Instrumentation for the Pharmaceutical Industry

1 Instrumentation for the Pharmaceutical Industry Born to find out Anton Paar has been developing, producing and distributing high- precision measuring and analytical Instrumentation for laboratory and process applications since 1922. At the forefront of high-precision engineering, the company has always been fueled by a passion for innovation and its close-knit contact with the scientific community. In the Pharmaceutical sector, where quality and traceability count above all else, the analysis of relevant parameters employing Anton Paar instruments ensures the consistent high quality of Pharmaceutical products. Anton Paar's Instrument Guide for the Pharmaceutical Industry 1 - 2. Introduction and Content 3 - 4. Technologies for Physical and Physico-chemical Analysis 5 - 6 Pharmaceutical Qualification and Validation 7. Service Programs 8 - 21. Instruments for for the Pharmaceutical Industry 22 - 23. About Anton Paar Technologies for Physical and Physico-chemical Analysis Anton Paar's instruments embody decades of technical know-how.

2 This continuously growing knowledge at the cutting edge of technological developments forms the basis for robust and reliable analytical instruments. Anton Paar's deep understanding of each analytical method results in precise instruments with excellent performance and reproducibility. Openness towards customer requirements and attention to new market trends are the source of new ideas which meet the needs of customers. You want to . raw materials, intermediates, excipients, active Pharmaceutical ingredients (APIs), proteins, infusion solutions, ointments and many other kinds of formulations. 3. Ensuring Pharmaceutical Quality In Quality Control & Production Performing first identifications Evaluating the stability Testing the quality Detecting impurities Checking the purity Defining new analytical quality assurance Assessing conformity with the specifications methods In Research & Development Defining and screening new medical Investigating drug delivery behavior and entities kinetics Developing and optimizing methods in the Investigating the phase transition and its early stages influence on the properties of formulations Determining the homogeneous size or medical substances distribution of formulations Investigating temperature- and humidity- Providing structural information on size, induced changes shape aggregation behavior, crystal structure and molecular weight 4.

3 Pharmaceutical Qualification and Validation Anton Paar understands your need for completely traceable results and supports you with a qualification and validation package following the 4Q model which fulfills the requirements of the Pharmaceutical Industry : GMP, 21 CFR Part 11, GAMP5, USP<1058>. This package aids you in achieving and maintaining the qualified status of your instrument. For the Pharmaceutical , biotechnological, cosmetics and food industries. For defined instruments Anton Paar offers an instrument- specific qualification and validation package to meet the strict Pharmaceutical regulations. This package covers all steps to perform a complete instrument qualification: DQ, IQ, OQ and PQ. Risk Analysis 21 CFR Part 11 checklist Deviation List Traceabilty Matrix SOP. Certified Anton Paar representatives assist in the whole process if required. For all Industry segments. After Anton Paar's documented qualified instrument installation, your in-house qualification officer can easily integrate the instrument into your process and create the complete qualification and validation documentation.

4 For all Industry segments. Delivery and installation of the instrument. Anton Paar's instruments are thoroughly tested and calibrated according to official guidelines, such as ASTM, T V, CE, etc. Embedded into Anton Paar's ISO system are the guidelines for preparing an instrument-specific pharma qualification and validation package. 5. Anton Paar's Certified Service provides the right service level for you: AllInclusive StandardPlus Standard Service and Support Anton Paar accompanies you with certified service throughout the whole life cycle of your instrument. Depending on your needs choose from Anton Paar's specially designed service programs: To keep your results on-spec To ensure the instrument's long working life To profit from trained and qualified Anton Paar service engineers To ensure use of certified test equipment for the highest level of accuracy Comprehensive Service for Lifelong Reliable Operation Anton Paar's certified service provides: Preventive maintenance Regular maintenance Unplanned maintenance in emergency situations Depending on the service level agreement, you benefit from: Calibration and adjustment checks Electrical safety checks according to standards Electrical and mechanical alignments Firmware and software upgrades Spare parts service Depot repair service Loaner instruments Additionally Anton Paar supports you during the qualification and validation process, during requalification of the instrument and during the retrospective qualification if an older instrument needs to be qualified.

5 Anton Paar's documented service proves that your instrument has been checked to the highest standards. This meets your need for monitored quality for inspections and audits. For repair and emergency cases Anton Paar provides phone support and clearly specified short reaction times. For detailed information on Anton Paar's Certified Service, refer to or email 7. Instrument Qualification and Instrument Re-qualification To achieve and to further maintain the qualified status of your instrument, Anton Paar supports you with a Pharma Qualification and Validation Package for defined instruments. This shortens the time until the instrument can be used in your production process and saves you money and time during the implementation process. The 4Q Model DQ Design Qualification Design and quality criteria are defined. A qualification plan and risk analysis are the start of a risk-based qualification instruction and procedure. IQ Installation Qualification This ensures that the instrument fits the specifications.

6 Defined test points assure the correct and quick installation and availability of the instrument. OQ Operational Qualification This ensures that the instrument operates as specified. OQ covers all the defined operational test points, including: Adjustment Calibration Customer reference sample 21 CFR Part 11 Check List User SOP. These points make sure that the instrument works as specified in the defined environment. PQ Performance Qualification This ensures that the instrument works under routine conditions within the defined specification. With Anton Paar's Pharma Qualification and Validation Package you are prepared for inspections. It is the correct and approved procedure for a validated instrument used in the production cycle. Anton Paar offers: A range of instruments which provide complete conformity and traceability via: A complete user management system Audit trail functionality GMP-compliant printouts and reports 21 CFR Part 11 Check List Electronic signature 6.

7 Density & Concentration Measurement Density measurement is used to characterize binary mixtures and provide density and concentration results. A combined density and sound velocity meter accurately determines the concentration of tertiary mixtures. Due to their robust design, Anton Paar density meters are very popular at manufacturing sites, R&D and quality control laboratories. They provide quick and accurate measurement results to ensure the right density and concentration values of solved Pharmaceutical material during production and in the final product. Portable and benchtop density meters for concentration measurements The first-ever digital density meter was launched by Anton Paar. These DMA. density meters have been continuously developed, resulting in highly reliable, repeatable and accurate density instruments with the following benefits: Measurement of liquid samples of any viscosity Investigation in the lab or quick checks directly at the sampling location Small sample volume of approx.

8 1 mL. Non-destructive measurements Drift-compensated measurement at different temperatures Fast viscosity correction across the samples' entire range Filling errors detected automatically to guarantee reliable results and save time Only one adjustment at one temperature required Automatic sample changer for up to 96 samples High degree of modularity (Modulyzer systems providing density values with turbidity and refractive index values). Anton Paar's density and concentration meters: DMA 35 portable density meter DMA 4100 M, 4500 M and 5000 M density meters DMA 500 density meters DSA 5000 M density and sound velocity meter 8. Temperature Measurements Almost all measurement parameters are in some way influenced by temperature. To guarantee complete quality assurance, Anton Paar provides certified test equipment for temperature checks, the calibration of other instruments and high-precision temperature measurements. Exceptional accuracy measurement uncertainties in the Millikelvin range The benefits of Anton Paar's temperature measuring instrument are: Ensures and maintains continuous quality of the products Monitoring of quality-relevant instruments can be proven to auditors Traceable to national standards and can be ordered with officially accredited sensors Compliant to ITS-90 and IEC 751.

9 Two channels make the MKT 50 perfectly suitable for comparison calibration Measurement uncertainty of 400 Ohm (equal 1 mK ( C)). with an ideal Pt 100 sensor Portable instrument less weight (< 2 kg) and operation up to 10 hours without batteries Digital interfaces for flexible use Anton Paar's temperature measuring instrument: MKT 50 millikelvin thermometer 9. Polarimetry Determination of optical rotation is the method of choice to ensure use of the correct and optically pure Pharmaceutical substances in all areas of Pharmaceutical production, quality control and R&D. This is important for chiral drugs, for example, as some enantiomers can be inactive or even toxic. The optical rotation is a measure of the concentration of optically active substances and therefore directly proportional to the sample concentration and path length of the used sample tube. Laboratory cell measurement of optically active substances The benefits of Anton Paar's polarimeters are: Multi-wavelength option meets the requirements of pharmacopoeia Automatic detection of the sample cell ensures complete traceability Automatic transfer of calibration and adjustment data from the quartz control plate ensures error-free calibration and adjustment Use of certified calibration standards Automated checks and adjustment procedures Measurement of light and strongly colored samples with the same quality via self-adjusting light intensity Built-in Peltier temperature control Wide range of sample cells Numerous communication ports Compliance with national/international standards Wireless ToolmasterTM function Anton Paar's polarimeters: MCP 200.

10 MCP 300. MCP 500. Propol automatic process polarimeter 10. Refractometry The Refractive Index is a physical property and is therefore characteristic for every substance. The refractive index of liquid and solid substances is quickly and easily measured using a refractometer. The refractive index exactly correlates to the concentration of dissolved substances and can also be used for concentration measurements. From stand-alone to modular . a refractometer for every task The benefits of Anton Paar's refractometers are: For all kinds of samples, including turbid, colored solid, toxic, poisonous and opaque samples Sample volume in the microliter range No sample preparation required Also for samples with high or low refractive index For determining dispersion and measuring refractive index at different wavelengths Fast and convenient serial analysis Wide range of accessories and options: Sample cells for every task Xsample 122 sample changer Optional built-in peristaltic pump pH module Modularity DMA Generation M density meters MCP polarimeters Lovis 2000 M/ME microviscometers Anton Paar's refractometer series: Abbemat 200, 300, 350, 500 and 550.