ProductnamePharmaSolutions for the
Pharmaceutical Industry

Solutions for the
PharmaceuticalIndustry
ANTON PA AR’S PORTFOLIO FOR THE
PHARMACEUTICAL INDUSTRY COVERS A WIDERANGE OF YOUR MEASUREMENT NEEDS AND
ALLOWS YOU TO BE FULLY COMPLIANT AT THE SAME
TIME.

Samples such as gels, creams, infusions, APIs,
blood samples, essential oils, proteins, andpolymers can be investigated by measuring
various parameters such as density, viscosity,
refractive index, optical rotation, particle size,
turbidity, and many more.
Our instruments can be easily combined to create
multiparameter measurement systems. Our
solutions support you in the laboratory as well as
in-line and at-line, meeting your requirements from
R&D to quality control.
AP Connect Pharma, the software for yourpaperless lab: It connects your instruments,
communicates measurement information, andensures compliance.

DON’T WORRY, BE COMPLIANTFIND OUT MORE

www.anton-paar.com/pharmaAnton Paar’s
PharmaQualification
Packages
Our instruments comply with the methods
stated in US Pharmacopeia (USP),
European Pharmacopoeia (Ph.Eur.), and otherPharmacopoeias to ensure easy method validation.
We offer two Pharma Qualification Packages fordifferent levels of regulations: PQP and PQP-S(mart).
They both cover Anton Paar’s 6Q model
which includes:

INSTRUMENT QUALIFICATIONQUALIFICATION INSTRUCTION (QI)
DESIGN QUALIFICATION (DQ)
INSTALLATION QUALIFICATION (IQ)
OPERATIONAL QUALIFICATION (OQ)PERFORMANCE QUALIFICATION (PQ)
FINAL QUALIFICATION (FQ)

PQP

Covers the complete instrument-specific pharma
qualification procedure according to the USP <1058>
4Q model, also including: risk analysis, deviation list,
traceability matrix, reports for every qualification step,
21 CFR Part 11 checklist to fulfill all requirementsof FDA 21 CFR Part 11, and standard operatingprocedure (SOP) as a Word file that can be used as
the basis for your internal instrument SOP.
PQP-S(MART)Your ideal tool if you have to follow GAMP 5 and GMP
but don't have to be compliant with 21 CFR Part 11,
also including: risk analysis and standard operatingprocedure (SOP) as a Word file.

ISO 9001:2015

The backbone of Anton Paar’s
qualification documentationTEST

REQUALIFICATION

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PQ P- S ( M A
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An instrument qualification isn't a one-time event.
Depending on your needs and on the reasons forrequalification (e.g., yearly re­­qualification, changeof location, soft­ware update, etc.), a customized
document is created based on the initial instrument
qualification (PQP/PQP-S).

-

PQP
PQP-S
Requalifications
According to USP <1058> and EU GMP Annex 15
SOP as a Word file

COMPLIANT AND RELIABLE INSTRUMENTS- Pharma-compliant software features, such as user
management, audit trail, and electronic signature- Complete compliance and traceability, reducing theworkload required to integrate the new device into
your system
INSTALLATION SUPPORT- The instrument is qualified and ready for use after
one to three days
- Personalized qualification documents- Installation, qualification, and user training
performed by representatives trained and certified
by Anton Paar
MODULARITY- Individual multiparameter measuring systems or apreconfigured Modulyzer system- Combinations of density meters, refractometers,
rolling-ball viscometers, and automation units in one
lab workstation- Expansion of the system at a later date, if neededComplete Control
in the PharmaceuticalIndustry

CHECKING INCOMING MATERIALS

1-

Density
Digestion for determination of elemental impurities
Optical & specific rotation
Viscosity
Refractive index & concentration
Consistency
Particle analysis
Flow properties & rheological investigations
Surface area & pore size
Chemical composition

FILLING

3

2
RESEARCH

PRODUCTION

-

-

-

Density
Optical & specific rotation
Turbidity
Reference temperature
measurement & calibration
Microwave synthesis
Digestion & extraction
Automated pipetting, sampling,
dosing, and weighing
Nanostructure analysis
Surface analysis on solid samples
Inline refractive index
Particle analysis
Refractive index & concentration
Viscosity
Flow properties & rheologicalinvestigations
Surface area & pore size
Chemical composition

Density
Optical & specific rotation
Viscosity
Refractive index & concentration
Inline density measurement
Inline refractive index
Consistency
Particle analysis-

DensityConcentration & optical rotation
Viscosity
Refractive index & concentration
Inline density measurement
Inline refractive index
Consistency
Particle analysis
Flow properties & rheological investigations

FINAL QUALITY CONTROL

4-

Density
Digestion for determination of elemental impurities
Optical & specific rotation
Viscosity
Refractive index & concentration
Inline density measurement
Inline refractive index
Consistency
Particle analysis
Flow properties & rheological investigations
Refractive index
Extraction
Reference temperature measurement & calibration
Surface area & pore size

Product Portfolio
DENSITY MEASUREMENT OF LIQUIDSLAB EXECUTION SOFTWAREDENSITY MEASUREMENT OF SOLIDSDMA 4101/4501/5001

DMA 1001

AP Connect Pharma

Ultrapyc series- The DMA 4101/4501/5001 density meter series
provides up to 6-digit accuracy for density anddetermines numerous concentration values
simultaneously- Automation for user-independent filling with
Xsample sample changers- Can be combined with pH and turbidity measuring
modules for multiparameter analysis- Supported by AP Connect- Software compliance with 21 CFR Part 11- Available documentation: PQP/PQP-S- The compact stand-alone lab instrument is themost straightforward way to comply with yourindustry standards, it measures with 4-digit
accuracy and is perfectly suited to measuring
density at a fixed temperature- Software compliance with 21 CFR Part 11- Available documentation: PQP/PQP-S- Software for data storage from all connected
instruments in a central database, offering features
for handling data automatically or upon request- Connection of up to 30 out of 50+ instrumentswith one license key- Data can be checked anytime across the entire
company network (multi-user architecture)- Data integrity and full compliance with regulatory
requirements- Compliant with 21 CFR Part 11- Pharma-essential functions:- Configurable approval process of all your datawith electronic signature- User management: Active Directory support tomanage AP Connect users- Role management: configuration of specific roles
with dedicated permissions- Audit trail for full traceability: complete audit trailof all connected instruments and the software
itself; full review function from any place in thecompany network- Available documentation: PQP- Precise and simple-to-use gas pycnometers
measure the true and skeletal density of powders
and tablets- TruPyc technology ensures accurate
measurements for various sample amounts- PowderProtect mode eliminates the risk of
instrument contamination- Ultrapyc 5000 instruments feature built-in
temperature control- Available documentation: PQP-S

USP <841> | Ph.Eur. 2.2.5 | JP 17 2.56 |ChP 2020 (Vol IV) 0601

DMA 501- The rugged and compact 3-digit density meter
easily fits into tight spaces in storage facilities or
production areas and is ideal for quick quality
checks on incoming liquids and intermediate
products- Available documentation: PQP/PQP-S
ChP 2020 (Vol IV) 0601

USP <841> | Ph. Eur. 2.2.5 | JP 17 2.56 |ChP 2020 (Vol IV) 0601

DMA 35- The portable density and concentration metermeasures incoming raw materials and intermediate
products in a few seconds- 2 mL sample volume, filling with the built-in pump,measurement on-site- Available documentation: PQP-S

USP <699> | Ph.Eur. 2.9.23

Autotap- Density analyzer that measures packed powder
density- Provides data for compressibility and flowability
calculations (Carr, Hausner)- Available with one or two measuring stations- Available documentation: IQ/OQ
USP <616> | Ph.Eur. 2.9.34

Product Portfolio
FLOW PROPERTIES & RHEOLOGICAL INVESTIGATIONSMCR 72 and MCR 92 – MCR Evolution rheometer series- The two best choices for quick and easy rheological measurements in
QC- For checking the rheological properties of materials such as liquids
and gels to ensure consistently high quality of raw materials and end
products- Toolmaster™, the automatic tool recognition and configuration- feature, ensures easy handling and error proofing- The RheoCompass™ software provides reports and documentation incompliance with 21 CFR Part 11- Powder cells for the complete characterization of powder behavior:
flowability, compressibility, permeability, fluidization properties, and manyother parameters- Available documentation: PQP/PQP-S
USP <912> , <1174>, <1911>, <1912> | Ph.Eur. 2.2.8, 2.2.10

PARTICLE ANALYSIS

RheolabQC rotationalrheometer- Rotational rheological tests:
from liquid-like emulsions tosemi-solid lotions- Toolmaster™ for automatic
bob detection- Bar code option for sample
identification- The RheoCompass™
software provides reports anddocumentation in compliancewith 21 CFR Part 11- Available documentation:
PQP
USP <912>, <1911>, <1912> |Ph. Eur. 2.2.8, 2.2.10

Litesizer- For measurements of the particle size, zeta
potential, and molecular mass of liquid dispersions
using light-scattering technologies and thedetermination of the transmittance and refractive
index- The ingeniously simple Kalliope software for
Litesizer and PSA provides customizable reports
as well as a one-page workflow function,customizable user management, and audit trails- Software compliance with 21 CFR Part 11- Available documentation: PQP
USP <729>, <1430>

PSA- Measures the particle size of dry powders andliquid dispersions, from the upper nanometer tothe millimeter range, by laser diffraction- PSA particle size analyzers are calibrated
according to the ISO 13320 and USP <429>
standards- Software compliance with 21 CFR Part 11- Available documentation: PQP
USP <429>, <729>, <1430>

Product Portfolio
VISCOSITY MEASUREMENTDIGESTION & EXTRACTIONMICROWAVE SYNTHESISSVM viscometers

ViscoQC 100 rotational viscometer

Multiwave 7000

Monowave 400/450- The SVM series measures viscosity and densityfrom one syringe- FillingCheck™ detects filling errors- SVM viscometers can be combined with
Anton Paar refracto­meters- Automation for user-independent filling with
Xsample sample changers- Supported by AP Connect- Software compliance with 21 CFR Part 11- Available documentation: PQP/PQP-S- Determines single-point dynamic viscosity ofliquids from infusions to ointments- Non-storage mode
- Traceability of results by automatic spindle, guard
detection, and digital leveling function- Available documentation: PQP-S- The Multiwave 7000 microwave digestion system with the pressurized
digestion cavity (PDC) delivers the solutions you need; digestion of all
samples at up to 300 °C and 199 bar in one run − no sample clustering
needed- Software compliance with 21 CFR Part 11- Available documentation: PQP- The Monowave 400/450
microwave reactor allows
sequential reactions at up to
300 °C and 30 bar

USP* <912>, <1911>, <1912> | Ph. Eur. 2.2.8, 2.2.10** for Newtonian liquids only
Lovis 2000 M/ME
- This microviscometer provides high-precisionviscosity measurements on low-viscosity
substances- Automation for user-independent filling with
Xsample sample changers- Software compliance with 21 CFR Part 11
USP <913> | Ph.Eur. 2.2.8, 2.2.49

USP <912>, <1911>, <1912> | Ph. Eur. 2.2.8, 2.2.10

ViscoQC 300 rotational viscometer- Determines multi-point dynamic viscosity of liquids
from infusions to ointments- Upgrade with V-Comply software to fulfill
regulations of 21 CFR Part 11- Traceability of results via automatic spindle, guard
detection, and digital leveling function- Bar code option for sample identification- LIMS functionality for data processing- Supported by AP Connect- Available documentation: PQP
USP <912>, <1911>, <1912> | Ph. Eur. 2.2.8, 2.2.10

Multiwave 5000
- Multiwave 5000 is a modular platform system, offering maximum
flexibility for your configurations; this versatile concept allows uniqueapplications and methods, including microwave acid digestion, acidleaching, solvent extraction, and synthesis- GS and ETL certification- Software compliance with 21 CFR Part 11- Available documentation: PQP
Multiwave GO Plus
- Multiwave GO Plus is the smallest and most economic rotorbased microwave digestion system on the market for digesting up to
12 different samples in a single run- Available documentation: PQP-S
USP <232>, <233> | Ph.Eur. 5.20, 2.4.8

Multiwave 5000
- The Multiwave 5000
microwave reactor performs
parallel synthesis at up to
300 °C and 80 bar of up to
96 samples- GS and ETL certification- Software compliance with
21 CFR Part 11- Available documentation:
PQP

Product Portfolio
CONCENTRATION &REFRACTIVE INDEX WITHTEMPERATURE CALIBRATIONOPTICAL & SPECIFIC ROTATIONIDENTITY TESTING
WITH RAMAN SPECTROSCOPYCONSISTENCYINLINE DENSITY & REFRACTIVE
INDEX MEASUREMENT

Abbemat refractometers

MCP polarimeters

Cora 5001 for Pharma

PNR 12 penetrometer

L-Dens 7000 series- These instruments provide
quick and reliable refractive
index and concentration
measurements- Measurements in a wide
range from 1.26 nD to 1.72
nD
- Supported by AP Connect- Abbemat T-Check calibrates
and adjusts the internal
temperature sensor to ensure
precision- Automation foruser-independent filling with
Xsample sample changers- Software solutions for data
integrity: embedded or fully
desktop-controlled operations
mode possible- Software compliance with
21 CFR Part 11- Available documentation:
PQP/PQP-S- These instruments measure
the optical rotation of chiral
substances- FillingCheck™ automaticallydetects filling errors- A multiple-wavelength option
for up to eight different
wavelengths is available- Supported by AP Connect- Software solutions for data
integrity: embedded or fully
desktop-controlled operations
mode possible- Software compliance with
21 CFR Part 11- Available documentation:
PQP/PQP-S- Cora 5001 Raman
spectrometer, whencombined with Anton Paar's
Spectroscopy Suite software,
is a solution tailored toincoming goods inspections
and R&D in the regulated
environment- All workflows, like running
samples, setting up methods,
and generating reference
libraries, are specificallydesigned to adhere to
stringent complianceregulations- Lifetime data integrity- 100 % traceable audit trailwith search function- Transparent and secure
electronic signing- Compliant with
21 CFR Part 11- Available documentation:
PQP- The PNR 12 penetrometer
determines the consistency
and plasticity of pasty,
creamy, semi-solid, and highly
viscous samples- Test kits according
to European and
US Pharmacopeia are
available- Program navigationis performed by aself-explanatory jog wheel- Available documentation:
PQP-S- This series of density sensors
provides continuous density
measurement and calculationof concentrations

USP <831> | Ph.Eur. 2.2.6

USP <781> | Ph.Eur. 2.2.7

USP <858>, <1858> |Ph.Eur. 2.2.48

USP <915> | Ph.Eur. 2.9.9

USP <841> | Ph.Eur. 2.2.5.

L-Rix 5000/5100/5200- These inline refractometers
deliver refractive index andconcentration results
USP <831>* | Ph.Eur. 2.2.6** These sensors are easily
connected to common
evaluation units and PLCs

TURBIDITY MEASUREMENT

Haze 3001/
Haze 3001 Heavy Duty
- These turbidity modules
measure the turbidity ofliquids using a ratio method
based on the evaluation of
scattered light at 0°, 25°, and90°; this analysis method
considers particles of any size
and is not influenced by the
sample’s color- Haze 3001 Heavy Duty
withstands aggressive
cleaning liquids and samples
thanks to the Kalrez® sealings
used- Supported by AP Connect
USP <855> | Ph.Eur. 2.2.1.

Product Portfolio
SURFACE AREA & PORE SIZE ANALYSISSURFACE CHARGE ANALYSISON SOLID SAMPLESREFERENCE TEMPERATURE
MEASUREMENT & CALIBRATIONNANOSTRUCTURE ANALYSISAUTOMATED PIPETTING, SAMPLING,
DOSING, & WEIGHING

autosorb iQ-MP series

SurPASS 3

MKT 10 | MKT 50

SAXSpoint 5.0 | SAXSpace

Modular Sample Processor- High-vacuum volumetric surface area analyzers that measuresamples with a very low surface area (analysis gas: krypton)- Available with one, two, or three analysis stations- Built-in sample preparation (vacuum degassing) stations- Includes 21 CFR Part 11-compatible software features- Available documentation: IQ/OQ- SurPASS 3 analyzes the zeta
potential of solid surfaces andgives insights into the charge
and adsorption characteristics
at solid/liquid interfaces- An integrated titration unit
provides fully automated pH
titration- SurPASS 3 features
calibration-free electronics
as well as maintenance-freeelectrodes- The MKT 50 Millikelvinthermometer provides
traceable comparison
calibration (PRT) and fixedpoint calibration (SPRT);
it provides a resolution of
0.1 mK and 40 μΩ, andcomplies with DIN EN 60751
and ITS-90- MKT 10 is ideal for at-line
measurements and quick
measurements on-site as it
measures with an accuracy of
10 mK- Small- and wide-angle
X-ray scattering systems forstructure investigations on
nanometer-sized structures,such as biomolecules insolution under biologicalconditions- Resolving nanostructures up
to 300 nm in diameter- Simultaneous and continuous
small- and wide-angle
measurements up to 74 ° 2θ- Carries out automatic dosing,blending, subsampling, andtransferring of liquids prior to
analysis- Available as a stand-alone
benchtop unit or optional
integration into completely
automated workflows- After individual adaptations,
the Modular Sample
Processor perfectly carries
out any desired liquidhandling operation

Nova series- Vacuum volumetric gas adsorption analyzer that measures surface
area, pore volume and mesopore size
- Fully integrated design with four sample preperation ports and up to
four analysis stations- Analyze with velocity: four samples for 5-point BET surface area within
20 minutes- Available documentation: IQ/OQ
QUADRASORB evo- High-performance surface area and pore size analyzer- Four independent analysis stations for workflow flexibility- Available with high-vacuum capability for low surface area
(analysis gas: krypton)- Includes 21 CFR Part 11-compatible software features- Available documentation: IQ/OQ
USP <846> | Ph.Eur. 2.9.26

PoreMaster series- Mercury intrusion porosimeters measure meso- and macropore size
distributions in granules and tablets- Advanced safety features- Available documentation: IQ/OQ
USP <267>

ENGINEERS WITH THE RIGHTSKILLS & QUALIFICATIONSYour Anton Paar service
engineer is trained andauthorized by Anton Paar to
perform all maintenance workand additionally receives training
on GMP and other relevant
regulations needed to installyour instrument, including thePharma Qualification Packages.

KEEP YOUR RESULTS
ON-SPEC AND COMPLIANTCOMPLETE DOCUMENTATION

Regular checks, calibrations,and adjustments, e.g.,
performed during annual
maintenance, ensure thatyour instrument continues
to deliver measuring resultsthat meet the specifications
and standards. Based on our
Pharma Qualification Packages,
individual requalifications can beissued to ensure the complianceof your instrument over its whole
life cycle.

Benefit from the Pharma
Qualification Packages withour certified installation andrequalification services. After
maintenance performed by
one of our certified service
engineers, you receive
a separate service andmaintenance record, which isa highly useful document foryour audits. Know that yourinstrument is checked according
to the highest standards.

CERTIFIED TEST EQUIPMENT

Our service engineers only
use certified test equipment
to check and adjust yourinstrument, so rest assured you
will reach the highest level ofaccuracy.

YOUR MAINTENANCE BUDGETS
ARE NOW EASY TO PLAN
ELECTRICAL SAFETY CHECK

Investing in an Anton Paar
Certified Service program means
you can plan and approve asingle expense on service per
year, ensuring no unpredictable
costs and giving you peace ofmind.

Your Anton Paar service
engineer carries out a safety
check to ensure that theelectrical safety devices in the
instrument are in full working
order.

XPAIP023EN-LTR-I© 2022 Anton Paar GmbH | All rights reserved.
Specifications subject to change without notice.