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Pharmaceutical production and quality control tools

Calculate dispensing, capsule fills, assays, dissolution and impurity limits, plan cleanroom air changes, media fills and sampling, and trend batch data.

  • 46 tools
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  • Free previews, no sign-up

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The calculations a GMP plant and its QC lab repeat

For production pharmacists, QC analysts, validation and QA teams in pharmaceutical plants and contract labs. The tools cover the arithmetic of a batch from dispensing to release: how much active ingredient to weigh, what a capsule can hold, the results of an assay or a dissolution run, cleaning and impurity limits, and the cleanroom figures inspectors ask about.

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The main tools, compared

Tool When to pick it What you give it What you get Works offline Stays on your device
API Dispensing Quantity Calculator (Potency, Water and Salt Factor) Ultimate Corrects the weight of an active ingredient for its potency, water or solvent content and salt form, so each batch gets the labelled amount. Numbers Free preview: the method, the limits that apply and the verdict for your input; computed figures stay hidden until the pass Yes Yes
Capsule Size and Fill Weight Calculator (Sizes 000 to 5) Ultimate Finds the fill weight and volume of a capsule formulation, the sizes it fits, the weight limits for each capsule and the machine time for a batch. Numbers Free preview: the method, the limits that apply and the verdict for your input; computed figures stay hidden until the pass No Yes
Dissolution % Released Calculator (UV or HPLC, Volume Correction) Ultimate Turns UV or HPLC readings at each time point into the percentage released, correcting for the volume withdrawn at every pull. Numbers Free preview: the method, the limits that apply and the verdict for your input; computed figures stay hidden until the result is unlocked Yes Yes
Impurity Thresholds (ICH Q3A/Q3B) for a Whole Impurity List Ultimate Applies the reporting, identification and qualification thresholds of ICH Q3A and Q3B to a whole impurity list at once. Numbers Free preview: the method, the limits that apply and the verdict for your input; computed figures stay hidden until the pass Yes Yes
Media Fill (APS) Planner and Acceptance Calculator Ultimate Plans an aseptic process simulation and judges its result against the acceptance limits for contaminated units. Numbers Free preview: the method, the limits that apply and the verdict for your input; computed figures stay hidden until the pass Yes Yes
Cleanroom Air Changes per Hour and Recovery Time Calculator Ultimate Works out air changes per hour from airflow and room size, and the recovery time to clean conditions after a disturbance. Numbers Free preview: the method, the limits that apply and the verdict for your input; computed figures stay hidden until the pass No Yes
MACO Calculator for Cleaning Validation (HBEL, Dose, 10 ppm) Ultimate Sets the maximum allowable carryover between products for cleaning validation by health-based limits, dose criteria or 10 ppm. Numbers Free preview: the method, the limits that apply and the verdict for your input; computed figures stay hidden until the result is unlocked Yes Yes
Continued Process Verification and APQR Trend Report Builder Ultimate Builds the trend charts and tables of batch results that continued process verification and the annual product quality review need. Spreadsheet or CSV Free preview: the method, the limits that apply and the verdict for your input; computed figures stay hidden until the pass No Yes

Worked example: choosing a capsule size for a 250 mg dose

A 250 mg capsule is made from a blend with 62.5 % drug load and a bulk density of 0.72 g/mL, using an active ingredient that assays 99.2 %.

  1. Correcting for the assay, each capsule needs 250 ÷ 0.992 = 252.0 mg of the active ingredient, so the fill is 252.0 ÷ 0.625 = 403.2 mg.

  2. At 0.72 g/mL that fill occupies 0.560 mL.

  3. A size 0 capsule holds 0.68 mL, about 489.6 mg of this blend, so it is 82.4 % full; size 1 would be too small at 116.7 %.

  4. With ±5 % on each capsule the fill must stay between 383.1 and 423.4 mg, and a machine making 45,000 capsules an hour fills the 300,000-capsule batch in about 6.7 hours.

Questions

Why correct a dispensing weight for potency and water?

A batch of active ingredient rarely assays exactly 100 % and may hold water or a salt counter-ion, so weighing the label amount would under-dose. The dispensing calculator raises the weight to deliver the labelled amount of the active part.

How full should a capsule be?

Fills well inside the capsule’s volume run more evenly on the machine; the capsule calculator shows the share of each size the fill would take, so you can choose one with room to spare.

Do these calculators replace a validated system?

No. They give a worked calculation you can check and file, but records used for batch release must come from your validated systems and approved procedures.

Which guidance do the sterile-area tools follow?

The cleanroom and media fill tools cite EU GMP Annex 1 and the FDA’s guidance on aseptic processing among their sources.

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All 46 tools

Every tool here by name, grouped by what it is for.

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Tablets, capsules & coating

5 tools

Dispensing, batch formulas & yield

4 tools

HPLC, assay & titration

5 tools

Dissolution testing

3 tools

Method, system & process validation

3 tools

Cleaning validation, cleanrooms & water

4 tools

Format & clean

1 tool

Check & analyze

7 tools

Calculate

7 tools

Create & generate

1 tool

Time & plan

6 tools

Good to know

  • All 46 tools run in your browser: what you open or paste is not uploaded.
  • 36 of 46 keep working without a connection once loaded.
  • Results are estimates for planning and learning, not engineering advice. Check the method and assumptions on each tool’s page.

What a pass opens here

46 Ultimate tools here need a pass.

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