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Unit II · Baddi — A, B, CD, F, GH

Environmental Monitoring
User Guide

You manage plate exposure outside the cleanroom. Every action you take is timestamped, attributed, and permanently logged. This guide walks you through every step — from your first login to exporting a GMP-ready PDF record.

6 round stages3 user roles3 PDF report typesEvery event audit-logged

Before you start

Complete the Admin Setup checklist. Map your EM plates. Freeze the layout. Then you're ready to run rounds.

During a round

Log PLACED and RETRIEVED events for every plate from the Rounds panel or directly on the floor plan canvas.

After exposure

Retrieve All closes exposure. Log incubator-in, enter colony counts after the 120h gate, mark checked, and export the PDF.

01 — Overview

What you're looking at

When you log in, you land on your facility's live floor plan — drawn to true scale with every EM location pinned exactly where it sits on the cleanroom floor. You never carry a device into the grade zones. You plan, log, and sign off from right here.

Cleanroom Tracker building view — live floor plan with EM pins and status legend
A Block — Cephalosporin (Unit II, Baddi), signed in as Admin. Orange pins are due today, green are complete.

Floor plan canvas

The Konva-rendered facility map. Pins mark every settle plate, air sampler, and surface swab location. Pin colour = grade zone. The ring around each pin shows the current round state.

Mode panel

The control card on the right side of the screen. Switches context without reloading the floor plan — Building, Rounds, Check, Reports, or Setup.

Navigation rail

The icon strip on the far left. One click changes the mode panel. The floor plan underneath stays live at all times regardless of which mode you're in.

Live HUD

Status cards overlaid on the canvas during an active round — shows T1 timestamp, plate counts by status, and the process-time buffer for the current grade zone.

◎Facilities and units

Cleanroom Tracker runs two units: Unit I — Panchkula (four area layouts across two floors of the Large Volume Parenterals facility) and Unit II — Baddi (facilities A, B, CD, F, and GH). If your account can see more than one facility, use the switcher at the top-left of the screen — it groups facilities by unit and shows which one you're currently in.
Facility switcher dropdown showing Unit I — Panchkula (GF-IC, GF-FILL, FF-QCM, FF-SOL) and Unit II — Baddi (A, B, CD, F, GH)
The facility switcher — top-left of every screen. Each deployment is normally scoped to one unit; this view shows both because it's an unscoped development environment.

02 — Roles

Who can do what

Three roles, each with a clear lane. Every action any user takes is permanently recorded with their name, role, and a precise timestamp.

Operator

Runs the rounds. The primary user during a sampling shift.

Can do

  • ✓Start rounds, record Place All/Retrieve All, and log incubation + colony counts
  • ✓Log plate events — Placed, Retrieved, Deviation, Skipped
  • ✓View the live floor plan and active round progress
  • ✓Export PDF records for closed and checked rounds

Cannot do

  • ✕Map or freeze EM plate positions (Check mode)
  • ✕Open Setup — master data, users, media, or process timings
  • ✕Work in a facility they haven't been assigned to (Setup → People)
Checker

Owns the floor plan layout and signs off on rounds. Typically the QA/microbiology lead.

Can do

  • ✓Everything an Operator can do
  • ✓Open Check mode to add, move, or remove EM pins, and freeze/unfreeze the layout
  • ✓Open Setup to manage rooms, EM locations, media batches, and process-time offsets
  • ✓Mark a round checked once the 120h gate and colony counts are complete

Cannot do

  • ✕Create, edit, or deactivate user accounts (admin-only)
Admin

Configures the system. Typically the QA manager or IT lead.

Can do

  • ✓Everything a Checker can do
  • ✓Create, edit, and deactivate user accounts, and assign roles
  • ✓Assign operators to the facilities they work in
  • ✓Access the full audit trail

✦New operator? Assign them to a facility first

A freshly created Operator account can't see any facility until an Admin assigns one in Setup → People. Until then they'll see a "No facility assigned" screen after signing in — that's expected, not an error.
Operator view with no facility assigned
Operator, not yet assigned to a facility — nav shows only Building, Rounds, Operator, Reports.
Checker view with full navigation rail
Checker — same rail as Admin, including Check and Setup.

04 — Rounds

Running an EM round

A round is the complete exposure and incubation cycle for a set of grade zones. It moves through six clear stages — the timeline below shows the flow at a glance.

01

Plan

Choose grade + shift

02

Start · T1

Confirm operator + media

03

Place All

Start exposure

04

Retrieve All

Close exposure

05

Incubation

120h gate + counts

06

Checked

Part of the audit trail

Rounds panel — plan a new round, view rounds filtered by stage
The Rounds panel. Filter chips: All active, Overdue, In progress, Retrieved, Incubation, Awaiting check, Checked.
1

Plan a round for today

Plan

Select one or more grade zones (A, B, C, D), optionally filter by plate type, and pick a shift (Day or Night). Click Plan round for today. The round appears in Today's Rounds with status Planned.

You can plan multiple rounds for the same day — for example, a Grade A settle-plate round and a Grade B air-sampling round running in parallel.
2

Confirm operator and media, then start

Start · T1

Select the operator and media batch (lot number). Click Start round — capture T1. The T1 timestamp is recorded and the round turns live. The process-time buffer for the grade zone is displayed so operators know when to enter the cleanroom.

T1 starts the transit/pre-exposure clock. Exposure duration begins only when Place All is recorded.
3

Start exposure

Place All

After the configured entry/transit time, press Place All. If placement happens early, the app refuses the action until you provide an override reason — that reason becomes part of the round's permanent timeline.

Exposure duration is calculated from Place All to Retrieve All, so transit time is never counted as exposure.
4

Close exposure, not the round

Retrieve All

When all plates are collected, click Retrieve All. The exposure phase is closed, missing plate events are auto-completed for the selected round locations, and the round moves into incubation.

5

Log incubator-in, then wait for the 120h gate

Incubation

Log incubator-in from the round panel. Colony-count fields stay locked until 120 hours have passed since incubator-in — the panel shows the exact ready time. Entering counts earlier is possible, but only with a deviation reason, which is audit-logged the same way the Place All override is.

Once the gate opens (or a deviation reason is given), enter bacterial and fungal counts per plate and click Save colony counts.
6

Mark checked

Checked

Once every plate has counts saved and the incubation gate has been satisfied, click Mark checked. The round becomes immutable — no further edits to counts are possible through the app. Checked rounds appear in the Reports page for PDF export.

Round timeline showing T1 start captured with real timestamp
T1 captured — a real, system-generated timestamp, not something an operator types in.
120h incubation gate modal requiring a deviation reason
Entering counts before 120h is possible only with a logged deviation reason.
Round marked checked — full timeline with T1, Place All, Retrieve All, Incubator in, Results, and Checked, each attributed to a real user
A fully checked round. Every stage — including Results and Checked — is attributed to a real signed-in user with a real timestamp.

⚠Cancelling a round

A round with status Planned can be cancelled before it starts. Hover over the round in Today's Rounds and click ✕. A confirmation dialog appears — the cancellation is audit-logged with your name and timestamp and cannot be undone. Rounds that have been started (T1 captured) cannot be cancelled.

05 — Check mode

Mapping EM plates

Before running any rounds, a Checker must pin every EM location onto the floor plan and freeze the layout. Operators cannot move pins once it's frozen — which protects the map's integrity during live rounds.

1

Switch to Edit mode

Click Edit in the top-right of the Check panel. The canvas enters placement mode — existing pins become draggable and a cursor prompt appears on the floor plan.

2

Add a new plate

Click anywhere on the floor plan to drop a pin. The system auto-assigns a code based on the room it lands in (e.g., A-01, B-03). Codes can be renamed in Setup.

3

Reposition a plate

In Edit mode, click and drag any existing pin to its correct position. Pins snap to a 30 cm grid to maintain spatial accuracy.

4

Remove a plate

Right-click (or long-press on touch) a pin to open the context menu, then choose Remove. Removals are audit-logged with your name and timestamp.

5

Freeze the layout

When all plates are confirmed, click Freeze. The layout locks — no operator can move or remove plates during live rounds. Only Checkers and Admins can unfreeze to make adjustments.

06 — Reports & PDF

Three types of GMP record

Every completed round is a permanent record. The Reports page offers three views — each exports its own GMP-formatted PDF for your site file. All three share the same A4 design: gradient accent rule, metadata strip, doc-ref ID, and a sign-off block.

Round Report PDF with Chain of Custody block
A checked round's exported PDF, including the Chain of Custody block at the bottom.
Round Reportone per round · EMR/FACILITY/DATE

The primary record for a single EM round. Generated from the Round Records tab. Contains: facility metadata, media lot number, start, Place All, Retrieve All, and incubation timestamps, calculated exposure and incubation durations, a full EM locations table with per-plate counts and deviation flags, reference document IDs, and a chain-of-custody block.

✦Chain of custody

Every stage of the round — Place, Retrieve, Incubate, Enter Results, Check — is listed with the real name, role, and timestamp of whoever performed it, each marked "recorded in software." This replaces a single pre-printed signature with a full step-by-step provenance trail.
Location History Reportone per EM location · LOC/FACILITY/CODE/DATE

A longitudinal view of a single EM location across all rounds in a date range. Generated from the Location History tab by clicking PDF ↓ next to any location. Contains: location code, room, grade, EM method, and an exposure history table with date, shift, operator, lot number, exposure duration (calculated from PLACED to RETRIEVED), and result per round. Deviation rows are highlighted in amber.

Facility Summary Reportone per facility · FSR/FACILITY/DATE

A bird's-eye view of all rounds and locations for a given period. Generated from the Facility Summary tab. Contains: grade coverage breakdown table (active locations vs. sampled, coverage %, events logged, rounds run), a full completed-rounds list with operator and lot number, reference documents, and a sign-off block.

⚠Coverage warning

If overall coverage falls below 80%, a warning banner appears at the top of the printed report — listing exactly how many locations were missed. This is your signal to investigate before sign-off.

How to export

Click PDF ↓ on any record. A print-ready A4 page opens in a new tab. The browser print dialog opens automatically — choose Save as PDF. The ← Back button in the toolbar returns you to the app.

Date range filter

Use the From / To pickers at the top of the Reports page to narrow the date range before exporting. All three report types respect the active filter.

Status colour coding

Checked (green) = signed off, immutable. Closed (amber) = exposure done, awaiting incubation/check. Live (pulsing green) = round in progress. Cancelled rounds are excluded from all exports.

Pagination

The Round Records tab shows 10 rounds per page with previous / next controls. Page resets automatically whenever you change the date filter.

07 — Setup

Configuring the system

Checkers and Admins can open Setup via the icon at the bottom of the nav rail. Before your team runs their first round, work through each tab in order.

Setup overview page with master data tabs
Setup — Overview tab. Rooms, EM locations, People, Media batches, Process & schedules.
People

Manage who can access the system and what they can do. Admin only for account changes.

  • Create accounts with full name, email address, and assigned role
  • Assign role: Operator, Checker, or Admin
  • Assign each operator to the facility (or facilities) they work in — an unassigned operator sees "No facility assigned" after signing in
  • Deactivate accounts — deactivated users cannot sign in, but their full audit history is preserved
Media

Track media batches so every round is linked to a specific lot. Checker or Admin.

  • Add batches: lot number, media type (TSA, SDA, etc.), expiry date, quantity
  • Expired batches are flagged — operators see a warning if they try to select one
  • Incubation days set per batch — shown on the PDF record and in the post-close checklist
Process

Set grade-zone entry buffers so operators know exactly when to enter. Checker or Admin.

  • Configure gowning time + walk-to-first-plate time + exit time per grade zone
  • These offsets appear on screen after T1 is captured, telling the operator when to move
  • Grade A and B typically require longer gowning — configure each grade independently

First login checklist

  1. 01

    Sign in with the seed admin credentials from your deployment configuration

  2. 02

    Go to Setup → People — create a real admin account with your own email and password

  3. 03

    Deactivate the seed admin user

  4. 04

    Create Operator and Checker accounts for your team members

  5. 05

    Assign each operator to the facility (or facilities) they'll work in

  6. 06

    Go to Setup → Media — add your current media batch (lot number, type, expiry)

  7. 07

    Go to Setup → Process — set grade-zone entry offsets for your facility

  8. 08

    Open Check mode — pin all EM plate positions to the floor plan

  9. 09

    Freeze the layout once all positions are confirmed

Once you reach the last step — you're ready to run your first round.

You're all set

Every round. Every plate. Every timestamp.

Cleanroom Tracker keeps the paper trail so your team doesn't have to. Sign in, run your round, export the record. That's the whole workflow.

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