Albumin is a heat-sensitive biological product. Once prepared, purified, formulated and stabilized, it is sterile-filtered and aseptically filled into final glass vials or bottles. Because it is not subjected to conventional terminal sterilization at 121°C, the filled and sealed containers undergo validated pasteurization at 60°C for at least 10 hours to support viral inactivation while preserving protein stability and product quality.
Albumin pasteurization is traditionally performed in water-bath systems. Although effective for heat transfer, this established approach requires very large quantities of process water, increasing utility consumption, wastewater generation and operating costs across a long and production-critical treatment.
We replace immersion in large volumes of water with an Air/Steam pasteurization cycle developed for the specific requirements of albumin.
Independent control of temperature and chamber pressure, continuous regulation of the steam-air mixture and advanced ventilation maintain the complete load at 60°C within ±0.5°C throughout the holding phase of at least 10 hours. Homogeneous circulation limits temperature stratification and overshoot, supporting repeatable heating, holding and cooling profiles. As containers are neither immersed nor sprayed, the process substantially reduces water consumption and allows the product to leave the chamber dry.
The solution can also integrate automatic loading and unloading, as well as upstream washing and steam sterilization, or combined washing and sterilization, of filling-line parts. Tech Center testing develops the cycle around the actual formulation, container, fill volume and load configuration.
Independent pressure and temperature control applies counterpressure through heating and cooling, protecting 5–7 N seals while delivering effective terminal sterilization
Magazines leave the sterilizer and transfer directly toward secondary packaging, sustaining line continuity and eliminating manual product handling after treatment.
Robotic handling moves magazines from primary packaging to the sterilizer without product extraction or operator contact, maintaining throughput and a touchless production flow
Compatible reusable parts are packaged in bags or loaded into closed canisters before steam sterilization. The process is developed around the complete load configuration to govern air removal, steam penetration, condensate management and drying. Once treated, the selected packaging or transfer system preserves the sterile state during unloading, movement and introduction into the aseptic processing environment.
For reusable parts that cannot withstand steam, low-temperature H₂O₂ sterilization provides an alternative route when supported by material, geometry and packaging compatibility. The complete configuration is evaluated to establish sterilant access, microbial reduction, aeration and residual removal. The treated load then follows a protected transfer route designed to preserve its required state up to the aseptic interface.
Bulk stoppers are washed and steam sterilized in one integrated process developed to control cleanliness, sterility and residual moisture. Following treatment, the closures are discharged directly into a sterile transfer tank. This eliminates intermediate bagging and creates the starting point for a closed route from stopper preparation to automated delivery at the isolator.
Washing and steam sterilization are integrated within one system to establish cleanliness and sterility through a coordinated process. This architecture reduces equipment interfaces, material movements and classified-space requirements while strengthening control between the two treatments. It is selected for compatible reusable loads when layout efficiency, operator protection or a more contained process route drives the transfer strategy.
RTU components and other pre-sterilized materials already contain a protected sterile product within sealed packaging. The low-temperature H₂O₂ process treats the external surfaces before introduction into the aseptic environment without reopening the package or altering its internal sterile state. Cycle development addresses packaging geometry, surface accessibility, load arrangement and aeration as part of the complete transfer configuration.
The automated manipulator connects treatment and point of use through controlled loading, unloading, movement and delivery operations. Depending on the selected route, it handles canisters, sterile tanks or treated materials and manages their interface with the isolator or filling line. Automation removes avoidable manual interventions precisely where exposure, repeated handling and open connections create the greatest vulnerability.
Validated washing removes process residues and establishes the required cleanliness state for reusable product-contact, machine and format parts. Cycle parameters, load configuration and mechanical action are developed around the materials and geometries involved, preparing every surface for the selected downstream treatment and preventing cleaning from becoming an uncontrolled variable within the aseptic-transfer route.
Small molecules continue to represent a major share of sterile pharmaceutical manufacturing worldwide. For heat-stable formulations, terminal sterilization remains the preferred sterility assurance approach because it allows the final packaged product to be sterilized after filling and closing.
Yet sterilizing liquids in closed containers is not simply a question of lethality. During heating and cooling, thermal expansion and vapor generation continuously change the pressure inside the container.
The rapid growth of biologics, nanoparticle-based medicines and Advanced Therapy Medicinal Products (ATMPs) is redefining the relationship between pharmaceutical formulations and primary packaging.
Interactions between proteins such as insulin, nanoparticles and container surfaces are well-recognised phenomena that can influence product stability, efficacy and patient safety. As these therapies become increasingly sensitive, material compatibility can no longer be considered an intrinsic property of the container alone.
When manufacturers seek to move away from EtO towards a method that reduces toxic-residue concerns and the potential burden on patients, workers and the environment, selecting an alternative sterilant is only the beginning.
This is particularly true for the low-temperature sterilization of RTU glass vials in their complete packaging configuration. The sterilant must pass through the outer transport box, multiple porous barriers and enclosed packaging interfaces before reaching the internal vial surfaces. The same structure must then release residual sterilant within an acceptable aeration time.
Air/Steam offers an alternative that avoids immersing or spraying the containers. This substantially reduces process-water consumption and wastewater generation while allowing the load to leave the chamber dry. Precise regulation of temperature, chamber pressure and steam-air circulation maintains the required 60°C condition across the load throughout the extended holding phase.
Albumin is a heat-sensitive biological product. Filled and sealed containers undergo pasteurization at 60°C for at least 10 hours to support viral inactivation while preserving protein stability and product quality, rather than undergoing conventional terminal sterilization at 121°C.
At this relatively low operating temperature, variations in chamber pressure or the steam-air mixture can affect temperature distribution. Precise regulation and homogeneous circulation are therefore required throughout heating, holding and cooling to maintain the complete load within the specified temperature range.
Unlike a conventional water-bath process, the Air/Steam cycle does not require the load to be immersed in large volumes of water. Containers are also not sprayed during processing, substantially reducing process-water demand and the associated wastewater compared with water-bath systems.
Independent control of temperature and chamber pressure is combined with continuous regulation of the steam-air mixture and advanced ventilation. These functions support homogeneous circulation, limit stratification and overshoot, and deliver repeatable heating, holding and cooling profiles across the load.
Development considers the albumin formulation, stabilizers, container format, filling volume, load configuration, temperature tolerance, pressure sensitivity and heating and cooling behaviour. Production capacity and facility layout are also evaluated when defining the final equipment and cycle configuration.
Knowledge Hub Regulatory
Read this article
