For the Most Demanding cGLP/GMP Laboratories ......RudolphResearchAnalytical 55NewburghRoad,Hackettstown,NJ07840USA•Phone:973-584-1558•Fax:973-584-5440•E-mail:[email protected]•Internet:

TECHNICAL BULLETIN 924

For the Most Demanding cGLP/GMP Laboratories

The DDM 2910Automatic Density Meter

NVLAP LAB CODE: 200898-0Accreditation to ISO/IEC 17025:2005

United States Department of CommerceNational Institute of Standards and Technology

ApplicationsThe DDM 2910 Density Meter, with high precision Peltiertemperature control of sample, has the featuresto meet the needs of today’s industries.

Flexible Method ManagementFactory installed measurement methods allow forimmediate selection of the correct method to matchthe most common applications.

For unique measurement applications, create a sample methodusing an unlimited number of Concentration Tables, Formulas,and Polynomials to match the measurement methods used inyour laboratory. A few customized sample methods shown below:

• Concentration D2O – Heavy Water • Mole Fraction of Methanol

• Baumé of Hydrochloric Acid • % HNO3

• Normality of Sulfuric Acid • Monomer Solutions

• Density of Gasses and Aerosols • Potassium Permanganate

• Drug to Propellant Ratio • Hydrogen Peroxide

• Lead Content • Molar Solutions of EDTA

• ppm Gold in Acid • SG of Urine

• % Toluene in Heptane • Sweeteners

• Fat in Lubricant • Sodium Hydroxide

Setting up your custom method is as simple as filling out a fewscreens like the one below.

Densitometry

PETROLEUM• Measure API Values in accordancewith ASTM D1250, ASTM D4052,ASTM D5002 and DIN 51757

• QC incoming raw materials

• Research new products and additives

• Withstands harsh and heavyuse environments

• Calibrate using petroleum standards

CHEMICAL• Measure in units of Kg/m3, g/cm3,g/mL, pounds/gallon, specific gravity,Baumé and more

• Determine concentrations in: %,molarity, normality, mole fraction,ppm, and more

• Check batch consistency and ensureproper blending ratios

• Wetted materials compatible with themost aggressive chemicals

PHARMACEUTICAL• Capable of multiple measurementswith standard deviation, minand max reading for truecGLP/GMP compliance

• Complete IQ/OQ/PQ documentation

• Checking of raw materials andproduct release

• 21CFR11 Compliance; ElectronicSignature and Secure Data Storage

• Compliant with USP 29<841>, JP, BPand EP

BEVERAGE• Measure both alcoholic and non-alcoholic beverages with easy bubbledetection using VideoView™

• Direct and accurate means of°Brix determination, °Plato, Extract,% Solids

• Use apparent density function forproper filling volume monitoring

Rudolph Research Analytical 55 Newburgh Road, Hackettstown, NJ 07840 USA • Phone: 973-584-1558 • Fax: 973-584-5440 • E-mail: [email protected] • Internet: www.rudolphresearch.com

Density

Density Meterv(B)3.0.0.207 [DDM2910]

24-May-2012

12:05:40HELP

Specific Gravity

Method Information

Sample

Method

Measurement Mode

Measurement Criteria

Normality

Hydrochloric Acid

Baume

MENU METHOD PRINT EXPORT AIR PUMP ACCESSORIES

HCl

Multiple [5]

RAPID

Sample ID

Lot ID

Temperature (Deg C)Heated

Interface

Set

Sample

START

VIDEO

20.00

20.00 OFF

MEASUREMENTPARAMETERS

DISPLAYPARAMETERS

DISPLAYSETTINGS

SAVE CANCEL

>

Method Settings [Density]

Measurement Stability Criteria

Measurement Mode

Temperature Stability Criteria

Temperature

Air Pump Switch off mode

Density Input

Sample Details

Product

(+ or - 0.0000150 g/cm 3 for 30 secs with 5 decimals)

RESET

HEATED INTERFACE

DEFAULT AUTO DRY

1

0

Single

FULL

+/- 0.03

20.00

deg for 20 secs

secs

Deg C

Auto

Manual

Timeout

Density NC

Sample Lot ID

YES

Method Management

ADD

EDIT

RENAME

DELETE

VIEW

RESULTS

PRINT CONFIGURATION

CLOSE

NAME TYPE

AOAC Ethanol FactoryBrix FactoryCrude Oil FactoryDensity FactoryDensity Continuous FactoryDensity through Temperature FactoryDensity VC FactoryFactory QC Testing FactoryFuel Oil FactoryHCl CustomLubricants FactoryOIML Ethanol Factory

Versatile Communication CapabilityThe DDM 2910’s standard communication package includes:

• Ethernet Port for Network Cable Connection

• 5 USB ports

• 2 RS 232 ports

Allowing the capability to:

• Connect directly to Rudolph’s service department for remotetesting and diagnostics via Internet connection.

• Connect to any Windows® based printer via USB or direct tothe server via Windows® Print Library

• Save measurement data locally and directly to yourNetwork/Server

cGMP/GLP PrintingSample measurement reports are edited quickly and easily. Justimport your logo to the DDM 2910 Density Meter and print yourcompany’s customized “C of A” directly.

Traceable Calibration StandardsRudolph knows how important it is to calibrate with TraceableStandards and therefore, we include a standard in theaccessories provided with your density meter. The DDM 2910standard accessories include:

• Quick Start Guide • IQOQPQ Documentation

• Luer Syringes • Filling Nozzles

• Connecting Fittings & Tubing • Traceable Standard

• Rinse/Sample Waste Container • Manual


Full cGMP/GLP Compliance

Print your customized Certificateof Analysis including your

company logo directly from theDDM 2910 touch screen

Capable of making multiplemeasurements on a single sampleand reporting complete statisticaldata and all measurement results

Rudolph Research Analytical55 Newburg RoadHackettstown, NJ 07840 USA

Date: 26-Jan-2007

This sample was measured on DDM 2910 serial number 20212, manufactured by RudolphResearch Analytical, Hackettstown, NJ, USA.

Lot ID 2019

Temperature: 20.0 Deg C

No Sample ID Density Sp. Gravity Normality HCL % wt ° Baume Time

1 8421 1.0980 1.1000 6.009 19.95 12.94 14:20:50 PM1 8421 1.0980 1.1000 6.009 19.95 12.94 14:21:40 PM1 8421 1.0980 1.1000 6.009 19.95 12.94 14:22:30 PM1 8421 1.0980 1.1000 6.009 19.95 12.94 14:23:20 PM1 8421 1.0980 1.1000 6.009 19.95 12.94 14:24:10 PM

Counts : 5Average : 1.0980SD : 0.0000Maximum : 1.0980Minimum : 1.0980

NIST Standards Available


VideoView™ provides superior high resolution visual bubbledetection within your samples with live on-screen videoviewing. A full view of the entire U-tube is possible withoutany obstruction and provides Rudolph’s industry leading 10Xmagnification of bubbles if present in the sample.

Automatic scanning of the entire length of the U-tube ispossible as well as manually controlled viewing positions.The video clarity, magnification, and resolution is thevery best available. Rudolph’s exclusive VideoView™is protected under Patent #7,437,909.

Full 21CFR Part 11Instrument Level ComplianceThe DDM 2910’s 21CFR Part 11 software module is easilyenabled through the user friendly touch screen.This module gives you full compliance with:

• Electronic signature• Access levels• Internal write protected storage• Unique passwords• Write protected documents sentdirectly to server

The Simplicity of Touch Screen Measurement w

Oscillating U-Tube with ViscosityCorrection and Reference Oscillator

(Patent # 7,735,353)

The DDM 2910’s oscillating U-tube with full range viscositycorrection and reference oscillator allows long termcalibration stability and measurement at all temperatureswith a single calibration.

Density


24-May-2012

12:05:40HELP

Specific Gravity

Method Information

Sample

Method

Measurement Mode


Normality

Hydrochloric Acid

Baume


HCl

Multiple [5]

RAPID

Sample ID

Lot ID


Interface

Set

Sample

START

VIDEO

20.00

20.00 OFF

DensityVideoView Beta Ver.2.1.0.101

START

U-TUBE VIEW

CLOSE

Density

MEASURING 3 of 5

Mean:1.0474; Max:1.0474; Min:1.0474; SD:0.0000, n:2

Mean:1.0474; Max:

1.0474 g/cm 3>


24-May-2012

12:23:10HELP

Specific Gravity

Method Information

Sample

Method

Measurement Mode


Mean:2.095; Max:

Normality

Mean:9.95; Max:9.9

Hydrochloric Acid

Mean:6.81; Max:6.81; Min:6.80; SD:0.00, n:5

Baume


Sample ID

Lot ID

Temperature (Deg C)

Set

Sample

STOP

VIDEO

OFF

21CFR Part 11 Settings

CFR Settings Terminology OK CANCELPasswordSettings

Minimum Password Length 4

Password Expiry 48

Maximum login Attempts 3

Days

Full Feature VideoView™ with Automatic Scanning of Entire U-Tube


with the Flexibility of Embedded Windows® 7

Computer Embedded Windows 7 Based Flexibility• 8 gigabytes of internal memory allow almost unlimited capacity for savingmeasurement data. The DDM 2910 is network ready and data may also besaved directly to your server or to any directory desired.

• Internet access is possible directly from the DDM 2910’s touch screen. Theembedded Disk Protection feature protects the operating system againstmalware infections in networked environments.

• Embedded Windows 7 based navigation architecture is so intuitive that mostoperators will never read the manual. But should you wish to reference themanual, it is stored right on the DDM 2910’s internal memory.

• Copy methods,transferconcentrationtables, downloaddata, etc., viathe USB ports onthe front of unit.

• Five USB portsallow for quickand easyconnection to amouse, keyboard,printer, bar codescanner,or memory stick.

cGMP/GLP Calibration• Calibrate the DDM 2910 with 2 or 3Traceable Standards – calibrating withmerely air and water appears inconsistentwith cGMP/GLP compliance regulations.

• Can print out complete methodconfiguration, communication settings, aswell as calibration verification andcalibration adjustment data/history.

• Measured values canbe showncontinuously astemperature stabilityis being reached or, atthe discretion of theuser, measured valueswill only be displayedonce the final answeris reached andcompletely stable.

• Unlimited number of customizedcalibration adjustments andcalibration verifications possible.

• Complete History of CalibrationAdjustments and Verifications areavailable to View, Print, and/or Export

• Possible to set calendar reminders asto when Calibrations are due

Density


24-May-2012

12:05:40HELP

Specific Gravity

Method Information

Sample

Method

Measurement Mode


Normality

Hydrochloric Acid

Baume


HCl

Multiple [5]

RAPID

Sample ID

Lot ID


Interface

Set

Sample

START

VIDEO

20.00

20.00 OFF

Calibration Adjustment

Available Calibration Adjustments

Air, WaterAir, Water and 3rd PointTemperatureViscosityBarometric Pressure

PERFORM

SETTINGS

HISTORY

CLOSE

Calibration Verification

Calibration Verifications List

Water at 25CWater at 20CNIST Toluene Standard

PERFORM

ADD

EDIT

DELETE

HISTORY

CLOSE

Density


24-May-2012

12:05:40HELP

Specific Gravity

Method Information

Sample

Method

Measurement Mode


Normality

Hydrochloric Acid

Baume


HCl

Multiple [5]

RAPID

Sample ID

Lot ID


Interface

Set

Sample

START

VIDEO

20.00

20.00 OFF

Export Settings

Export Data

Data Location

File Naming Option

User Defined FileName

File Types

Delimiter

FIELD SETTINGS SAVE SAVEAUTO EXPORT SETTINGS

Yes

User Defined

Results Exp

CSV

Comma Overwrite file

Append to file

Browse For Folder

Select a directory to store the result

X?

Make New Folder OK Cancel

My Computer

Local Disk (C)

HP v125w (D)

densitymeter on ‘172.27.32.135’ (P:)

densitymeter on ‘172.27.32.163’ (Q:)

densitymeter on ‘172.27.32.151’ (R:)

Control Panel

Shared Documents

+

+

+

+

+

+

+


12RRA197 7/12

Automation Flexibility• Rudolph’s AutoSampler can be loaded with up to 240 samples

• Combine density and specific gravity measurementswith a polarimeter, refractometer, and colorimeter forsimultaneous measurements of:– Density/Specific Gravity– Refractive Index– Color– Optical Rotation/Specific Rotation

• Up to three different rinse solventsavailable for use;fully programmable

• Two sample loading modes; pressurized and suction;for optimizing sample transfer and measurement

• Customer’s unique sample bottles may be used to eliminatethe need to transfer samples into specialsized test tubes.

• Emergency samples measured at any time withoutstopping the AutoSampler or moving sample vials.

• Numerous configurations and solutions. Call us today forthe solution that is right for your application.

Measurement Density: 0 to 3 g/cm3

Ranges: Temperature: 0 °C to 95 °C(controlled via Peltier)Pressure: 0 to 10 bars

MeasurementModes: Continuous, Single, Multiple

MeasurementTechnique: Mechanical Oscillator Method

Accuracy: Density: 0.0001 g/cm3

Temperature: 0.05°C

Repeatability: Density: 0.00005 g/cm3

Temperature: 0.02 °C

Resolution: Density: 0.00001 g/cm3

Temperature: 0.01 °C

MinimumSample Volume: Less than 1mL

Wetted Materials: Borosilicate glass, Teflon(PTFE, ECTFE)

Operating System: Embedded Windows 7;embedded software safe from malwareand viruses

Display: 10.4 inch diagonal TFT type LCD withwide viewing angle, anti-glare flat paneltouch screen, 300 nits brightness, 800 x600 pixels, chemical and scratchresistant monitor, the industry’s largestand most flexible interface

Communication Touch Screen User InterfaceInterface: 5 – USB Ports

2 – RS232 PortsEthernet Port for NetworkConnection, Keyboard,Bar Code Scanner, Mouse,Network Capabilities

Video Scanning Video assisted view of entire cell,& Magnification: capable of approximately 10X

magnification with scanning camera

Internal Memory: 8GB Non-removable Compact Flash

Shipping 24.5" (L) x 17.5" (W) x 22" (H)Dimensions: 62cm (L) x 44cm (W) x 56cm (H)

Shipping Weight: 50 lbs. (23 kg)

Power Supply: 85 to 260 VAC; 48 to 62 Hz

PowerConsumption: 140 Watts at peak

MeasurementTime: 30 - 60 seconds

Origin ofManufactureand Design: USA

Specifications of the DDM 2910