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Indicator tape vs indicator strips: what each one proves

Why CSSDs use Class 1 indicator tape outside packs and Class 4, 5 or 6 strips inside — what each proves, how to choose by process, and how to record them.

In short: indicator tape goes on the outside of a pack and only shows that the pack has been processed. Indicator strips go inside the pack and show whether the conditions that reached the inside met the indicator’s stated values. Most CSSD policies use both: tape (Class 1) on every wrapped pack and a strip (Class 4, 5 or 6) inside.

Side by side

Indicator tapeIndicator strip
ISO 11140-1 classClass 1 — process indicatorClass 4, 5 or 6
Where it goesOutside the pack, closing the wrapInside the pack, at the hardest point for the sterilant to reach
What it showsThe pack has been through a sterilization processCritical variables were met inside the pack
When it is readBefore storage and before issueWhen the pack is opened at the point of use
Process-specificYes — steam, EO and plasma tapes differYes — and Class 6 is specific to one cycle

Why tape alone is not enough

Tape reacts quickly on the surface. A wrapped tray can show fully changed tape while the centre of the tray never saw adequate steam — for example, after poor air removal or an overloaded chamber. Only an indicator inside the pack shows what happened there.

Why a strip alone is not enough

A strip inside a pack cannot be seen until the pack is opened. Without tape or a printed process indicator outside, a processed pack and an unprocessed pack look the same on the shelf, which is how unprocessed items get issued by mistake.

Choosing the class of strip

  • Class 4 — responds to two or more variables; widely used for routine in-pack monitoring, including plasma and EO.
  • Class 5 — responds to all critical variables of steam, with performance set against a biological indicator.
  • Class 6 — responds to all critical variables of one specific cycle, such as 134 °C for 3.5 minutes; choose the one that matches your validated cycle.

For a full comparison of all six classes, see chemical indicator classes explained.

Matching tape and strips to the process

ProcessOutsideInside
Steam 121 °C / 134 °CSteam indicator tapeSteam strips, Class 4, 5 or 6
Ethylene oxideEO indicator tapeEO in-pack indicator
H₂O₂ plasmaPlasma indicator tapePlasma strips, Class 4

Reading and recording

Compare the strip against the reference colour printed on it. A strip that has not reached the reference colour is a fail: do not use the contents, quarantine the pack and report it, and check the rest of the load. Record results in the load record so each pack can be traced to its cycle.