Laboratoire Bioluz
Bioluz is an independent pharmaceutical laboratory recognized for producing sterile solutions. It offers specialized know-how in small and medium series with high quality standards, providing personalized services to healthcare industry manufacturers. Located entirely in France, the company is committed to independence, local expertise, and quality of life at work, with a focus on innovation in sterilization and aseptic filling processes.
Industries
Nr. of Employees
small (1-50)
Laboratoire Bioluz
Saint-jean-de-luz, Aquitaine, France, Europe
Products
Injectable glucose solutions in flexible bags (5% and 10%)
Aqueous injectable glucose solutions supplied in flexible bags across multiple volumes for human and veterinary use.
Injectable sodium chloride solutions in flexible bags (0.9% and 7.2% hypertonic)
Isotonic and hypertonic sodium chloride injectable solutions supplied in flexible bags in multiple volumes for human and veterinary indications.
Injectable Ringer lactate in flexible bags (veterinary)
Ringer lactate injectable solution supplied in flexible bags across veterinary volume formats.
Injectable glucose solutions in flexible bags (5% and 10%)
Aqueous injectable glucose solutions supplied in flexible bags across multiple volumes for human and veterinary use.
Injectable sodium chloride solutions in flexible bags (0.9% and 7.2% hypertonic)
Isotonic and hypertonic sodium chloride injectable solutions supplied in flexible bags in multiple volumes for human and veterinary indications.
Injectable Ringer lactate in flexible bags (veterinary)
Ringer lactate injectable solution supplied in flexible bags across veterinary volume formats.
Services
Aseptic filling of small and medium series into flexible bags (PP, EVA, PVC) performed in isolators; includes fill-and-finish for thermolabile solutions and non-filterable preparations.
Steam autoclave sterilization for PVC or PP flexible bags with validated cycles and control of pre-sterilization bioburden; applicable to human, veterinary and medical device products.
In-house microbiological controls (sterility test in isolator, endotoxin, bioburden) and chemical analyses (titration, HPLC, QDA); analytical transfer or full validation services provided.
Execution of pilot batches and support for industrializing or adapting manufacturing processes for flexible container products.
Preparation of regulatory documentation and validation files including analytical technique validation, process validation and sterilization validation.
Aseptic filling of small and medium series into flexible bags (PP, EVA, PVC) performed in isolators; includes fill-and-finish for thermolabile solutions and non-filterable preparations.
Steam autoclave sterilization for PVC or PP flexible bags with validated cycles and control of pre-sterilization bioburden; applicable to human, veterinary and medical device products.
In-house microbiological controls (sterility test in isolator, endotoxin, bioburden) and chemical analyses (titration, HPLC, QDA); analytical transfer or full validation services provided.
Execution of pilot batches and support for industrializing or adapting manufacturing processes for flexible container products.
Preparation of regulatory documentation and validation files including analytical technique validation, process validation and sterilization validation.
Expertise Areas
- Aseptic filling and isolator operations
- Terminal sterilization of flexible containers
- Microbiological testing and endotoxin control
- Chemical analytics and method validation
Key Technologies
- Aseptic filling under isolator
- Sterile filtration 0.22 µm (double filtration)
- Steam autoclave terminal sterilization (F0 cycle control)
- Hyperbaric sterilization
News & Updates
Since 2013, Bioluz has been committed to maintaining local skills, know-how, and jobs, recognized by awards such as the 2020 departmental economic prize in Nouvelle-Aquitaine.
Since 2013, Bioluz has been committed to maintaining local skills, know-how, and jobs, recognized by awards such as the 2020 departmental economic prize in Nouvelle-Aquitaine.