There are many factors to consider when selecting an appropriate bag chamber for a single-use system to support your bioprocess. The task can seem overwhelming, so it is important to lean on stringent procedures to ensure a successful outcome.
ASTM E3051-16 Standard Guide for Speciﬁcation, Design, Veriﬁcation, and Application of Single-Use Systems in Pharmaceutical and Biopharmaceutical Manufacturing describes a rigorous process for implementation of single-use systems, which is intended to conform to regulatory requirements following a risk-based approach. The basic elements of E3051 can be applied to bag chamber selection for use in a single-use system. Below we provide an example of the following concepts of E3051 for bag chamber selection.
The first step is to comprehensively define your user requirements: specific requirements should be identified and provide the basis of detailed specification, design and verification of the SUS.
Typical bag chamber-specific user requirements would include:
- Integrity risk assessment
- Particulate risk assessment
- Intended chamber contents
- Liquid volume
- Application (liquid or frozen, storage, shipping, mixing, etc.)
- Temperature range
- Chemical compatibility
- Duration of application
- Light sensitivity
- Barrier requirements (oxygen, carbon dioxide, water vapor, etc.)
- Handling considerations
According to E3051, the specific requirements relative to product quality and patient safety should be based upon the following:
- Product knowledge and understanding refers to the process fluid itself and can help identify risks to the product or process fluid from the system, or risks to the system from the product or process fluid.
- Process knowledge and understanding help identify risks that the process can bring to the bag chamber or that failure of the bag chamber can bring to the process.
- Materials knowledge and understanding will help guide the bag chamber selection since bag chambers are available with different construction materials.
- Supply chain knowledge and understanding can help you identify risks to supply interruption.
- Knowledge of the regulatory requirements for the application will help avoid selecting the wrong bag chamber.
- Many companies have defined quality requirements specific to different applications or as blanket requirements for the selection of single-use system components. A summary of these requirements is useful to bag chamber selection.
Qosina offers bag chambers made from different materials, in many volumes, port configurations and types. We maintain an extensive ISO 13485 controlled database of relevant product attributes to help in the selection of components that meet your needs, including bag chambers.
|Description||Aramus 2D Bag Chamber, Non-Sterile||Flexsafe® 2D Bag Chamber, Non-Sterile||Flexboy® Bag Chamber, Non-Sterile||ILC 2D Bag Chamber|
|Product Information||Manufacturing Facility Certification||Certified ISO 9001||Certified ISO 9001||Certified ISO 9001||Certified ISO 9001|
|Manufacturing Environment||SO Class 5 / 100 / Grade A||ISO Class 7 / 10,000 / Grade C||ISO Class 7 / 10,000 / Grade C||ISO Class 7 / 10,000 / Grade C|
|Manufacturing Aids or Mold Release||No||Yes||No information currently available||No|
|Use of Regrind||No||No||No information currently available||No|
|% of Regrind if Used||0||0||0||0|
|Shelf-life Non-irradiated (Months)||24||36||No information currently available||24|
|Shelf-life Post-irradiation (Months)||N/A||36||36||24|
|Shelf-life Post-irradiation (Months)||N/A||36||36||24|
|Regulatory Information||REACH Declaration Available?||Not submitted||Not submitted||Not submitted||Not submitted|
|RoHS3 (2015/863)||Component conforms to requirements of RoHS 2015/863 (RoHS3)||Component conforms to requirements of RoHS 2015/863 (RoHS3)||Component conforms to requirements of RoHS 2015/863 (RoHS3)||Component conforms to requirements of RoHS 2015/863 (RoHS3)|
|Conflict Minerals||Component is not known to contain tantalum, tin, tungsten or gold||Component is not known to contain tantalum, tin, tungsten or gold||Component is not known to contain tantalum, tin, tungsten or gold||Component is not known to contain tantalum, tin, tungsten or gold|
|California Prop 65||No information available||No information available||No information available||NO SUBSTANCES on the California Proposition 65 list have been knowingly or intentionally added to any materials used to manufacture the component|
|Contains Plasticizers||No||No information available||No information available||No|
|Latex in Product||Item not intentionally made with natural latex||Item not intentionally made with natural latex||Item not intentionally made with natural latex||Item not intentionally made with natural latex|
|Latex in Packaging||Packaging not intentionally made with natural latex||Packaging not intentionally made with natural latex||Packaging not intentionally made with natural latex||Packaging not intentionally made with natural latex|
|Animal-Derived Ingredients (BSE/TSE)||Certified animal-derived component-free (ADCF)||Conforms with EMA/410/01 rev. 3||Conforms with EMA/410/01 rev. 3||Conforms with EMA/410/01 rev. 3|
|Human-Derived Ingredients (EU MDR)||Does NOT intentionally contain human-derived ingredients||Does NOT intentionally contain human-derived ingredients||No information available||Does NOT intentionally contain human-derived ingredients|
|Nanomaterials (EU MDR)||Does NOT intentionally contain nanomaterials||Does NOT intentionally contain nanomaterials||No information available||No information currently available|
|EU MDR 10.4.1 (CMR/ED) Declaration Available?||Not submitted||Not submitted||Not submitted||Not submitted|
|Pyrogens||Not tested for pyrogens||Pyrogen free - Tested via USP <85>||Pyrogen free - Tested via USP <85>||No information currently available|
|European Pharmacopeia (EP) 3.1.x||No information available||Pass 3.1.5 Polyethylene||Pass 3.1.7 EVA||Pass 3.1.5 Polyethylene|
|Medicinal Substances (EU MDR)||No information available||Does not intentionally contain medicinal substances||No information available||No information currently available|
|Biocomp||ISO 10993-X||ISO 10993-4||ISO 10993-5||ISO 10993-10, ISO 10993-11, ISO 10993-5||ISO 10993-4, ISO 10993-5, ISO 10993-6, ISO 10993-10, ISO 10993-11|
|ISO 10993-x claim based on||Finished component||Finished component||Finished component||Raw material|
|USP <87>||Finished component passes <87>||Finished component passes <87>||Finished component passes <87>||No information currently available|
|USP <88>||Passes USP <88> 50C||Passes USP <88>, 50C temperature not stated||Passes USP <88>, temperature not stated||Passes USP <88>, temperature not stated|
|USP <87> <88> claim based on||Finished component||Finished component||Finished component||Raw material|
|Sterilization||Sterilization Compatibility||Gamma||Gamma, X-Ray||Gamma, X-Ray||Gamma|
|Maximum E-Beam Dose (kGy)||0||0||0||0|
|Maximum Gamma Dose (kGy)||40||45||50||50|
|Maximum X-Ray Dose (kGy)||0||0||0||0|
|Maximum Autoclave Temperature (⁰C)||N/A||N/A||N/A||N/A|
|Other||ICH Q3C Residual Solvents||No ICH Q3C testing performed||No information currently available||Contains NO ICH Q3C Class 1 or 2 residual solvents||No information currently available|
|ICH Q3D Elemental Impurities||No ICH Q3D testing performed||Contains NO ICH Q3D Class 1, 2, 2B or 3 Elemental Impurities||No ICH Q3D testing performed||No information currently available|
|Protein Adsorption Data Available||No||No||No||No information currently available|
|Extractables Testing||Other report|
|Visible/Subvisible Particulate Claim||USP <788>||USP <788>||USP <788>||USP <788>|
|Bioburden: USP <61> <62>||No bioburden information available||No bioburden information available||No information currently available||No information currently available|
|Tested via USP <661.1>||No||No||No||Yes|
|Integrity Tested||Yes, 100%||Yes, 100%||Yes, 100%||Yes, routine random samples are tested|
|CAD Model Available?||N/A||N/A||N/A||N/A|
|Any Restricted Uses?||N/A||N/A||N/A||N/A|
The information in the above table is true as of the writing of this content. Qosina is continuously improving our database with the most complete and up-to-date information. If you require specific information that is not available, please contact Qosina for assistance.
By comparing your user requirements against the specifications maintained in our systems, you can ensure that you make the right choice when selecting bag chambers.