セントラル科学 List of Products and Services

"PAL-pH" is a portable pH meter that can be used in a wide range of fields, including food and beverages, soil, water-soluble cutting oils, and alkaline cleaning solutions.

• pH Meter
• pH meter
• pH meter

Scuba 3s is a smart and multifunctional water quality tester that can easily measure up to 9 parameters of water quality, such as residual chlorine, pH, and cyanuric acid. It meets the needs for "easy measurement" and "sending data to a smartphone" in water quality management for pools, spas, and bathing facilities.

• Water quality testing
• Residual chlorine meter
• Simple water quality test

The MD150 series is a multi-parameter photometer that can quickly and accurately measure multiple water quality parameters. It features an innovative optical system and an intuitive user interface, making it ideal for use in various settings such as pools, laboratories, and fieldwork. It is equipped with a robust design compliant with IP67 standards and flexible data management capabilities via NFC/USB-C. 【Key Features】 Multi-parameter support: Chlorine, pH, bromine, ozone, chlorine dioxide, cyanuric acid, alkalinity, calcium hardness, and more Intuitive operability: Guided by icons and animations, LCD with backlight One-time zero function: Valid for 8 hours as long as the power is not turned off, reducing measurement time High robustness: IP67 compliant, dustproof and waterproof design, ergonomic design with anti-slip features Data management: Compatible with AquaLX app and Lovibond Data Expert via NFC or USB-C GLP compliant: Automatic data saving, protocol recording, user-defined method support

• Water quality testing

The MD50 series is a high-precision spectrophotometer specialized for single parameters. It combines an innovative optical system with intuitive operability, enabling rapid and accurate water quality analysis in the field. Its robust design compliant with IP67 allows for stable measurements even in harsh environments. 【Main Features】 - High precision & rapid measurement: The innovative optical system and one-time zero function enable accurate measurements in a short time. - Intuitive operability: Guidance through icons and animations, with result notifications via backlight (green = normal, red = abnormal). - Data management: Data can be transferred via NFC or USB-C. Equipped with GLP-compliant automatic data saving function. - High versatility: Compatible with various reagents such as tablets, powders, and liquids. - Durability: IP67 waterproof design, capable of up to 5000 measurements with two AA batteries.

• Water quality testing

Ultra-high sensitivity detection: 0.010 to 100 ppb B, quantification limit 0.030 ppb B Rapid measurement: 3-minute or 6-minute measurement cycle Selectable flow path configuration: 1-path / 2-path model Intuitive operation: 10.1-inch multi-color touch screen High dust and water resistance: IP45 rating Diverse output options: Analog output, RS-232, Modbus TCP/IP, etc.

• Ultrapure water production equipment
• Water quality testing
• Pharmaceutical water production equipment and facilities

In the pharmaceutical industry, processes that are free of waste and continuous improvement are required. Efficient processes enable the provision of safe and high-quality pharmaceuticals when needed. By adopting real-time testing of pharmaceutical water, it is possible to streamline the manufacturing process while ensuring quality. At Central Science, real-time testing of TOC and conductivity using the Sievers TOC analyzer optimizes the monitoring of pharmaceutical water systems, achieving better process control, productivity improvement, and risk management for cGMP processes. **Features** - Reduces costs, resources, contamination, lab errors, and data delays associated with traditional lab analysis - Detects and addresses OOS and OOT in real-time - Continuous control and system validation - Setting of alert levels and action levels based on trend data In the PDF data, you can find technical materials related to TOC real-time testing and information on the "Online TOC Analyzer Sievers M500" and "Sievers M9 Lab Model for Pharmaceutical Water/Cleaning Validation." *For more details, please download the catalog or contact us directly.*

• Pharmaceutical water production equipment and facilities
• Water quality testing
• Other water quality analysis

The SD series pocket testers are easy to carry with one hand and are small enough to fit in your pants pocket. With a refreshed design, they can instantly measure pH, ORP, conductivity, salinity, TDS, and more on-site. - Transparent lid for easy maintenance and storage - Optimal design for stable vertical placement - Screen display designed for ease of use - Easy battery and electrode replacement

• Water quality testing

The SD series pocket testers are easy to carry with one hand and are compact enough to fit in your pants pocket. With a refreshed design, they can instantly measure pH, ORP, conductivity, salinity, TDS, and more on-site. - Transparent lid for easy maintenance and storage - Optimal design for stable vertical placement - Screen display designed with user-friendliness in mind - Easy replacement of batteries and electrodes

• Water quality testing

The SD series pocket testers are easy to carry with one hand and are compact enough to fit in your pants pocket. With a refreshed design, they can instantly measure pH, ORP, conductivity, salinity, TDS, and more on-site. - Transparent lid for easy maintenance and storage - Optimal design for stable vertical placement - Screen display designed for ease of use - Easy battery and electrode replacement

• Water quality testing

The SD series pocket testers are easy to carry with one hand and are compact enough to fit in your pants pocket. With a refreshed design, they can instantly measure pH, ORP, conductivity, salinity, TDS, and more on-site. - Transparent lid for easy maintenance and storage - Optimal design for stable vertical placement - Screen display designed with user-friendliness in mind - Easy battery and electrode replacement

• Water quality testing

【High Precision】 - High precision and rapid measurement with an innovative optical system - Quick measurement with one-time zero function - Data storage compliant with GLP 【Ease of Use】 - Simple operability - Display with animations - Automatic storage of measurement results for 100 times 【Durability】 - Portable design for any environment - Robust design with IP67 rating - Capable of up to 5000 measurements on dry batteries

• Water quality testing
• Residual chlorine meter

【High Precision】 - High precision and rapid measurement with innovative optical systems - Quick measurement with one-time zero function - Data storage compliant with GLP 【Ease of Use】 - Simple operability - Display with animations - Automatic storage of up to 100 measurement results 【Durability】 - Portable design for any environment - Robust design with IP67 rating - Capable of up to 5000 measurements on dry batteries

• Water quality testing

【High Precision】 - High precision and rapid measurement with innovative optical systems - Quick measurement with one-time zero function - Data storage compliant with GLP 【Ease of Use】 - Simple operability - Display with animations - Automatic storage of up to 100 measurement results 【Durability】 - Portable for any site - Robust design with IP67 rating - Capable of up to 5000 measurements on dry batteries

• Water quality testing

【High Precision】 - High precision and rapid measurement with innovative optical systems - Quick measurement with one-time zero function - Data storage compliant with GLP 【Ease of Use】 - Simple operability - Display with animations - Automatic storage of up to 100 measurement results 【Durability】 - Portable design for use in any environment - Robust design with IP67 rating - Capable of up to 5000 measurements on dry batteries

• Water quality testing

【High Precision】 - High precision and rapid measurement with innovative optical systems - Quick measurement with one-time zero function - Data storage compliant with GLP 【Ease of Use】 - Simple operability - Display with animations - Automatic storage of up to 100 measurement results 【Durability】 - Portable for any site - Robust design with IP67 rating - Capable of up to 5000 measurements on dry batteries

• Water quality testing

【High Precision】 - High precision and rapid measurement with innovative optical systems - Quick measurement with one-time zero function - Data storage compliant with GLP 【Ease of Use】 - Simple operability - Display with animations - Automatic storage of up to 100 measurement results 【Durability】 - Portable design for any environment - Robust design with IP67 rating - Capable of up to 5000 measurements on batteries

• Water quality testing
• Turbidity meter/color meter

【High Precision】 - High precision and rapid measurement with innovative optical systems - Quick measurement with one-time zero function - Data storage compliant with GLP 【Ease of Use】 - Simple operability - Display with animations - Automatic storage of up to 100 measurement results 【Durability】 - Portable for use in any environment - Robust design with IP67 rating - Capable of up to 5000 measurements on dry batteries

• Water quality testing
• Residual chlorine meter

【High Precision】 - High precision and rapid measurement with an innovative optical system - Quick measurement with one-time zero function - Data storage compliant with GLP 【Ease of Use】 - Simple operability - Display with animations - Automatic storage of measurement results for 100 times 【Durability】 - Portable for any site - Robust design with IP67 rating - Capable of up to 5000 measurements on dry batteries

• Water quality testing
• Residual chlorine meter

【High Precision】 - High precision and rapid measurement with innovative optical systems - Quick measurement with one-time zero function - Data storage compliant with GLP 【Ease of Use】 - Simple operability - Display with animations - Automatic storage of up to 100 measurement results 【Durability】 - Portable design for any environment - Robust design with IP67 rating - Capable of up to 5000 measurements on dry batteries

• Water quality testing

【High Precision】 - High precision and rapid measurement with innovative optical systems - Quick measurement with one-time zero function - Data storage compliant with GLP 【Ease of Use】 - Simple operability - Display with animations - Automatic storage of up to 100 measurement results 【Durability】 - Portable design for any environment - Robust design with IP67 rating - Capable of up to 5000 measurements on dry batteries

• Water quality testing

- For managing sludge accumulation in initial and final sedimentation tanks, thickener, etc. Monitors up to a maximum water depth of 15m. - Long-term maintenance-free. Removes interfering bubbles with a non-contact wiper. - No calibration required. - Connects to the IQ sensor network system. Control and display unit 282/284 or 2020 3G / Graphically displays signal strength and water depth. Can be monitored in combination with DO, pH, SS, and ammonia.

• Water quality testing

Sievers brand TOC analyzers, standard solutions, and consumables have been used by users around the world for over 30 years. Recognized as a global leader in TOC measurement technology, Sievers provides the highest quality standard solutions and consumables through expertise and Six Sigma methods. The pre-prepared standard solutions are designed for applications such as calibration, verification, and system suitability, and can also be used with TOC analyzers from other manufacturers. Additionally, we offer TOC vials with a cleaning guarantee of less than 10 ppb and cleaning validation kits.

• Analytical Equipment and Devices

In the pharmaceutical industry, cleaning validation and product changeover are essential processes to ensure product quality and safety. However, traditional laboratory sample analysis is time-consuming and costly, leading to delays in production schedules. Therefore, the introduction of at-line TOC measurement is gaining attention. - Benefits of Introducing Portable TOC Meters The Sievers M9 portable TOC meter provides measurement results that are equal to or better than those obtained in the lab. The manufacturing team can perform sampling and measurement on-site and quickly document the results, eliminating the need for the quality control team to report results and wait for equipment approval. By implementing at-line TOC methods, annual sampling costs can be significantly reduced.

• Analytical Equipment and Devices

In the pharmaceutical industry, cleaning validation and product changeover are essential processes to ensure product quality and safety. In particular, the use of at-line TOC measurement based on PAT is very useful. - PAT Guidance Introduced in 2004, PAT guidance is an innovative framework for drug development, manufacturing, and quality assurance. This guidance provides a scientific, risk-based approach and promotes innovation and efficiency improvements by the industry and regulatory agencies. The PAT guidance introduces the "at-line" method, which involves sampling and measurement close to the process. By using the Sievers M9 portable TOC meter, it becomes possible to test rinse samples and swab samples for cleaning validation and product changeover at-line.

• Analytical Equipment and Devices

In the pharmaceutical industry, cleaning validation of manufacturing equipment is a crucial element of quality control. In particular, accurately detecting residues of alkaline cleaning agents is essential for ensuring product safety and quality. Here, we will introduce a method for simultaneously measuring the TOC and conductivity of alkaline cleaning agents using the Sievers M9 TOC analyzer. - Characteristics and Importance of Alkaline Cleaning Agents We selected CIP-100Ⓡ as the alkaline cleaning agent commonly used for cleaning manufacturing equipment during product changeovers in the pharmaceutical industry. Its composition includes potassium hydroxide (10-30%) and disodium EDTA (1-5%), which contribute to its cleaning effectiveness. In cleaning validation, it is important to confirm that no cleaning agent remains on the equipment after the final rinse.

• Analytical Equipment and Devices

In the pharmaceutical industry, cleaning validation is an essential element for ensuring the reliability and quality of the manufacturing process. In particular, cleaning validation using TOC is gaining attention for its accuracy and efficiency. Sievers' validation support package for cleaning validation provides a systematic approach to building cleaning validation and complements the existing quality management standards, requirements, and guidelines commonly used in the pharmaceutical and biopharmaceutical industries. This document includes guidance, construction examples, worksheets, templates, and sample protocols, significantly reducing the time and effort required to establish cleaning validation.

• Analytical Equipment and Devices

Cleaning validation is an essential process in pharmaceutical manufacturing. However, traditional manual sampling and swab testing are time-consuming, carry a high risk of human error, and are costly. This is where Process Analytical Technology (PAT) comes into play. Based on guidance published by the FDA in 2004, this technology provides recommendations for understanding, controlling, and continuously verifying processes. By using PAT, it becomes possible to understand processes without manual sampling or analysis, leveraging real-time data. Utilizing real-time data on TOC, IC, and conductivity from online TOC analyzers enables comprehensive understanding of the cleaning process through online cleaning validation.

• Analytical Equipment and Devices

In the food and beverage industry, effective cleaning of manufacturing equipment is essential to deliver high-quality and safe products to consumers. It is particularly important to appropriately reduce the risk of contamination by microorganisms. According to the FDA, the primary cause of product recalls in the food and beverage industry in 2017 was product contamination by microorganisms. Therefore, proper cleaning processes are required to reduce microbial contamination. Additionally, it is important to have means to verify the effectiveness of the cleaning process. TOC (Total Organic Carbon) is a widely adopted non-specific analytical method for detecting potential contaminants such as product residues, detergents, and microorganisms. To use TOC, it is necessary to consider the recovery rates and linearity of substances that may remain after cleaning. While testing for chemical contaminants and compounds using TOC is common, there is limited information regarding the recovery rates of microorganisms. By using the Sievers M9 TOC analyzer, it is possible to detect microbial residues at lower concentrations than visual inspection in cleaning evaluations. TOC analysis is effective for measuring residues, monitoring cleaning processes, and reducing overall risks. This enables more accurate and efficient microbial management in the cleaning evaluation of manufacturing equipment.

• Analytical Equipment and Devices

In recent years, the demand for gluten-free products has surged. Consequently, in food and beverage factories, the cleaning of manufacturing equipment has become an increasingly important issue when producing both gluten-containing and gluten-free products. In particular, strict cleaning between batches is required to prevent carryover of materials between products. - Challenges in Gluten-Free Management When dedicated equipment for gluten-free products cannot be secured, it is necessary to thoroughly clean the manufacturing equipment. Allergen testing is mandated to prove that no specified ingredients remain after cleaning, but this requires time and skilled techniques. Traditional testing methods, such as the ELISA method, have high accuracy but are labor-intensive and time-consuming, leading to a demand for more efficient methods. Against this backdrop, the Sievers M9 TOC analyzer is gaining attention. This instrument can simultaneously measure TOC and conductivity, making it very effective for determining the nature of contaminants remaining after equipment cleaning.

• Analytical Equipment and Devices

In the pharmaceutical industry, cleaning validation is an essential process to ensure the quality and safety of products. In particular, accurately detecting residues of protein samples is crucial for guaranteeing the cleanliness of manufacturing equipment. TOC analyzers consist of a combination of oxidation methods and detection methods. - Oxidation Method of TOC Analyzers Commercially available TOC analyzers oxidize organic compounds to carbon dioxide using methods such as combustion oxidation or oxidants combined with ultraviolet oxidation. - Detection Method of TOC Analyzers To detect the concentration of carbon dioxide generated from the oxidation of organic compounds, non-dispersive infrared absorption (NDIR) methods and conductivity methods are commonly used. - Sievers Measurement Technology Sievers TOC analyzers employ a wet ultraviolet oxidation combined with gas-permeable membrane conductivity measurement method, allowing for high accuracy in measuring recovery rates even for protein samples, thus providing reliable data. This is expected to ensure product quality and safety and contribute to the overall reliability improvement in the industry.

• Analytical Equipment and Devices

In the pharmaceutical and cosmetics industries, cleaning validation of manufacturing equipment is a very important process. In particular, accurately detecting residues of insoluble and difficult-to-decompose compounds is essential for ensuring product quality and safety. TOC analyzers are widely adopted non-specific analytical methods for detecting residual products and cleaning agents in manufacturing equipment. The Sievers M9 TOC analyzer can measure with high accuracy even for insoluble and difficult-to-decompose compounds, providing reliable data.

• Analytical Equipment and Devices

In the pharmaceutical industry, cleaning validation of manufacturing equipment is a crucial element of quality control. In cleaning validation, conductivity is useful for detecting residual cleaning agents, but it cannot accurately assess the concentration of organic substances. TOC is very useful in the cleaning evaluation of manufacturing equipment because it can detect both types of organic substances (conductive and non-conductive). Particularly in cases where non-conductive organic substances are present, relying solely on conductivity for cleaning evaluation increases the risk of missing organic contamination.

• Analytical Equipment and Devices

Potassium hydroxide is a commonly used cleaning agent in the pharmaceutical industry. However, it cannot be detected by TOC because it does not contain carbon. Therefore, using conductivity as a detection method is effective. However, there are often trace amounts of residual organic matter, and TOC measurement is essential to detect this. The Sievers M9 TOC analyzer can measure both conductivity and TOC simultaneously, making it useful for detecting residual concentrations of potassium hydroxide.

• Analytical Equipment and Devices

Sodium hydroxide is a commonly used cleaning agent in the pharmaceutical industry. However, it cannot be detected by TOC because it does not contain carbon. Therefore, using conductivity for detection is effective. However, there are often trace amounts of residual organic matter, and TOC measurement is essential for detecting this. The Sievers M9 TOC analyzer can simultaneously measure both conductivity and TOC, making it useful for detecting residual concentrations of sodium hydroxide.

• Analytical Equipment and Devices

Cleaning validation is an essential process to ensure the cleanliness of manufacturing equipment. This process requires highly sensitive and reliable swab or rinse sample analysis. In particular, vials with a low and stable TOC background are necessary. Using kits with high TOC or significant variability increases the risk of errors, leading to incorrect assessments of equipment cleanliness and the possibility of unnecessary cleaning. Sievers' cleaning validation kits provide low TOC backgrounds with minimal variability, resulting in more sensitive and accurate results. Additionally, using vials with a cleaning guarantee ensures the accuracy and completeness of the analysis.

• Analytical Equipment and Devices

The design of a robust cleaning process for pharmaceutical manufacturing is crucial for cleaning validation. Traditionally, the design of cleaning processes in pharmaceutical manufacturing has focused on reducing the most potent and toxic active pharmaceutical ingredients (APIs). For validated cleaning processes, the emphasis is on reducing risks and demonstrating process control and understanding. A newly highlighted concept for risk reduction is the identification of comprehensive cleanability and master soil. In the past, potential substances were considered individually, and all substances were ranked based on the time required for cleaning completion under worst-case cleaning conditions. The master soil was established based on the time to cleaning completion, and the cleaning process was optimized around the reduction of the master soil. Often, this relied on subjective ranking through visual confirmation as a qualitative indicator. To optimize the cleaning process of pharmaceutical manufacturing facilities, we propose a method to measure total organic carbon (TOC) and conductivity in real-time to evaluate cleanability.

• Analytical Equipment and Devices

The TOC meter Sievers M9 is very effective in quantitatively detecting trace residues of cleaning agents and plays an important role in cleaning validation and process validation. Furthermore, by simultaneously measuring conductivity and TOC, it allows for a deeper understanding of the cleanliness of both ions and organic substances after the cleaning process.

• Analytical Equipment and Devices

Cleaning validation in the pharmaceutical industry is a crucial process to ensure the quality and safety of products. This importance increases significantly when dealing with complex compounds. We will introduce the evaluation of recovery rates of alkaline cleaning agents using Sievers' TOC measurement technology.

• Analytical Equipment and Devices

The evaluation of the cleaning process is a very important issue in manufacturing. In particular, to ensure product quality, it is necessary to confirm that the cleaning standards are appropriate. Here, we will introduce a method to evaluate the validity of cleaning standards using the process capability index.

• others
• Analytical Equipment and Devices

- Establishing the Cleaning Validation Process Each process of cleaning validation is unique, and factors such as raw materials, process flow diagrams, work procedures, and minimum batch size (MBS) influence the cleaning process. The cleaning validation process is divided into three stages: design, qualification, and verification, and these should be continuously confirmed and updated throughout the duration of the process. It is necessary to set a Maximum Allowable Carryover (MAC) when switching products in production equipment. The MAC is the amount of the previous product that can be present in the next product without posing a risk to the patient. Here, we will introduce the method for calculating the Maximum Allowable Carryover (MAC) in cleaning validation.

• Analytical Equipment and Devices

In cleaning validation, when considering worst-case scenarios involving low solubility compounds or poorly designed cleaning processes, TOC analysis is effective. TOC analysis is a non-specific analytical method that can detect substances remaining on surfaces such as APIs, surfactants, and decomposing agents.

• Analytical Equipment and Devices

- Purpose and Challenges of Cleaning The cleaning process is designed to effectively remove compounds, ensuring that no decomposition products or residual cleaning agents are left in the manufacturing equipment, allowing it to be used for the production of the next batch. Relying on specific analytical methods can take years from design/development/completion and requires significant manpower.

• Analytical Equipment and Devices

TOC and conductivity are important analytical items that support cleaning validation, cleaning verification, and cleaning monitoring. TOC measurements can be performed in response to user requests in various settings, including laboratories, manufacturing sites (at-line), and online (final rinse water monitoring from CIP).

• Analytical Equipment and Devices

Cleaning validation is a very important process in the pharmaceutical industry. Various analytical methods are used to ensure that manufacturing equipment is properly cleaned. Among these, TOC analyzers and HPLC are widely used as representative methods. Here, we conducted a cost comparison of TOC analyzers and HPLC from various perspectives (initial costs, maintenance costs, and labor costs).

• Analytical Equipment and Devices

- Portable residual chlorine meter usable as a testing method for tap water - Visually easy to understand and simple to operate - Supports three types of reagents (tablet reagents, powder reagents, liquid reagents) with one device - Durable and robust, suitable for fieldwork (IP67) - Accurate, reproducible, and reliable measurements - Ergonomically designed - Automatic data storage - Data transfer via wired or wireless connection

• Residual chlorine meter