Solutions for sterile powder manufacturing

Preparing the production line for the next campaign.

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.

Restoring sterility before production begins.

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.

Introducing sensitive materials without thermal stress.

Not every production material can tolerate steam sterilization or dry heat. Thermosensitive accessories, environmental monitoring tools and auxiliary production materials are transferred into the classified manufacturing area through validated hydrogen peroxide bio-decontamination. This approach enables safe material introduction while preserving aseptic conditions and avoiding thermal damage to sensitive components.

Establishing the required cleanliness state.

Before sterile processing can begin, reusable aluminium kegs are washed to remove manufacturing residues and prepare every product-contact surface for downstream depyrogenation. Washing represents the first operation of the production campaign, creating consistent starting conditions for sterile container preparation while supporting repeatable processing of every batch of reusable primary containers.

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.

Preparing sterile and pyrogen-free primary containers.

After washing, aluminium kegs undergo validated dry-heat depyrogenation before entering the protected aseptic workflow. The process combines sterilization with endotoxin reduction, preparing reusable primary containers for direct contact with sterile powder products. By establishing both sterility and pyrogen control upstream of filling, depyrogenation extends contamination control beyond microbial reduction alone.

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.