Method and system for characterization of a bag for biopharmaceutical fluid content

A system for characterization of a calibrated defect of a film of a bag for biopharmaceutical fluid, characterized in that the system comprises:

• a test device,
• a bag film sample provided with a calibrated defect installed in the test device,
• a fluid applying controlled fluid stresses to the bag film sample provided with the calibrated defect in the test device, allowing to conduct a leak test,
• a measurement device for measuring a result of the leak test,
• recording means to record characteristics of the bag film sample provided with the calibrated defect, characteristics of the controlled fluid stresses, and the result of the leak test in a database.

A computerized method for characterization of a bag for biopharmaceutical fluid content, the bag comprising at least one film, wherein,

• by means of an interface of a programmable machine, a user provides information relating to the use of the bag, the information relating to the use of the bag comprising at least one of the following items of information:
• characteristics of the biopharmaceutical fluid to be contained in the bag, mechanical conditions of the bag use, duration of the bag use, ambient conditions, level of fluidtightness required for the bag,
• the programmable machine receives, from a computer, characteristics of at least one film that is determined by comparing the information relating to the use of the bag with a database containing results of leak tests previously carried out for bag film samples provided with calibrated defects subjected to various fluid stresses, and
• a processor causes said characteristics to be displayed on the interface.

A computerized method for characterization of a bag for biopharmaceutical fluid content, the bag comprising at least one film, wherein,

• a computer receives information relating to the use of the bag, provided by a user by means of an interface of a programmable machine, the information relating to the use of the bag comprising at least one of the following items of information:
• characteristics of the biopharmaceutical fluid to be contained in the bag, mechanical conditions of the bag use, ambient conditions, duration of the bag use, level of fluidtightness required for the bag,
• the computer determines characteristics of at least one film by comparing the information relating to the use of the bag with a database containing results of leak tests previously carried out for bag film samples provided with control defects subjected to various fluid stresses,
• the computer sends the characteristics for display on the interface by a processor.

A computerized method for characterization of a bag for biopharmaceutical fluid content, the bag comprising at least one film, wherein,

• by means of an interface of a programmable machine, a user provides information relating to the use of the bag, the information relating to the use of the bag comprising at least one of the following items of information:
• characteristics of the biopharmaceutical fluid to be contained in the bag, mechanical conditions of the bag use, ambient conditions, duration of the bag use, level of fluidtightness required for the bag,
• a computer determines characteristics of at least one film by comparing the information relating to the use of the bag with a database containing results of leak tests previously carried out for bag film samples provided with calibrated defects subjected to various fluid stresses,
• the computer sends the characteristics to the programmable machine,
• a processor of the programmable machine causes said characteristics to be displayed on the interface.

A system for characterization of a bag for biopharmaceutical fluid content, the bag comprising at least one film, the system comprising:

• a programmable machine provided with an interface enabling a user to provide information relating to the use of the bag, the information relating to the use of the bag comprising at least one of the following items of information:
• characteristics of the biopharmaceutical fluid to be contained in the bag, ambient conditions, mechanical conditions of the bag use, duration of the bag use, level of fluidtightness required for the bag,
• a computer adapted to determine characteristics of at least one bag by comparing information relating to the use of the bag with a database containing results of leak tests previously carried out for bag film samples provided with calibrated defects subjected to various fluid stresses,
• a system of communication between the computer and the programmable machine,
• the programmable machine comprising a processor adapted to cause the characteristics to be displayed on the interface.