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Frequently Asked Questions

• How do we order Aguettant Ltd products?
• Are Aguettant solutions Latex free?
• Can Aguettant provide special sterile IVs?
• Is our sterile water Deionised?
• I want distilled water - not deionised water
• How long can an open bottle of Versol sterile water for irrigation be kept open?
• Is Versol Sterile water for irrigation Pyrogen free?
• Is Versol Sterile water for irrigation suitable for use in humidifiers?
• Can we heat Versol Sterile water and Sodium Chloride 0.9% for irrigation above 40°C ?
• Can bags of sterile irrigation fluid be warmed to 38°C ?
• Why is there moisture between the inner and outer bag of Urology sterile irrigation ?
• Why is the inner bag of sterile irrigation fluid cloudy?
• Is the outside of the inner bag sterile?
• Atracuruim Storage Conditions

How do we order Aguettant Limited products?

Aguettant Ltd can accept orders through fax 01934 876 790 or phone 01934 835 694 or email at info@aguettant.co.uk or the GHX/Pharmacy messaging service and AAH Medicator services.

Are Aguettant solutions Latex free?

Yes. We have a letter on file to say our products are Latex free. A copy can be emailed, faxed or posted.

Can Aguettant provide special sterile IVs?

Yes, we can and have produced special electrolyte IVs.

Is our sterile water Deionised?

Yes - the process of water preparation is to:

    1. Draw water from than underground well

    2. Sand filter to remove gross particles

    3. Deionised to remove calcium (to stop the rest of the process 'furring up' )

    4. Purify by a process called 'Reverse osmosis'.

I want distilled water - not deionised water

It is necessary to remove Calcium - deionise - before distilling to stop the system furring up like a kettle. Calcium (chalk) is replaced with Sodium in this process. When the water is boiled to produce steam Sodium is removed so distilled water has to be deionised first.

How long can an open bottle of Versol sterile water for irrigation be kept open?

Once the bottle is opened – sterility is compromised and growth of organisms in water is possible, especially in a warm ward environment. Our recommendation is to use once only and discard the remainder.

Is Versol Sterile water for irrigation Pyrogen free?

Yes, it is called pyrogen free but there is a limit below which pyrogens cannot be detected. So it is difficult to say it is totally pyrogen free. The Aguettant limit is 0.125 EU/ml (We are below the EP limit of 0.25 EU/ml).

Is Versol Sterile water for irrigation suitable for use in humidifiers?

Yes, our product is CE marked for use in Humidifiers and so is perfect for the job! We can supply a device to fit our bottles to humidify incoming oxygen.

Can we heat Versol Sterile water and Sodium Chloride 0.9% for irrigation above 40°C?

Versol is a Medical Device containing a sterile apyrogenic solution.
The containers are autoclave sterilised at 115°C.
Stability studies have been carried out at room temperature 25°C and 40°C for 6 months. Results show Versol is stable for 2 years in all test conditions.
Studies have been carried out on Versol bottles heated in a Microwave to check deformation as a result of temperature .
Deformation of the bottle and ease of unscrewing the cap was tested.
The results show that at temperatures up to 69°C all parameters were within Spec.
The reason for the statement ‘Do not heat above 40°C before use’ is to make sure the water at point of use is likely to be at or near body temperature.
Heating above this temperature may potentially allow the contents to scald users or patients.

Can bags of Urology sterile irrigation be warmed to 38°C ?

Yes. The normal advice we give is that the bags should be stored at 25°C over their shelf life to be sure the product remains within its specification at the end of the expiry date printed on the bag.
The bags have been stability tested at 25°C & 60°C for 6 months following sterilisation in an autoclave at 121°C. This would suggest that maintaining the bags at 38°C will not cause the bags to deform and they will remain within specification until expiry date.
We recognise that the bags need to be warmed before giving to a patient as irrigation. Normally this is done in a warming cabinet in Theatre and often bags are left in the cabinet from one operating session to another. We do remind users that it is important the bags are only warmed to about 37°C to be sure the fluid does not scald the patient.
The bags can be kept in the warming cabinet for up to 8 weeks provided the cabinet temperature does not exceed 38°C  (recognising the bags will cool before use).

A system should be adopted in Theatre to ensure that if the bags have been stored for the full 8 weeks in the warming cabinet, the bags are used immediately and not returned to stock for use later or warmed again.

These measures will allow flexibility within theatre, minimise waste but ensure the products are used safely.

Why is there moisture between the inner and outer bag of Urology sterile irrigation ?

During the manufacturing process, the bags are rinsed with water for injections after filling to ensure there are no residual contents on the outside of the bag. The individual bags are leak tested by applying pressure before being sealed inside a more rigid outer bag. This is necessary as the plastic material of the inner bag allows water vapour to pass to the atmosphere. The outer bag allows less water vapour to pass and a longer shelf life can then be guaranteed
The package is then autoclaved. The autoclaving process requires a degree of moisture to be present between the inner and outer bag so the moisture turns to steam that ensures sterility of the outside of the inner bag.
On cooling, the steam condenses back to sterile water. Because this moisture is present between the bags – it may appear to the user that the bag is leaking. If the visible amount of water is such that it accumulates in the corner of the outer bag, then please contact us or your Pharmacy.

Why is the inner bag of Urology sterile irrigation cloudy?

During the manufacturing process, the bags are rinsed with water for injections after filling to ensure there are no residual contents on the outside of the bag. The individual bags are leak tested by applying pressure before being sealed inside a more rigid outer bag. This is necessary as the plastic material of the inner bag allows water vapour to pass to the atmosphere. The outer bag allows less water vapour to pass and a longer shelf life can then be guaranteed
The package is then autoclaved. The autoclaving process requires a degree of moisture to be present between the inner and outer bag so the moisture turns to steam that ensures sterility of the outside of the inner bag.
During autoclaving, the plastic of the inner bag sometimes becomes cloudy. This is because moisture is trapped in the plastic. Usually, once the inner bag has been removed from its outer bag, this cloudiness or bloom evaporates to leave a clear bag.
Always check that the contents of the inner bag are completely clear before use. If unsure, then please contact us or your Pharmacy.

Is the outside of the inner bag sterile?

Yes, as the bags are sterilised within an outer bag with a small amount of water for injection. After sterilisation in the autoclave, this ensures that the outside of the inner bag is sterilised. The outer bag can be ripped open and the inner bag dropped onto a sterile field for the 'scrubbed' nurse to handle.

Atracuruim Storage Conditions

We have not supplied this product for more than 12 months now.

We do not have access to updated storage or safety data for this product.

For Information about Atracurium – please direct your enquiry to Actavis:

Medical Information Contacts