The Biowelder® TC is an automated device for making sterile connections between thermoplastic elastomer (TPE) tubing elements. This proven technology uses unique rotating tube holders to connect dry- or liquid-filled TPE tubing and ensures total containment of process fluids by reconnecting discarded tube ends. The TPE tubing are typically used for safe fluid transfer during pharmaceutical manufacturing process. These tubings are weldable and sealable which simplifies operations without the need for extra connectors.
Here, I will give an overview of requirements for qualification testing of a typical Biowelder used in bio-pharmaceticals or advance bio-pharmaceuticals industries.
In general, the qualification testing requirements are based on the specification of user requirements and regulatory industry guidelines which are documented in the User Requirement Specification (URS). These requirements are then tested in the qualification protocol especially in the Installation & Operational Qualification (IOQ) and tracked thorough Requirement Traceability Matrix (RTM) document throughout the equipment lifecycle.
Before, outlining the Installation and Operational Qualification testing of the Biowelder, it is important know the basic principle & functionality of the equipment. I will particularly explain the basic principle of Sartorious Biowelder as I did have hands on qualification experiences in Biopharmaceutical industries.
The Biowelder® TC is used for the sterile welding of two tube pieces. Every piece of tube is connected on one end to a container, bag or process unit. The other end is sealed with a clamp, plug or another seal. To create a sterile connection, first place the two tubes in the tube holder of the Biowelder® TC. Then a new blade is inserted into the blade holders of the device. Closing the cover and pressing the start button activates the steps in the welding programme. In the first step the blade is heated to over 400°C and held for 5 seconds at this temperature . This step guarantees that the blade is sterile and pyrogen-free. Then the blade is cooled to the required cutting and welding temperature which depends on the type of tube. Afterwards the heated blade simultaneously cuts through the two pieces of tube. The blade temperature is controlled during the cutting process. Once the tubes have been cut through, the device turns the tubes so that they line up. The blade is then pulled back, the tubes pressed together and the weld cooled off. The release of the cover signals the end of the welding and the device can be opened. The welded tube is taken out and is now ready for use. The used blade and the waste tube are removed.
Installation and Operational Qualification testing for a Bio welders generally cover the followings at minimum:
-Verification on Equipment Tag as per the defined standard operating procedure (SOP), make, model, serial no. and location
-CE certification of Equipment
-Cleanroom suitability of the equipment (If used in cleanroom)
-Calibration Certificate of Biowelder by Vendor i.e. 3 point Calibration on Temperature
-Verify that the equipment is in the maintenance schedule
-Verification of the Standard Operating Procedure of Biowelder is in place
-Training verifications of users i.e. Users are trained on their own SOP or users are trained by Vendor
-Testing for Weldings i.e. Wet-Wet, Dry-Wet, Dry-Dry conditions on tubings of sizes i.e. IDxOD (1/8”x1/4”) (1/4”x3/8”), (3/8”x5/8”), (1/2 x 3/4”) etc.
to be used. Check for visual deformation like holes within the weld and the weld must not restrict the flow through.
-Pressure testing on welded tubing to verify the weld can withstand the pressure as per the process range i.e. no leakage or damage to the of welds
In conclusion, the basic of qualification testing of a BioWelder has been discussed above. Feel free to comment or share your opinion or if you have any queries regarding the relevant topic. I will try to share my own experiences and knowledge to respond.
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