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Single Use Technology Implementation An increasing attractive option that must be weighed for both research and production is the implementation of Single Use Disposable Manufacturing Technology. We can assist in weighing the cost-benefits of disposable manufacturing technology implementation and assist in the implementation of either standard or custom single use technology. For internal implementation, bioprocessing steps to be selected and integrated may include bioreactor processes, mixing, transfer, connection/disconnection, filtration, chromatography, storage, and filling. We can provide the resources to help you make the choice that provides the best flexibility along with economic benefits and risk management depending on requirements driven by your company's product pipeline. |
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| Our consulting services can help with planning and testing leading to a successful implementation of new technology and help you avoid pitfalls that may lead to delays or supply chain or cost issues. Behind our consulting services are numerous years engineering experience and training in different bioprocess areas (including cell culture, fermentation, protein purification, aseptic processing and validation), a strong background in disposable manufacturing technology, process filtration, disposable manufacturing technology product development, and specific training in the area of gamma irradiation and industrial sterilization processes. |
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| Whether designing a product for internal use or for offering to the marketplace, product requirements must be defined. Any requirement related to robustness to perform in a process must be assessed. Cleanliness, extractable, and adsorption limits must be determined to allow for the selection of the proper materials. Prototype design must be undertaken and testing to verify the product meets the predefined requirements must be conducted prior to implementation. If the product is required to be “sterile” versus only gamma irradiated, the steps to validate this claim and the associated cost must be defined early in the product development process. |
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Please contact us at request@pendotech.com for more information. Click here to fill out our online form to join our mail list for new product and service updates. Copyright © 2007, by PendoTECH |
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