Bioreactor suite

13 min

A monoclonal antibody fermentation suite running ISA-88 batches: media charge, bioreactor, harvest, with the cleanroom environment judged across the whole batch. Five devices and 94 tags over Modbus TCP.

Operator view	port 4011
Protocol server	port 5021
Devices and tags	5 devices, 94 tags
Litmus Edge driver	Modbus TCP
Image	pharma-bioreactor-demo

Scenarios

A batch that cannot be released. A critical process parameter leaves its recipe band for long enough to matter. The deviation is recorded against the batch, not against a shift, and it is visible while the batch is still running.

Right first time. Across a campaign, the proportion of batches that completed without a deviation, which is the number a quality organisation is actually measured on.

The batch record itself. An electronic record assembled from what Litmus Edge recorded: phases, parameters, deviations and environment, exportable at the end of the batch.

What it creates on Litmus Edge

Five DeviceHub devices covering the reactor, the media charge and harvest vessels, the temperature control unit and the cleanroom, with 94 tags. A Digital Twin model and instance per vessel. Analytics groups behind the deviation, yield and release figures.

Requirements

Litmus Edge 4.0.x, reachable over HTTPS from the host running the solution

An API token for that Edge, or a username and password, or a client id and secret

Docker, and Docker Compose for the compose deployment

A network path in both directions: the solution reaches the Edge's API, and the Edge reaches this host on the protocol port

Deploy

The solution ships two ways. Use the registry if the host can reach Google Artifact Registry, and the downloaded archive if it cannot.

Option 1: pull from the registry

Requires a read-only registry credential, supplied by Litmus separately.

cat key.json | docker login -u _json_key --password-stdin https://us-docker.pkg.dev

Save this as docker-compose.yml:

services:
  pharma-bioreactor:
    image: us-docker.pkg.dev/litmus-customer-facing/litmus-solutions/pharma-bioreactor-demo:0.6.1
    container_name: pharma-bioreactor-demo
    restart: unless-stopped
    ports:
      - target: 4011
        published: 4011
        protocol: tcp
      - target: 5021
        published: 5021
        protocol: tcp
    environment:
      # Fill these in.
      EDGE_URL: "${EDGE_URL:-}"
      EDGE_API_TOKEN: "${EDGE_API_TOKEN:-}"
      SIM_HOST: "${SIM_HOST:-auto}"
      APPLY_ON_START: "${APPLY_ON_START:-1}"
      EDGE_VERIFY_TLS: "${EDGE_VERIFY_TLS:-0}"
      # Optional: publish the twins into Litmus Unify.
      UNIFY_URL: "${UNIFY_URL:-}"
      UNIFY_USERNAME: "${UNIFY_USERNAME:-}"
      UNIFY_PASSWORD: "${UNIFY_PASSWORD:-}"
      UNIFY_CONNECTOR: "${UNIFY_CONNECTOR:-}"
      HTTP_PORT: "4011"
      MODBUS_PORT: "5021"
      AUTOSTART: "1"
      TICK_SECONDS: "0.2"
      SEED: "11"
      LOG_LEVEL: "INFO"

EDGE_URL=https://10.0.0.5
EDGE_API_TOKEN=your-token
SIM_HOST=10.0.0.9

docker compose up -d

Or, without Docker Compose, run the same image with the same .env:

docker run -d \
  --name pharma-bioreactor-demo \
  --restart unless-stopped \
  -p 4011:4011 \
  -p 5021:5021 \
  --env-file .env \
  -e APPLY_ON_START=1 \
  -e EDGE_VERIFY_TLS=0 \
  -e HTTP_PORT=4011 \
  -e MODBUS_PORT=5021 \
  -e AUTOSTART=1 \
  -e TICK_SECONDS=0.2 \
  -e SEED=11 \
  -e LOG_LEVEL=INFO \
  us-docker.pkg.dev/litmus-customer-facing/litmus-solutions/pharma-bioreactor-demo:0.6.1

Flags given with -e take precedence over .env, so change APPLY_ON_START or EDGE_VERIFY_TLS on the command line rather than in the file.

Open http://localhost:4011.

The page stays on its waiting panel until the Edge carries this solution's devices. That is deliberate: the simulation does not tick and no value is shown until Litmus Edge is verified to hold the devices and poll them, so nothing on screen can be mistaken for data that never made the trip. With APPLY_ON_START at its default of 1 the solution configures the Edge itself on startup, which takes 30 to 60 seconds. If you set it to 0, or the apply failed, press Apply to Edge in the page header.

Option 2: load the downloaded archive

Download pharma-bioreactor-demo-0.6.1-amd64.tar.gz from the solution's page on portal.litmus.io. The archive is the container image, not a source bundle, and needs no registry access.

docker load -i pharma-bioreactor-demo-0.6.1-amd64.tar.gz

docker load prints the image it added:

Loaded image: us-docker.pkg.dev/litmus-customer-facing/litmus-solutions/pharma-bioreactor-demo:0.6.1

That reference is the one the compose file above already names, so the same docker-compose.yml and .env, or the docker run command above, now work offline with no docker login:

docker compose up -d

To run it without Compose, pass the same three values on the command line:

docker run -d \
  --name pharma-bioreactor-demo \
  --restart unless-stopped \
  -p 4011:4011 \
  -p 5021:5021 \
  -e EDGE_URL=https://10.0.0.5 \
  -e EDGE_API_TOKEN=your-token \
  -e SIM_HOST=10.0.0.9 \
  us-docker.pkg.dev/litmus-customer-facing/litmus-solutions/pharma-bioreactor-demo:0.6.1

Configuration

Variable	Default	What it does
EDGE_URL	the Docker host	Litmus Edge to configure
EDGE_API_TOKEN	unset	token for that Edge. Or a username and password, or a client id and secret
SIM_HOST	auto	address the Edge polls to reach this solution
APPLY_ON_START	1	configure the Edge on startup
EDGE_VERIFY_TLS	0	1 checks the Edge's certificate
UNIFY_URL	unset	optional: Litmus Unify to publish the twins into
UNIFY_USERNAME	unset	optional: a Unify user
UNIFY_PASSWORD	unset	optional: that user's password
UNIFY_CONNECTOR	the Edge's only one	optional: which Litmus UNS connector on the Edge to publish through
AUTOSTART	1	start a batch on boot
SEED	11	makes a run repeatable

Litmus Unify (optional)

This solution can also publish its 5 Digital Twins into Litmus Unify, one message per asset under litmus/pharma-site-01/.... It stays off until two things are true: the UNIFY_ values above are set, and the Litmus Edge has a Litmus UNS connector, which the Solutions provisioner can pair in one click. The next apply then publishes the twins, the page header shows how many are arriving, and removing the solution from the Edge removes its branch from Unify as well. Leave the values empty to keep Unify out of it.

Operator view

The batch runs through its ISA-88 phases along the top: sterilise in place, charge media, growth, harvest. Below, the vessels fill and drain, the agitator turns, and each critical process parameter is shown against the recipe band it has to stay inside.

The environment section is judged across the whole batch rather than sampled, so a room pressure excursion during growth counts against the batch even if the reading has recovered by harvest.

Preview or export the batch record at any point to see what has been recorded so far.

Faults available include parameter excursions, a jacket temperature fault and a cleanroom pressure loss.

Apply and remove

docker compose down

Use Clean up in the Solutions provisioner to remove what it created on the Edge.

Support

[email protected]