As the result of developing new biological drugs and following their success, there is an increasing need for low temperature terminal surface sterilization of delivery devices with sensitive biological products or other drug products with sensitive ingredients. VHP process that stands for vaporized hydrogen peroxide has proven to be both very efficient for microbial control and is a safe application that is relatively easy to adapt to manufacturing facilities. VHP has been used for low temperature sterilization and room decontamination applications already for several decades.
Implementation of such process is relatively easy with the pre-designed production capacity sized range of units now available in the market. The safe environmental properties of hydrogen peroxide is also a true advantage, as removing peroxide from the process after exposure through a catalyzer leaves you only with water and oxygen as by-products of the cycle.
Typical products to be sterilized are single-packaged delivery devices with parenteral drugs such as biologicals, biosimilars or other sensitive products, e.g. with specific proteins that are heat or radiation sensitive.
To fulfill GMP requirements, a sterilization cycle needs to have controlled environment – meaning control over critical process parameters and environmental conditions in the sterilization chamber. The VHP LTS-V sterilization cycle is performed in vacuum conditions in order to achieve this and this ensures a sterilized load. It is also very important to run a dry vapor VHP process to avoid any condensation that could harm the process equipment and product load as well as could prevent the required uncompromised 6-log microbial kill. The cycle is tested against a number of biological indicators containing Bacillus Stearothermophilus spores with a minimum of 106 CFU, set in a load-specific array to prove microbial kill in various load representative locations.
Typical VHP LTS-V sterilization cycle time (door close to door open) is from 2 to 4 hours mainly depending on load configuration, and package materials. After cycle it is required to have <1 ppm residue of peroxide to ensure safe processing.
Significant advantages of automated terminal surfaces sterilization process can easily be realized for the drug manufacturer in practice, as implementing VHP LTS-V process can decrease manual labor per work shift, enable in-house processing instead of contract sterilization, and increased throughput with fast product-tailored process supported by well-established methods for feasibility testing, cycle development and validation support services that lead to minimizing on-site validation efforts and providing the optimal cycle and full sterilization efficacy.
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