4 indicator responds to several specified parameters.

However, it does not necessarily monitor every critical parameter of the process.

A Colour Change for Easy Reading

Each strip features a reactive chemical indicator designed to change appearance when the specified conditions have been achieved.

After the sterilisation cycle, the operator can compare the result with the reference provided by the manufacturer.

This system allows:

• Quick visual verification.

• Identification of satisfactory or unsatisfactory reactions.

• Convenient reading after the cycle.

• Integration of the result into the monitoring procedure.

• Possible retention of the indicator in traceability records.

The initial colour, final colour and precise acceptance criteria must be checked against the product instructions.

An incomplete or unusual colour change must be treated as an abnormal result requiring investigation.

Two Specified Monitoring Conditions

The supplier indicates two conditions of use for these strips.

Monitoring at 134°C:

• Specified temperature: 134°C.

• Specified duration: 4 minutes.

• Use with a compatible, validated cycle.

Monitoring at 121°C:

• Specified temperature: 121°C.

• Specified duration: 15 minutes.

• Use with a compatible, validated cycle.

These conditions identify the reaction parameters stated for the product.

It is essential to verify that the indicator is compatible with the autoclave programme and the reprocessing requirements of the instruments.

The reaction conditions of an indicator must not be confused with the sterilisation parameters required for the instruments being processed.

A Suitable Solution for Piercing Studios

In piercing studios, certain reusable instruments must be sterilised before use.

Type 4 indicator strips can be incorporated into steam sterilisation monitoring procedures.

They are particularly useful when processing compatible instruments, including:

• Reusable piercing forceps.

• Professional scissors.

• Autoclavable metal instruments.

• Certain reusable technical accessories.

• Small equipment compatible with steam sterilisation.

Their use provides an additional chemical indicator for monitoring exposure to the specified conditions.

They therefore contribute to the organisation of equipment reprocessing procedures.

A Practical Solution for Tattoo Studios

Tattoo studios may also use reusable instruments and accessories requiring sterilisation.

Type 4 indicator strips complement sterilisation cycle monitoring procedures.

They can help to:

• Check exposure to specified parameters.

• Monitor loads containing compatible instruments.

• Support sterilisation procedures.

• Identify results requiring further investigation.

• Facilitate the documentation of monitoring results.

They do not replace the other checks required to validate and monitor the sterilisation process.

Designed for Steam Autoclaves

These indicators are intended for steam sterilisation processes compatible with their specified reaction conditions.

They can be used in professional autoclaves whose programmes correspond to the indicator's characteristics.

Before use, it is important to check:

• The type of steriliser.

• The selected programme.

• The intended temperature.

• The exposure time.

• Indicator compatibility.

• The autoclave manufacturer's instructions.

• The applicable monitoring protocol.

These strips are not intended for dry heat, plasma or other sterilisation processes unless expressly authorised by the manufacturer.

Monitoring by Level or Tray

The supplier recommends using one strip per level or tray during the cycle.

This method allows indicators to be distributed across different loading areas of the autoclave.

It can help to:

• Monitor several locations within the load.

• Compare indicator reactions.

• Identify potential localised abnormalities.

• Facilitate visual checks after the cycle.

• Complement equipment monitoring procedures.

However, the exact positioning must comply with the studio's validated protocol and the manufacturer's recommendations.

For certain packaged instruments, internal indicators must be placed inside the packaging, according to the process requirements.

A strip placed on a tray does not necessarily verify the conditions achieved inside every package.

Additional Monitoring of Critical Parameters

Steam sterilisation relies on several parameters that must be controlled.

Type 4 chemical indicators are designed to respond to several specified parameters.

They provide information that complements the data recorded by the autoclave.

They may therefore be used alongside:

• Temperature records.

• Pressure records.

• The duration of the different cycle phases.

• Steam penetration tests when required.

• Chemical indicators appropriate to the load.

• Periodic checks specified by the protocol.

Monitoring must be performed according to the requirements applicable to the sterilisation process.

Helping Detect Abnormalities

An unsatisfactory result may indicate that the indicator's specified reaction conditions have not been achieved.

This may prompt the operator to examine:

• The selected programme.

• The recorded parameters.

• The indicator's position.

• The arrangement of instruments.

• The autoclave loading configuration.

• Cycle compatibility.

• The indicator's condition and expiry date.

If an indicator produces an unsatisfactory result, the load must not be considered suitable for release solely on the basis of other visual indicators.

The studio's non-conformity management procedure must be followed.

Complementary to Other Sterilisation Tests

Type 4 indicator strips do not replace other autoclave monitoring devices.

Depending on the process requirements, they may be used alongside:

• Type 1 process indicators.

• Bowie-Dick tests.

• Helix tests.

• Type 5 or Type 6 chemical indicators.

• Biological indicators when required.

• Physical autoclave records.

Each device performs a specific function.

A Type 4 indicator does not replace a Helix test, a Bowie-Dick test, or steriliser qualification and maintenance.

Supporting Sterilisation Traceability

Chemical indicators can be incorporated into the documentation system used to monitor sterilisation operations.

Depending on the establishment's protocol, the result may be associated with:

• The cycle date.

• The cycle number.

• The autoclave identification.

• The programme used.

• The load identification.

• The operator's name.

• The monitoring results.

• The decision to release or reject the load.

This organisation allows a record of the checks performed to be maintained.

Physical retention of the indicator strips must comply with the manufacturer's recommendations and applicable traceability procedures.

Single-Use Indicator Strips

Each indicator is intended for use during one monitoring cycle only.

Once exposed, it must not be reused.

Single use helps to:

• Prevent confusion between different cycles.

• Keep a result associated with one specific exposure.

• Facilitate traceability.

• Ensure a new indicator is used for subsequent cycles.

• Maintain a consistent monitoring procedure.

An indicator strip that has already been exposed must never be placed back into the autoclave for another check.

A Box of 250 Indicator Strips

Type 4 Steam Indicator Strips are supplied in a box of 250 pieces.

This packaging is particularly suitable for professionals who regularly perform sterilisation cycles.

It allows professionals to:

• Keep a supply of 250 indicators.

• Facilitate restocking.

• Organise sterilisation consumables.

• Take the required number of strips for each cycle.

• Simplify inventory management.

The number of cycles that can be monitored depends on the number of strips used per cycle and the protocol followed.

Packaging sold: 1 box of 250 Type 4 indicator strips.