Tubing Assemblies: General Information
Custom Tubing Assemblies and Manifolds
Tubing Assemblies are custom designed and manufactured to meet your specific requirements for aseptic fluid transfer. Creation is a three stage process :
1. Specification and Design
The design phase to develop a new tubing assembly is operated under an ISO 9001:2008 quality system. This is a fully interactive process between you and Biofluid Focus/Cellon. During this phase the assembly is designed, the materials selected and the requirements for in-process testing and post-assembly processing are determined.
You are supplied with detailed CAD diagrams and bills of materials (designated PR for prototype) for project review/approval. Any changes are recorded and resubmitted for approval. If desired, samples can be made available for testing.
Following evaluation, the design can be further modified. Once the PR CAD is approved the PR CAD is converted to an SG CAD issue 1, indicating that the specified graphic diagram is final and the specifications are set for manufacturing.
At this point, the tubing assembly design is locked and future changes can only be made via our documented change control procedure. Changes documented through this process are recorded and indicated by an increase in the issue number of the SG-CAD.
Manufacture of Octopus tubing assemblies, and final packaging, is carried out within an ISO 14644-1 Class 7 cleanroom facility operated under ISO 9001:2008 and ISO 13485:2003 quality systems
Assembly process instructions (APIs) are produced from SG CAD specifications approved by you. In addition to the API, an assembly batch record (ABR) is produced which details the specific test requirements for the assembly.
The ABR is also used to record the batch details of all components used in the tubing assembly and to record any test result data. All documents are controlled via a controlled documents procedure. Approved component parts are counted into the clean room in the number required and the assemblies are built according to the API.
Each tubing assembly is visually checked by a second clean room technician and tested as defined in the API and ABR. Quality control personnel perform additional visual inspection on a specified number of assemblies before releasing the batch to final packaging. The completed ABR and all associated documents are then combined to form a “job pack” which is submitted to the quality department for review. Only after QC approval of the job pack is the product released.
The document control system ensures only current documents are used for reference, traceability and recording of test results during manufacture. Document changes are controlled via a change control system which requires your approval before any change can be implemented. Obsolete documents are stored electronically allowing easy retrieval in the event of a customer requesting an “obsolete” part or any information relating to that part.
3. Post manufacture processing.
You determine the level and type of post manufacture processing carried out on each specific assembly, based on the intended use of the assembly within your facility. Post manufacture processing, such as irradiation, is sub-contracted to approved independent service providers depending on what processing is required.
Please contact Biofluid Focus for more information.