Your challenge Who we are Generate reliable test results within the shortest possible time ERWEKA – A visionary and experienced partner for the pharmaceutical industry As a long-standing partner of the pharmaceutical industry we are fully aware of the challenges inherent in the dissolution test proce-Erweka is one of the leading international manufacturers of premium dure. Test results have to be reliable, reproducible and document-test equipment for development and quality control of pharmaceu-ed fully and comprehensively. At the same time laboratory staff tical solid dosage forms. For more than 65 years we have supplied is faced with enormous time constraints, in view of ever shorter our products to major pharmaceutical and life science companies, production cycles and the need to release batches in increasingly development and test laboratories and pharmaceutical-techni-shorter time. cal universities worldwide. Our vast product portfolio ranges from physical testers to dissolution testers in accordance with USP 1, 2, Although traditional semi-automatic dissolution testers provide 3, 4, 5, 6 and 7, and our experience in this sector is second to none. some improvement for these test procedures, demands on time We are committed to a philosophy of continuous innovation, which and human resources are still enormous. In addition, the human in-spurns us on to ever new achievements in the development of our fluence on the process is high – which may result in time-consum-products – with a continuous focus on automation. ing and costly errors. Our vision: A fully automated dissolution test system designed to supply highly reliable results and ac-celerate the test process several times over. 2 3 Your challenge Who we are Our innovation - RoboDis II RoboDis II – the only parallel-working, fully automated dissolution tester on the market RoboDis II is the only parallel-working, fully automated dissolution test system currently on the market. All stages of the dissolution processes are computer-controlled and therefore carried out entirely without user intervention. The key element of the fully automatic system is the Disso.NET software developed by ERWEKA, which handles all system functions, including the precise movement of the robot arm, control of the analytic devices, data processing and full documentation. In the standard configuration, RoboDis II tests up to 10 batches in accordance with USP methods 1 (Basket) or 2 (Paddle). The parallel sampling approach enables very short cycle times for recording of detailed drug release profiles to be selected by the user. Integrated System Suitability Tests (SST) and video monitoring ensure a high degree of reliability. Like all ERWEKA products, RoboDis II is fully USP/EP/JP compliant. - RoboDis II is therefore the answer to all challenges of dissolu-Robo tion testing: a eparation with Highly accurate and reliable testing: Im-save proves drug safety. can you e than 2x1m. Results space Accelerated testing: Avoids bottlenecks in floor Width 1.80 m/Height 2.30 m the batch release process.. eat of oductivity of a single RoboDis II 10-batch system with conventional semi-automatic systems:10+ m amount the Automatic execution of repetitive tasks: Re-is duces operator fatigue, enabling operators to focus on higher-value tasks. . this - ed to achieve the pr equir cleaning Long-term cost reduction: RoboDis II will pay back for itself within a short term. . ee complete semi-automatic dissolution testers including media pr vessel Small Footprint, Gr Thr and Dis II 10-batch system, which has a footprint of no mor Laboratory space r 4 5 Our Innovation Small footprint, great results A flexible specialist RoboDis II in R&D Multiple dosage forms Various options for connecting to analytic devices RoboDis II is capable of handling pharmaceuticals in a variety of differ-RobDis II features fully automated, integrated online analytics, offering a ent dosage forms. Regardless of whether your laboratory handles tablets, broad spectrum of capabilities ranging from simple spectrophotography with granulates or powders - RoboDis II is the ideal, highly flexible and full au-a UV/Vis device to complex HPLC chromatography, or a combination of both. tomated dissolution system for your requirements. Even sinkers up to 34 mm are supported. Six reference standards Flexible filtering options Central to the development were flexible reference standards for rapid test-There are virtually no limits for filtering with RoboDis II – the system sup-out of a variety of different formulations – no problem for RoboDis II and its ports Poroplast inline filters, membrane filters and even double filtration. integrated media preparation features. pH change: half change and optional full change RoboDis II provides fully automatic pH change (half-change and optional full change) - simply configure your method with our powerful Disso.NET software and start the test - RoboDis II will handle all further steps. 6 7 RoboDis II in R&D Boost Your Productivity RoboDis II for quality control Productivity to suit your requirements with 10, 20 or 40 Robotic precision & fault monitoring batches Each step of the RoboDis II test procedure is fully automated and is verified RoboDis II’s productivity can be conveniently scheduled well in advance, automatically by the software – this means that RoboDis II always performs independent of staff working hours. Equipped with 40 batches, RoboDis II test procedures in exactly the same way, thereby eliminating the human can run, for example through an entire weekend, and have the results ready factor. RoboDis II offers maximum reliability and frees your laboratory staff for evaluation by your laboratory staff on the following weekday. Video refor more challenging tasks - such as the analysis of the data obtained. cording enables laboratory staff to go back to any desired point of the test for visual inspection and verification. Space-saving footprint High sample volumes - 40 batches Achieving the productivity of a RoboDis II system with other, semi-automatic systems would require four times more space (for a 10-batch sys-Testing non-stop – there is nothing that RoboDis II can do better. The tem). 40-batch option enables a rate of testing commonly achieved only by em-ploying multiple semi-automatic systems, requiring much more laboratory space and more laboratory staff. Parallel action RoboDis II is a parallel-acting system - the medium for the subsequent test is prepared even while the current test run is in progress. In addition, extremely short cycles can be achieved, e.g. by sampling after only 5 mi-nutes. Needless to say all this happens fully automatically. 8 9 RoboDis II for quality control RoboDis II features 40-batch filter magazine Built-in media prepa- ration The 40-batch option with re- volving magazines comes with a The built-in media preparation 40-batch filter holder. These Po- feature fully automatically pre- Sample magazine for roplast filters are mounted and pares the medium for the testing 10, 20 or 40 batches dismounted fully automatically for procedures. Media preparation is each test by the robot arm. configured through the Disso.NET In the 40-batch version, RoboDis software, with RoboDis II taking II enables true 24/7 testing and care of all other steps. is capable of handling 40 batches without human intervention. Seven test vessels Precise piston pump Seven USP-compliant test vessels The highly precise piston pump A high-precision ro- in the RoboDis II system support with ceramic heads is virtually bot arm testing in R&E and in quality con-maintenance free and ideally suit-trol. In quality control, for exam-ed to the high sample volumes A Festo pneumatic robot arm ple, six samples may be compared handled by RoboDis II. takes care of all repetitive tasks to a reference sample. Alternative-within the RoboDis II system: ly, seven different samples can be Placement and removal of all tested in parallel for Research & De-sample containers and filters, filling with medium, sample velopment. withdrawal, basket (dis)mount- ing and cleaning of the vessels. Online UV-Vis analysis or HPLC Integrated controller with Disso.NET RobDis II supports integrated on- line UV-Vis or HPLC analytic de- Control of all RoboDis II functions is vices. Samples are withdrawn fully provided by an industrial controller automatically and transferred to the with integrated Disso.NET software analytics devices. through the local RoboDis II net- work. All integrated devices, such as analytic devices, video cameras or sample magazines are linked through a high-speed Gibabit Ethernet network. Use of paddles and baskets Japanes sinkers and sinkers up to 34 mm pH changes RoboDis II supports the use of RoboDis II supports the use of both paddles (USP 2) and baskets sinkers to max. size of 34 mm. Optional pH measurement per- (USP 1), both of which can be ex- Dropping and removal of sinkers mits pH changes according to changed by the user (guided with take place fully automatically with USP Method A (half change) Disso.NET). the sinker tool provided. and Method B (full change). 10 11 RoboDis II features RoboDis II features Disso. NET The key element in the RoboDis II test system RoboDis II is controlled fully automatically by its integral controller Highlights equipped with the Disso.NET software. Designed by ERWEKA spe-RoboDis II performs routine cially for the purpose, the Disso.NET-Software constitutes the key Complete audit tasks more precisely than any System Suitability Tests (SST) element of the RoboDis II system: trail according to human operator – but without a 21 CFR Part 11 In each individual process step, RoboDis II self-checks by means human operator all its powerful A user-friendly editor enables the required dissolution test meth-of integrated System Suitability Tests (SSTs). Several built-in light fully automatic features would barriers validate the steps performed by Robo Dis II, thus prevent-ods to be defined and started. Disso.NET then manages all steps be worth nothing. It is the hu-ing false starts. of the dissolution process from media preparation through to anal-Video support man operator who defines the ysis. The software also controls the precise movement of the robot test methods, checks results for arm and the connected analytical devices. Disso.NET logs all test plausibility and interprets the results and times, and automatically creates an audit trail. Upon Support of USP data obtained. To enable him or Complete documentation completion of the test, the software generates extensive reports methods 1 & 2 her to focus on these tasks, we and enables export of all test results. In addition, the software con-have equipped RoboDis II with Each step of the test is logged in accordance with the industrial trols the System Suitability Tests and the video recording functions. a number of safety features. standard 21 CFR Part 11. This will enable you to check, for exam-reliable ple, whether RoboDis II actually did test all 40 batches completely Highlights MS SQL database e over the weekend ■ Comprehensive management of users, methods and reports ■ Multi-user support including allocation of different user roles Advanced report High-quality system components (user, senior operator, administrator) generation ■ Awarding of different user rights to users and administrators , but mor RoboDis II is built with tried-and-tested, reliable system components, amongst them, e.g., ERWEKA’s maintenance-free PVP ■ Complete audit trail in accordance with 21 CFR Part 11 includ-pump and the robot arm made by the internationally renowned ing date, time stamp and user ID pneumatics manufacturer Festo. The use of premium components guarantees maximum precision and lowest downtimes. ■ MS SQL database - Reliable backup and storage features ■ Extended reporting features in various formats (xml, xls, pdf, pdf-A) including export function Video recording Not smarter RoboDis II optionally records the entire dissolution process ■ Connectivity to LIMS possible with six integrated video cameras. This allows validating the entire test upon completion, or overlaying the dissolution curve on a time-lapse video recording. Thanks to the LED light strip the water bath can be illuminated at night, allowing 24 hour video recording without the need for external lighting. 12 13 Not smarter, but more reliable Disso.NET Premium Service for a premium product Our aim is to serve you right from the point when you express an interest in purchasing our RoboDIS II system: Together we will anal-yse your real requirements, select the fitting components and then build the system exactly to your specifications. This means that ev-ery RoboDis II is a purpose-built, fully automated system. Following installation of the system, we will develop a customized service strategy geared towards our four service objectives: main-taining durability, ensuring measuring accuracy, providing highly responsive customer support, and, above all, ensuring that users are optimally trained in the use of the system. Based on the jointly developed service schedule, service costs will be predictable and consistent. RoboDis II is a premium product for which we provide premium preventive maintenance service. All service requests will be given top priority by us. References Our ERWEKA service commit- ment: Maintaining durability If you would like to talk to RoboDIS II users to find out how the ■ Fast response times system is integrated into their laboratory environment, simply call us: We will be happy to provide you with a contact! ■ Speedy expert service ■ Installation by two RoboDis II specialists covering a ■ Service bases all over the period of one week world ■ Preventive Maintenance by RoboDis II specialists at ■ Unique manufacturer know- 6-monthly intervals Please feel free to contact us: how ■ Inspection by RoboDis II specialists at 6-month intervals +49 6104 6903-0 ■ ERWEKA-certified service staff ■ Full availability of spare parts Ensuring measuring accuracy ■ Customized service strategy ■ Installation Qualification (IQ) ■ Operation Qualification (OQ) ■ Automation Verification Test for dissolution systems (AVT) Highly responsive support ■ 24 h RoboDis response hotline ■ Your direct service contact ■ Immediate repair service 14 15 Premium Service References The Facts Paddle, baskets and sinkers Tablet handling (baskets) ■ Tablet holders / baskets ■ Mounting & dismounting of baskets by robot arm ■ Handling of 10 (optionally up to 40) batches per robot ■ Used baskets are automatically dropped in cleaning start container ■ Vessels / baskets easily accessible in the cabinet door ■ No negative influence of temperature or humidity ■ Handling of tablets, granulate and pellets ■ Supports handling of sinkers measuring up to 34mm Automatic basket handling 40 batches tablet holder Basic sampling system Media & media preparation ■ USP-compliant sampling station with Poroplast inline filters ■ Automatic media preparation and supply ■ Temperature measurement in each vessel ■ Mobile tank for 120 litres of medium with optional stirrer ■ Parallel sampling with valve-free ceramic piston pump ■ Supports up to 6 (SUPAC) different media or media PVP, virtually maintenance-free concentrates per start ■ Closed-loop sampling system ■ Preheating and vacuum degassing in accordance with USP guidelines ■ Dosing with gravimetrically controlled precise piston Poroplast filter handling pump ■ Parallel preparation of the next medium during the dissolution test run ■ Supports handling of foaming media Advanced sampling system Up to 6 different calibration standards ■ USP-compliant sampling station with Poroplast inline filters (pre-filtering) ■ Additional filtration with membrane filters with AFC 825 filter changer Tablet handling (with paddles) ■ Parallel tablet drop ■ Handling of sinkers up to 34 mm, handling of japanese sinkers ■ High accuracy and reliability of process steps ■ Supports pellets and granulates Handling of japanese sinkers, paral el tablet drop 16 17 The Facts The Facts The Facts pH change 24/7 testing ■ pH change in accordance with USP method A (half ■ LED light strip illuminates water bath and allows use of change) and USP method B (full change) new video capturing capabilities without the need for ■ Handling of pH sensor by robot arm external lights ■ Automatic measurement of pH value in one or each ■ Energy efficient vessel ■ Perfect brightness for recording at night without the ■ Documentation of all data obtained including calibration need to illuminate the complete lab of pH meter LED light strip for 24/7 video record-pH change in accordance with USP ing method A (half change) System control with Disso.NET software Automatic cleaning ■ 21 CFR Part 11 compliant Disso.NET software suite according to GAMP 5 ■ Parallel cleaning performed automatically ■ Interactive communication between RoboDis II and ■ Number of cleaning steps can be chosen analytical method ■ Result of the cleaning process could be checked (SST) ■ User-defined reports via “Crystal Reports”; online control of rpm and temperature ■ Contaminated media can be separated ■ Integrated water stop ■ Bidirectional LIMS interface via XML Vessel cleaning Dissolution curve Video recording ■ Video recording of dissolution process in time-lapse mode ■ Supports connection of light-sensitive cameras ■ Overlaying of dissolution curve ■ Support for formulation and dissolution method development ■ Gigabit Ethernet camera connection - high bandwidth and easy integration into RoboDis II local network ■ LED light strip allows video recording at night without external light Video recording 18 19 Facts The Facts Contact Are you curious and want to find out more? Head over to our website and download our product brochures, watch videos of our equipment in action or find the ERWEKA dealer of your country. E-Mail: sales@erweka.com Tel.: +49 6103 92426-200 Fax: +49 6103 92426-999 support@erweka.com www.erweka.com spareparts@erweka.com www.facebook.com/erweka.gmbh ERWEKA GmbH Pittlerstr. 45 E-Mail: sales@erweka.com 63225 Langen Telefon: +49 6103 92426-200 Technical specifications of products described are stated without warranty and subject to change at Germany Fax: +49 6103 92426-999 any time without further notice. v.1.3.4.19