide engagement
Plant-wide reliability program · Request engagement.
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