الإجابة المختصرة
When the strength of an ingredient changes from lot to lot, weight is the wrong unit. A potency-adjusted formula states what you need in active content, and the system works out how much of today's lot delivers it.
Weight is the wrong unit
A supplier ships two lots of the same active ingredient. One assays at 98%, the other at 92%. The certificate of analysis says so, the drum label says the same thing it always did, and the formula says 20 kg.
If the formula means 20 kg of powder, the batch is short on active in both cases, and by different amounts. If it means 20 kg of active, someone has to do a small calculation before every dispense, with the right lot's assay in hand, at the booth, in a hurry. That calculation is where errors live.
Illustrative figures chosen to show the arithmetic; they are not customer data and not from our test runs. Our tablet scenario, separately, uses a 98% potency lot.
| Lot assay | Powder to weigh for 20.00 kg of active | Active delivered if you weigh 20.00 kg of powder | Shortfall |
|---|---|---|---|
| 98% | 20.41 kg (20.00 divided by 0.98) | 19.60 kg | 0.40 kg |
| 92% | 21.74 kg (20.00 divided by 0.92) | 18.40 kg | 1.60 kg |
The lower the assay, the larger the error, and a weighing that looks perfect on the scale can still deliver an 8% short dose of the one thing that matters.
Write the formula in what you actually want
A percentage formula states each ingredient as a share of the batch rather than as a fixed weight. It scales cleanly: a batch of 500 kg with 4% active needs 20 kg of active, and a batch of 1,000 kg needs 40 kg. It also lets you scale to a vessel instead of a number on a paper recipe.
Potency adjustment then turns that required active content into a weighed quantity, using the assay of the lot that will be used. Yield adjustment works alongside it: if the process is known to lose a share of the batch, the formula asks for more input to deliver the same output. Done in the formula, rather than in the formulator's head, the adjustment is the same on every shift and visible on the record.
When the planned lot is not the lot on the shelf
Real plants rarely get to use the lot they planned around. A drum is quarantined, a supplier delivers late, a second lot with a different assay arrives. Three controls matter here.
Lot attributes
Potency, moisture and fat travel with the lot, so the strength used in the calculation is the strength of that lot.
- Lot status runs from quarantine to released
- Expiry follows the earliest-expiring ingredient
Approved substitutes
A formula can name an alternative ingredient that has been agreed in advance.
- The decision is made by the formulator, not at the booth
- The substitute is on the record with the batch
Change requests
A change to the formula goes through a request rather than an edit on the day.
- QA sees what changed and why
- Cost simulation shows the effect before the change goes live
The order of events matters. A substitute or a changed percentage should be agreed before the shift starts, so the operator is following an approved formula, not improvising a new one.
At the dispensing booth
The calculation is only useful if it reaches the person with the scoop. Shop-floor dispensing in ManufacturingFlow 365 suggests lots to dispense, checks potency, and converts litres, with the dispensed quantities fed in from shop-floor systems such as MESFlow 365.
The litre conversion deserves a mention because liquid ingredients cause their own errors. A formula that needs 12.00 kg of a liquid additive with a density of 0.80 kg per litre needs 15.0 litres. Dispensing by volume while the record reads in kilograms is easy to get wrong by hand and trivial for a system to get right. (Illustrative figures, as above.)
What you want is a booth screen that says: take this lot, this much, and tells you if the lot you scanned is not the one you should be using.
What to look for in any potency system
Whichever product you choose, check these before you commit.
- Does the required quantity change automatically when you pick a lot with a different assay?
- Is the assay a lot attribute that QA enters, or a number the operator types?
- Can the formula be edited at the booth, or only through a change request?
- Does the batch record show which lot, which assay and which adjusted quantity were used?
- What happens when an ingredient lot is quarantined or has expired?
In Business Central
- Percentage formulas scaled to a batch size or a vessel, with yield adjustment.
- Potency-adjusted consumption, driven by lot attributes such as potency, moisture and fat.
- Approved substitutes, change requests and cost simulation.
- Shop-floor dispensing that suggests lots, checks potency and converts litres.
- Lot status from quarantine to released, and genealogy forwards and backwards.
- Demo data for a tablet formula, created by one action in a sandbox.
Limits
The tables above are illustrative arithmetic. ManufacturingFlow 365 is designed from 63 identified gaps, of which 27 are implemented and 36 partly. Electronic batch record, e-signature and change approval have not been tested with a second user, so we describe them as supporting traceability and audit trails and nothing more. The apps have been run in a UAT sandbox with demo data and no live customer is recorded. Ask to see how your own assay convention is handled, for example whether a result is stated on an as-is or dried basis.
See it on your process
Send us a certificate of analysis and the formula it feeds. We will run it through the dispensing step: book the tablet formula potency scenario.
Keep reading: a mock recall in 15 minutes and why one item per production order breaks process plants.