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 should not be used for the preparation and administration of cytostatics, nor in neonatology, obstetrics, or paediatrics.

Containers

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

• PVC is not recommended because it releases phthalates (DEHP) and can adsorb certain medicines. For example, it is incompatible with cytostatics and certain drugs like amiodarone. Its use is also not recommended in neonatology, obstetrics, and paediatrics. Since 2020, PVC flexible bags are no longer the MSF standard.
• Flexible PVC-free bags offer the most advantageous logistic properties, including low volume and low weight.
• Semi-rigid PVC-free bottles made of PE (polyethylene) or PP (polypropylene) remain standard for specific products where there is no. or only a limited number of sources available of PVC-free flexible bags. They also provide benefits in specific situations, such as when large volumes need to be injected into the infusion solution or when a container that can stand upright is required.

Injection sites

Containers should have two injection sites, both protected from contamination:

• 1 site for adapting the infusion set
• 1 additional site for the possible addition of medicines (beware of incompatibilities). Use 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. Blow-fill-seal bottles are manufactured with a flattened head, and the Eurohead device is inserted in non-aseptic class before the entire system is autoclaved.
• The Nipple head system should be avoided due to the risk of microbial contamination through micro-leaks in the primary packaging.

Secondary packaging

To prevent containers, especially 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, based on 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.