Sterile single dose and limitation of contamination risks

Packaged in a sterile environment without preservatives, sterile single-dose formulation avoids microbial contamination and meets the current needs of patients in many medical specialities.  

Packaging suitable for many medications

Cosmetics, medical devices and medication in the form of sterile single doses are increasing in numbers on the market. 

Amongst the most widespread are saline solution, hypo-allergenic liquid soap or disinfectant solutions, but also eye collyrium or asthma treatments. 

Some medical specialities such as rhinology, ophthalmology and pneumology use it regularly and routinely.

The advantage of this pharmaceutical form is that it is packaged in a sterile environment to limit microbial contamination until the patient opens the product. 

The medication in its sealed, “protected” and therefore healthy environment, does not require preservatives, thereby providing better product tolerance. 

These preservatives (alcohol, parabens, ammonium, etc.) are in fact often added to guarantee the stability of the medication and its better conservation. However, some are considered to be potential allergens, and even dangerous for the sensitive mucosa of the eyes and nose and are increasingly eliminated.

Nevertheless, to avoid any additional contamination risks specific to this packaging, it should be reminded that all opened single doses should never be reused and should be disposed of immediately after opening.    

This innovating form also has another significant advantage: it guarantees patients the correct product quantity, especially in cases of low concentrations of active ingredients. Indeed, some therapies need very low but accurate quantities of active ingredients as part of ocular or inhaled treatment administration.  

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Specific production in a sterile environment

These single doses are produced using the so-called “Blow-Fill-Seal” (BFS) technology of which Unither, a French CDMO, is the world leader. This technology consists in shaping, filling and sealing the single dose in one production step in a sterile environment guaranteeing that the products are free from all contaminating micro-organisms. Low density pharmaceutical grade polyethylene (PE) is used to create the single dose. It is first stored in large silos/tanks in pellet form which is then heated and melted at high temperatures in order to be blown into specific BFS machine moulds. Needles are used to fill the pre-shaped single dose which is then permanently sealed before being ejected to go to final packaging. 

Just a few seconds are all it takes to create and fill a row of 10 attached single doses. 

Thanks to the use of sterilising filters before filling and during the operation, the medication remains completely sterile.   

Several singe dose models and sizes are manufactured for volumes from 0.5 ml to 20 ml depending on their ultimate use.

A practical, hygienic and cost effective format

Hygienic, sterile and disposable, single doses also have an undeniable economic aspect since they make it possible to only use the amount of active ingredient required for the treatment to be effective. There is no wasted medication or product. Product storage is also reduced (compared to other packaging) resulting in space being saved in warehouses or in dispensing chemist storage.

To conclude, the availability of pharmaceutical specialities, cosmetics and medical devices in sterile single dose form is an option that has been plebiscited for daily use by many patients and families. Practical and easy, this packaging is especially adapted to a nomad lifestyle.