Blood products such as albumin or immunoglobulins are indispensable molecules for the treatment of over 70 pathologies, but they are sensitive and cannot withstand heat. Additionally, as their high molecular weight does not allow oral administration, injectable methods are preferred. It is thus imperative for the product to be filled aseptically, implying a separate sterilisation of the primary packaging.
With the increase in the number of biologicals, Technoflex has developed a standard line of Inerta® polypropylene sterile bags combining the company’s latest R&D innovations. Fitted with either one or two tubes, these bags are specially dedicated to aseptic filling. Their ‘butterfly’ design reduces the number of folds that form during filling and facilitates product flow. ‘Boat ports’ welded directly onto the bag body replace the standard tubes. They guarantee tightness whilst avoiding any potential tearing when the outer packaging is opened. A twist-off is welded to the tubular part of the first boat port, and the second is welded shut. This system keeps the bag free of micro-organisms after radiation. To facilitate product traceability, a specific area on the upper part of the bag is set aside for laser marking. Lastly, the volume of the bags (50 to 500 ml) allows the injection of gas (nitrogen or argon) for products sensitive to oxygen, such as immunoglobulins or albumin.
The primary packaging has to guarantee the stability and integrity of the drug. To meet the requirements of these complex, sensitive molecules, the bags are sterilised by Beta radiation, then placed in a double packaging in accordance with the ISO 11607 standard. This precaution maintains the sterility of the bags until they are used in ISO 5 controlled atmosphere areas.