The active part of the sampler is integrated into the pharmaceutical production facility. With a new drug sampling system, users can obtain the required samples for inspection (even high-activity media samples) without interruption of the production process for real-time detection. The double-sealed structural design makes this possible.
The real-time process analysis technology PAT can only be realized under the conditions of real-time detection of chemical components. For a long time, in the real-time detection and analysis of active ingredients of high active drugs, sampling without cross-contamination is a major problem. Using Asam1+2, developed and produced by Andocksysteme GUntch, a new cross-contamination drug sampling system can solve such problems. From a design point of view, this new drug sampling system draws on the advantages of a double seal design in its docking system. The multiple sealing system consists of an active sealing cap and a passive sealing cap that avoids the media in the production equipment coming into contact with the surrounding environment during the sampling process. These two sealing caps are interlocked for both manual and automatic operation. Special support components prevent blanks between the seals in the uninterlocked or semi-interlocked state, avoiding cross-contamination. The sampler is similar to the docking system, with active and passive sampling devices at Asam1 and Asam2. When the active sampling component is installed on the pharmaceutical production equipment, the passive sampling device also allows manual sampling from the pharmaceutical production equipment.
In order to collect the drug sample, the passive sampling device and the active sampling device are docked to each other. In the closed state, the two parts of the sampling system are isolated from the production equipment and from the surrounding environment before the sample is taken. In order to obtain a sample of the drug, the two parts of the docking exercise together and interlock. Both parts are made of PTFE PTFE seals (capable of CIP in-situ cleaning and SIP in-situ disinfection), so that the two parts form a complete whole, thus ensuring non-polluting access under continuous production conditions. Samples were sent to avoid cross-contamination.
At the time of sampling, the hemispherical double seal cap is rotated 180° to the state of connection with the production equipment. In this half, there is a sampling hole, and the drug sample falls into the hemisphere through the sampling hole. In this state, both the active and passive sampling devices are not in contact with the metal material because the interlocking samplers can be installed in different parts of the pharmaceutical production equipment, such as silos, dryers, and cartridges. In docks, mixers and pipes, this docking system is available in sizes ranging from 50 to 300 mm. The sample of the drug collected is only about 40~50ml, which is a great saving for the valuable active ingredients of the drug.
Saving sampling time is another advantage of the system. Traditional sampling systems often require rinsing, cleaning, and some even require disinfection before sampling. In the new sampling system, all related to complicated sanitary cleaning, sanitation or sterilization. Both time and cost can be reduced or reduced because the sampling system of the new system is integrated into the standard sanitation work.
Low cross-contamination risk An independent testing laboratory in Switzerland tested the docking system (100 mm diameter) of Andocksysteme G. Untch in three different conveyor systems under a commission contract from an internationally renowned Swiss pharmaceutical group. The pollution index is less than 0.01 ug/m3. At the time of testing, the technical specifications used were the ISPE Good Practice Standard 'Assessing the Particulate Containance Performance of Pharmaceutical Equipment'. The inspection project and inspection process are in accordance with the current GoodPracticeGuide guidelines and the SMEPAC technical specifications. The test indicators specified by the contractor stipulate that the limit value of the solid matter in the gas is 0.1 ug/m3. This value shall be measured without the need for auxiliary cleaning, opening the butt joint and shall meet the specified requirements. In gas detection, the average concentration obtained during the entire test time is less than 0.01 ug/m3; significantly lower than the value specified by the contractor.
This docking system did not use cleaning equipment and pumping equipment during the test. The sealing material at the contact portion with the drug medium during the test was PTFE polytetrafluoroethylene. The sealing material at the double seal cap is EPDM ethylene propylene rubber. According to the manufacturer, no system has achieved similar results in the past 20 years. Therefore, it can be said that this docking system is a * level docking system using PTFE PTFE sealing material.
The real-time process analysis technology PAT can only be realized under the conditions of real-time detection of chemical components. For a long time, in the real-time detection and analysis of active ingredients of high active drugs, sampling without cross-contamination is a major problem. Using Asam1+2, developed and produced by Andocksysteme GUntch, a new cross-contamination drug sampling system can solve such problems. From a design point of view, this new drug sampling system draws on the advantages of a double seal design in its docking system. The multiple sealing system consists of an active sealing cap and a passive sealing cap that avoids the media in the production equipment coming into contact with the surrounding environment during the sampling process. These two sealing caps are interlocked for both manual and automatic operation. Special support components prevent blanks between the seals in the uninterlocked or semi-interlocked state, avoiding cross-contamination. The sampler is similar to the docking system, with active and passive sampling devices at Asam1 and Asam2. When the active sampling component is installed on the pharmaceutical production equipment, the passive sampling device also allows manual sampling from the pharmaceutical production equipment.
In order to collect the drug sample, the passive sampling device and the active sampling device are docked to each other. In the closed state, the two parts of the sampling system are isolated from the production equipment and from the surrounding environment before the sample is taken. In order to obtain a sample of the drug, the two parts of the docking exercise together and interlock. Both parts are made of PTFE PTFE seals (capable of CIP in-situ cleaning and SIP in-situ disinfection), so that the two parts form a complete whole, thus ensuring non-polluting access under continuous production conditions. Samples were sent to avoid cross-contamination.
At the time of sampling, the hemispherical double seal cap is rotated 180° to the state of connection with the production equipment. In this half, there is a sampling hole, and the drug sample falls into the hemisphere through the sampling hole. In this state, both the active and passive sampling devices are not in contact with the metal material because the interlocking samplers can be installed in different parts of the pharmaceutical production equipment, such as silos, dryers, and cartridges. In docks, mixers and pipes, this docking system is available in sizes ranging from 50 to 300 mm. The sample of the drug collected is only about 40~50ml, which is a great saving for the valuable active ingredients of the drug.
Saving sampling time is another advantage of the system. Traditional sampling systems often require rinsing, cleaning, and some even require disinfection before sampling. In the new sampling system, all related to complicated sanitary cleaning, sanitation or sterilization. Both time and cost can be reduced or reduced because the sampling system of the new system is integrated into the standard sanitation work.
Low cross-contamination risk An independent testing laboratory in Switzerland tested the docking system (100 mm diameter) of Andocksysteme G. Untch in three different conveyor systems under a commission contract from an internationally renowned Swiss pharmaceutical group. The pollution index is less than 0.01 ug/m3. At the time of testing, the technical specifications used were the ISPE Good Practice Standard 'Assessing the Particulate Containance Performance of Pharmaceutical Equipment'. The inspection project and inspection process are in accordance with the current GoodPracticeGuide guidelines and the SMEPAC technical specifications. The test indicators specified by the contractor stipulate that the limit value of the solid matter in the gas is 0.1 ug/m3. This value shall be measured without the need for auxiliary cleaning, opening the butt joint and shall meet the specified requirements. In gas detection, the average concentration obtained during the entire test time is less than 0.01 ug/m3; significantly lower than the value specified by the contractor.
This docking system did not use cleaning equipment and pumping equipment during the test. The sealing material at the contact portion with the drug medium during the test was PTFE polytetrafluoroethylene. The sealing material at the double seal cap is EPDM ethylene propylene rubber. According to the manufacturer, no system has achieved similar results in the past 20 years. Therefore, it can be said that this docking system is a * level docking system using PTFE PTFE sealing material.
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