| 摘要 |
Process of producing a biopharmaceutical product includes providing a pouch unit including a pouch and at least one port, and optionally, a functional device; filling the pouch with the product; carrying out the production process, and at at least one stage thereof, using or generating a liquid or small solid incident body within the biopharmaceutical product; the pouch unit incorporating a support and replacement element formed by or integrated in the pouch wall, or in the port or functional device so as to be accessible from the inside space and be in direct physical contact with the contents of the pouch, arranged so as to be able to be loaded with the incident body and pass between the support and replacement element and the contents, such that the incident body is loaded on the support and replacement element when it is not or should not be within the biopharmaceutical product. |
