Tamper-Evident Packaging Calculator
Cost and method selection for tamper-evident packaging features.
About this calculator
This calculator compares five tamper-evident (TE) methods on total cost per unit, factoring in both the recurring material cost and the upfront equipment investment. Each method carries its own built-in cost profile: shrink bands run about $0.02/unit with $15,000 equipment and 100 units/minute line speed; induction seals about $0.03/unit with $25,000 equipment at 80 UPM; breakable caps $0.05/unit but only $5,000 equipment (the cheapest capital outlay, at the cost of higher per-unit material) and 60 UPM; blister packs are the most expensive per unit at $0.08 with $50,000 equipment and the slowest line speed at 40 UPM; and shrink wrap is a middle-ground $0.04/unit, $20,000 equipment, but the fastest application speed at 120 UPM. The calculator amortizes each method's equipment cost over a 5-year assumed useful life divided across your annual volume, then adds that per-unit equipment share to the material cost to produce a true total-cost-per-unit figure — a method with cheap materials but expensive equipment can lose its apparent advantage at low annual volumes, and vice versa at high volumes. It also reports the run-hours needed to apply TE features to your full annual volume at that method's line speed, useful for production scheduling.
If you flag the product as an OTC drug, the tool notes that FDA 21 CFR 211.132 mandates tamper-evident packaging with a visible indicator of tampering — note this flag only records the regulatory trigger and does not itself validate that a specific method meets FDA's substantive requirements. This calculator deliberately reports no compliance verdict: nothing you enter here (method, volume, container diameter, OTC flag) can establish that a finished package satisfies the regulation, which turns on validation testing of your actual package. Shrink-band-specific dimensional outputs (circumference, band height as a fraction of container diameter) only apply when the shrink band method is selected.
Inputs
Results
Total Cost/Unit ($)
$0.05
Figures current as of 2026. Source: Food and Drug Administration, 21 CFR 211.132, Tamper-Evident Packaging Requirements for Over-the-Counter (OTC) Human Drug Products
How to Use This Calculator
- Select the tamper-evident method: shrink band, induction seal, breakable cap, blister, or shrink wrap.
- Enter annual production volume, container diameter, and whether the product is an OTC drug subject to FDA 21 CFR 211.132.
- Read the required tamper-evident feature specification per FDA 21 CFR Part 211 or equivalent.
- Tamper evidence must be obvious to the consumer once broken — a feature that conceals its own damage does not satisfy the regulation, whatever it costs here.
- Document tamper-evident feature validation testing in the product quality file.
How the result changes with Annual Units
| Annual Units | Total Cost/Unit ($) |
|---|---|
| 50,000 | $0.08 |
| 75,000 | $0.06 |
| 150,000 | $0.04 |
| 250,000 | $0.03 |
What each input means
- TE Method
- Tamper-evident method, which sets material cost, equipment cost, and line speed.
- Annual Units
- Annual production volume.
- Container Diameter (in)
- Container diameter for band sizing.
- OTC Drug? (0/1)
- 1 = FDA 21 CFR 211.132 requirement applies.
What each result means
- Total Cost/Unit ($)
- Material + amortized equipment per unit.
- Material Cost/Unit ($)
- Tamper-evident material cost per unit.
- Annual Material ($)
- Yearly TE material expense.
- Equipment Cost ($)
- Application equipment investment.
- Application Speed (UPM)
- Units per minute for this TE method.
- Annual Run Hours
- Hours to apply TE to annual volume.
- FDA Required? (1=Yes)
- Whether FDA tamper-evident mandate applies.
How this is calculated
Worked example, using the default values
- Identify Input Parameters4 parametersTE Method = 1, Annual Units = 100000, Container Diameter (in) = 2, OTC Drug? (0/1) = 1 = 4 input(s) provided
- Calculate Total Cost/UnitTotal Cost/Unit = materialCostPerUnit + equipmentPerUnit0.05 = $0.05
- Calculate Material Cost/UnitMaterial Cost/Unit = method.costPerUnit0.02 = $0.02
- Calculate Annual MaterialAnnual Material = materialCostPerUnit * annualUnits2000 = $2,000
Figures and sources
- FDA tamper-evident packaging requirement for OTC drug products (2026) — Food and Drug Administration, 21 CFR 211.132, Tamper-Evident Packaging Requirements for Over-the-Counter (OTC) Human Drug Products
Engine last updated . Checked against 2 independently-derived tests — how we verify calculators. Built by Paul Gunder, a software engineer, not a licensed financial, medical, or legal professional.
Frequently Asked Questions
Why might breakable caps be cheaper overall than shrink bands at low volume?
Breakable caps have the lowest equipment cost at $5,000 versus $15,000 for shrink bands, so at low annual volumes the amortized equipment share per unit is much smaller for breakable caps even though its per-unit material cost ($0.05) is higher than shrink band's ($0.02). Since equipment cost is divided across annual units times 5 years, a low-volume producer often comes out ahead choosing the cheaper-equipment option, while a high-volume producer amortizes the equipment cost down to nearly nothing and the lower material cost of shrink bands wins instead.
Does this calculator tell me whether my packaging is FDA compliant?
No, and it deliberately reports no compliance verdict. The only regulatory output is 'FDA Required?', which just mirrors the OTC drug flag you entered to record whether the 21 CFR 211.132 trigger applies — it says nothing about whether the method you picked satisfies the regulation. Compliance turns on the finished package: a tamper-evident feature that is visible to the consumer, that cannot be replaced without visible evidence, and that is described on the label. Establishing that requires the validation testing called out in the steps above, documented in your product quality file; picking a method from the dropdown is not evidence of it.
How is the equipment cost turned into a per-unit figure?
The calculator divides each method's flat equipment cost by your annual unit volume multiplied by 5, assuming the equipment stays in service for 5 years. That per-unit equipment share is then added to the method's fixed material cost per unit to produce the total cost per unit, so higher annual volume always lowers the equipment's per-unit contribution.
Why do the band circumference and height outputs show a value even when I haven't selected shrink band?
Band circumference is computed directly from container diameter regardless of which method is selected, since it's just π times diameter, but band height is only set to a nonzero value (30% of container diameter) when the shrink band method (option 1) is chosen — otherwise it's zero. Treat these dimensional outputs as relevant only when shrink band is the selected TE method.
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