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. Unless heat transfer and chamber pressure are controlled around this behaviour, the product, container or closure system may be compromised.
The challenge is therefore twofold: achieving the required sterility while preserving product quality and container-closure integrity.
Based on the formulation, the container-closure system and the required production performance, we select and configure either steam-air or superheated-water technology.
We configure the technology around the product, not the product around the technology.
Each cycle is therefore engineered around the actual behaviour of the product-container system, allowing heat transfer, counterpressure, lethality and cooling to be governed together, achieving sterility while protecting product quality and package integrity.
A controlled steam-air mixture allows chamber pressure to be regulated according to the temperature.
Magnetically driven fans and flow deflectors maintain a homogeneous steam-air mixture, ensuring continuous circulation and uniform heat distribution throughout the chamber and the load.
Superheated water is recirculated through a heat exchanger and distributed over the load through a top cascade and lateral sprays.
Controlled water coverage supports uniform heat transfer and rapid thermal transitions, including across high-density and thermally demanding loads.
Counterpressure is adapted throughout heating, sterilization and cooling to the pressure developing inside the containers.
This protects bags, plastic bottles, syringes, vials and other pressure-sensitive packaging from deformation, rupture, leakage or closure failure.
A rotating basket maintains the complete load in controlled motion during processing.
Adjustable speed, direction and intermittence help preserve product homogeneity and improve heat transfer in emulsions and other heterogeneous formulations.
Our Process Control architecture provides dedicated functions specifically developed for terminal sterilization of liquid products:
Together, these functions provide objective evidence of sterilization performance, support validation activities and ensure complete process traceability throughout the entire cycle.
LVPs, SVPs and other small-molecule liquid pharmaceuticals require uniform lethality without unnecessary thermal exposure. Heat transfer, counterpressure and cooling are developed around formulation behaviour, fill volume, container characteristics and load configuration.
Prefilled syringes combine a sensitive drug product with multiple pressure-sensitive components and interfaces. Coordinated temperature, pressure and cooling control protects the syringe, plunger, closure and final product throughout the cycle.
Bags, plastic bottles and other deformable containers are particularly vulnerable to changes in internal pressure. A controlled counterpressure profile protects package geometry and integrity during both heating and cooling.
Closed blister systems, including contact lenses, require sterilization without compromising seal integrity, package geometry or peel performance. The cycle and load configuration are engineered around the specific blister system.
These formulations can separate or lose homogeneity during thermal processing. Controlled rotation keeps the complete load in motion, supporting product homogeneity and heat transfer throughout the cycle.
In saturated-steam processes, pressure is directly related to temperature. Closed containers may develop internal pressures that cannot be balanced without independently controlling chamber pressure, creating a risk of deformation, rupture, leakage or closure failure.
Selection between steam-air and superheated-water technology is based on formulation behaviour, viscosity and density, container-closure characteristics, internal pressure development, load configuration, compatibility with the processing medium and required cycle load size. The product category alone does not determine the technology.
Controlled counterpressure is adapted throughout heating, sterilization and cooling to the changing pressure inside the containers. The pressure profile is developed around the specific behaviour of the product-container system.
Yes. Steam-air technology can execute controlled thermal processes including pasteurization while superheated-water technology is particularly suited to pasteurization and other low-temperature treatments benefiting from water-mediated heat transfer.
Yes. A rotating basket keeps the complete load in controlled motion during processing. Rotation speed, direction and intermittence can be adjusted to help preserve product homogeneity and support heat transfer within the containers.
Contact lens manufacturing combines high-volume production, delicate ophthalmic products and increasingly sophisticated packaging concepts.
As manufacturers introduce ultra-thin blister formats, easy-peel packaging designs and fully automated production environments, terminal sterilization must ensure both sterility and packaging integrity throughout the entire process.
IV bags are commonly manufactured in large quantities for the delivery of infusion solutions, electrolytes, nutrients and pharmaceutical formulations. Once filled and sealed, the complete product-container system must reach the required sterility assurance without compromising the formulation, the flexible bag, its seals or its ports.
For high-volume lines, the challenge extends to the economics and continuity of the complete production flow. Process time, bags per batch, loading and unloading, utility demand, water and wastewater, drying and downstream readiness all influence line output and cost per processed bag.
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
Hyaluronic acid pre-filled syringes combine a thermally sensitive formulation with a pressure-sensitive container-closure system. Product performance depends on the molecular weight and rheological behaviour of the formulation, while moist heat progressively reduces viscosity as exposure continues. At the same time, heating increases the internal pressure of the filled syringe through liquid expansion and vapour pressure, potentially causing plunger movement, leakage or loss of container integrity.
A pre-filled syringe is a hermetically sealed container with a movable plunger. During thermal sterilization, the liquid expands, part of it vaporizes, dissolved gases are released and the gas already present in the headspace increases in pressure.
An aqueous solution expands by approximately 6% when heated from ambient temperature to 121°C, while the volume of a glass syringe increases by only about 1%.
A sealed blister changes throughout thermal sterilization. As temperature rises, the liquid expands, part of it may vaporize and the gas in the headspace increases in pressure. The resulting internal pressure acts directly on the blister cavity and its peel seal.
The same interaction continues during cooling, when the product, the headspace gas and the sterilization environment may respond at different rates. If chamber pressure does not follow the changing internal conditions closely enough, the differential can deform the blister, stress the seal or compromise package integrity.
A multichamber bag enters the sterilization process as a single container, but its chambers do not behave as a single product.
Different fill volumes, headspaces and geometries create different thermal inertias within the same packaging. The smallest chambers can rapidly follow the process temperature and begin accumulating lethality, while the largest chamber is still heating.
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