Storage and Shelf life for Hygiena environmental and microbiology testing devices.

ATP Environmental surface hygiene and water tests.

SuperSnap and UltraSnap – Environmental surface Hygiene swab tests.

AquaSnap Total and Free Water test devices.

Standard Shelf life and Storage conditions.

For all tests listed above the shelf life from the date of manufacture is 15 months.

Always refer to the expiration date on the device label.

For maximum shelf, life devices need to be stored in refrigerated conditions at 2 – 8 °C (36 – 46 °F)

Keep devices out of direct sunlight.

Storage at ambient temperature.

Test devices will tolerate temperature abuse for 4 weeks at room temperature (< 25 °C)

If devices are subjected to a maximum of 7 days ambient temperatures at < 25 °C they can be refrigerated and still maintain the shelf life as indicated on the device label.

If subjected to greater than 7 days, then they should be used within 28 days.

(Packs should be marked or labelled to indicate they have been subjected to storage at ambient temperatures).

Up to 28°C there will be minimal impact on the RLU result but above this, the result for a given amount of ATP will be reduced and shelf significantly results.

For more details on using tests in hot and cold conditions see.

https://help.hygiena.com/kb-doc/effects-of-environmental-light-and-temperature-on-hygiena-atp-test-devices/

Surface Protein / Residue test devices

Pro-Clean Rapid Protein Residue Test

Store devices at 2 – 25 °C (36 – 77 °F)

Devices have an 18-month shelf life.

Keep devices out of direct sunlight.

Always check the expiration date on the label.

AllerSnap Rapid Protein Residue Test

Store devices at 2 – 25 °C (36 – 77 °F)

Devices have an 18-month shelf life.

Keep devices out of direct sunlight.

Always check the expiration date on the label.

Spotcheck

Store devices at 2-8°C

Devices have an 18-month shelf life from the date of manufacture.

Devices may be stored at room temperature (9-22°C) for up to 4 weeks.

Keep devices out of direct sunlight.

Always check the expiration date on the label.

MicroSnap product range

MicroSnap

The following applies to MicroSnap Total, MicroSnap EB, MicroSnap Coliform, and MicroSnap E Coli Test. This for both the Step 1 Enrichment and Step 2 Detection tubes.

Storage & Shelf Life:

Devices should be stored at 2 – 8 °C and have a 12-month shelf life.

Keep devices out of direct sunlight.

Always check the expiration date on the label.

InSite Tests

The following applies to the following test devices

InSite Listeria , InSite L.mono Glo , InSite Salmonella spp

Store at 2 – 8 °C (35 – 46 °F)

Devices have a 12-month shelf from the date of manufacture.

Keep devices out of direct sunlight.

Always check the expiration date on the label.

Process Efficiency tests

ZymoSnap™ ALP (Alkaline Phosphatase)

Store devices in a cool dark place (2 – 8 °C)

Devices have a 12-month shelf life.

Keep devices out of direct sunlight.

Always check the expiration date on the label.

Positive Control Kit for ZymoSnap™ ALP (Alkaline Phosphatase)

Positive Controls have a 12-month shelf life. Store Positive Control vials at 2 – 8 °C.

Keep devices out of direct sunlight.

Always check the expiration date on the label.

Note Negative Control should be used within 48 hours when stored at 2 – 8 °C.

Reconstituted Positive Controls must be used within 7 days when stored at 2 – 8 °C.

Cross Check

Store at 2 – 8 °C (36 – 46 °F)

Keep devices out of direct sunlight.

Devices have a 12-month shelf life from the date of manufacture

Always check the expiration date on the label.

Positive controls

ATP /Protein  Positive Control Kit.

Store at 2 – 8 °C (36 – 46 °F)

Devices have a 24-month shelf life.

Keep devices out of direct sunlight.

Always check the expiration date on the label.

Side by Side comparison Kit.

Store at refrigerated temperatures (2 – 8 °C) until ready for use.

Do not freeze.

Keep devices out of direct sunlight.

Note ATP standards degrade rapidly when left at room temperature for extended periods of time.

Always check the expiration date on the label.

 

Hygiena™ Product Stability During Shipping

Hygiena products are robust and have a long shelf life at the recommended long-term storage temperatures.

In the case of extended shipping times beyond Hygiena’s control, it is possible

that Hygiena products may arrive at a customer site with ice packs that have thawed.

Hygiena has therefore conducted stability studies to confirm that our products are resistant to temperature conditions found with potential extended shipping times.

Assay performance met or exceeded our product release specifications after temperature abuse in ship/shock testing.

As a result, we are issuing the following guidance: Hygiena Environmental Monitoring devices such as:

ATP hygiene monitoring devices,  InSite, MicroSnap,  can tolerate 28 days at 21°C or 7 days at 37°C without significant loss of activity.