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Cleaning validation using the Sievers TOC meter.

The use of TOC in cleaning validation is gaining attention.

TOC is an effective tool for cleaning validation of pharmaceuticals, cosmetics, and medical devices. By using TOC for cleaning validation, improvements in quality, risk reduction, and efficient operations can be achieved. TOC is a simple analytical method that rapidly detects low concentrations of organic compounds and can identify degradation products and contaminants that HPLC cannot detect. Compared to HPLC, which is a specific analytical method that detects only specific components, TOC, being a non-specific analytical method, can comprehensively confirm that excipients, degradation products, and cleaning agents are adequately cleaned. Furthermore, TOC simplifies method development and minimizes equipment downtime, leading to increased efficiency. By using TOC, not only can the cleaning process be evaluated quickly, but it also reduces the workload, maintenance costs, and running costs compared to HPLC.

Related Link - https://aqua-ckc.jp/cleaningvaridation

basic information

The Sievers TOC analyzer accurately measures organic matter in samples without being affected by coexisting substances, using its unique gas-permeable membrane conductivity measurement method. Sievers helps simplify method development and sample pretreatment. If the TOC concentration of a sample is unknown, the automatic reagent feature can ensure complete oxidation of the organic matter. With Sievers' proven technical expertise, excellent accuracy and recovery rates are guaranteed.

Price range

Delivery Time

Model number/Brand name

Sievers M9

Applications/Examples of results

Pharmaceutical cleaning validation Medical device cleaning validation Chemical cleaning evaluation Food and beverage cleaning evaluation

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Real-time release through online cleaning validation using total organic carbon, inorganic carbon, and conductivity data.

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TOC recovery rate of complex compounds: cleaning agents

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Comparison of TOC Cleaning Validation Swab Kits.

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TOC measurement of 0.2M sodium hydroxide using the Sievers M9 type.

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TOC measurement of 0.2M potassium hydroxide using the Sievers M9 type.

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Simultaneous measurement of TOC and conductivity to analyze non-conductive organic substances in cleaning agents.

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TOC recovery rate using STERIS Life Sciences' cleaning agent_Sievers M9 type

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Validation of TOC Method for Cleaning Validation in the Pharmaceutical Industry

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Calculation of Maximum Allowable Carryover (MAC) in Cleaning Validation

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Sievers Validation Support Package for Cleaning Validation

TECHNICAL

PAT Application: At-line TOC measurement for cleaning validation and product changeover.

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Reduction of cleaning validation and product changeover costs by 92% through in-line TOC measurement.

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Cleaning validation: Verifying the performance of the cleaning process.

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Evaluation of the validity of cleaning standards based on engineering capability index

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Analysis method for cleaning validation

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Detection of TOC and conductivity of CIP-100 using the Sievers M series.

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TOC recovery rate of insoluble and difficult-to-decompose compounds

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Cost comparison of TOC and HPLC (using TOC analyzers for cleaning validation)

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Sievers M9 type used for lab_atline_online_cleaning_validation

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Real-time low-flow cleaning efficacy evaluation of pharmaceuticals using TOC and conductivity.

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Cleaning evaluation: Microbial TOC recovery rate and linearity

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Comparison of TOC measurements in the cleaning validation of protein samples.

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Swab TOC recovery rate of the compound in the worst-case scenario (feasibility test)

APPLICATION_NOTE

TOC Analyzer for Pharmaceuticals Sievers M9

PRODUCT

Sievers TOC Vial Style_Infographic

PRODUCT

Five Tips for Successful Cleaning Validation

TECHNICAL

Cleaning Validation: Transition from HPLC to TOC - Three Factors to Consider

TECHNICAL

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Since our establishment in 1967, we have been dedicated to the development and dissemination of water quality measurement devices that anyone can use quickly, easily, and with high precision. In today's world, where the effective use of water, a limited resource, is required alongside environmental conservation, we aim to be a total solution provider that responds to all water environments by utilizing our water quality measurement devices, technology, and services. Furthermore, leveraging the latest technology and years of know-how, we are committed to delivering user-friendly and reliable water quality measurement devices more affordably, quickly, and widely.