This procedure describes the proper installation and use of the Safe-Septum material transfer system by manufacturing and quality control technicians.
2.0 Scope
This procedure applies to the general use of the Safe-Septum for line and process vessel sampling and transfer of materials into process vessels and lines.
3.0 Responsibility
Anyone who uses a Safe-Septum system to transfer materials across the aseptic barrier of a process vessel or line is responsible for understanding the content of this SOP. Training in the proper installation of the Safe- Septum fittings and septum cartridges and general knowledge of aseptic technique is required before a person is qualified to perform this procedure.
4.0 Procedure
The Safe-Septum system for material transfer is used to achieve aseptic transfer of materials into and out of the aseptic barrier of process vessels and lines. It is most suitable for use in applications involving the transfer of low viscosity, low particulate liquids at flow rates compatible with the size of the hypodermic needle in the procedure.
4.1 Installation of the Safe-Septum fitting
4.1.1 The Safe-Septum fitting must be installed according to the recommendations of QMI engineers and in a manner that is compatible with its intended use.
For example: A fitting may be welded into a process line or the side of a process vessel. In this case, all qualification procedures for welding joints must be observed.
4.2 Installation of the Safe-Septum septum cartridge
4.2.1 The Safe-Septum septum cartridge must be installed according to the instructions from QMI accompanying the package.
For example: A seven port septum cartridge would be removed from its sterile wrapping and placed in the open fitting. The retaining collar is then tightly screwed on to the fitting finger and the septum cartridge is checked for even seating in the fitting. Finally, the retaining collar is tightened one half turn using the wrench provided by QMI.
4.3 Penetration of the Safe-Septum septum and transfer of materials
4.3.1 Penetration of the Safe-Septum system for transfer of materials is achieved by using a hypodermic needle to pierce the septum. Septum material used in the Safe-Septum septa is non-coring when penetrated by any commercially available hypodermic needle. The practical limitation on needle size is gauge 14. Hypodermic needles used must be sterile and appropriately packaged to maintain sterility until moment of use.
4.3.2 An appropriate device must be attached to the hypodermic needle to effect the transfer of material.
For example: The needle may be attached to an appropriately sized sterile syringe that can be used to withdraw material. Alternatively, the syringe can be aseptically filled with material to be injected across the septum and used to add material to a process.
For example: The needle can be attached to feed tubing and a controlled pump and used for the periodic addition of control liquids like acid, base and anti-foam.
4.3.3 Step-wise procedure for penetration of the Safe-Septum and materials transfer:
Swab the smooth plastic surface of the Safe-Septum septum cartridge with sanitizing agent for an appropriate time period (typically 15-20 seconds).
Use proper sterile technique to remove the needle from its sterile packaging.
Line the needle up with one of the penetration channels and push the needle gently through the smooth plastic surface and all the way through the rubbery septum material below it into the interior of the vessel or line.
Carry out the transfer of material.
After the material transfer is completed, withdraw the needle and cover it to prevent accidental needle sticks. Discard the needle properly in a container for sharps.
5.0 The material transfer must be recorded on the appropriate batch production record.
QMI (Quality Management, Inc.) 426 Hayward Avenue North
Oakdale Minnesota 55128
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Tel: 651-501-2337 Fax: 651-501-5797 Email: info@qmisystems.com *Manufactured under license from Galloway Co., Neenah, WI **QMI products are protected by the following U.S. Patents: 4,941,517; 5,086,813; 5,269,350,5,119,473
