From the elimination of cleaning and cleaning validation to a reduction in capital costs, labor, and space requirements, the myriad benefits of using disposable systems are well-established. However, presterilization is one area that deserves more attention. Presterilization goes to the heart of the disposables concept, which is to minimize opportunities for contamination, whether through operator error, the process, or the product.
As the size and complexity of disposable systems continue to increase, presterilization will become increasingly advantageous and, in some cases, necessary. For example, conventional sterilization techniques such as autoclaving do not always fit a manufacturer's timeline, especially in the case of campaign-based vaccine production. Steam used during autoclaving is also known to damage paper, some plastics, and other heat-labile products and does not always ensure complete sterilization.
In addition to providing validation strategies for presterilization using gamma irradiation, this article addresses the overall benefits of disposables and explains how to minimize revalidation during scale-up.Validation: An Important Early Process Consideration
The different production operations shall be carried out in accordance with GMP; manufacturing facilities must be laid out to allow effective cleaning and reduce cross-contamination risk; equipment used for manufacturing operation, which are critical to the quality of the product, shall be subjected to appropriate qualification and validation.
Presterilized Filtration Systems
Filtration systems exemplify disposable technologies that can be presterilized. Disposable filtration systems are offered in a range of sizes, so that corresponding filters and bags are available for every stage of development, ensuring that the most appropriate and economical disposable filter scheme is used. By using the same materials of construction, these systems also generate reproducible results during scale up. Also, like presterilized filter cartridges, the entire single-use filtration system can be gamma irradiated before delivery to the biopharmaceutical manufacturing site. These systems, which generally comprise disposable bags, capsule filters, tubing, clamps, adaptors, and connection devices, also simplify many biopharmaceutical processes, such as preuse filter integrity testing.
To make certain that the process is scaled up with minimal material revalidation, biotechnology and pharmaceutical companies should use components that are made from the same materials from small scale-up to manufacturing scale.
A variety of capsule filter configurations are available to support processes as they are scaled up. Ideally, these differently-sized capsules contain identical filter media and hardware materials. This helps ensure that scale-up and scale-down studies yield relevant information and minimum requalification for various batch sizes.
The availability of a variety of capsules for small-scale operations is especially beneficial for new product development. Since all new biopharmaceutical products may not become commercialized, capital investment can be a concern. Single-use capsules and systems make it possible to produce new products during the early development stages without a large capital investment. Together, these factors can streamline drug development to increase manufacturing capacity, while meeting validation requirements.