Life sciencesManufacturing process improvement

Cleanroom kitting that saved two hours per batch in its pilot

Operators spent 45% of the observed cleanroom time waiting. Opyflow traced which parts of material preparation and coordination were interrupting the work, then designed kits around the manufacturing sequence and piloted them.

Situation

Preparation work kept competing for the attention that operators and verifiers needed for the process itself.

Opyflow's role

After measuring the work, Opyflow redesigned material preparation and kit contents around the sequence operators had to follow, and reorganised the workplace to suit it.

Documented outcomeRealised result

Two hours saved per batch, on the first production day · 45% of observed operator time spent waiting (baseline) · Hundreds of individual items consolidated into a small set of kits

The challenge

The cleanroom process depended on a close partnership between operator and verifier. Organising supplies or preparing the next step broke into that partnership, as did any communication outside the room, and the operator was left waiting.

In the sessions observed, preparation and transfer activities were repeated in the material flow. More of that work could be done before the operator needed it, provided every control governing entry to the cleanroom still applied.

Opyflow's work

Opyflow followed operators and verifiers together and measured how they used their time. Along the route from material picking to the workstation, each delay was traced back to the preparation, movement or coordination behind it.

The team then specified kits by manufacturing step, with materials grouped in the order they would be used, and assessed the preparation point against cleanroom requirements. In the design that went to pilot, a small set of kits replaced the handling of hundreds of individual items, so far fewer separate items had to be presented for transfer.

Equipment position, mobile shelving, workstations and access to consumables were arranged around the kits. The next step was then ready when it was needed, and the verifier could give more attention to checking the process. At the steps most vulnerable to mistakes, instructions, labels and visual distinctions were revised.

The pilot ran the design on the line. Its action plan set out the procedural and training changes that each physical change required, and every change had an owner.

Measure wherethe work waitsGroup materials byproduction stepPrepare and positionthe kitsPilot the revisedworkflow
Illustrative explanation of the work; not a client deliverable.

What changed

On its first production day, the pilot saved two hours per batch. The 45% waiting figure is the baseline measured by observation before the change.

How were the kits tied to the manufacturing process?

Each kit belonged to a manufacturing step and matched the way operator and verifier worked together. Where the kit was prepared, how it was transferred and presented, and the instructions that went with it were designed as one flow.

See the capability: Operational excellence & turnaround →

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About Opyflow

Opyflow is an operations and supply chain consultancy, founded in 2019, working with manufacturers in regulated and high-complexity industries. Offices in Kiryat Ono, Israel and Melbourne, Australia; projects across Israel, Europe, the US and India. The senior person you talk to is the one who does the work.

We are done when it's in the P&L.

Every cleanroom prepares material and pairs operator with verifier in its own way, so the waiting at your site may have causes other than the ones found here.