Batch and Campaign Capacity Calculator

Enter the dosage form, batch size and fill volume and the calculator returns units per batch after yield loss, hours on the line, batches needed for your annual requirement, campaign duration and the date stock is actually released.

What the calculator asks for

• Dosage form — liquid vial, ampoule, pre-filled syringe, lyophilised vial, contrast bottle, tablet, capsule, oral liquid, cream or serum
• Batch size in litres or kilograms
• Fill volume in ml, or unit weight in mg or g
• Annual requirement in units, if you want campaign planning
• Containment — standard, contained cytotoxic, or cold chain
• Sterilisation route — terminal, aseptic, or not applicable

Units per batch is not batch size divided by fill volume

Every batch loses units to line priming, first-fill rejects, automated visual and particulate inspection, and analytical sampling. The calculator applies a realistic yield by dosage form — about 96% for liquid vials, 95% for ampoules and contrast bottles, 94% for pre-filled syringes, 93% for lyophilised vials and 97-98% for oral and cosmetic forms — so the number you see is saleable units, not theoretical ones.

Why a small batch costs more per unit

Each batch carries fixed hours that do not shrink with batch size: compounding, line clearance, set-up, sanitisation, in-process sampling and documentation. On a lyophilised product those fixed hours include the drying cycle itself, which is why a 40-hour cycle on 4,000 vials and on 32,000 vials costs the same calendar time. Contained cytotoxic work adds roughly 45% to fixed hours for change-over, cleaning verification and gowning.

Validated batch envelope by dosage form

Liquid vials and ampoules run from 20 L to 1,200-1,500 L, pre-filled syringes to 600 L, lyophilised products from 10 L to 400 L, contrast media and large volume presentations from 50 L to 2,000 L, tablets and capsules from 25 kg to 400-500 kg of blend, oral liquids to 5,000 L and cosmetic emulsions to 5,000 kg. Below the validated minimum we can still run development and engineering batches, but commercial campaigns are quoted from the minimum.

Release is part of the lead time

Filling is not finishing. Sterility testing alone carries a 14-day incubation, so a terminally sterilised parenteral takes about 21 days from end of fill to released stock and an aseptically processed one about 24. Non-sterile orals run about 12 days and cosmetics about 9. Planning a launch from the fill date rather than the release date is the most common scheduling error we see.

Before you plan a campaign

These are planning figures from validated envelopes and representative line rates, not a quotation. Actual cycle times, yields and release periods are established during technology transfer and engineering batches. Send your dosage form, batch size and forecast to Stancor Pharma and we will confirm capacity in writing.

For availability, a full release data pack and a capability and capacity response, contact Stancor Pharma.