PTWS 820D USP/EP Tablet Dissolution Testing Instrument. Hardware Features User Interface Automation Capabilities Serviceability

Transcription

1 PTWS 820D USP/EP Tablet Dissolution Testing Instrument Hardware Features User Interface Automation Capabilities Serviceability 1

2 PTWS 820D A New Design and Quality Concept What is the PTWS 820D? PTWS 820D is the first instrument from Pharma Test s next generation line of tablet dissolution testing instruments. It is an 8 position, single drive compact tablet dissolution testing instruments for solid dosage forms as described in USP chapter <711/724> and EP section <2.9.3/4>. It is operated using a large colour touch screen. Friday, October 31,

3 PTWS 820D Hardware Features What Kind of Stirring Tools Does PTWS 820D Use? PTWS 820D uses the Pharma Test MonoShaft system. The tools consist of a main shaft and interchangeable tool heads (adapters). The main shaft can remain in place regardless of what tool is to be used. Clearance between tool and vessel bottom will always be correct once the immersion depth has been qualified once with any tool head. PTWS 820D supports staggered start and sampling for each testing position. Friday, October 31,

4 About Staggered Start and Sampling What Does Staggered Start and Sampling Mean? Staggered start and sampling means that the stirring will only start when the tablet is already inside the vessel and down at centre of the spherical bottom. If the stirrers start earlier, the tablet may start to flow and rotate, which will change the dissolving rate. Staggered start and sampling instruments allow to start each stirring position individually. This means, the user can drop the 1 st tablet and when it is down in the vessel, he starts the 1 st stirrer. Now he waits for seconds before starting the 2 nd stirrer, as this is the time he will need to withdraw a sample and refill the media manually. This process is repeated until all samples are inside the vessels. Parallel start is possible for all automated dissolution systems, which are connected to a fraction collector, auto sampler or spectrophotometer with a multiple cell changer. This systems always drop and withdraw all samples at the same time. Friday, October 31,

5 PTWS 820D Hardware Features What Kind of Lift Mechanism does PTWS 820D Use? PTWS 820D features a motorized and electronically controlled lift system. The lift mechanism is centrally located above the water bath to offer ideal access to every dissolution vessel and to ensure that the tool shafts are always kept parallel at a 90 angle to the vessel walls when in working position. 8 Lift positions can be freely programmed and stored on the instrument depending on the type of stirring tool used. A protocol printer can be connected as an option. Friday, October 31,

6 PTWS 820D Hardware Features PTWS 820D Makes Optimal Use of Your Available Bench Space! The flexible design of PTWS 820D makes it possible to setup the instrument either in a 2x4 or 4x2 orientation. The display module can be installed in two corresponding positions on the instrument head. Friday, October 31,

7 PTWS 820D Hardware Features Fully Encased EPE-820 Sampling Manifold Design The new EPE-820 auto-sampling manifold with an encased design removes all tubing lines from the working area. The connectors for the connection of the external pump are collected on the backside of the instrument s head. Friday, October 31,

8 PTWS 820D Hardware Features Fully Encased EPE-820 Sampling Manifold Design The EPE-820 is automatically driven into the programmed sampling position at the interval times. The probes remain in the dissolution medium only during the sampling times. The new sampling probe design combines the sampling and back flush probes into one probe with an inner and an outer tube, thereby reducing the number tubes inside the veessel and the number of holes required in the tablet magazine to help prevent evaporation. The optional media replacement is done through a second tube. Outer Tube ITM Temperature Sensor Inner Tube Friday, October 31,

9 PTWS 820D Hardware Features ITM-820 Media Temperature Monitoring System The ITM is attached to the EPE Auto Sampling System and used to monitor and record the media temperature of each one of the dissolution vessels inside of the PTWS 820D. The measuring probe is moved into the dissolution vessels always when a sample has to be removed. With a delay of about 3 seconds it starts to record the media temperature. The results is either transferred to an external unit, or printed in the run time log. ITM Temperature Sensor Friday, October 31,

10 PTWS 820D Hardware Features Re-Designed TM-820 Tablet Magazine The re-designed manual TM-820 or automated TMA-820 tablet magazine features integrated convex vessel covers. The convex shape causes condensed medium to drop back into the dissolution vessel. This grants greater media volume precision. The integrated covers seal the vessel thereby reducing any evaporation significantly. Friday, October 31,

11 PTWS 820D Hardware Features Re-Designed TM-820 Tablet Magazine The TM-820/TMA-820 tablet magazine is held by flexible metal strings to elimate any risk of jamming during the lift movements. Friday, October 31,

12 PTWS 820D Hardware Features Quick and Easy Tubing Cleaning System The TM-820/TMA-820 tablet magazine features a cleaning system for the tubing lines of an automated system. Magnets are integrated into the magazine plate and small beakers containing a cleaning fluid can be attached to them. This way the whole system can easily be flushed using the EPE-820 and the connected pump. Friday, October 31,

13 PTWS 820D Hardware Features PTWS 820D Features Individual Vessel Centring! Every dissolution vessel in the PTWS 820D can be centred individually by 3 points and safely secured by self-tightening screws. Vessels are held in position in the instrument support framework by 3 adjustable positioners. Vessel centricity is an important factor for a successful performance qualification (PQ)! Friday, October 31,

14 PTWS 820D Hardware Features PTWS 820D Features External Heating System! To reduce vibration transfer the heating system is placed inside a separate box, while the pump is mounted to a spring loaded platform. Temperature is controlled by a digital sensor, system safety is provided by a flow sensor, a thermo switch and a thermo fuse. The new 1500 W heating tube offers ultra fast heating of the bath and media inside the vessels. This reduces the total testing time of a tablet dissolution run drastically. Friday, October 31,

15 PTWS 820D Hardware Features PTWS 820D Features High End Precision! Solid and precise design of each mechanical part built into the instrument stays for long term reliability Individual vessel position marking, individual batch coding of all tool items, eases the assembling of important testing tools Long instrument life, availability of spare parts, easy to maintain, user friendly design secures the investment We call it THE GERMAN GRÜNDLICHKEIT Friday, October 31,

16 PTWS 820D User Interface Colour Touch Screen Interface Method Management Access Control OQ Features Friday, October 31,

17 PTWS 820D User Interface PTWS 820D Features a Large Colour Touch Screen! PTWS 820D features a completely new set of control electronics using CAN bus technology. CAN bus (for controller area network) is a standard designed to allow microcontrollers and devices to communicate with each other within an instrument without a host computer. The instrument is controlled by means of a large, color LCD touch screen. The touch screen uses resistive technology; therefore it is easy to be used as it responds to pressure, no problem of use even when wearing laboratory gloves, for example. The user data is stored on a SD card and can be copied to a PC for backup or to be transferred to another instrument. This way, all information like test methods can be copied from one instrument to another. Friday, October 31,

18 PTWS 820D User Interface The PTWS 820D User Interface is Easy to Use! A dissolution run is fully described including stirrer speed, temperature, sampling position, duration etc. This becomes a method The number of methods to be stored on the SD card is practically unlimited PTWS 820D features an easy and convenient user administration system including access rights information Four user groups to operate the instrument can freely be edited (user name, password, user rights) Additional user menu exist for administration and service personnel Friday, October 31,

19 PTWS 820D User Interface The PTWS 820D User Interface is Easy to Use! The lift and sampling positions can be freely programmed Eight different working positions (stirrer immersion position) can be saved The positions can be labelled for easy identification during method creation If the instrument is equipped with the EPE-820 automated sampling manifold, 8 sampling positions inside the media vessels can be programmed in the same manner Friday, October 31,

20 PTWS 820D User Interface Test Menu The Method Creation System is Very Flexible! The test menu of PTWS 820D is designed to be easy to use and to offer the user as much information as possible at a glance During the course of a test run the user is guided through every step by on-screen commands Once a test is running, the instrument switches into a Operator Information mode, displaying critical information in a large font, so that the user can stay informed even when he is moving away from the instrument Friday, October 31,

21 PTWS 820D User Interface Test Menu The Method Creation System is Very Flexible! It is also possible to perform a QUICK TEST directly from the start screen without the need of creating any methods or logging on to the instrument beforehand (this function can be disabled by the administrator) Another possibility is to control the major functions of the instrument (bath temperature, stirrers and lift) directly through the user menu making the PTWS 820D one of the most flexible instruments on the market. Friday, October 31,

22 PTWS 820D User Interface Method Creation The Method Creation System is Very Flexible! A method stores all parameters for a dissolution test (stirring speed, target temperature, lift and sampling positions, sampling intervals). Just 10 steps to create a new testing method. It is possible to create up to 10 different interval groups, which each can be repeated up to 999 times. Each interval includes the sampling time (hours & minutes) and how often it should be repeated. Maximum time for 1 interval is 999 hrs. 59 min., this can be repeated maximum 999 times for one interval sequence. 10 of those sequences can be programmed. Friday, October 31,

23 PTWS 820D User Interface Method Creation The Method Creation System is Very Flexible! An Infinity Test with a separate setting for stirrer speed and temperature can also be programmed in the method to be performed after the end of the regular test run. This parameter is often used during method validation, an additional sampling point (often 30 minutes after the last regular time point) and maximum stirring speed (usually 250 rpm) and if required a higher temperature are programmed to test if maximum drug release was obtained. It is possible to enter a maximum running time to stop stirring and drive the head lift if this is required. Friday, October 31,

24 PTWS 820D User Interface User Administration The User Administration is Simple and Effective! It is possible to establish a total of 4 user groups. Access is grated by selecting the button with the name of the group and entering the password. Only the system administrator can program the groups and their access mode. Users can run a test using an existing method. Qualification and validation of the instrument can be done by a service user. Friday, October 31,

25 PTWS 820D User Interface Active Test Information Important Operator Information Screens From the main menu select the task which needs to be started Colored information bars display if any setting is not within the established limits A status line and a run time clock inform the operator when his action is required or the next test step will be performed automatically Friday, October 31,

26 PTWS 820D Automation Capabilities Offline and Online Automation Pump Technologies Software Package 26

27 Dissolution Automation Why Think About Automating Your Tablet Dissolution Testing? Dissolution testing is probably the most time and human resource consuming test in a pharmaceutical company: instrument and media preparation, sample introduction, sampling, data evaluation, and cleaning are steps which have to be done by the operator. In manual operation usually the user has to be present at the instrument in order to take the samples within a narrow time frame with just +/- 2% of tolerance. This means if he has, for example, to remove a sample every 5 minutes, he should not be more than 6 seconds early or late. Testing sustained release tablets which may take 6 hours, 8 hours or up to several days (transdermal patches) is usually impossible to handle with manually operated equipment. Friday, October 31,

28 Dissolution Automation Advantages Dissolution Automation Offers Many Advantages to the User! Increased quality of results due to higher reproducibility (by reduction of human errors) Possibility of un-attended operation Flexibility to select analytical method Online sample preparation Faster information Easier documentation Friday, October 31,

29 Dissolution Automation DFC Systems What is an Offline Automated System? An offline automated dissolution system includes a dissolution bath, a pump and a fraction collector. Friday, October 31,

30 Dissolution Automation DFC Systems What is an Offline Automated System? In such a system the sample volume is pumped from the dissolution vessels and collected in vials inside a fraction collector for later analysis. Pharma Test offers different types of pump technologies as well as fraction collectors offering extended media handling features like dilution and sampling directly into HPLC vials. Pharma Test offers these systems under the category name DFC. Friday, October 31,

31 Dissolution Automation ADS Systems What is a Closed Loop System? A closed loop or online dissolution system includes a dissolution bath, a pump and a spectrophotometer with a multiple cell changer. Pump 1 Runtime Demo Bath 1 Runtime JM SA500 Spectrophotometer 4567 Friday, October 31,

32 Dissolution Automation ADS Systems What is a Closed Loop System? In such a system the sample volume is pumped in a closed loop between the dissolution vessel and the flow-cells inside a spectrophotometer and then returned back into the dissolution vessels. Each vessel has its own loop. There is no cross contamination and no carry over. Furthermore, in these system there is no media loss during the run and there is no need for dissolution media replacement Pharma Test offers these systems under the category name ADS. Friday, October 31,

33 PTWS 820D ideal for Dissolution Automation The PTWS 820D is Ideally Suited for Dissolution Automation! Automated lift drive to move the instrument head into the working position and upwards once a test is completed: Friday, October 31,

34 PTWS 820D ideal for Dissolution Automation The Pharma Test PTWS Series is Ideally Suited for Dissolution Automation! TM manual or automated tablet drop magazine to ensure: Synchronous sample introduction Sealed close up of all vessels Attachable tube cleaning device Friday, October 31,

35 PTWS 820D ideal for Dissolution Automation The Pharma Test PTWS Series is Ideally Suited for Dissolution Automation! EPE automated sampling manifold to ensure: Synchronous withdrawal of all samples Sampling position in compliance with USP/EP/FDA requirements and media volume Identical position for each sampling point The sampling probes are inside the dissolution medium only at the time of sampling Friday, October 31,

36 PTWS 820D ideal for Dissolution Automation The Pharma Test PTWS Series is Ideally Suited for Dissolution Automation! ITM individual media temperature monitoring and reporting system: Synchronous media temperature measurement Bath and Media temperature monitoring Printed report for system validation Friday, October 31,

37 PTWS 820D ideal for Dissolution Automation The Pharma Test PTWS Series is Ideally Suited for Dissolution Automation! Encased Tubing System: No tubing within the operating area Reduced risk of tube clocking and damaging Labelled quick tube connection ports Friday, October 31,

38 PT-SP Multi-Syringe Pump Features The PT-SP Multi-Syringe Pump Offers Highly Precise Dissolution Sampling! The PT-SP multi-syringe pump is available equipped with either 8 or 6 high precision glass syringes It is possible to link multiple PT-SP pumps together in case more sampling lines are required or for auto media refilling Syringe pumps offer the highest precision for dissolution sampling! Friday, October 31,

39 Peristaltic Pump Features Peristaltic Pumps Offer the Most Cost Effective Way of Transporting Media in a Dissolution System! When using a spectrophotometer with a flow through cell in an ADS dissolution system, the accuracy provided by a peristaltic pump is perfectly adequate for the application. For offline applications the suitability of peristaltic pumps depends on the number of sampling cycles and the quality of the pump tubing. Friday, October 31,

40 DSR-M Features The DSR-M is a Highly Integrated Solution of Offline Dissolution Testing Systems! The DSR-M features an integrated high precision piston pump module. The flexible, modular design allows auto media refilling, dilution and transfer into HPLC vials for six to twelve station dissolution baths. The new CAT-MRM module eliminates the need for separate refilling tubing lines. Using the optional MFC-12 filter changer, 0.45 micron round filter can be exchanged easily and quickly between runs. Friday, October 31,

41 PTFC-2/8 Features The PTFC-2/8 is a Proven and Cost Effective Fraction Collector for Offline Systems The PTFC fraction collector is easy to use and can either be controlled by the Pharma Test dissolution bath or be directly programmed on the instrument. Auto media refilling is possible as well by using the optional E-VEN pinch valve system or an additional syringe pump. The PTFC now features 8 (PTFC-2/8) or 16 (PTFC-16) positions for 20 (10 in case of PTFC-16) sampling cycles. Friday, October 31,

42 T70 UV/VIS Spectrophotometer The T70 UV/VIS Spectrophotometer Comes Complete with an 8-Cell Changer! The T70 split-beam UV/VIS spectrophotometer offers a wavelength range of nm and is delivered with a built-in 8-cell changer as standard. It is therefore very well suited for use in an ADS fully automated online dissolution testing system. The large cell changer compartment is fully enclosed but still offers easy access. Thanks to the cell holder design, all of the installed UV cells are always reproducibly positioned in the light path. Friday, October 31,

43 ADS Systems Size of Cuvette When Should a 1, 2, 5 or 10mm Cuvette be Used? If the concentration and the absorbance of the solution is too high for a measurement with a spectrophotometer it is possible to either dilute the sample using a DSR-M Sampling System or to use a smaller path length for the flow through cuvette. Using a 1 mm path length flow cell instead of a 10 mm one equals a dilution factor of 1 : 10 Friday, October 31,

44 ADS Systems Size of Cuvette Law of Lambert Beer: A = e b c Where A is absorbance, e is the extinction coefficient (the molar absorptivity with units of L mol - 1 cm -1 ), b is the path length of the sample (that is, the path length of the cuvette in which the sample is contained) and c is the concentration of the compound in solution (expressed in mol L -1 ). Most of the spectrophotometers have an absorbance measurement limit of ~1.2. If you take a look on the equation the only possibility to change the absorbance is to change b (the path length) or c (concentration by dilution) because e is a constant. Friday, October 31,

45 WinDiss ARGUS WinDiss ARGUS is a Revolutionary Scientific Dissolution Data Management Software! WinDiss ARGUS is a tool for instrument control and advanced data acquisition, management, processing and reporting designed by users for users. Whether you perform dissolution tests occasionally or several times each day WinDiss ARGUS will make you more productive in running tests and analyzing results. Intuitive wizards help anyone in your lab work better your next dissolution test is running in just a few clicks. WinDiss ARGUS allows you to multi-task without using multiple software packages. Friday, October 31,

46 WinDiss ARGUS 21 CFR Part 11 WinDiss ARGUS Offers Full 21 CFR Part 11 Compliance! Systems which are software controlled have to be validated, specifically the software has to meet the following USP/FDA 21 CFR Part 11 guidelines: Software hierarchy Electronic signature Password administration Audit trail Electronic records must be protected against corruption from outside immediate results Friday, October 31,

47 PTWS 820D Serviceability Hardware Features OQ Programs Trouble Shooting Data Loss Prevention Friday, October 31,

48 PTWS 820D Serviceability Build Quality Interior Build Quality Inner values which count! Use of high quality materials and bearings also on the inside. Instrument head rests on a solid metal support plate. CAN bus technology to connect all indivdual electronical components Friday, October 31,

49 PTWS 820D Serviceability Heating Safety Heating System Safety Measures Four-way overheating protection measures: 1. Digital safety temperature sensor 2. Digital flow sensor 3. Mechanical temperature protection switch 4. Mechanical temperature protection fuse Friday, October 31,

50 PTWS 820D Serviceability OQ Features PTWS 820D Features Integrated OQ Programs The integrated qualification programs assist during regular operation qualification (OQ) and maintenance tasks. Red buttons indicate that this particular OQ interval has elapsed and that the OQ should be performed. The interval can be adjusted during instrument installation. Each of these programs guides the user with on-screen commands through the qualification process. All results are either automatically determined by the instrument or can be entered by the user. Each test concludes with a full report. Friday, October 31,

51 PTWS 820D Serviceability Data Loss Prevention The PTWS 820D Data Storage Concept Makes Backing Up and Restoring Data Simple and Efficient! PTWS 820D stores user and machine data on two separate SD flash memory cards. The user SD card stores for example testing methods and these can be copied to a standard PC for backup and to transfer those to another dissolution bath. Machine configuration data is stored on a micro SD card on the CPU board inside the instrument. In case the CPU board has to be replaced, all configuration data can be restored from this micro SD card. It is possible to perform firmware updates simply by coping the firmware file onto the user SD card and inserting it into the instrument. The instrument will recognize the new firmware and automatically update the individual board. No external programmer or PC connection is required. Friday, October 31,

52 Trouble Shooting PTWS 820D Serviceability Trouble Shooting During each start up sequence the instrument will check itself for errors. All electronics board inside the instrument are connected by a CAN bus system. This enables the instrument to generate detailed status reports about each board and peripheries like for example temperature sensors. In case any errors are detected they will be displayed and an error report can be saved on the user SD card. This report can be ed by the user to a service technician. This way many errors can be diagnosed prior to a service visit at a customer site. The user can choose to ignore uncritical errors but a copy of the error log is always saved to the machine SD card, to help give service technicians a complete picture of the instrument. Friday, October 31,

53 PTWS 820D USP/EP Tablet Dissolution Testing Instrument Rigid, reliable, robust mechanical design State of the art electronics User friendly design Precision and long term support = GERMAN GRÜNDLICHKEIT 53