Terminal sterilization should be used when possible. The flexible bags must be sterilized in air-steam autoclaves or in superheated water to avoid bursting. The sterilization cycles are defined in accordance with the decision tree published by the EMEA
Aseptic filling is the required technique when terminal sterilization is not possible. Each application is specific and requires a particular adaptation in terms of filling volume, type of container, EVA, PVC, PP, or type of connection. We carry out these operations in an isolator for small series.
The Bioluz laboratory is an independent laboratory specializing for 40 years in the filling, sterilization and packaging of bags of injectable solution.
Either on its own account with :
- Perfudom ® (Human medicines)
- Vétoflex ® (Veterinary Drugs)
- Bioviflex ® (Medical devices)
Either on behalf of third parties as part of a contract manufacturing activity for small and medium series. Our control laboratory can perform all physico-chemical (titration, HPLC, etc.) or microbiological (sterility test, endotoxin assay, bioburden) analyzes of aqueous solutions. The processes used are either terminal sterilization or aseptic filling.All activity, production, control, logistics is located in France in St-Jean-de-Luz.Our activity is centered on the manufacture of sterile products in flexible bags. There are two processes to meet this need: terminal sterilization and aseptic filling.Learn more >
GAMME PERFUDOM® (MÉDICAMENTS HUMAINS)
SOLUTION INJECTABLE DE GLUCOSE 5% en poches souples
SOLUTION INJECTABLE DE GLUCOSE 10% en poches souples
SOLUTION INJECTABLE DE NACL 0,9 % en poches souples