Description

🧪 Environmental Chamber Mapping & Validation (IQ/OQ/PQ)

Overview

We perform full thermal/humidity mapping and validation of controlled-environment equipment and spaces, including stability chambers, environmental chambers, incubators, cold rooms (2–8 °C), freezers (−20 °C), ultra-low freezers (−80 °C), and stability/conditioning rooms.
Our protocols follow risk-based IQ/OQ/PQ methodology with NIST-traceable sensors, statistically defensible sampling plans, and acceptance criteria aligned to your SOPs and regulatory requirements (e.g., FDA/EMA expectations, ISO/IEC 17025).

Scope (What we validate)

• Temperature: steady-state stability, spatial uniformity (Tmax−Tmin), transient behavior, recovery.

• Relative Humidity (RH) (if equipped): stability, uniformity, control response, condensation risk.

• Controls & Alarms: setpoint accuracy, high/low limits, alarm logic, notifications, data retention.

• Use Conditions: empty, loaded (worst-case), door-open events, power loss/restart, seasonal stress (as applicable).

Test Plan (IQ/OQ/PQ)

IQ — Installation Qualification

Verifies the chamber is installed and documented correctly.

• Nameplate and firmware, wiring, sensor locations, airflow path, insulation, door seals.

• Calibration status of built-in probes and external references (traceable to NIST).

• Manuals, SOPs, drawings, and maintenance records.

OQ — Operational Qualification (Empty Chamber)

Characterizes the chamber without product load.

• Setpoint accuracy & drift (e.g., 5–10 h dwell at each setpoint).

• Spatial uniformity: grid of mapped points (e.g., 9–27+ loggers) across shelves/zones; compute U = Tmax − Tmin.

• Temporal stability: per-probe σ and RMS over steady state.

• Control response & recovery: door-open challenge (e.g., 30–60 s), log time-to-recovery to within tolerance.

• Alarm challenges: force high/low T/RH, verify annunciation, latching, and notification paths.

• Data integrity: confirm logging rate, gap detection, and time-sync.

PQ — Performance Qualification (Loaded / Worst-Case)

Demonstrates fitness for your actual payload and workflow.

• Load chamber with worst-case mass/packaging (largest thermal inertia, most restrictive airflow).

• Repeat mapping at operational setpoints (e.g., 25 °C/60%RH, 40 °C/75%RH, 2–8 °C).

• Identify hot/cold spots and edge effects (near door, fan, top/back corners).

• Door-open sequences and routine handling simulations per SOP.

• Calculate MKT (Mean Kinetic Temperature) for storage qualification where applicable.

Acceptance Criteria (typical—tailored to your SOP)

• Setpoint accuracy: ≤ ±0.5–1.0 °C; RH ≤ ±3 %RH (instrument/spec dependent).

• Uniformity (U = Tmax − Tmin):

  • Small chambers: U ≤ 2.0 °C (T), ≤ 5 %RH (RH).

  • Large rooms: U ≤ 3.0 °C (T), ≤ 6 %RH (RH).

• Temporal stability (σ at steady state): ≤ 0.3–0.5 °C; ≤ 2–3 %RH.

• Recovery time (after 30–60 s door open): back within tolerance in ≤ 10–15 min (T) and ≤ 20–30 min (RH).
  (We align final numbers to your quality system and device specification.)

Instrumentation & Methodology

• Sensor fleet: 9–36+ NIST-traceable data loggers (calibrated with as-found/as-left certificates).

• Grid design: 3D spatial grid covering all shelves, corners, centerline, near-door, near-fan.

• Logging interval: typically 30–60 s; tighter for transient tests.

• Dwell time: ≥ 5 h per setpoint after stabilization to capture diurnal cycles and control behavior.

• Statistics & visuals: min/max/mean, σ, uniformity envelopes, heatmaps, isotherms, time-series plots, and recovery curves.

Deliverables

• IQ/OQ/PQ protocol & report (PDF) with purpose, method, results, acceptance decisions.

• Certificates for all reference loggers (traceable).

• Raw datasets (CSV) + plots (PNG/embedded).

• Heatmaps and spider/box plots highlighting worst-case locations.

• Deviation log with CAPA recommendations if criteria are not met.

• Requalification plan (e.g., annual or seasonal for large rooms).