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TOC and Conductivity Analyzer, purified and injectable water control loops, model 500RL

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Description

Specifications

Parameters

Standards

Accessories

The Sievers Model 500 TOC Analyzer is a process analyzer suitable for compliance with all Pharmacopeia regulations for purified water and water for injection. It is designed to measure with accuracy and precision, generating in the process reliable results comparable to laboratory measurements. The analyzer allows continuous measurement at different sampling points and can also be used for measurement of samples taken in vials at the point of use. It automates functional verification procedures for performance, including Calibration, Suitability; Accuracy, Precision, Linearity, Specificity and Ruggedness.

Meets CFR21 Part 11 computer records security requirements.
Complies with USP ˂643˃, USP ˂645˃, EP 2.2.44 for TOC and Conductivity for Purified Water (PW) and Water for Injection (WFI) and JP 16.
Allows online measurement and measurement of samples taken in bottles or vials.
Low Maintenance.
Stable calibration for one year.

Pharmaceutical industry: - TOC measurement according to the requirements of the EP, USP and JP Pharmacopoeia monographs for Purified Water and Water for Injection. - On-line cleaning validation. Monitor TOC and conductivity of wash water to determine the presence of residues during cleaning. As of March 31, 2021, it has been replaced by the new model M500 / M500e.

TOC range: 0.03 ppb to 2500 ppb

Accuracy: ˂ 1% RSD

Accuracy: ±5 of measurement

Conductivity range: 0.01 to 35 µS/cm

Accuracy: ˂ 0.25% RSD

Accuracy: ±0.005 µS/cm

Modes of analysis: on line, and vials

Stable calibration for 12 months

Analysis time: 6 minutes

Sample temperature: 1 to 95 ºC

Ambient temperature: 10 to 40 ºC

Sample pressure: Up to 100 psi

Sample flow rate: 50 to 300 ml/min

Outputs: 4-20 mA (3); Serial RS232 (1); USB (1); Printer (1)

Power supply: 100 – 240VAC, 100W, 50/60 Hz

Dimensions: 42cm x 48cm x 27cm

Weight: 16.9 Kg

CE, UL/cUL certified

TOC / Conductivity / T / IC / TC

US Pharmacopeia (USP) <643>

European Pharmacopeia (EP) 2.2.44 Total Organic Carbon

Indian Pharmacopeia (IP) 2.4.30, Chinese Pharmacopeia (CP) Appendix VIII R

Japanese Pharmacopoeia 16 (JP16) 2.59 monographs for purified water and water for injection.

SuperIOS. Automates functional verification protocols for system performance, including Calibration, Suitability, Accuracy, Precision, Linearity, Specificity and Robustness.

DataGuard facilitates compliance with CFR21 Part 11 computer records security.

DataShare. Software for results reporting and verification.

Validation Documents (IQ, OQ and PQ).

Certified standards for validation protocols.

Other accessories, Consult us

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