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GC Agilent .pptx
- 1. Agilent 8890 Gas Chromatography Product Introduction June 19, 2023 1 INDONESIA DISTRIBUTOR Present by : PT Vision Scientific
- 2. Vision is Pharma Industries Solution Chromatography (LC/GC) Dissolution & Disintegration tester Mass Spectrometry / TOF Laboratory Informatics Spectrophotometer Elemental Analysis Total Organic Carbon Analyzer - USP 643 - USP 661 - Cleaning Validation - PAT - Waste Water Cleanroom / sterile production HEPA Filter Testing Microbiological Sampler USP 788 – Liquid Particle Realtime Monitoring System Environmental sensor GPC – Molecular Weight - HES (Hydroxyl Ethyl Starch) - Heparin Sodium Serialization & Aggregation Laboratory Information Management System (LIMS) Stability Management System Material Management System Cleaning Validation Management System Consumable Inventory Calibration & Validation Management System Quality Management System Gas Generator H2 Gas Generator N2 Gas Generator Zero Air Gas Compressor Liquid Nitrogen Generator Serialization Logistic Trace & Track
- 3. Position 74 Management 2 Sales & Dev 15 Marketing 2 Service & App 32 Back office 20 Vision is Pharma Industries Solution Education PhD 1 Master 3 Pharmacist 3 Bachelor 42 Diploma 13 Vision teknik – Vision Scientific Sales Service Calibration Validation Troubleshooting Preventive Maintenance Method Development Qualification Service (Cleanroom) Sample Trial Training Rental Instrument Engineering /Custom Machine
- 4. Vision is Pharma Industries Solution
- 5. Vision is Pharma Industries Solution
- 6. June 19, 2023 Confidentiality Label 6 Vision is Pharma Industries Solution
- 7. 7 Demonstrated Track Record For Innovation 5970 MSD Fused Silica Capillary Column Microprocessor Control 5840 GC 5880 GC AutoInjection 5890 GC Hyperbolic Gold Quad Inert MS Ion Source 6890 GC 7200 GC QTOF 7000 GC Triple Quad 7890 GC Capillary Flow Technology Electronic Pneumatic Control Retention Time Locking 2nd Gen Linear Electron Capture Detector Low Thermal Mass Technology Multi-Mode Inlet 8890 GC System with 7693A Automatic Liquid Sampler 7890B GC/5977A MSD New GC Agilent in 2019
- 8. 8 The Principle of Gas Chromatography
- 9. 9 Built on core 7890/8890 architectures … Modern UI … Advanced Intelligence Capabilities 8860 GC Touchscreen • Configuration/flowpath • Setpoints/actuals • Status • Signal Plot
- 10. 11 8860 – Powerful browser user interface Status Methods Sequence Maintenance Diagnostics Help Status Method Check your system configuration, and access status of instrument and run Call up method parameters Adjust and save as needed.
- 11. 12 Expanded Capabilities to meet more types of routine analysis needs 8860 GC 3rd Detector - Top • FPD (Env/Food, other) • TCD 3rd GSV (Energy & Chemical) 3rd Detector - Side • TCD (Energy & Chemical) • ECD • 2 LSV’s
- 12. 13 Agilent 8890 GC System
- 13. 14 Highlight Features Column smart key and USB … and other product design enhancements Touchscreen, 7 inch • View at the GC Enhanced Diagnostics Maintenance Instrument Status Extensive User Info • Capacitive touch screen Browser Interface • GC info available via PC, Tablet, Mobile • All GCs
- 14. 15 Enhanced Features 3rd or 4th Aux Carrier Detector • FID • ECD • TCD • NPD 6th Generation EPC • 8 EPC’s • Autonomous Leak-Check (Hands-Free) 3rd Top Detector • TCD • FPD 8 heated zones
- 15. The Ultimate in Smart Connected Power Agilent Restricted 16 ‘Touchtone phone to smartphone’ A User Interface Paradigm Shift is Taking Place
- 16. 17 Agilent 8890 GC System in summary Future-proof: ready for anything flexibility and expandability — Smart, variable speed oven fan — Dual simultaneous injection — Generation 6+ precision EPC — 4 valves, 8 heated zones — Large valve oven option — Smart keys — 7-inch color touch display
- 17. 18 KEY SPECIFICATION - Agilent 8890 GC System with Flame Ionization Detector - Agilent 7693A Automatic Injector - Agilent 7697A Headspace Sampler with Transfer Line Interface Accessory - OpenLab CDS Workstation Software
- 18. 19 ANALYSIS OF USP METHOD <467> RESIDUAL SOLVENT ON AGILENT 8890 GC SYSTEM
- 20. 21 Residual Solvent Organic volatile chemicals used or produced in the making of drug subtances or excipients or in the preparation of drug products. There is no therapeutic benefit from residual solvent Drug products should contain no higher levels than can be supported by safety data and be patient acceptable.
- 21. 22 Classification Class 1 (Solvents should be avoided) • Known human carsinogens, strongly suspected human carsinogens, solvents particularly known to have ozone-depleting properties Class 2 (Solvents should be limited) • Nongenotoxic animal carcinogents or possible causative agents of other irreversible toxicity, such as neurotoxicity or teratogenicity Class 3 (Solvents with low toxic potential) • Solvents with low toxic potential to humans, no-health-based exposure limit is needed
- 26. 19/06/2023 27 EQUIPMENT Equipment An 8890 GC was configured with : • a split/splitless inlet (SSL) • dual FIDs • sampling was performed using an Agilent 7697A headspace sampler • An inert tee was used to split the flow equally between the two columns Inert Tee, Capillary Flow Technology P/N. 3184-60065
- 27. 19/06/2023 28 Sample Preparation Residual Solvent Revised Method <467> Class 1 (p/n 5190-0490) Class 2A (p/n 5190-0492) Class 2B (p/n 5190-0491) Three stock solutions of residual solvents in DMSO
- 28. 19/06/2023 29 Sample Preparation • 1.0 mL of stock solution + 9 mL of DMSO, diluted to 100 mL with water • 1.0 mL of the solution diluted to 100 mL with water • 10.0 mL of the solution diluted to 100 mL with water • 1.0 mL of the solution + 5 mL of water into Headpace vial Class 1 solvents: • 1.0 mL of stock solution vial, diluted to 100 mL with water • 1.0 mL of the solution + 5 mL of water into Headpace vial Class 2A solvents : • 1.0 mL of stock solution vial, diluted to 100 mL with water • 1.0 mL of the solution + 5 mL of water into Headpace vial Class 2B solvents :
- 29. 19/06/2023 30 Experimental Parameters (GC System) • J&W DB-Select 624 UI for USP 467, 30 m, 0.32 mm, 1.80 µm (p/n 123-0334UI) Column 1 • J&W HP-INNOWax, 30 m, 0.32 mm, 0.25 µm (p/n 19091n-113I) Column 2 • Helium Carrier gas • 2 mL/min in constant flow on column 1, Column 2 flow controlled by column 1 Flow • 40 °C (hold 5 min) to 180 °C at 18 °C/min (hold 3 min) Oven • 140 °C Inlet Temp. • Split mode, split ratio 5 : 1 Mode • 250 °C FID (both Channels) • 400 mL/min Air • 30 mL/min H2 • 25 mL/min Makeup (N2)
- 30. 19/06/2023 31 Experimental Parameters (Headspace) • 1 mL Sample Loop • 85 °C Oven Temperature • 85 °C Loop Temperature • 100 °C Transfer line Temperature • 40 minutes Vial Equilibration • 0.5 minutes Injection Duration • 10 mL Vial Size • On, Level 2 (25 shakes/mL) Vial shaking • Default; Flow to pressure Vial Fill Mode • 15 psi Vial Fill Pressure • 20 psi/min Loop ramp rate • 0 psi Final Loop Pressure • 0.05 minutes Loop equilibration time
- 31. 19/06/2023 32 Headspace Parameters • Sample in volume (mL) Sample Loop • Oven temperature for vial equilibration Oven Temperature • Temperature of sample loop and valve Loop Temperature • Temperature of the transfer line (isothermal) Transfer line Temperature • Time for vial to equilibrate in the oven Vial Equilibration • Amount of time to sweep the sample loop vapors into the GC Injection Duration • Select the sample vial size for all vials using this method. Vial Size • Set the level of shaking for the sample during equilibration in the oven. (111 vial model only) Vial Shaking • Select how to pressurize the vial. Vial Fill Mode • Target sample vial final pressure. Vial Fill Pressure • How quickly to fill the sample loop. Loop ramp rate • Final target pressure for the filled sample loop Final Loop Pressure • Time set for the sample loop to stabilize after pressurization Loop Equilibration Time
- 32. 19/06/2023 33 Results (Class 1 Solvents) Column 1 (J&W DB-Select 624 UI, 30 m, 0.32 mm, 1.80 µm) Compound RT (mins) Area RSD (%) RT RSD (%) 1,1 - Dichloroethene 4.018 2.8 0.31 1,1,1 - Trichloroethane 7.590 3.7 1.4 Carbon Tetrachloride 7.781 2.9 0.060 Benzene 8.026 3.6 0.0050 1,2 - Dichloroethane 8.094 3.2 0.059 Column 2 (J&W HP-INNOWax, 30 m, 0.32 mm, 0.25 µm) Compound RT (mins) Area RSD (%) RT RSD (%) 1,1 – Dichloroethene 2.058 4.2 0.092 1,1,1 – Trichloroethane 2.952 3.61 0.057 Carbon Tetrachloride 2.952 Coelutes with 1,1,1 – Trichloroethane Benzene 3.734 4.9 0.021 1,2 – Dichloroethane 6.458 3.2 0.018 *Repeatability (n = 10)
- 33. 19/06/2023 34 Results (Class 2A Solvents) Column 1 (J&W DB-Select 624 UI, 30 m, 0.32 mm, 1.80 µm) Compound RT (mins) Area RSD (%) RT RSD (%) Methanol 2.665 1.9 0.36 Acetonitrile 4.608 1.6 0.078 Methylene chloride 4.882 3.8 0.029 Trans-1,2-Dichloroethane 5.384 4.9 0.031 Cis-1,2-Dichloroethane 6.935 4.3 0.0092 Column 2 (J&W HP-INNOWax, 30 m, 0.32 mm, 0.25 µm) Compound RT (mins) Area RSD (%) RT RSD (%) Methanol 3.222 2.0 0.41 Acetonitrile 5.039 2.4 0.034 Methylene chloride 3.585 4.1 0.034 Trans-1,2-Dichloroethane 2.759 4.5 0.039 Cis-1,2-Dichloroethane 4.760 4.3 0.039 *Repeatability (n = 10)
- 34. 19/06/2023 35 Results (Class 2A Solvents) Column 1 (J&W DB-Select 624 UI, 30 m, 0.32 mm, 1.80 µm) Compound RT (mins) Area RSD (%) RT RSD (%) Tetrahydrofuran 7.337 2.3 0.029 Cyclohexane 7.670 4.1 0.0091 Methylcyclohexane 9.051 4.5 0.0059 1.4-Dioxane 9.211 1.7 0.012 Toluene 10.183 4.4 0.0053 Chlorobenzene 11.621 4.1 0.0055 Ethylbenzene 11.714 4.4 0.0057 m-Xylene 11.842 4.4 0.0056 ρ-Xylene 11.842 Coelutes with m-Xylene o-Xylene 12.226 4.1 0.0054 Column 2 (J&W HP-INNOWax, 30 m, 0.32 mm, 0.25 µm) Compound RT (mins) Area RSD (%) RT RSD (%) Tetrahydrofuran 3.585 Coelutes with Methylene Chloride Cyclohexane 2.042 4.2 0.045 Methylcyclohexane 2.207 4.5 0.046 1.4-Dioxane 6.369 2.4 0.039 Toluene 6.859 4.3 0.034 Chlorobenzene 8.679 4.1 0.32 Ethylbenzene 7.398 4.5 0.04 m-Xylene 7.498 4.7 0.026 ρ-Xylene 7.609 4.4 0.016 o-Xylene 8.193 4.1 0.31 *Repeatability (n = 10)
- 35. 19/06/2023 36 Results (Class 2B Solvents) Column 1 (J&W DB-Select 624 UI, 30 m, 0.32 mm, 1.80 µm) Compound RT (mins) Area RSD (%) RT RSD (%) n-Hexane 5.859 1.5 0.052 Nitromethane 6.777 1.8 0.031 Choloform 7.392 4.4 0.0081 1,2-Dimethoxyethane 8.044 1.9 0.031 Trichloroethane 8.797 4.7 0.0061 Column 2 (J&W HP-INNOWax, 30 m, 0.32 mm, 0.25 µm) Compound RT (mins) Area RSD (%) RT RSD (%) n-Hexane 1.804 2.9 0,17 Nitromethane 7.586 1.8 0.014 Choloform 5.512 4.4 0.014 1,2-Dimethoxyethane 3.533 2.1 0.086 Trichloroethane 4.795 4.9 0.0019 *Repeatability (n = 10)
- 36. 19/06/2023 37 Results (Class 2B Solvents) Column 1 (J&W DB-Select 624 UI, 30 m, 0.32 mm, 1.80 µm) Compound RT (mins) Area RSD (%) RT RSD (%) Pirydine 10.168 3.3 0.015 2-Hexanone 10.852 2.8 0.0077 Tetralin 15.894 3.7 0.0052 Column 2 (J&W HP-INNOWax, 30 m, 0.32 mm, 0.25 µm) Compound RT (mins) Area RSD (%) RT RSD (%) Pirydine 8.679 3.2 0.085 2-Hexanone 6.732 2.8 0.015 Tetralin 12.123 3.7 0.085 *Repeatability (n = 10)
- 37. 19/06/2023 38 Conclusion • The 8890 GC System, equipped with a 7697A Headspace sampler and inert tee, provides an excellent method for separating, identifying, quantifying all residual solvents 1 • Beyond the expected coelutions, the peaks in all three classes are well resolved from each other, showing sufficient S/Ns and can be quantified repeatably 2 • The resulting RSD% values (area and RT) were less than 5.0%, indicating high repeatability and stability of the column, the 7697A Headspace sampler, and the 8890 GC/FID System. 3
- 38. 39
Editor's Notes
- Introducing the first GC today to take advantage of these legacy and new technologies, … the 8860 GC. The first thing you’ll notice is that the 8860 has been built from the ground up with architectures based on our 7890, 8890 and even Intuvo GC’s. Developed within the same project, 8860 shares the same oven and firmware architecture with the 8890 to help ensure common operability. The 8860 shares the same electronic architecture featuring a dual core processor which underpins intelligence capabilities. And the 8860 also shares 6th generation core EPC architecture with the 8890 and Intuvo providing greatly enhanced reliability and enhanced capabilities. Next, the 8860 features modern user interfaces, like the color touchscreen and a browser interface which provides a gateway to an extensive set of intelligence functions. So let’s look at this color touchscreen on the 8860. The home screen features flowpath information so you always know how the GC is configured. The next screen provides a listing of setpoints and actual values for different zones. You can turn zones on/off at the GC to initiate maintenance. The green bar along the bottom provides status information such as sequence, method and sample name as well as time elapsed in the run. Finally, there is a signal plot to let you know that the run is progressing smoothly. Now we’ll look at the browser interface, the gateway to advanced intelligence capabilities
- In making Agilent GCs smart and connected, we’ve developed a rich connected experience for the 8860 through an embedded browser interface. Connecting to the 8860 through your secure enterprise network, you can access the 8860’s homepage wherever you are. You might be in a meeting, or off-site, and need to know the status of your system or sample batch. The 8860’s browser interface can give you access to a host of information, including status, methods, sequences, maintenance, diagnostics and help
- The 8860’s browser user interface is very easy to learn and use. Accessed through a mobile devices like a tablet or on a laptop, through your secure enterprise network. This richer interface gives you deep access to the configuration and status of your system. It allows you to call up methods and adjust and save them as needed.
- The 8860 now features a 3rd detector that can be mounted on the top or side of the GC. For Environmental/Food, where GC detectors are still used, one can now have the common configuration of FID, ECD and FPD, covering a variety of analyses. For energy and chemical, having a 3rd detector as TCD mounted on the side, and now up to 3 valves total (gas or liquid sampling), gives the 8860 the ability to do a wide range of liquid and gas analyses.
- Introducing the new Agilent 8890 GC System. Our new top of the line GC, offering the most flexibility and expandability you need to future proof your lab for years to come.
- More about smart keys – Let’s discuss the new enhancements to the next flagship Agilent GC. One of the most obvious changes is the removal of the keypad and replacing it with a 7 inch capacitive touchscreen. From the local user interface you can access the enhanced diagnostics, chromatographic attributes, perform maintenance routines, and use the help function and user information. As with all the new Agilent GCs, Intuvo, 8860 and 8890 we have the browser user interface which is served up from the GC to a PC, Tablet or mobile device. An advancement that was leveraged from Intuvo are the column smart keys. These are not tethered to the column cage due to the possibility of creating a hot spot on the column if it touched and and no way to get the tether safely out of the oven. Some other new product designs are the traffic light on the top right shown in green, this gives a visual status at a distance of the state of the GC. The power switch also has an LED and the oven door latch was redesigned.
- Another Intuvo enhancement that the 8860 and 8890 have are the 6th generation EPC modules. These are a microchannel designed EPC which will lead to less clogging. This design will lead to a significant reduction of EPC failures. Now there is expanded capabilities of 8 EPC modules in a bookshelf configuration, up from 6 EPC’s. The new EPC’s also allow for autonomous leak checking on the 8890 without having to remove connections or block off certain flows. The autonomous leak checking will be discussed on depth later on the presentation. Further enhancements have been made to the atmospheric detectors. On the top of the GC oven there is the ability to add a third detector which can be a TCD or FPD. However putting a third detector on top does not allow for the large valve oven. Maintaining the left side carrier in the design allows for a third or fourth detector. The expanded capabilities include a FID and NPD along with the ECD And TCD that could be configured on the 7890. And finally the 8890 increases the heated zones from six to eight heated zones allowing for more advanced configurations.
- If you have seen the new Agilent Smart GCs, the first thing you would have noticed is that the user interface is changing. The keypad that you see is from our 7890B GC system and these keypads have identified an Agilent (or HP) GC system since the 5890 days. The new touchscreens [click] are visibly different. The touchscreen allows much more of the intelligence inside our Smart GCs to be front and center and at your fingertips.
- Residual Solvent : Bahan kimia organik yang volatil (mudah menguap), yang digunakan atau dihasilkan dalam pembuatan bahan obat atau bahan pengisi atau dalam pembuatan produk obat. Tidak ada manfaat terapeutik dari sisa pelarut Produk obat tidak boleh mengandung tingkat yang lebih tinggi daripada yang dapat didukung oleh data keamanan dan dapat diterima oleh pasien.
- Karsinogen manusia yang diketahui, sangat dicurigai sebagai karsinogen bagi manusia, pelarut yang secara khusus diketahui memiliki sifat perusak ozon Karsinogen hewan Non Genotoksik atau agen penyebab yang mungkin dari toksisitas ireversibel lainnya, seperti neurotoksisitas atau teratogenisitas Neurotoksisitas adalah kapasitas agen kimia yang dapat menimbulkan efek merugikan bagi sistem saraf. Teratogenik berarti perkembangan tidak normal dari sel selama kehamilan yang menyebabkan kerusakan pada embrio. Pelarut dengan potensi toksik rendah bagi manusia, diperlukan batas pemaparan tanpa dasar kesehatan
- saluran masuk split / splitless (SSL) FID ganda pengambilan sampel dilakukan dengan menggunakan headspace sampler Agilent 7697A Tee inert digunakan untuk membagi aliran secara merata antara dua kolom
- Coellutes : Proses dimana dua atau lebih senyawa kimia terelusi dari kolom kromatografi pada saat yang bersamaan, membuat pemisahan dan identifikasi menjadi sulit.
- Proses dimana dua atau lebih senyawa kimia terelusi dari kolom kromatografi pada saat yang bersamaan, membuat pemisahan dan identifikasi menjadi sulit. Sistem 8890 GC, dilengkapi dengan 7697A Headspace sampler dan tee inert, memberikan metode yang sangat baik untuk memisahkan, mengidentifikasi, mengukur semua pelarut sisa. Di luar koelusi yang diharapkan, puncak di ketiga kelas diselesaikan dengan baik satu sama lain, menunjukkan S / N yang cukup dan dapat diukur secara berulang. Nilai RSD% (luas dan RT) yang dihasilkan kurang dari 5,0%, menunjukkan pengulangan dan stabilitas kolom yang tinggi, sampel Headspace 7697A, dan Sistem 8890 GC / FID.