Analytics

Was 25 °C / 60 %RH held?
Both at once?

A stability specification states a combined condition. Most chamber software reports temperature and humidity separately and leaves you to guess. ProcessView+ measures the condition itself, and shows you every reading that decided it.

Scatter of temperature against relative humidity, with the warn window for both loops drawn as a rectangle around 25 °C / 60 %RH 23 24 25 26 27 54 57 60 63 66 69 Temperature (°C) %RH Warn window (both loops)
Joint Temperature / Humidity Window: every observed soak reading, plotted against the warn window. Illustrative data

Why two percentages aren’t enough

95% and 95% can still mean the condition was barely held.

If temperature drifts out while humidity is in, and then humidity drifts out while temperature is in, both loops report a high figure, and the combined condition was lost twice. The joint window counts only the time both were in band together.

Temperature in band95.0%
Humidity in band95.0%
Joint window: both at once90.0%

Worked example: excursions on the two loops that never overlap.

The figures

What each figure measures, and exactly how

Every method is published here and in the user manual, so your QA team, or your auditor, can check it.

Setpoint-pair dwell & joint window

Was the combined condition held?

For each temperature / humidity condition the profile commands: the share of commanded soak time with both loops inside their warn bands, the longest unbroken hold, and the total held.

Show the math
joint window % = time both in band ÷ commanded, observed time × 100

Soak steps only. A setpoint change counts nowhere. Logging gaps are excluded from both sides: time nobody watched can’t be claimed as held. One reading out of band, or a gap, ends a hold. It is a measurement, reported beside the verdict, not part of it.

Mean kinetic temperature

Did the product see more thermal stress than its storage condition?

The single constant temperature with the same cumulative effect as the varying history. Per channel, over the whole run including ramps, shown in the channel’s own unit.

Show the math
MKT = (ΔH/R) ÷ −ln( (1/n) · Σ exp(−(ΔH/R) / Tᵢ) )
ΔH = 83.144 kJ/mol · ΔH/R = 10 000 K · Tᵢ in kelvin

Missing readings are counted from the recorded logging interval; a partial record gives a partial figure with its coverage stated. Readings repeated during a communication outage are counted as logged; only holes in the log reduce coverage. A humidity channel says it is not a temperature, rather than showing a number.

Time in tolerance

How long was each channel in band, in warn, in alarm?

Against the bands captured when the run started. Per step, with minutes out of band, excursion count and the longest excursion, and for the whole run when every step carries the same bands.

Show the math
in band % + warn % + alarm % = 100% of observed time

Each interval is classified by the reading at its start; the three slices are exclusive so they can’t be misread as adding past 100%. Gaps over 120 s and readings taken during an outage are excluded, and the unobserved time is reported. No band means no figure, never 100%. When steps carry different bands there is no whole-run figure; the on-screen grid shows the worst step and says so.

Sample coverage

Was every reading actually observed?

Each logged reading is marked as observed from the controller or repeated during a communication outage. Coverage is stated beside the verdict on the report.

Show the math
coverage % = observed ÷ (observed + repeated) × 100 → shown as “at least”

An outage longer than three polls or 12 s, whichever is longer, raises the verdict to REVIEW: an unobserved period can’t be claimed as clean. A shorter one lowers coverage and leaves the verdict alone. Sessions logged before readings were marked show “coverage unknown”, not a guess.

Dew point & absolute humidity

How much water was in the air, and where would it condense?

Dew point for each held condition, and absolute humidity for the run, calculated from the dry bulb and relative humidity and printed on the report with their source.

Show the math
IAPWS-IF97 Region 4 (IAPWS R7-97(2012)), Eqs. 30 & 31
W = 621.945 · p_w / (P − p_w) g/kg, at P = 101.325 kPa

A published, freely available international formulation, so the figure can be checked independently. Absolute humidity assumes standard atmospheric pressure, and the report says so. No dew point is given below freezing, when the dry bulb is below 0 °C, or when it isn’t clear which loop is the dry bulb.

The run verdict

PASS, REVIEW or FAIL, and why?

Decided by each step’s criticality and the worst excursion on it, with the reason printed under the verdict and the rule printed on the cover.

Show the math
FAIL: a Critical step alarmed, or the profile was aborted before its last banded step
REVIEW: a Critical step warned, an Advisory step alarmed, a monitor-input alarm was withheld, an outage longer than three polls, or a step never reached
PASS: otherwise

A run that can’t be shown clean isn’t called clean. A run whose status wasn’t recorded is N/A, not a failure. The verdict is decided live, with the settle window, dwell and hysteresis you set; the measured figures above have none of these, so the two can disagree on the same run.

Where you’ll see it

Calculated once. The same number everywhere.

01

The analytics grid

One row per zone, for any stored session, on screen.

02

The CSV export

Per zone, per step and per condition, for your own spreadsheets.

03

The QA report

On the cover, beside the verdict, with the charts on the pages that follow.

04

The signed record

With electronic signatures on, MKT is part of what a Part 11 signature covers.

By industry

The figures your auditor asks for

MKT per channel

On the cover, and in the signed record when signatures are on.

Joint window at 25/60

The combined condition, measured directly.

Every outage accounted for

Coverage beside the verdict, and an outage longer than three polls raised to REVIEW.

Try it in the free trial: Stability Demo, 25 °C / 60 %RH, about 40 minutes of process time.

See it on your own screen, with no chamber attached.

Start the Stability Demo, explore while it runs, and open the finished QA report.

ProcessView+ is 21 CFR Part 11 ready and AMS 2750 ready. Software supports compliance; your system is validated by you. Demonstration runs are simulated and are not test results.