Our Sterile Pharmaceutical Technologies
Our manufacturing capabilities cover a full range of filling and finishing sterile solutions and emulsions, with aseptic processing or terminal sterilization. We not only process our standard range of containers, we can support you in developing and processing containers with your specifications and in a product- specific configuration.
Aseptic manufacturing processes put high demands on the manufacturing plants. Personnel and equipment have to fulfil stringent guidelines. High standards for engineering, training, monitoring and house keeping have to be in place at the manufactruing site to be able to constantly guarantee good working aseptic production processes. These requirements make aseptic products great candidates for outsourcing. Fresenius Kabi Contract Manufacturing is able to offer aseptic competence of Fresenius Kabi plants to its customers.
Sterilization of a product at the final stage of production can increase the level of sterility. Therefore terminal sterilization can be used on a vaste range of aseptically filled products packed in ampoules, vials, bottles and bags. Our manufacturing facilities are equipped with state-of-the-art autoclaves for terminal sterilization.
Handling of high-active APIs
Potent active pharmaceutical ingredients (HAPIs) such as steroids, hormones, prostaglandins, and chemotherapeutics work at doses of 1 mg or lower. More effective drugs are good news for patients, but also create new challenges for drug manufacturers. For the workers involved in manufacturing these HAPIs, the acceptable occupational exposure limits (OELs) can be as low as nanograms per cubic meter. Although there is some disagreement about what is occupationally "potent" or "toxic", the drug industry typically uses this rating for compounds with OELs at or below 10 μg/m3.
At Fresenius Kabi Contract Manufacturing, we are proud to offer the technology for handling these drugs also to our partners. Some of our manufacturing sites are equipped with state-of-the-art isolators to handle HAPIs.
Blow Fill Seal (B/F/S)
B/F/S technology is a completely automated system with minimal operator interface. The basic concept of the system is the combination of three processing steps: container molding, filling, and sealing. The plastic extrusion area and critical fill zone are designed as a partially isolated area with localized protection. There is minimized exposure of the product and container to the environment. We can offer an extensive range of customized containers, tailored to meet the unique needs of our partners.
Emulsions are heterogeneous systems in which one immiscible liquid is dispersed as fine droplets in another liquid. Intravenous emulsions are established as excellent carriers for a wide variety of lipophilic drugs, as potential sustained release dosage forms (e.g. for barbiturates) or as directed drug delivery to various organs (e.g. for cytostatic drugs). At Fresenius Kabi, emulsions are produced in state-of-the-art equipment under full cGMP compliance, in batch sizes ranging from 5 liters to 6000 liters. The emulsification itself is achieved with fully-automated high pressure homogenizers. Intensive research efforts at Fresenius Kabi for more than 30 years have been focussed on designing special injectable emulsion formulations and Fresenius Kabi has built up extensive knowledge on how to design, produce and market these special drug carriers.
Fresenius Kabi specializes in manufacturing sterile products for IV use, especially for complex formulations containing all kinds of lipid vehicles for drug transport and delivery. Primarily, this means formulations of drug products that need hydrophobic environments for solubility reasons. Such formulations can be made using classical emulsion systems – containing oils as the solvent medium for the drug molecules, stabilized by emulsifiers – or liposomes that are formed by emulsifiers alone. Liposome formulations are often lyophilized in order to increase the shelf life of the product.
Fresenius Kabi offers a wide range of Infusion Solutions in a huge variety of small and large containers. The portfolio covers everything from sterile water and sodium chloride to specialized electrolyte and carbohydrate formulations. The solutions are used in their own right and also for reconstitution of drugs and as carriers for drugs such as cytostatics and antibiotics.
Lyophilization of aqueous solutions and liposomal formulations is a common technology applied for compounds that cannot attain an adequate shelf life in aqueous solution because they are susceptible to hydrolysis, unwanted reactions with other substances or loss of activity for other reasons. At Fresenius Kabi lyophilization has been a well-established technology for some time. Fresenius Kabi Contract Manufacturing offers services in the development and commercial manufacturing of lyophilized products for aqueous and liposomal formulations.
Suspensions are obtained through aseptic compounding and filling is performed with carboy recirculation to maintain suspension during the process.
Fresenius Kabi is a leader in clinical nutrition focused on improving patient care. With many years of experience in the field of oil-based formulations production, we can now support our partners to develop and manufacture their oil-based products.
Our extensive manufacturing network allows us not only to process our standard range of containers, we can support you in developing and processing containers with your specifications and in a product-specific configuration. Get to know more about our containers selection.