Pharmaceutical Polarimeter, Industry Standard AUTOPOL® V PLUS
The AUTOPOL® V Plus is the ideal Pharmaceutical Polarimeter. The V PLUS has the validation tools and features to satisfy today’s global pharmaceutical companies, including: instrument level 21CFR Part 11 compliance, NIST traceable calibration standards and a global list of installations. Rudolph Research has thousands of satisfied customers who praise the Autopol® V Plus’s quality, accuracy and reproducibility.
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AUTOPOL® V Plus Pharmaceutical Polarimeter Standard Features and Accessories
- TempTrol™ — Electronic cooling & 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
- Domestic 3-year warranty and 20-year support guarantee
- International warranty varies by country
- Standard Accessories: TempTrol™, NIST Traceable Quartz Standard (single rotation), TempTrol™ 100mm Polarimeter Cell, TempTrol™, Temperature Validation Cell, Built-In Sample Measurement Probe
The AUTOPOL® V Plus Pharmaceutical Polarimeter Advantage
- 6m HCl acid resistance: Silco Steel coating on the polarimeter chamber temperature transfer surface and a Hastelloy measurement cell with NIST certificate certifying optical path length.
- To meet the FDA’s latest position on measurement bracketing, the Autopol® V Plus comes with a 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 (shown below).
Network and Printer Communications Simplified
- Ethernet Port for Network Cable Connection
- Internet access allowing connection to Rudolph’s service department 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
2 Quartz Plates are stored within the instrument, ready for automatic calibration. Rudolph is the only Polarimeter manufacturer in the world producing certified 3 rotation Quartz Calibration Standards accredited by NVLAP and traceable to NIST, with an accuracy of ± 0.002 degrees Optical Rotation.
Rudolph strongly encourages and customers considering a Pharmaceutical Polarimeter should strongly consider 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 Standard is certified by an accredited independent body (NVLAP ) and Traceable to NIST.
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.
Patented TempTrol™ Technology Eliminates the Need for a Water Bath. Here is How the TempTrol™ System Works:
Temperature stability is a requirement for a Pharmaceutical Polarimeter, speed and easy of coming to temperature is also required. The the Autopol V PLUS, Temperature is selected via touch screen. Temperature selection of 25°C shown above.
TempTrol™ cell with mating heating & 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 your TempTrol™ equipped Autopol® 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).
Place the TempTrol™ cell in your TempTrol™ equipped Autopol® polarimeter sample chamber to measure 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
• Rudolph supplies Ceramic Quartz Cells as standard on Autopol V, V PLUS and VI polarimeters
• Resistant to 6 Molar HCL – Ceramic Quartz Cells are impervious to acids and transfer heat quickly and evenly.
• Rudolph’s exclusive, patented TempTrolTM cells use an acid resistant transfer surface to mate with the Proprietary Ceramic Coating TempTrolTM active heating and cooling transfer
surface.
• Rudolph Polarimeter cells are easy to handle, lightweight, easy to fill and easy to clean. Cell ends are removable for thorough cleaning.
• Rudolph 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.
Rudolph provides a temperature validation cell with every TempTrol™ system. The temperature validation cell along with optional NIST traceable thermometer is designed to validate the temperature control performance of the polarimeter and cell to ±0.2°C.
Pharmaceutical Polarimeter with an Intuitive Windows® Embedded Based 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 AUTOPOL® V PLUS’s touch screen. This feature allows real time contact with Rudolph Research Analytical’s Service and Technical Support Team who can access your instrument remotely to assist in Window navigation, 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 right on the AUTOPOL® V PLUS’s 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 like the one shown to the right.
Pharmaceutical Polarimeters require full 21CFR Part 11 Instrument Level Compliance
The AUTOPOL® V PLUS’s 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
- Pharmaceutical Polarimeters are required to have very strict protocols – none can be overlooked.
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.
Pharmaceutical Polarimeter must provide 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.
Rudolph Research Analytical — still protecting your Pharmaceutical Polarimeter investment after 30 years
Today our Service Technicians have access to state of the art diagnostic tools and have a depth of knowledge that often lets them solve problems right over the phone. Our customers really appreciate the same day phone call by a real technical service person who wants to solve their problem. Our customers know that they can expect this support for many years to come as Rudolph is still repairing instruments which were built in the 70’s. We manufacture Digital Polarimeters and back them with a 20 year commitment to service them!
All Rudolph Instruments carry our exclusive 20 Commitment to service your instrument.
Rudolph Research Analytical offers a comprehensive range of Preventive Maintenance and Service Programs. Rudolph has demonstrated a commitment to its customers by keeping installed instruments operational, not only for 20 years, but in some cases for over 40 years. This long-term commitment to keeping our instruments running makes the cost of ownership, over the life of a Rudolph Instrument, one of the lowest in the laboratory market segment. At the date this document was published, there is no other laboratory instrument manufacturer guaranteeing service and technical support for 20 years. View the entire 20 Service Guarantee.
