Galenic Product Program.» Disintegration Testing» Tablet Hardness Testing» Friability Testing.

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1 Galenic Product Program» Disintegration Testing» Tablet Hardness Testing» Friability Testing

2 the german gründlichkeit We love high quality materials, because for us hygiene and cleaning are no empty rethoric. We back on sustainability, so that our instruments will have long term effects for you. Inner values do count, at the latest during maintenance. Where quality comes as standard In the pharmaceutical industry, quality and safety standards are extremely high. Meeting these standards requires the use of reliable test equipment and systems. As a globally renowned manufacturer and supplier of pharmaceutical test equipment, we are committed to upholding these standards. We continuously develop and optimise our product range to offer our customers both cutting-edge technology and a standard of quality that satisfies the most stringent requirements. Quality is simply an integral part of what we do. This commitment to quality is reflected in all our products. Every product in our range is made of sturdy, high-quality materials and complies with all the relevant safety standards. Crucial components are made of stainless steel rather than plastic, which means our products contain no plastic axle mountings or bearings. This makes them easier to clean, more hygienic and more durable for everyday laboratory use. After all, it's the tablets that should disintegrate, not the equipment. Precision measurements throughout the lifetime of the machine Absolute precision is vital in the pharmaceutical industry. Any errors in measurement could have serious consequences and must be avoided at all costs. Pharma Test is synonymous the world over with high-quality test equipment that's designed to produce accurate analysis results. We strive for perfection to give you the best results. Complete flexibility No two laboratories are the same. That's why an increasing number of our devices are designed to be installed both either lengthwise and or crosswise. After all, bench space is always at a premium. The interchangeable control units allow the devices to be adapted to different circumstances for maximum flexibility in installation. All-in-one solution Any pharmaceutical production line requires regular testing of various parameters. But why measure just one parameter? With our test devices

3 Any pharmaceutical production line requires regular testing of physical properties and active pharmaceutical ingredient (API) content. For over 30 years, Pharma Test has been synonymous with the development and production of high-quality test devices and systems for quality-testing tablets, capsules, suppositories, ampoules, bulk materials and other solid dosage formats. We offer a complete product range from manual instruments for physical testing to fully automated analytical test systems to analyse the active chemical composition of a dosage form. Our foremost priority is to develop products with the quality you would expect from the Made in Germany label The German Gründlichkeit. We think holistic, because everything always influences something else. Our fraction collectors are individually attuned, because the exact result is always the most important thing. Why work with only one value? Test thickness, diameter, hardness and weight in one go. you can measure tablet thickness, hardness, diameter and weight all at the same time. Measuring all these parameters in the same unit process saves time, space and the money that would otherwise be spent on additional equipment. As well as being versatile, our products are intelligent: every test specimen is accurately and automatically fed to the right place in the machine with no change of format. Commitment to sustainability Pharma Test is continually working to improve sustainability, both in the production process and in the life cycle of our products. We choose only durable materials and operate a comprehensive maintenance programme to keep our products working reliably. Our high standard of quality forms an integral part of our commitment to sustainability, because the durability and reliability of our products not only delivers economic benefits it reduces their environmental impact too. Complete product range We offer a complete product range designed to meet all of your laboratory and QC needs. From high-quality test equipment and systems to software, made-to-measure solutions, maintenance and service, we cover almost every requirement. Your needs will be dealt with by a single contact person, who is part of the fully trained Pharma Test Team. So contact us today and tell us how we can help you. From the very beginning, Pharma Test has set itself the goal of satisfying the stringent requirements of the international pharmaceutical industry. Our range of high-quality test equipment includes analytical products, automated systems and galenical products.

4 Tablet Disintegration Testing PTZ S Disintegration Testing Instrument DIST 3 Disintegration Testing Instrument The PTZ S manual disintegration testing instrument conforms to all major Pharmacopoeias, like USP <701/2040> and EP<2.9.1/ >. The PTZ S is the most basic yet cost effective instrument in our range of disintegration testers and is ideally suited for new or limited budget installations. Quiet, vibration free operation is a trade mark of the whole range. Stroke height is fixed at 55mm and number of strokes is set to 30/min. Operation time can be adjusted and there is a digital display for the elapsed test time. The water circulation system is fully protected from overheating. Using a thermometer the temperature of the test medium can be checked at any time. The PTZ S arrives ready for operation, fully equipped. The standard basket is supplied with six glass tubes and six plastic discs. Optionally, the three tube basket according to apparatus B for larger samples can be used without any further modifications. The DIST-3 fully conforms to USP <701/2040> and EP <2.9.1/ > Pharmacopoeias. Three test baskets connected to a central stroke arm offer greater throughput than the PTZ S, while remaining a basic and very cost effective instrument in the disintegration testing range. The vibration free operation and technical specifications are equal to the PTZ S. Stroke height is fixed at 55 mm and the number of strokes set at 30/min. The total test duration can be adjusted and there is a digital display for the elapsed test time. The water circulation system is fully protected from overheating. The instrument comes fully equipped, ready for use. The standard basket is supplied with six glass tubes and six plastic discs. Optionally, the three tube basket according to apparatus B for larger samples can be used without any further modifications. Silent operation Vibration free basket movement, constant 55 mm with 30 hubs per minute Small footprint due to compact design Silent operation Vibration free basket movement, constant 55 mm with 30 hubs per minute Higher throughput due to additional testing stations Fully USP <701> and EP < > compliant Standard basket easily exchangeable for B -type basket for larger samples Rapid display of test run time and set max. disintegration time Automated shutdown when max. disintegration time is reached Fully USP <701> and EP < > compliant 3 testing basket with centralized lifting mechanism Standard basket easily exchangeable for B -type basket for larger samples Rapid display of test run time and set max. disintegration time

5 Semi-Automated Disintegration Testing PTZ AUTO Series Disintegration Testing Instruments The PTZ AUTO series of disintegration testing instruments are fully compliant to the USP <701/2040> and EP <2.9.1/ > Pharmacopoeias. The convenient and unique stop watch mode of operation allows to document the actual disintegration time for each individual sample in a testing basket. The PTZ AUTO series allows the entry and recall of stored methods and offers an easy to navigate interface for routine use as well as user access control features. A large LCD screen and a alphanumerical keyboard is used to edit product and test information, such as the disintegration time for each station, bath and media temperature. A printout of the method, medium and results gives a permanent record of each test. The PTZ AUTO is available as a one, two, three and four station version. All multiple station instruments feature fully independent movement of all stroke arms. For cleaning and maintenance, the Plexiglas water bath can be easily removed. At the end of a test run, the basket is automatically and completely removed from of the test media. This is also useful if a medium change is required. Testing baskets for PTZ AUTO and PTZ AUTO EZ series All instruments of the PTZ AUTO series are upgradeable at any time to a fully automated version, with an electronic basket to automatically detect the individual disintegration time of each sample. Fully USP <701> and EP < > compliant 1 to 4 independently operateable testing stations Method storage and direct output of test results on connected printer Large display, alphanumeric keyboard and user friendly menu system Independent operation of each testing station in instruments with multiple stations Stop watch function to document disintegration time with the push of one button Lift mechanism for each station, test basket is fully removed from the medium at the end of a test

6 Fully Automated Disintegration Testing Instruments PTZ AUTO EZ Series Disintegration Testing Instruments The PTZ AUTO EZ series is fully compliant with USP <701/2040> and EP <2.9.1/ > Pharmacopoeias. They determine the exact disintegration time of all tablets in the disintegration baskets fully automatically. The working principle of the electronic PT-MKT baskets is simple in design and operates through electrical contacts in each of the six basket positions. The PT-MKT baskets also feature a temperature sensor, which provides temperature readings from inside the disintegration vessels shortly after the start of a test. The PTZ AUTO EZ is an easy to maintain device and offers the user the additional security, that any of the electronic discs may be used in any of the disintegration tubes. Any disk from this system will work in any of the disintegration tubes. PT-MKT basket with split sieve bottom The PTZ AUTO EZ instruments feature a built-in capacity for the storage of up to 16 methods and all other features of the PTZ AUTO series. The PTZ AUTO EZ is available as a one, two, three and four station version. All multiple station instruments feature fully independent movement of all stroke arms. The optional PTZ32 software package (21CFR part11 compliant) provides a complete data management and documentation solution. It features effective data and hardware management for tablet disintegration studies and quality control. It also includes batch comparison statistics, temperature recording and user access control. No visiual detection by the user required, fully automated operation Independent operation of each testing station in instruments with multiple stations Lift mechanism for each station, test basket is fully removed from the medium at the end of a test Fully USP <701> and EP < > compliant Fully automated disintegration time detection 1 to 4 independently operateable testing stations Method storage and direct output of test results on connected printer

7 Suppository Disintegration Testing PTS-3E Suppository and Pessary Testing Instrument SPT-6 Suppository Penetration Test Insert The PTS-3E instrument is designed for the manual control of suppository and pessary disintegration time. It conforms to the current EP <2.9.2> Pharmacopoeia. Three samples are tested simultaneously over a user selectable, pre-set period of one minute to ten hours. The sample containers are rotated by 180. The water bath has a capacity of 12 litres. The time between the 180 rotations is set to 10 minutes, and the normal disintegration time is approx.. 30 minutes. The bath, sample holder and test baskets can be removed from the instrument for easy cleaning. The thermostat design (circulating from the bottom of the bath) makes sure that no suppository excipient material enters the heating system. To test pessaries, unlock the drive arm und empty the water bath until the baskets are only submerged up to the upper sieve. Place the samples there and cover them with the glass plate. The pessaries slowly disintegrate in the moist atmosphere. The SPT-6 suppository penetration test insert is used for the direct measurement of the softening time of six suppositories as per EP < > apparatus A. It can be used in connection with a PTZ S, PTZ AUTO or PTZ AUTO EZ disintegration testing instrument. The samples are placed glass tubes filled with 10 ml of medium. The testing rods are inserted and the test is started. The penetration time of the testing rods is measured. If the SPT-6 is used in a PTZ S or PTZ AUTO standard disintegration tester, the water bath is heated by the disintegration tester control electronics while the penetration time has to be tested visually. When using the SPT-6 together with a PTZ AUTO EZ instrument, the penetration time can be tested fully automated and a test report is available. Testing of suppositories and pessaries in the same instrument Simple operation Heating system protected against grease intrusion and overheating Adds another way of using already existing tablet disintegration testing instruments Simple to install and remove again Fully automated detection of melting time with a PTZ AUTO EZ instrument Fully EP <2.9.2> compliant 3 testing stations for simultaneous testing in 12 litres of medium Automated baskte rotation by 180, defaul rotation interval 10 minutes, adjustable from 1 to 10 minutes Integrated circulating heating system, bath temperature adjustable from 30 to 40 C Fully EP < > Apparatus A compliant Testing of the softening time of 6 suppositories Can be used in PTZ S, PTZ AUTO 1-4, PTZ AUTO 1-4EZ or by using an available external thermostat Supply scope includes water bath and tubing connection to heating system of disintegration testing instrument

8 Tablet Hardness Testing PTB 111E Tablet Hardness Testing Instrument PTB 311E 3 in1 Tablet Testing Instrument The PTB 111E is in full compliance with the monograph for tablet hardness testing in the EP <2.9.8> and USP <1217> Pharmacopoeia. The hardness test results are displayed at once and the auto re-start functionality ensures a high throughput of 6 to 10 samples per minute depending on the sample hardness. Connect a PCL or Matrix printer for immediate result presentation including statistics. Full 3-point calibration and validation programs for the hardness test station are included. Reference blocks and weights are used for adjustment and calibration, break point detection reproducibility is checked with the PT-MT3 magnetic test tablet. The optional PTB32 software to handle methods and store results is fully 21 CFR Part 11 compliant. It features batch comparison, networking options and LIMS export. Other options for the PTB 111E include oblong test jaws for both normal and score line tension breakpoint tests and extension of the hardness testing range up to 500 N or up to 70 mm diameter. The PTB 311E is one of our most popular instruments for measuring thickness, diameter (or length) and hardness of a tablet. It is in full compliance with the monograph for tablet hardness testing in the EP <2.9.8> and USP <1217> Pharmacopoeia. A variety of tablet thickness jaws are available for diameters of up to 26mm. The auto re-start functionality ensures a high throughput. Connect a PCL or Matrix printer for immediate result presentation. Full calibration and validation programs are included. The PTB 311E features 3-point calibration of all testing stations. Reference blocks and weights are used for adjustment and calibration, break point detection reproducibility is checked with the PT-MT3 magnetic test tablet. The optional PTB32 software to handle methods and store results is fully 21 CFR Part 11 compliant. It features batch comparison, networking options and LIMS export. Other options for the PTB 311E include oblong test jaws for both normal and score line tension breakpoint tests and extension of the hardness testing range up to 500 N or up to 70 mm diameter. Hardness test mode either with linear force or linear speed increase Configure the testing distance to test soft samples (gel capsules, herbal samples), max. force is documented Configure break detection to recognize deforming when sample is not broken Hardness test mode either with linear force or linear speed increase Configure the testing distance to test soft samples (gel capsules, herbal samples), max. force is documented Configure break detection to recognize deforming when sample is not broken Fully EP <2.9.8> and USP <1217> compliant Test tablet hardness up to 300 N (500 N optional) Result display in Newton, Kilopond or StrongCobb Test 6 to 10 samples per minute (depending on sample hardness) Fully EP <2.9.8> and USP <1217> compliant Height up to 15 mm, diameter up to 40 mm, hardness up to 300 N (500 N optional) Result display in Newton, Kilopond or StrongCobb Test 6 to 10 samples per minute (depending on sample hardness)

9 Tablet Hardness Testing PTB 302 Tablet Hardness Testing Instrument PTBA 211E Ampoule Breakpoint Testing Instrument The PTB 302 is the current iteration of the worldwide first electronic tablet hardness testing instrument. It is made in compliance with the <EP 2.9.8> and USP <1217> Pharmacopoeia and includes a built-in thermo printer and RS232 data interface. The samples are placed onto the sample support. Start the test and observe the result shown on the digital LED display. The result is simultaneously printed on the built-in thermo printer or the optionally available external serial printer. Due to the auto re-start functionality the sample throughput is approx. 6-8 tablets per minute. The samples are placed manually on the testing station. The testing jaw moves forward, pushes the tablet against the load cell and applies force until the tablet breaks. The maximum force value is saved, displayed and printed. The PTB 302 can measure hardness up to approx. 300 N, a 500 N option is available. The PTBA 211E ampoule breakpoint testing instrument operates according to DIN/ISO 9187 and fully complies with this standard. According to this, ampoule hardness has to be tested in order to control the quality during production. Ampoules with a volume of 1 to 30 ml may be tested. Up to 250 tests per series for statistical evaluation are possible. The auto re-start functionality ensures a high throughput of 8-15 ampoules per minute with simultaneous result documentation. The testing mode for ampoules is defined in the standard with 10 mm per minute but the PTBA 211E can also be configured for linear force increase and variable speed increase. The instrument features easy calibration and validation with full reports. Hardness test mode with adjustable linear force increase Print results with statistics, calibration and adjustment reports on integrated printer Auto start mode for high throughput Hardness test mode with adjustable linear force increase Print results with statistics, calibration and adjustment reports on connected printer Auto start mode for high throughput Fully EP <2.9.8> and USP <1217> compliant Test tablet hardness up to 300 N (500 N optional) Result display in Newton, Kilopond or StrongCobb Test 6 to 10 samples per minute (depending on sample hardness) Fully DIN/ISO 9187 compliant Test ampoule break point up to 300 N (500 N optional) Result display in Newton, Kilopond or StrongCobb Test 8 to 15 samples per minute (depending on sample hardness)

10 Fully Automated Tablet Testing WHT 3ME 4 in 1 Tablet Testing System Orientation flaps to position the samples The WHT 3ME instrument is designed to automatically measure the four parameters weight, height, diameter (or length) and hardness for either round or odd shaped tablet forms. It is in full compliance with EP <2.9.8> and USP <1217> Pharmacopoeia. It features unique sample positioning flaps for correct orientation of oblongs, caplets or other odd shaped samples in the combined hardness and diameter test station. Having a built-in carousel for sample transport, the WHT 3ME can be used with or without an automated batch feeding system. Simply place one sample into each of the 20 available segments of the carousel and start the test. This is especially useful to do a quick trial run on a small batch of samples during R&D or method development. There are two batch feeders for auto transport of samples directly into the WHT 3ME available: each of the ten sample containers within the WHT SM can have a different method associated with it; the WHT SM1 single batch feeder is able to collect samples directly from a sample chute of a tablet press. In both cases vibration tracks are used to separate the samples and introduce them into the WHT 3ME. The two system components, feeder and testing system, are not connected to each other to avoid vibration transfer, reduce the tare time of the balance and ease cleaning for both units. The system is controlled by the WHT 32 software which features many adjustable parameters to reliably test most shapes and forms of tablets. Unique flap mechanism to precisely position samples for hardness and diameter test Perform 8 to 15 test per minute depending on hardness and shape of the sample, testing is automatically optimized by the system Hardness test mode either with linear force or linear speed increase Fully EP <2.9.8> and USP <1217> compliant Automated 4 in 1 testing of weight, thickness (max. 15 mm), diameter (max. 30 mm) and hardness (max. 300 N, optional 500 N) of tablets Multi and single batch feeders available Controlled by WHT32 software

11 Accessories and Qualification Tools PT-MT3 Qualification of Break Point Detection PTB-CAL15 Qualification Weight Set Unlike any other gauge system for calibrating hardness stations, the PT-MT3 not only qualifies the ability to measure a particular force, but also serves as an indicator if the load cell is able to detect exactly when the tablet has broken. A magnetically held finger acts as a reproducibly breakable tablet. The force required to make this break can be stepplessly adjusted up to a maximum of 500N. The integrated load cell measures at what force the magnetic field was overcome. Every hardness tester can be qualified in this way. The PTB-CAL 15 calibration weight set can be configured as a 5, 10, and 15 kg dumbbell, thus reducing unnecessary weight of a calibration weight set. It can be used to adjust and qualify any hardness tester and therefore may be used throughout our hardness tester range for the calibration of the load cells contained in the hardness test station. PT-MT3 for dynamic calibration of tablet hardness testing instruments PT-MT3 can be used with all Pharma Test instruments and many competing instruments PTB-CAL15 provides all necessary calibration weights in one set PT-MT3 qualifies the break point detection directly in the working condition PT-MT3 acts as a reproducibly breaking tablet PTB-CAL15 weight set reduces the overall load compared to individual weights WHT32 Software Control and evaluate results of the WHT 3ME system The WHT32 software to control the WHT 3ME is installed on a separate PC. WHT32 can be upgraded to be fully 21 CFR Part 11 compliant, including user administration and audit trail features. The testing procedure for each sample is stored as a method including instrument control information such as force increase rate for the hardness test, break detection, transport speed of the feeder, movement of the flaps as well as product descriptive information. All test results are immediately displayed, filed and presented as reports including statistical information and batch comparison features. For further calculations export to Excel is supported. Also available are network and LIMS data transfer options. Save methods for later use Special routines to handle gelatine capsules and dragees Integrated tests for sensors, linearity of testing stations which immediately report errors Software IQ and OQ documentation available (optional) Fully 21 CFR Part 11 compliant Immediate results even without target values All stations can be calibrated and ajusted in case of deviating results Networkable, optional LIMS export

12 Friability Testing PTF 10E/ER, 20E/ER Friability Testing Instruments The PTF E/ER series of friability testing instruments is fully compliant with the current EP <2.9.7> and USP <1216> pharmacopeia. The PTF E instruments with fixed rotation speed are ideally suited to routine measurements. In case variable rotation speeds are required, the PTF ER instruments may be used. The run time is set via the keypad and the display continually informs about the elapsed test time. By the push of a button the target time can be displayed. Vorteile Geräuscharmer Lauf Vibrationsfreie Hubbewegung, konstant 55 mm bei 30 Hub pro Minute Geringer Platzbedarf durch kompakte Bauform Friability IQ und OQ drum Dokumentation made gehören zum serienmäßigen Lieferumfang from acrylic glass The instruments are delivered ready to use with one or two friability drums (also known as Roche drums). The drums are made of transparent acrylic glass and are available with optional anti-static coating. Also as an option a lamella drum with 11 lamellas to which the samples continuously rub may be used. This simulates the physical stress the samples have to bear during transport from the tablet press to the packaging machine. For larger samples (>13 mm) the whole instrument may be tilted by 10 using a set of optional feet. Stainless steel housing to fit well into a production area Reliably predict the weight loss of a tablet during coating, transportation and packaging processes Programmable for number of drum revolutions or rotating time Fully EP <2.9.7> and USP <1216> compliant 1 (PTF 10/10ER) or 2 drums (PTF 20E/ER) Fixed at 25 RpM (PTF 10E/20E) or adjustable from RpM (PTF 10ER/20ER) Optional lamella drums to test abrasion and 10 foot for large samples

13 Friability Testing PTF 30ERA/60ERA Friability Testing Instruments with Auto Discharge PTF 1DR/3DR Friability Testing Instruments with Balance Connection The PTF ERA series of friability testing instruments is fully compliant with the current EP <2.9.7> and USP <1216> pharmacopeia. The three (PTF 30ERA) or six testing drums (PTF 60ERA) which automatically discharge the samples at the end of test into separate stainless steel collectors, are ideally suited for large throughput. Filling the drums is possible without disassembling them. The drum rotation speed is variable. The drums are made of transparent acrylic glass and are available with optional anti-static coating. Also as an option a lamella drum with 11 lamellas to which the samples continuously rub may be used. This simulates the physical stress the samples have to bear during transport from the tablet press to the packaging machine. For larger samples (>13 mm) the whole instrument may be tilted by 10 using a set of optional feet. The PTF DR series of friability testing instruments is fully compliant with the current EP <2.9.7> and USP <1216> pharmacopeia. The can be used for automated testing and documentation. The instruments feature direct connection of an analytical balance (accuracy 0.1mg) and a RS232 printer connection. The samples are automatically discharged at the end of test into separate stainless steel collectors. The drum rotation speed is variable. The LCD screen guides the user through the operation. The drums are made of transparent acrylic glass and are available with optional anti-static coating. Also as an option a lamella drum with 11 lamellas to which the samples continuously rub may be used. This simulates the physical stress the samples have to bear during transport from the tablet press to the packaging machine. For larger samples (>13 mm) the whole instrument may be tilted by 10 using a set of optional feet. Automated discharge of samples after test Stainless steel housing to fit well into a production area Reliably predict the weight loss of a tablet during coating, transportation and packaging processes Directly connect balance and printer Automated discharge of samples after test Stainless steel housing to fit well into a production area Fully EP <2.9.7> and USP <1216> compliant 3 (PTF 30ERA) or 6 drums (PTF 60ERA) Rotation speed adjustable from RpM Optional lamella drums to test abrasion and 10 foot for large samples Fully EP <2.9.7> and USP <1216> compliant 1 (PTF 1DR) or 3 drums (PTF 3DR) Rotation speed adjustable from RpM Optional lamella drums to test abrasion and 10 foot for large samples

14 Powder Characterisation PTG-S4 Powder Characterisation Instrument Vorteile Geräuscharmer Lauf Vibrationsfreie Hubbewegung, konstant 55 mm bei 30 Hub pro Minute Geringer Platzbedarf durch kompakte Bauform IQ und OQ Dokumentation gehören zum serienmäßigen Lieferumfang The integrated dust protection allows easy access of the testing area The automated PTG-S4 powder testing system is used to measure the flow behaviour of granules and powders in compliance with the EP <2.9.16/36> and USP <1174> Pharmacopoeia. This instrument is suitable for testing powder flow time, measuring the cone angle of the collected powder mound, measuring the weight, calculating density and volume of the powder cone as well as the flowability result. This measures the flow time of 100g of sample through a specified pouring nozzle. The PTG-S4 is widely used to compare batches of powders, for example supplied by the same manufacturer over a period of time or for similar materials provided by different suppliers. The flow characteristics can be easily and quickly determined and used as a QC tool for inter batch reproducibility, as this may have a distinct bearing on the ease of production. Especially if the powders are prone to agglomeration and cohesion over time. The built-in printer and balance cell make the PTG-S4 a compact characterization and testing station with a small footprint. The PTG-S4 features an integrated dust protected testing compartment made from clear Plexiglas included in the standard scope of supply. The testing compartment can still be easily reached by a swinging door. The whole dust protection can be removed quickly for cleaning. Integrated dust protection hood Measure the flow behaviour of powders and granules to reduce process costs and maintain quality and consistency of the final product Stainless steel housing to fit well into a production area Fully EP <2.9.36>, USP <1174> and DIN/ISO 4324 compliant Measure flow-time, cone angle, flowability, cone density and cone volume Flow time from 0.1 to 999 sec., cone angle up to 45, flowability from 0.1 to 999 sec., weight up to 325 g, cone volume up to 275 ml and density up to 6.0 g/ml-1 Print out a cuve of the flow behaviour

15 Tap Density and Leak Testing PT-TD200 Tap Density Testing Instrument PT-LT Leak Detection Instrument The PT-TD 200 for tap or bulk density testing of powders and granules is fully compliant to the EP <2.9.15> and USP <616 App. 1-3> pharmacopeia. The instrument is used to determine additional physical product characteristics to particle size, size distribution and shape. Together with information describing the behavioural characteristics such as flow properties, density etc. the results are used to improve the design quality during development as well as the conformity of product in quality assurance and in-process control. The nominal (standard) test cylinder volume is 250 ml, an upgrade set allows the user to use a smaller test volume of 100 ml. The PT-TD 200 includes two drive systems to perform bulk density testing and automatically detects the cylinder dish position and switches to the correct stroke speed and height. Due to the noisy free fall motions, the PT-TD 200 inevitably develops operating noise, which may not be acceptable in laboratory environments. For this case an optional noise protection hood offers an efficient solution by the use of special sound damming materials. The PT-LT leak testing instrument is used to test the integrity of packed strips, blisters and small sachets containing tablets, granulates, liquids and similar items. The instrument is used to test the quality of the packaging process and to check that the seals enclosing the product are perfectly intact. The PT-LT is designed to detect the smallest holes and imperfections in blister packs and other semi-rigid product packaging. The leak test apparatus is widely applied in the pharmaceutical industry for checking of strips, blisters and bottles containing tablets, capsules, syrups and other containers. It also finds application in the food industry. Samples are placed into the desiccators housing then the pump starts to produce a vacuum, which is held for a preset amount of time. The tested package should keep its shape during this test, otherwise the sealing is not correct. Also, as the package is immersed in a coloured dye solution (usually Methylene Blue), the venting of the desiccators will allow any holes to be penetrated by the dye solution and the contents of the flexible packaging will be stained with the same colouring material. Determine bulk density of powders to improve product quality during development and to secure consistency in quality assurance Supports testing in compliance to both USP <616, Method 1 and 2> and EP <2.9.15> in the same instrument by using two cylinder positions Noise protection hood available as an option Ensure the quality of your packaging process Easy operation by programmed sequence Stainless steel housing to fit well into a production area Fully EP <2.9.15>, USP <616 Method 1-3> and DIN/ISO compliant 3 and 14 mm tapping height, tap count adjustable up to 9999, taping frequency selectable between 250 and 300 hub/minute Menu guided operation Integrated PQ program to check tapping height Programmable vacuum level and vacuum holding time Automated equalization of the vacuum at the end of a test Different sizes of desiccators available Automated print-out of test report via connected printer

16 Pharma Test Apparatebau AG Siemensstraße Hainburg/Germany Current as of May 2012 T F info@pharma-test.de Pharma Test Limited 12 Bell Mead CM21 9E Sawbridgeworth, Hertfordshire/Great Britain pharma-test.ltd@ntlworld.com PharmaTest Trade KFT Nagyszalonta u. 13/b Budapest/Hungary m.radikovics@pharma-test.hu Pharma Test North Africa 97, Kournish El Nile Rood El Farag Cairo/Egypt PharmaTest@link.net P.T. Pharma Test Indonesia Komplek Mutiara Taman Palem Blok H2/19, Cengkareng Jakarta Barat/Indonesia hans@pharma-test-indo.com Pharma Test Instruments India Pvt. Limited No.2, 2nd. Floor, Sree Datri Niwas, Nagwara Circle, Outer Ring Road Opp. Manyata Softech Park Bangalore/India c.neelam@pharma-test.de Over 70 distributors and agents serve your interests world-wide, with fully qualified and trained staff to service and maintain your investment.