Preventive Maintenance & Mission-Critical Industrial Support Services

FDA 21 CFR Part 820 requires that production equipment and facilities be maintained to prevent malfunctions that could adversely affect product quality. For cleanrooms, this means documented preventive maintenance of HVAC systems, HEPA/ULPA filters, differential pressure systems, and temperature/humidity controls. During an FDA audit, investigators request maintenance records to verify that the facility infrastructure has been consistently maintained within validated parameters. A cleanroom with expired filter integrity tests or no documented HVAC maintenance history is a major finding, regardless of current particle counts.

ISO 14644-2 requires periodic monitoring of HEPA and ULPA filter integrity as part of the ongoing cleanroom qualification program. The recommended frequency depends on the ISO classification and product risk level: ISO Class 5–6 cleanrooms typically require annual filter integrity testing (DOP/PAO challenge), while ISO Class 7–8 rooms may be on 12–24 month cycles. For FDA-regulated facilities, the maintenance SOP must specify the testing frequency, acceptance criteria, and corrective action procedure for any failed filter section.

A Us Tech cleanroom HVAC PM visit includes: (1) Visual inspection of all HEPA/ULPA filter housings for damage, bypass, or seal degradation; (2) Differential pressure measurement and recording for all filter banks; (3) Air volume measurement at all supply and return grilles; (4) Temperature and humidity mapping against validated setpoints; (5) Inspection and cleaning of coils, drain pans, and ductwork accessible points; (6) Fan belt and bearing inspection; (7) Control system calibration check; (8) Documented work order with all measurements, technician sign-off, and any corrective recommendations — formatted for FDA audit.

Thermographic (infrared) inspection uses a thermal imaging camera to detect hot spots in electrical equipment — overloaded conductors, loose connections, failing components, and unbalanced loads — before they cause equipment failure or fire. NFPA 70B (Recommended Practice for Electrical Equipment Maintenance) recommends annual thermographic inspection of all electrical distribution equipment. For FDA-regulated facilities, thermographic inspection records serve as evidence of proactive electrical infrastructure maintenance in the Quality System documentation.

Us Tech develops a facility-specific preventive maintenance plan (PMP) that inventories all maintainable assets (HVAC units, electrical panels, filters, fire suppression, compressed air, etc.), assigns maintenance frequency based on criticality and manufacturer recommendations, and creates a master maintenance schedule aligned with FDA and ISO 14644-2 requirements. The PMP is the foundational document for the maintenance program — it defines what gets maintained, how often, by whom, and to what standard. All PM records reference the PMP task number for traceability.

Preventive maintenance (PM) is scheduled work performed to prevent failure — filter changes, lubrication, calibration checks, and inspections. Corrective maintenance (CM) is unscheduled work performed in response to a failure or deviation. In a GMP context, both types must be documented in the maintenance system and any CM event that could affect product quality must trigger a deviation report and CAPA investigation. The ratio of CM to PM events is a quality system metric — a high CM ratio indicates an inadequate PM program and is a potential FDA 483 observation.

Yes — Us Tech provides emergency maintenance response for cleanroom HVAC, electrical distribution, and critical utilities. Emergency response typically involves: (1) same-day or next-day on-site response for critical systems; (2) preliminary root cause assessment and impact evaluation; (3) temporary corrective measures to restore operations; (4) permanent corrective action plan with timeline; (5) deviation documentation required for FDA and ISO quality systems. Emergency response is available under maintenance retainer agreements or as standalone engagements.

FDA investigators commonly request: (1) Preventive maintenance schedule or plan (PMP); (2) Completed PM work orders for the past 12–24 months, including HVAC, critical utilities, and electrical systems; (3) HEPA/ULPA filter integrity test reports; (4) Differential pressure, temperature, and humidity monitoring logs; (5) Equipment calibration records; (6) Corrective maintenance records and associated deviation/CAPA documentation; (7) Maintenance contractor qualifications and training records. Us Tech generates all records in a format that maps directly to FDA inspection categories.

ISO 14644-2 requires periodic re-testing of cleanroom classification to confirm the room still meets its designated ISO class. The re-qualification interval depends on the ISO class: typically 6 months for ISO Class 5–6 and 12 months for ISO Class 7–8. Gaps or failures in the interim maintenance program — unrecorded filter replacements, unmonitored pressure differentials, or uncalibrated sensors — can invalidate the re-qualification baseline and require a full re-classification test. Us Tech's PM programs are designed with ISO 14644-2 re-qualification cadence in mind, maintaining a continuous documented chain of facility condition between formal re-qualification events.