Pharma

More batches right the first time.

In a pharmaceutical plant the costly losses are a batch that fails release, a deviation that ties up QA for days, and utilities that run as hard on an idle day as on a full one.

Book a site survey See how it works

Our first deployments are with auto-component makers. In this industry we start the same way, with a site survey on your floor and a written read-out of where we would begin.

Where efficiency is lost

Four places a pharma plant loses efficiency.

Stamped builds models of your plant from the data it already records, finds where efficiency is lost across process, quality, planning and maintenance, and improves it with actions your team can take.

01 · Process and controlLearn more »
Run every batch better than your best.
Granulation end points, drying times, compression force and coating conditions vary between batches, shifts and equipment trains, even inside the validated ranges, and the operators who run the steadiest batches rarely write down why. Stamped models how each batch actually runs within those ranges, points out where a running batch is moving away from its best path and recommends improvements for your production and process teams to take through change control.
EnergyOver-drying and long granulation cycles use energy and time without adding anything to the batch.
02 · Quality and lot checksLearn more »
See a deviation coming before it becomes an investigation.
When an OOS result or a deviation comes in, most of the time goes into pulling together the batch record, equipment data, environmental readings and related lots. Stamped links that data to each batch as it is made and alerts the floor while a running batch can still be brought back, for example when a hold time is nearing its limit or a dryer is drifting off its profile. It also flags batches made under conditions that came before past deviations and puts the full record in one place for the investigation and for QA's release decision.
EnergyA batch that is reworked or rejected has already used all the utilities of a good one.
03 · Planning and schedulingLearn more »
Keep the campaign on plan when a step slips.
A cleaning that runs long, a granulator down for maintenance or material held at QC ripples through the week's campaign. Stamped keeps track of the whole site, from room and equipment status to cleaning, QC holds and dispatch dates, and proposes the sequence that works best across all of it, showing what each option does to batch output, changeovers and dispatch.
EnergyGrouping products to cut changeovers also cuts the cleaning and HVAC hours that come with them.
04 · MaintenanceLearn more »
Prescribe the fix before it triggers a deviation.
Stamped ranks equipment stops by the batch time they cost and watches specific energy consumption and other slow drift in utilities, such as an air handler drawing more power for the same airflow, a chiller losing efficiency, or a room pressure differential that keeps getting close to its limit. It prescribes the fix and a slot between campaigns, so engineering can act before it turns into an excursion.
EnergyAir handlers and chillers are usually the largest energy users on a pharma site.

In this plant

Production suites, cleanrooms and HVAC, QC and release, and utilities.

A pharma plant already keeps careful records for GMP, but the batch record, the building management system, the equipment logs and the lab results usually sit in separate places.

Granulation, drying, compression and coating
In oral solid dose and API production the questions are about end points, cycle times and in-process results, and Stamped compares each batch with the best batches of the same product so the production manager can see which step drifted.
Cleanrooms and HVAC
Room pressures, temperature, humidity and air changes have to stay inside their limits, and Stamped watches how close each room runs to them and how hard the air handlers work to keep it there, on production days and idle days alike.
QC and batch release
Every release depends on the record being complete and every deviation being closed, so Stamped gathers the process, equipment and environmental data for each batch in one place before QA needs it.
Chillers, purified water and compressed air
Utilities keep running whether or not a batch is in the room, and Stamped points out where chillers, pumps and compressors can follow the production calendar and where their performance is drifting.

Example actions

What the people who own the problem receive

Each action goes to the person best placed to act, with what to do, by when, and the reasoning behind it. Anything that touches a validated parameter goes through your change control.

Process

Drying, for the production manager

Drying on FBD 2 has run about [N] minutes longer than the best batches of this product, with inlet air humidity the main difference, so the moisture end point is worth checking before the next batch.

Quality

Compression, for QA

This batch was compressed while hardness drifted toward the upper limit for [N] minutes, similar to the batches behind last quarter's dissolution deviations, so it is worth an extra review before release.

Quality

Investigation, for the QA lead

Here is every equipment, environmental and process record for the batch, gathered in one place for the deviation opened this morning.

Planning

Planning, for the planner

Granulator 1 will be down for about [N] hours, and the proposed sequence brings the next product forward so this week's batches still finish on time.

Maintenance

HVAC, for engineering

Room 4's pressure differential has come close to its alarm limit on [N] days this month, each time late in the air handler filter's life, so a filter change before the next campaign is worth scheduling.

Energy

Utilities, for the utilities head

Air handlers serving the granulation suite ran at full flow through [N] idle hours last week, so an idle mode within what your validation allows is worth raising with QA.

These are examples, and numbers in [brackets] are placeholders. Your pilot writes the real ones from your own plant data.

Impact

What changes in the plant.

The first finding usually comes within about two weeks. Results are measured against your own baseline and published only with your permission.

Fewer rejections reach the customer

Because lots at risk are caught in real time, while they can still be saved.

More output from the same lines

With bottlenecks, idle time and restarts found and fixed, and control improved beyond your best runs.

Fewer surprise breakdowns

Since slow drift shows up in data you already collect.

Less energy for every good part

Once idle heat, reheats and scrap are counted and brought down.

Before you book

What owners usually ask us first.

Book a site survey

What does it cost?: Only the pilot price is agreed at the survey. The pilot is paid and priced on its own, and the annual price comes after, based on the pilot's results.
What do we need to install?: Nothing new to start. Stamped connects to the machines, meters, ERP and registers you already have, and the survey tells you plainly if that is enough.
How much of my team's time?: Some hours with your plant head and your quality and maintenance leads during the survey, planned around production. In the pilot, actions reach the people who already own that work.
Is our data safe?: We sign an NDA before the survey. Stamped runs on a zero-trust architecture with encryption, your data is stored on cloud servers in India, and we work only with the data your team agrees to share.

Book a site survey

FAQ

Common questions

Has Stamped worked with pharma plants?

Our first deployments are with auto-component makers. In pharma we start the same way, with a site survey on your floor and a written read-out of where we would begin, and we work within your quality system and change control.

Does Stamped make release or GMP decisions?

No. Release and disposition stay with your QA team, and Stamped gathers the records and flags what looks unusual so they can decide faster. Stamped recommends and your team decides.

Do we need new hardware, or another system next to MES, ERP and SCADA?

No hardware retrofit is needed to get started, because Stamped is software that works with the systems you already run. It is not another MES or CMMS: your MES, ERP and SCADA are where the data comes from, and Stamped works alongside them. Stamped brings their data onto one timeline, so they finally work as one picture of the plant.

How do we start?

We start with a site survey, which means a few days on your floor and a written read-out of where efficiency is being lost and what we would change first. If it makes sense, that is followed by a paid pilot on one line for eight to twelve weeks, and the first finding usually comes within about two weeks.

More batches right the first time.

Four places a pharma plant loses efficiency.

Run every batch better than your best.

See a deviation coming before it becomes an investigation.

Keep the campaign on plan when a step slips.

Prescribe the fix before it triggers a deviation.