21CFR Part 11 Pharmaceutical Polarimeter
The Rudolph Research Analytical Autopol V Plus is a pharmaceutical grade instrument
21CFR Part 11 compliant
Pharmaceutical grade polarimeter
Electronic cooling and heating
Automated sampling
21CFR Part 11 Compliant Polarimeter
The Autopol V Plus is the ideal pharmaceutical polarimeter. The V Plus has the validation tools and features required by today’s pharmaceutical companies, including instrument level 21CFR Part 11 compliance and NIST traceable calibration standards. The Autopol V Plus is known worldwide for quality, accuracy and reproducibility.
Autopol V Plus Polarimeter Standard Features and Accessories
- TempTrol: electronic cooling and heating from 15°-35°C
- Six Standard Wavelengths: 365nm, 405nm, 436nm, 546nm, 589nm and 633nm
- 21CFR Part 11 Compliance: Electronic Signature and secure local electronic data storage
- Standard Accessories: TempTrol, NIST traceable quartz standard (single rotation), TempTrol 100mm polarimeter cell, TempTrol temperature validation cell, built-in sample measurement probe
Try Before You Buy
The Autopol V Plus is available for a short term trial.
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Polarimeters
AutoPol V+ and VI
Measurement
Fill Station
Pharmaceutical Specification
- 6m HCl acid resistance with Silco steel coating on the polarimeter chamber temperature transfer surface and a Hastelloy measurement cell with NIST certificate certifying optical path length
- NIST traceable quartz plate with three rotations: +0.998° Arc, +10.998° Arc, -10.000° Arc. Each rotation has a NIST certificate
- Windows based navigation architecture is so intuitive that most operators will never read the manual. But should you wish to reference the manual, it is stored right on the Autopol V Plus
internal memory - Available with automated sampling
- Three USB ports allow quick and easy connection to a mouse, keyboard, printer, bar code scanner, or memory stick. One USB port is located on the front of the unit (shown above) and two USB ports are located on the back of the unit
Network and Printer Communications Simplified
- Ethernet port for network cable connection
- Internet access for remote testing and diagnostics
- Connect to any Windows based printer via USB or direct to the server via Windows print library
- Save measurement data direct to your Network/Server/USB Drive
Quartz Plates
2 Quartz Plates are stored within the instrument, ready for automatic calibration. Rudolph Resaerch is the only Polarimeter manufacturer in the world producing certified 3 rotation Quartz calibration standards accredited by NVLAP (Lab Code 200898-0) and traceable to NIST, with an accuracy of ± 0.002 degrees optical rotation.
Pharmaceutical Polarimeter should feature Quartz calibration standards with 3 rotational values above, below and near the sample under test to comply with FDA rulings related to “Sample Bracketing” and EP’s most recent calibration guidelines on linearity.
Each Quartz plate is positioned for calibration by the instrument right from the touch screen. Calibration is thus fully automated and requires no handling of the Quartz Control Plate.
TempTrol Technology Eliminates Water Bath
Temperature stability is a requirement for a pharmaceutical polarimeter, speed and ease of reaching temperature is also required. The Autopol V Plus temperature is selected via touch screen.
Temperature selection of 25°C
TempTrol cell with mating heating and cooling transfer surface manufactured with proprietary ceramic coating
TempTrol heating and cooling transfer surface
Temperature Measurement Port
For improved temperature performance or when working with acids (HCl) use the measurement port in the body of the cell. This also allows the inlet and outlet ports to be capped to avoid evaporation, fumes and spillage.
Temperature Measurement Probe
Place the TempTrol cell in the Autopol V Plus sample chamber to measure to within ±0.2°C of the USP, EP, JP or BP specified temperature (normally 20°C or 25°C ±0.5°C). For improved temperature performance or when working with acids (HCl) use the measurement port in the body of the cell. This also allows the inlet and outlet ports to be capped to avoid evaporation, fumes and spillage.
Ceramic Quartz Cells
- Supplied as standard on Autopol V Plus
- Resistant to 6 Molar HCL, ceramic quartz cells are impervious to acids and transfer heat quickly and evenly
- Patented TempTrol cells use an acid resistant transfer surface to mate with the proprietary ceramic coating active heating and cooling transfer
surface - Polarimeter cells are easy to handle, lightweight, easy to fill and easy to clean and cell ends are removable for thorough cleaning
- Cells are light and have a large thermal transfer surface so they come to temperature quickly and evenly across the cell
- Cell apertures are smaller than the internal bore diameter, therefore, small air bubbles do not impact sample measurement
A temperature validation cell is supplied with every TempTrol system. Along with an optional NIST traceable thermometer it is designed to validate the temperature control performance of the polarimeter and cell to ±0.2°C.
Pharmaceutical Polarimeter with Acid Resistance for a Long Life.
The Autopol V Plus polarimeter comes standard with Rudolph’s Hastelloy upgrade option. This option includes a Hastelloy cell and Silco Steel™ cell chamber for increased resistance to acids like 6 Molar HCl.
Pharmaceutical Polarimeter Intuitive Windows Interface
- 32 gigabytes of internal memory allow almost unlimited capacity for saving measurement data. The Autopol V Plus is network ready and data may also be saved directly to your server or to any directory desired
- Internet access is possible directly from the touch screen. This feature allows remote access to your instrument remotely to assist in method setup and troubleshooting
- Windows based navigation architecture is so intuitive that most operators will never read the manual. But should you wish to reference the manual, it is stored in the internal memory
- Three USB ports allow quick and easy connection to a mouse, keyboard, printer, bar code scanner, or memory stick. One USB port is located on the front of the unit and two USB ports are located on the back of the unit
Flexible Method Management
Install your own measurement methods for immediate selection of the correct method to match your most common tests. Setting up your own custom methods is as simple as filling out a few screens.
Full 21CFR Part 11 Instrument Level Compliance
The 21CFR Part 11 software module is easily enabled through the user friendly touch screen. This module gives you a Digital Polarimeter in full compliance with:
- Electronic signature
- Access levels
- Internal write protected storage
- Unique passwords
- Write protected documents sent directly to server
- Audit trail
- Strict protocols
21CFR11 mode is enabled via the Set 21CFR11 button
After clicking the Enable 21CFR11 button, the user must also select to either Enable Operator, Enable Review or both
Add/Edit Users allows the creation of new 21CFR11 users, the ability to edit an existing user, and the ability to lock and unlock accounts
Also available the Autopol IV, Autopol V and Autopol VI
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Specification
Measuring Mode: Optical Rotation Specific Rotation Specific Rotation Plus Concentration User Defined Scale Sugar Degrees °Z(ISS)
Measuring Scale: Degrees Arc, % Concentration
Measuring Range Arc Optical Rotation: ± 89.99°
Measuring Range Arc Specific Rotation: ± 999.99°
Measuring Range Concentration: 0-99.9%
Resolution: 0.001° Arc Optical Rotation 0.001% Concentration 0.001° Specific Rotation
Reproducibility: 0.002° Arc
Standard Model Accuracy: 0.002° up to 1°, 0.2% up to 5°, 0.01° above 5°
AP Model Accuracy and Resolution (Autopol V Plus Single) Accuracy: ±0.002° Arc over ±89.9° Arc Selectable Resolution 0.01°, 0.001°, 0.0001° Arc Optical Rotation
AP Model Accuracy and Resolution (Autopol V Plus Six Wavelength) Accuracy: (546nm and 589nm): ±0.002° Arc over ±89.9° Arc Selectable Resolution 0.01°, 0.001°, 0.0001° Arc Optical Rotation
Prism: Glan Thomson calcite quartz
Optical Wavelengths: 365nm, 405nm, 436nm, 546nm, 589nm, 633nm (other wavelengths available)
Wavelength Selection: Touch Screen Selectable: 6 Standard
TempTrol Range: Automatic Electronic Heating & Cooling 15°-35°C
TempTrol Accuracy: ± 0.2°C
Temperature Probe Range: 10°-100°C
Temperature Probe Accuracy: ± 0.1°C
Acid Resistance: Hastelloy measurement cell and Silco Steel™ sample chamber (standard)
Measurement Time: 4°/sec slewing rate & 5 sec nominal settling time
Light Source: Tungsten-halogen 6V, 20W, avg. 2,000 hr life
Sample Chamber: Accepts sample tubes up to 200mm
Data Storage: 32 GB Non-removable Compact Flash
Communication Interface: 3 USB Ports, 2 RS232 Ports, Ethernet Port for Network Connection
Calibration: Automatic calibration via touch screen
Operating System: Windows Embedded
Display: 10.4 inch diagonal, 800 x 600 pixels, colour, flat panel monitor with resistance touch screen interface, 200 nits brightness, gasketted for spill protection
User Interface: Touchscreen
Automatic Sensitivity Control: Measures samples with transmittance as low as 0.01% (up to O.D. 4.0)
Input Power: 85-260 VAC; 48-62 Hz, 150-200 Watts consumption
Dimensions: 813mm W x 292mm H x 457mm D
Weight: 41 kg