Refractometers & Polarimeters for the Pharmaceutical Industry - Bellingham + Stanley - #1

Offering the widest measuring range on the market (1.30-1.70 RI) and with Peltier temperature control, RFM800 refractometers are suitable for use in the pharmaceutical industry.

Strict controls within the pharmaceutical industry dictate the need for high levels of security in terms of sample analysis and data control. The level of security in the instrument can now be set to low, medium or high.

The highest standard of security is compliant with the technical requirements of FDA regulation 21CFR Part 11, where access to measurement and data transfer is strictly controlled. This makes use of extended passwords and electronic signatures that have a controlled schedule of validity and re-usage. Changes to the instrument configuration are also recorded in the instrument as an 'audit trail' that also records calibration activity, all of which may be extracted using PC software.

The ADP440 is a single wavelength, high accuracy polarimeter suitable for use in many applications and is especially suited for use in pharmaceutical laboratories where compliance with European Pharmacopoeia is required.

New optics featuring a 'no maintenance' yellow LED (589.3nm) and interference filter together with a photodiode detector allows reading of samples of up to 3.0 OD.

Data handling is in accordance with GLP providing a record of measurement date, time, batch and operator numbers. A calibration record is also available to be displayed or printed. Data handling may also be configured in accordance with the technical requirements of FDA regulation - 21CFR Part 11.

The PRH range of digital in-line refractometers derives from the successful technology used in the RFM laboratory refractometers, which are used in QA laboratories world-wide. PRH systems are suitable for a wide range of applications in the chemical and pharmaceutical industries. Recent installations within the pharmaceutical industry require the continuous measurement of sucrose for vaccination purposes.

B+S Ltd. offer a number of high accuracy calibration standards, some traceable to NIST and manufactured under the guidelines of BS ISO 17025, suitable for calibrating refractometers and polarimeters. Refractometer standards have a shelf life of 12-months whilst Quartz Control Plates are for calibrating polarimeters.

■ FDA Regulation 21CFR Part 11

■ BS ISO 17025

■ B+S Ltd. a UKAS accredited calibration laboratory number 0834

■ B+S Ltd. a UKAS accredited testing laboratory number

2798

A Validation Log is available for all instruments.

Longfield Road, Tunbridge Wells, Kent TN2 3EY, United Kingdom.

Telephone: +44 (0) 1892 500400 Fax: +44 (0) 1892 543115

Website: www.bellinghamandstanley.com Email: sales@bellinghamandstanley.co.uk

Refractometers and Polarimeters for the Pharmaceutical Industry/Mailshot/August 2006