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Approval Signatures:
Quality Control: ________________________________
Date: _________________________
Operations: __________________________________
Date: _________________________
Quality Assurance: _____________________________
Date: _________________________
1.0 Purpose
This procedure describes the proper installation and use of the QMI Aseptic Sampling System by manufacturing and quality control technicians.
2.0 Scope
This procedure applies to the general use of the QMI Aseptic Sampling System for line and process vessel sampling and transfer of materials into process vessels and lines.
3.0 Responsibility
Anyone who uses the QMI Aseptic Sampling 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 fittings and cartridges and general knowledge of aseptic technique is required before a person is qualified to perform this procedure.
4.0 Procedure
The QMI Aseptic Sampling System for material transfer (sampling or adding of liquids) 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 used in the procedure.
4.1 Installation of the QMI Aseptic Sampling System fitting
4.1.1. The QMI Aseptic Sampling System 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 on the side of a process vessel. In this case, all qualification procedures for welded joints must be observed.
4.2 Installation of the QMI Aseptic Sampling System cartridge
4.2.1. The QMI Aseptic Sampling System cartridge must be installed according to the instructions from QMI accompanying the package.
For example: A seven port sampling cartridge would be removed from its sterile wrapping and placed in the open fitting. The retaining collar (nut) is then hand tightened on to the fitting and the sampling cartridge is checked for even seating in the fitting. Finally, the retaining collar (nut) is tightened one quarter to one half turn using the wrench which can be purchased from QMI.
4.3 Penetration of the QMI Aseptic Sampling System and transfer of materials
4.3.1. Penetration of the QMI Aseptic Sampling System for transfer of materials is achieved by using a hypodermic needle to pierce the sampler. Material used in the QMI Aseptic Sampling System septa is non-coring when penetrated by any commercially available hypodermic needle. The practical limitation of needle size is gauge 14. Hypodermic needles used must be sterile and appropriately packaged to maintain sterility until the 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 sampler and used to add material to a process.
4.3.3. Step-wise procedure for penetration of the QMI Aseptic Sampling System and material transfer:
Swab the smooth plastic surface of the QMI Aseptic Sampling System cartridge with sanitizing agent for an appropriate time period (typically 15-20 seconds).
Use proper sterile techniques 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 sampling material below it into the interior of the vessel or line. Penetrate the Aseptic Sampler with a slight angle when sampling from the outer channel guides.
Carry out the transfer of material (sampling or filling syringe).
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.
Please note: The Aseptic Samplers are CIPable. Depending on Time, Temperature and Pressure, the Aseptic Sampler in Silicone may be recommended. Please contact us with your specs. and we will help determine which sampler is best for you.
QMI (Quality Management, Inc.) 426 Hayward Avenue North
Oakdale Minnesota 55128
Ask for your complimentary copy of the Safe Septum Training Video on CD today. We'll even take care of the shipping charge.
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
