Two pilot bioreactors from Infors with usable volumes of 20 and 100 liters (Techfors 30 and 150) are available for the cultivation of microorganisms for the production of biomass or various biotechnological products. The equipment allows the cultivation of sensitive microorganisms, different operating modes and precise process control.
Various rotor-stator dispersers including dispersing elements from IKA enable the quick and easy comminution and fine dispersion of liquid samples. Speeds of up to 16,000 min-1 can be achieved
The Ultimaker 3 is a dual extrusion fused deposition modeling (FDM) 3D printer that is used to produce a wide range of components from standard materials such as ABS, PLA, PP, PET or PC. In addition, filaments loaded with active ingredients are used to print single-dose pharmaceutical forms. Dual extrusion technology allows the combination of different filaments and thus, among other things, different release profiles for different compartments. Material-matched print cores with different nozzle sizes can be selected. The size of the installation space is 21.5 (19.7 for Dual Extrusion) x 21.5 x 20 cm.
The QicPic from Sympatec enables the dynamic image analysis of particles in a size range from approx. 1 µm to 10 mm. In addition to determining particle sizes and their distribution, geometric properties such as sphericity or the shape of agglomerates can also be measured.
The GranuDrum from Granutools is a device for analyzing the flow properties of powders. It uses a rotating drum to measure the behavior of powders under dynamic conditions. The fully automatic image-based evaluation provides precise information about the flowability, cohesion and possible thixotropy of the powders.
The dynamic differential calorimeter DSC3 from METTLER TOLEDO enables the investigation of the thermal properties of materials. It measures the amount of heat absorbed or released by a sample while it is heated or cooled in a controlled manner and thus enables the precise determination of e.g. phase transitions, glass transitions or crystallization.
The ERWEKA all-purpose equipment drive unit AR 403 is a module-based system used for versatile applications in the pharmaceutical and chemical industries as well as in research and development. The modular design is compact, economical and offers a powerful drive motor with a wide range of easily interchangeable fixtures perfectly suited for small-scale production. The following modules are available:
The Leistritz ZSE 12-HP-PH laboratory extruder used at the PVZ is suitable for investigating melt extrusion, melt granulation and wet granulation processes. Extensive accessories allow filaments and films to be produced, which can be broken up into granules or rounded into pellets by further processing. With a screw diameter of 12 mm, the extruder is specially designed for the early stages of process development. Due to its small size, conclusions can be drawn about process properties and processability even with a small amount of material. Due to the small size of the extruder, the temperature control of the individual zones can be regulated quickly, which prevents the machine from stopping and therefore saves time and material. In terms of process control, inline measuring systems such as NIR, Raman or UV/Vis probes can be integrated at the nozzle directly upstream of the discharge, while pressure and temperature can be recorded at the die at any time. All important additional units such as solid and/or liquid dosing, temperature control unit and discharge conveyor can be used directly on a modular basis.
The stirrer apparatus (Apparatus 2, Ph. Eur. 2.9.3) allows the investigation of drug release from solid dosage forms with low instrumental effort and high flexibility. Sampling times and subsequent analysis can be determined according to individual requirements.
The release apparatus CE 7smart from Sotax is a complete system for determining the release behavior of different dosage forms using a flow cell (Ph. Eur. 2.9.3, USP Apparatus 4). The release behavior can be determined by UV/Vis spectrometry in real time and/or collected in individual sample fractions for further analysis. The release profiles can be recorded according to individually created methods, taking into account the sampling times, flow rate or a change in the release medium.
The PTF 20 ER friability tester (Pharma Test Apparatebau AG) allows tablet abrasion to be tested in accordance with the pharmacopoeia (Ph. Eur. 2.9.7) and is therefore part of the standard repertoire of pharmaceutical analysis. Two rotating round containers move the tablets at a fixed speed, whereby the resulting loss of mass is used as a quality criterion. Different drum geometries are available for further investigations.
Various freeze-drying systems are available for the gentle drying of sensitive materials. The Beta 2-8 LSCplus freeze-drying system (Martin Christ Gefriertrocknungsanlagen GmbH) has an ice condenser capacity of 8 kg and an ice condenser temperature of -85 °C. Accessories are available for the single-chamber process with a heatable shelf with sealing device for freezing and drying inside the ice condenser and for the two-chamber process. In the single-chamber process, the total footprint is limited to 0.031 m2(approx. 110 2R vials). For the two-chamber process, a setup with 5 heated shelves (0.155 m2) and connections for 12 round-bottom flasks or wide-neck filter bottles or a chemical-resistant dry rack with 12 connections can be used. The Epsilon 2-4 LSCplus pilot freeze-drying system is also available. The ice condenser capacity is 4 kg, the ice condenser temperature is -88 °C and the footprint is 0.108 m2. The appliance is equipped with a sealing device and also offers 4 connections for round-bottom flasks or wide-neck filter bottles.
The self-designed and built granulate flow tester enables the measurement of the flow time of a predefined quantity of powder or granulate. Different diameters and geometries of the nozzle through which the powder or granulate is to flow can be selected. This makes it possible to compare the flowability of different materials and completes the portfolio of methods for determining flowability.
The high-shear granulator TMG from Glatt has mixing tools and a chopper so that the particles are simultaneously mixed, liquid distributed, granules compacted and the upper body crushed while a binder liquid is added. The high mechanical shearing enables more compact granules than in the fluidized bed process with a relatively high bulk density. The working vessel allows the processing of product quantities of up to 6.4 liters and temperature regulation via a temperature-controlled double wall. All critical process parameters and curves can be controlled and recorded via the integrated touch control.
The Ultrapyc 1200e from Quantachrome enables precise measurement of solid density using helium pycnometry. This is necessary for the calculation of structural properties such as the evaluation of porosity in compaction processes.
The GEA Niro Soavi Panda Plus high-pressure homogenizer enables homogenization processes at pressures of up to 2000 bar. The table-top device is designed for throughputs up to a maximum of 9 L/h and is equipped with a device for cooling the product to minimize thermal damage. At the Institute of Particle Technology, the device is mainly used for cell disruption.
Numerous different incubators are available for cultivating microorganisms in liquid culture media and on solid culture media. In addition to controlling the temperature and shaking frequency, the gas atmosphere can also be conditioned in some cases.
The fully continuous Granucon1® wet granulation system from Gebr. Lödige Maschinenbau is a wet granulation system based on the innovative ring layer principle with subsequent fluidized bed drying of the granules produced. The system available at iPAT represents a unique design on a laboratory scale, which, with a capacity of around 2 to 10 kg/h, enables granulation tests to be carried out with low material requirements. Two independent, gravimetric solids feeders ensure the addition of different components without prior mixing. This is realized simultaneously with granulation by the ring layer mixer. In addition, the modular design of the system also allows individual consideration of continuous mixing, continuous ring layer granulation and continuous fluidized bed drying.
A selection of climate test chambers from Binder and Weiß enables the short-term conditioning or long-term storage of samples under defined conditions to investigate the influence of temperature and humidity. It is possible to cover a temperature range of 10 - 70 °C and relative humidities of 10 - 80 %.
ProtoCOL3 Plus is an automated colony counting and inhibition zone measuring device. The device enables the differentiation of different colony colors and sizes on an agar plate and thus not only a count, but also an identification of specific microorganisms in mixed populations. The device can detect colonies from 0.043 mm in diameter and inhibition zones from 0.1 mm.
The Styl'One Evolution compaction simulator from Medelpharm used at iPAT enables a comprehensive analysis of tableting processes and compression properties of the materials used on the smallest quantities of powder. The Styl'One Evolution is equipped with high-resolution displacement and force sensors that allow a defined simulation of the compression profiles of any industrial rotary press with maximum compression forces of up to 50 kN. With the help of a flexible filling device, single-layer tablets as well as multi-layer tablets and shell-core tablets can be produced and their production recorded. The Analis software enables the evaluation of the pressing tests carried out with regard to customer-specific parameters such as tabletability, compressibility and compactability or scale-up behavior for transfer to production.
The zwickiLine table-top testing machine from Zwick/Roell can be used to perform mechanical tests, especially with small forces. The device on the iPAT can be used for quasi-static loads in tensile, compression and flexure tests with forces of up to 2.5 kN and test speeds of 0.0005 to 3000 mm/min. The various test tools allow the mechanical properties of samples with a wide variety of geometries to be tested.
The Picoline from Hosokawa Alpine is a modular platform that is suitable for fine grinding and/or sifting thanks to the use of individual function modules. All modules are designed for processing very small product quantities from just a few grams. Modules in the form of impact, fluidized bed counter jet and pin-counter pin mills are used. The classifying step using a deflector wheel classifier is partly integrated into the respective module for size reduction, but can also be used separately if required. Operating data, setting values, system flow diagrams and trend curves can be visualized and documented.
The different modules allow particle sizes of approx. 5 µm to 200 µm to be achieved, which have a relatively narrow particle size distribution due to the use of the deflector wheel classifier.
The TriboIndenter nanoindenter from Bruker (formerly Hysitron) enables mechanical and tribological characterization of materials on the nanoscale. For this purpose, hardness indentations are made in thin layers or small structures and force-displacement curves are recorded. Hardness and modulus of elasticity (quasi-static) or loss and storage moduli (dynamic) can be calculated from the curves. The stressing of particles, agglomerates and aggregates in the lower micrometer range between two parallel surfaces can also be carried out (microcompression). This makes it possible to measure the breaking force and calculate the breaking strength of the particles. The nanoindenter is equipped with different measuring heads for a wide range of sizes and forces. The ambient parameters of the measurements can be largely controlled by means of a temperature-controlled sample carrier and flushing with defined gases. In particular, it is also possible to measure biological samples in liquids.
The ASAP 2460 from Micromeritics enables the measurement of surfaces and porosities of materials by means of gas adsorption. Depending on the expected particle surface, both nitrogen and krypton can be used for the measurement.
The Mastersizer 3000 from Malvern Panalytical enables the measurement of particle sizes using laser diffraction, whereby a size range from 10 nm to 3.5 mm can be detected. Interchangeable dispersing units allow fast and efficient particle size measurement of wet and dry samples.
The Zetasizer from Malvern Panalytical is used to measure particle size as well as zeta potential and molecular weight. It uses dynamic light scattering (DLS) and electrophoretic light scattering (ELS). For a reliable measurement, the particle sizes should be in a range from 0.3 nm to approx. 1 µm.
The Alpha 300 R is a flexible confocal Raman microscope from WiTec. It enables spectral imaging and chemical mapping based on a complete Raman spectrum at each pixel, for example to make statements about the distribution of active ingredients in dosage forms. The individual sample components are calculated from the Raman spectra. In addition to the chemical quantification of the components, the Alpha 300 R enables topography detection for the investigation of boundary layers, for example, including the determination of their thicknesses in the micrometer range and surface roughness.
The Helios G4 CX from FEI Deutschland GmbH (today: Thermo Fisher Scientific) is an extensively equipped scanning electron microscope. In addition to an electron column with a resolution of less than one nanometer at an acceleration voltage of 1 kV, it has the following additional equipment:
The NanoWizard3 atomic force microscope from Bruker (formerly JPK BioAFM) enables the investigation of a wide variety of surfaces from individual molecules to coatings on a micrometer or nanometer scale. Among other things, topographical images of the surfaces can be generated in contact and non-contact mode, which can be used, for example, to calculate roughness. NanoWizard3 can also be used to create surface maps that show the local distribution of adhesive forces and/or mechanical properties (hardness, modulus of elasticity). The measurements can be carried out in air as well as in liquids that can be tempered from 15 °C to 60 °C.
The XL100 rotary press from KORSCH AG is used to carry out meaningful studies of the tableting process with small quantities of powder. The pilot-scale rotary press is equipped with a mixing rotor so that different punch formats (EU-B/D) can be used and different tablet shapes and sizes can be investigated. By using different filling shoe and agitator blade geometries as well as filling curves, a deeper understanding of the filling process in rotary presses can be developed. The XL100 has instrumentation to measure, record and analyze compression, ejection and tablet stripping forces, making it ideal for monitoring the limits of the tableting process in R&D and scale-up phases.
The 4M8-Trix from Procept is a spray dryer for R&D batch sizes ranging from a few ml to several liters. Depending on the solution used and the desired result, two-substance nozzles with different diameters (0.2 mm to 1.2 mm) can be used. Other variable process parameters include the temperature of the supply air, the pressure inside the device and the spray rate. The air flow is co-current and particles are separated using different cyclones down to a particle size of . Thanks to the glass design of the system, the process can be easily monitored and controlled visually from the outside. All process parameters are controlled via a touch control unit.
The Nikon Eclipse TS100 inverted microscope is available for microscopic images in reflected and transmitted light. With the help of the epifluorescence unit, simple fluorescence images can also be taken. With the help of the 20 MP digital camera and the appropriate software (MikroLive 5), direct image analysis can be carried out. The device also has two hydraulic micromanipulators including a pneumatic microinjector for sample preparation.
The TIDAS S spectrometer from J&M Analytik AG covers a wide range of the near-infrared spectrum from 1000 - 2150 nm. The device is equipped with a reflection measuring station with an integrated light source that suppresses extraneous light and thus enables easy measurement of samples such as powders, tablets or liquids. A second light source built into the device allows a light guide to be inserted into other processes such as granulation to monitor mixing quality or water content.
The PM 400 is a planetary ball mill with 4 grinding stations for grinding bowls with a nominal volume of 12 mL to 500 mL. The large sun wheel enables speeds of up to 400 min-1. The high centrifugal forces enable a high energy input and therefore short grinding times for dry and wet grinding. Typical areas of application are ultra-fine colloidal grinding in the nanometre range, mechanochemical preparations or mixing and homogenizing tasks.
The PT100 rotary sample divider from Retsch is used to precisely divide a larger bulk sample into smaller subsamples that are homogeneous in composition and correspond to the original bulk material. This is essential for subsequent reliable and representative analyses of the subsamples. Initial bulk solids with a volume of up to 1.6 liters can be divided into 8 subsamples, which in turn can be used for analyses, further divided or combined into larger subsamples.
With the Compact Rheometer MCR 302 module from Anton Paar, we have an extensively equipped device for investigating a wide range of questions in rheological research. We have a selection of different measuring geometries depending on the requirements of the sample. For example, investigations of liquid samples such as solutions, emulsions or melts can be carried out with coaxial cylinders, cone-plate or plate-plate displacement or force-controlled. If required, the latter can also be carried out with a profiled plate or disposable systems. A wide temperature range of up to 400 °C can be set using various base plates and heating mantles. In addition to the measuring geometries for liquid samples, we also have a flow cell for the fluidization of powders for powder rheological tests.
The MiniCer from NETZSCH GmbH is a compact and universally applicable stirred media mill on a laboratory scale. It is suitable for processing very small quantities of 0.25 to 0.5 l in a circular motion. By using small grinding media from 0.05 to 2 mm, comminution down to particle sizes in the nanometer range can be achieved. With the MiniCer it is possible to carry out many tests within a very short time with minimal product losses and meaningful results. An integrated cooling jacket also enables the processing of thermosensitive active pharmaceutical ingredients.
The RST-XS ring shear tester from Dr. Dietmar Schulze GmbH can be used to determine the flow properties, such as the flowability or time hardening of fine-grained powders and bulk solids. Both good and poor flowing materials can be examined. The RST-XS ring shear tester can be used in particular when only small sample quantities are available, as sample volumes of only 30 or 70 mL are required, depending on the shear cell used.
The TURBULA mixer from Willy A. Bachofen AG is a versatile and efficient 3D shaker mixer for the homogeneous mixing of powdered components. The extraordinary efficiency of the mixer is based on the inclusion of rotation, translation and inversion and delivers mixing results that meet the highest requirements within the shortest possible time. Sample containers up to a maximum volume of 2 liters can be used and the speed can be infinitely adjusted. The mixing processes are automatically terminated via a digital timer.
The CryoMill is a vibratory mill that is cooled with liquid nitrogen to comminute and homogenize heat-sensitive and elastic materials. The grinding bowl is cooled before and during grinding in order to embrittle the sample and improve the grinding result. At the same time, volatile components are retained. The use of liquid nitrogen is optional and can also be used for wet and dry grinding at room temperature. Grinding is essentially carried out by impact loading. For this purpose, the grinding containers vibrate at max. 30 Hz. The grinding bowl size is between 5 and 50 mL, or 6 x 2 mL.
The AS 200 CONTROL vibrating sieve shaker from Retsch can be used to carry out precise analytical sieving. The sieving parameters amplitude, time and interval can be individually adapted to the sieving task. Test sieves with mesh sizes from 25 µm to 3.5 mm are available for sieving, enabling high-resolution separation of the sieved material. The e200 LS air jet sieve from Hosokawa Alpine is also available for reliable separation even with very small mesh sizes.
Safety cabinets are available for the sterile handling of genetically modified microorganisms to protect the product and the person using it.
The tapped volume meter (Erich Tschacher Laboratoriumsbedarf) allows the tapped density of bulk solids to be determined in accordance with the pharmacopoeia (Ph. Eur. 2.9.34) in order to calculate bulk solids properties such as Hausner factor and compressibility index, which are used to assess the flow behavior.
The manual tablet tester MT50 from SOTAX enables the mechanical strength of tablets to be determined. It measures the strength, diameter and thickness with high precision and repeatability.
The Multicheck 6 from Erweka is a multifunctional testing device for comprehensive quality control of tablets. It measures several parameters fully automatically, including the hardness, diameter, thickness, width and weight of the tablets, enabling simple operation and fast data evaluation. Multiple batches can also be measured automatically.
The Kern DBS60-3 moisture analyzer is used for simple thermogravimetric tests. Here, samples up to 60 g can be analyzed at temperatures up to 200 °C with regard to their moisture or dry content. The readability is 0.001 g.
Numerous different drying ovens, tray dryers and high-temperature ovens up to 1400 °C are available for drying and tempering samples to cover a wide range of applications and temperatures.
The modular laboratory unit Solidlab 2 from Syntegon consists of a fluidized bed unit and a drum coater. Both units were designed for research and development and allow batch sizes of up to 12 kg. In the drum coater, tablets can be coated with an aqueous or organic coating using a two-substance nozzle. The size of the drums can be adapted to the respective batch sizes. The process can be monitored and controlled with regard to various parameters such as the temperature, humidity or speed of the supply and exhaust air or the spray rate of the nozzles.
Powerful ultrasonic homogenizers for different sample volumes are available for the disruption of cells, the dispersion of nanoparticles and for homogenization and sample preparation.
The InSpectro X probe from ColVisTec enables inline spectroscopic process monitoring using UV/Vis spectroscopy in the measuring range of 220-820 nm and can be integrated into a wide variety of processes such as extrusion or granulation processes. Complex spectral information is broken down into simple color values, converted and used as real-time indicators for ongoing processes.
The SPECORD 210 PLUS UV/Vis spectrophotometer is a dual-beam photometer for simultaneous measurement of sample and reference signal in the measuring range of 185-1200 nm. In combination with the Aspect UV software, individual measurement methods can be created in different measurement modes (photometry, spectrum, kinetics, thermometry and colorimetry) and thus individually adapted to the samples to be measured.
The VCM apparatus from MeltPrep allows the investigation of new formulations for hot melt extrusion. Thermoplastic samples are compressed, heated and melted in a vacuum without changing their properties through decomposition. Variably interchangeable modules enable the production of different sample geometries. The geometries of the samples are designed for subsequent measurements of various characteristics, e.g. tensile strength, rheological or thermal analysis. This allows important process-optimizing findings to be gained with regard to formulation development for subsequent hot-melt extrusion.
The trainer is based on a high-pressure emulsification system in which the necessary pressures are generated and measured pulsation-free using two pressure intensifiers and the temperatures of the fluids are recorded. Accordingly, the system can be used for the direct emulsification of two different phases in two pressure intensifiers or premix emulsification (homogenization) using a pressure intensifier. As an innovative emulsification process, pressures of up to 2000 bar can be achieved for microchannel emulsification (stainless steel systems) and up to 500 bar for metal or polymer membrane emulsification, resulting in droplet sizes of at least 100 nm.
The HC2-AW water activity sensor (Rotronic / Process Sensing technologies Ltd.) is used to measure the water activity of various samples. This allows the measurement of relative humidity in the range of 0...1 aw (0...10 %rh) at temperatures of -40...85 °C with an accuracy of ± 0.008 aw (± 0.8 %rh at 10...30 °C).
The modular laboratory unit Solidlab 2 from Syntegon consists of a fluidized bed unit and a drum coater. Both units were designed for research and development and allow batch sizes of up to 12 kg. The fluidized bed unit enables efficient granulation, drying or coating of powders or pellets. With three-substance nozzles in a bottom-spray arrangement, two liquids can be sprayed in to produce crust and adhesive granulates or coatings. The process can be monitored and controlled with regard to various parameters such as the temperature, humidity or speed of the supply and exhaust air or the spray rate of the nozzles.
Glatt's Mini-Glatt is a compact and versatile fluid bed system specifically designed for the development and production of small batches of granules and pellets. It utilizes fluid bed technology, where particles are suspended in a stream of air and agglomerated or coated by spraying liquids onto them. The Mini-Glatt offers flexible application possibilities for various processes such as drying, granulating and coating. It is suitable for batch sizes from 5 to 500 g and can be operated in bottom (including Wurster) and top spray processes.
Various refrigerated centrifuges for samples on a microliter scale up to 6 L of product (Avanti JXN-26, Beckmann) are available for different applications. The maximum speed of the centrifuge is 26,000 min-1 (82,000 g), the 6 L rotor allows speeds of up to 8,000 min-1 (15,970 g).
The DT50 disintegration apparatus from Sotax allows disintegration time testing of tablets and capsules in accordance with pharmacopoeia regulations (2.9.1). The tablets are moved in 6 tubes in the temperature-controlled release medium and the time required for disintegration is recorded. This is done either manually or automatically if disks are used.