MSF Specifications

MSF provides PVC-free containers for use in anaesthesia and emergency care and for the injection of drugs (including cytostatics) and additives.

PVC containers cannot be used for the preparation and administration of cytostatics, nor in neonatology, obstetrics and paediatrics.

Containers

Infusion containers should be unbreakable and collapsible (closed system).

• PVC is not recommended as it releases phthalates (DEHP) and can adsorb certain medicines, e.g. it is incompatible with cytostatics and certain drugs such as amiodarone. Its use is not recommended in neonatology, obstetrics and paediatrics. Since 2020, the PVC flexible bags are no longer MSF standard.
• Flexible PVC-free bags have the most advantageous logistic properties: low volume and low weight.
• Semi-rigid PVC-free bottles in PE (polyethylene) or PP (polypropylene) remain standard for specific products for which there is no or a limited number of sources available in PVC-free flexible bags. They also offer advantages in specific situations: the need to inject larges volumes into the infusion solution or the need for a container that can stand upright.

Injection sites

Containers should have two injection sites protected from contamination:

• 1 site for adapting the infusion set
• 1 additional site for the possible addition of medicines (beware of incompatibilities). Use the specific labels to indicate the medicines added to the infusion.

Container closure system

• The elastomer closure should be firm enough to allow a needle to pass through with the minimum release of particles.
• The Eurohead cap system offers the best option against the risk of contamination. The blow-fill-seal bottles are manufactured with a flattened head; the Eurohead device is then inserted, in non-aseptic class and the whole is then autoclaved.
• The Nipple head system should be avoided due to the risk of microbial contamination through micro-leaks in the primary packaging.

Secondary packaging

In order to prevent the containers, and in particular the flexible bags, from being compressed under their own weight and to avoid fatigue points at the closure system (which can lead to the formation of micro-holes), the secondary packaging (carton box) should meet some specifications:

• Strong enough to withstand transport conditions.
• The box should be tested for compressive strength and bursting strength according to the height of the stack and the weight of the box.
• The manufacturer should provide documentation of the compressive strength value of the packaging.

Infusion set

The infusions are supplied without infusion sets.

• Infusions sets should be ordered separately.
• Infusion fluids and infusion sets are supplied in separate packages. The corresponding quantities should be packed together before delivery to health facilities.