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Chromatography Columns

What Is a Chromatography Column?

A chromatography column is a narrow, tube-shaped apparatus packed with a stationary phase, primarily employed in liquid chromatography.

While chromatography encompasses techniques such as High-Performance Liquid Chromatography (HPLC) and gas chromatography, products labeled as “chromatography columns” or “columns for chromatography” typically refer to liquid chromatography (open column/flash chromatography) or ion chromatography. These columns play a crucial role in chromatography by separating and purifying mixtures through solute adsorption and elution.

Applications of Chromatography Columns

Chromatography columns serve as essential tools in chromatography, a technique utilized for the separation and purification of mixtures across diverse fields including chemistry, fragrances, food, and pharmaceuticals. Noteworthy applications encompass:

  • Separating and purifying synthetic products in organic chemistry
  • Extracting active constituents from natural substances
  • Analyzing flavor components and food additives in the food industry
  • Detecting components in residual pesticides and toxin tests
  • Analyzing active pharmaceutical ingredients and identifying by-products upon ingestion
  • Facilitating quality control across industrial, pharmaceutical, and food sectors
  • Analyzing disinfection by-products
  • Conducting environmental assessments such as water quality analysis
  • Examining fluoride levels in juices and tea
  • Separating sugars in food samples

This analytical approach proves indispensable for quality control and component identification across a spectrum of domains, from fundamental research to industrial applications.

Principle of Chromatography Columns

Chromatography involves segregating and detecting mixtures by utilizing a gas or liquid as the mobile phase and exploiting the physicochemical interactions between the sample substances and the stationary phase housed in the column. Chromatography columns are either filled with a stationary phase for single-use or come prefilled. Typically, these columns find application in liquid chromatography.

1. Open Column/Flash Chromatography

Columns utilized in open or flash chromatography are cylindrical glass apparatuses not prepacked with a stationary phase. The top remains open, while a tap is situated at the bottom. The stationary and mobile phases are introduced from the top, and the tap regulates the eluting solvent flow. The process entails:

  • Placing cotton or a similar substance at the bottom to adjust the flow rate
  • Packing with a stationary phase
  • Loading the sample, dissolved in a small solvent volume, atop the stationary phase
  • Introducing the mobile phase (eluting solvent) for separation and purification

2. Ion Chromatography

Ion chromatography segregates and purifies using ionic interactions, capable of measuring inorganic anions and cations, along with certain organic acids and amines. The chromatography column’s stationary phase often comprises ion-exchange resins.

Given that ion chromatography necessitates pressurizing the electrolyte solution mobile phase via a pump, akin to HPLC, the columns are typically constructed from metal or resin and come prefilled with a stationary phase. They can be reused post-cleaning with a washing solvent.

Types of Chromatography Columns

Chromatography columns encompass glass apparatuses for open columns and metal or resin columns for ion chromatography.

Ion Chromatography Columns

Columns used in ion chromatography are tailored specifically for either cation chromatography (cation columns) or anion chromatography (anion columns), each packed with ion-exchange resins of opposite polarity.

There are various types of cation and anion columns, including specialized variants for specific applications. For instance, anion columns may specialize in analyzing polyphosphates in seafood or in the analysis of ions such as I- and SCN-.

Guard columns, capable of filtering insoluble solid particles, are employed to prevent column contamination.

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Powder Dispensers

What Is a Powder Dispenser?

A Powder Dispenser is a sophisticated device specifically designed to accurately dispense a predetermined volume of powder. It falls under the category of automatic dispensing systems and is also known as a powder feeder or powder dispenser. These devices are commonly used in laboratories and the pharmaceutical industry, particularly for dispensing small amounts of powder, such as in milligram units.

Uses of Powder Dispensers

Powder Dispensers are primarily used in fields requiring precise powder dispensing related to chemistry and biology. They are employed in testing and research, the pharmaceutical industry, medical fields, the cosmetics industry, chemical engineering, and the food industry. These devices are used to accurately dispense minute quantities of powder, typically in milligram or microliter units, and commonly handle substances like:

  • Pharmaceutical ingredients
  • Reagents and raw materials for chemicals (such as resins or salts)
  • Food ingredients like powdered milk or soy milk
  • Food additives and seasonings
  • Dental amalgam powders
  • Agar and glass beads for biological and biochemical experiments
  • Silica gel
  • Veterinary powders
  • Fish feed

Depending on the device, substances of various granularities, including powders, granules, and beads, are often processed.

Principle of Powder Dispensers

Powder Dispensers typically work by ejecting filled powder to achieve accurate dispensing. Some use a mesh plate to manually sieve a set volumetric amount of powder into a microplate.

Filling the Powder

The method of filling powder varies by device, including manual filling into the dispensing head or devices equipped with powder suction functionality. In dispensing head systems, the heads are interchangeable, allowing for the quick processing of multiple materials in different quantities without the need for cleaning, thus preventing cross-contamination.

Dispensing

Dispensers operate either by volume or mass units, with manual systems generally dispensing by volume. For example, manual systems might fill powder into a cavity at the tip and use a plunger to eject it. Electric systems can dispense rapidly, with each dispensing action taking about 3 seconds, and are capable of continuous ejection.

Device Design

Devices come in various designs, including handheld and benchtop models. Electric benchtop models can perform automated dispensing using racks of microtubes, vials, or well plates.

Mesh Plate Method

In the mesh plate method, a well plate is placed under the mesh plate, and powder is filled onto the mesh with a slider inserted between the mesh and well plate. After filling the mesh plate with the correct amount of powder and removing excess with a scraper, the slider is removed to dispense the powder into the well plate below.

Types of Powder Dispensers

There are various types of Powder Dispensers, and selecting one appropriate for the application is essential. Volume-based dispensers typically accommodate powder volumes from 5 to 1000 μl. Mass-based dispensers commonly work with milligram quantities, with some capable of dispensing from 5 to 300 mg, and others up to 25 g.

Both electric and manual dispensers are available, with electric models particularly suited for automating large-volume dispensing. Some devices can also integrate with peripheral equipment for automated material mixing, reagent preprocessing, and cap opening/closing. While microtubes, vials, and well plates are commonly used dispensing containers, compatibility varies by device, and some may only accept specific containers. Additionally, while some Powder Dispensers are designed solely for powder, others can handle various solids, including granules and beads.

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Bowl Cutter

What Is a Bowl Cutter?

A Bowl Cutter, also known as a silent cutter or a bowl chopper, is a device used in food processing. It consists of rapidly rotating cutters within a spherical container, designed to shred food materials while simultaneously mixing and emulsifying them. This innovative tool is particularly suitable for foods made from ground meat or paste, such as ham and sausage.

Uses of Bowl Cutters

Bowl Cutters are used for the uniform shredding, mixing, pasteurization, and emulsification of food ingredients. They are commonly utilized for coarse and fine chopping and emulsification of meats, making them ideal for the production of ground meat, hamburgers, sausages, chicken nuggets, and various types of ham. They can process various parts of meat, including lean meat, fat, and sinew, and can be used with chilled or frozen meats. They are also capable of producing fish meat sausages.

Additionally, they are used for chopping chicken products, vegetables, salads, and in the production of processed cheese, functioning as a general mixer and cutter. They can mix soy protein and gluten protein with water or oil, used in the production of vegetarian hams. Beyond food processing, bowl cutter technology is also applied in the field of fine chemicals.

Principle of Bowl Cutters

Overview

Bowl Cutters are made from stainless steel, considering hygiene. They are electrically powered and use motors to operate the bowl and cutters. The combination of knife speed, bowl speed, and the number of knives allows for various shredding and mixing processes.

Bowl

The bowl’s shape is typically flat, similar to a large washbasin, or completely spherical. Flat-type bowls usually rotate, while in spherical types, a part called the baffle usually rotates to stir the contents. Bowl speeds range from 12 to 24 rpm, with products offering stepwise speed changes or continuous speed adjustments.

Cutter

The cutter part of a Bowl Cutter consists of multiple blades. Typically ranging from three to ten blades, depending on the device, it’s possible to change the number of blades by swapping the cutter part. Knife speeds are generally between 1500 to 3000 rpm, with devices offering stepwise speed changes or continuous speed adjustments.

Types of Bowl Cutters for Food Processing

Overview

Bowl Cutters come with various unique features depending on the product, including safety lock mechanisms that stop the blades automatically when the lid is opened, and meat thermometers to prevent the temperature of food materials from rising. Some devices can heat or cool the ingredients during use, circulating cold or warm water around the bowl for temperature control.

The size of the products varies, with compact models available for tabletop use. Some products enhance usability with touch panel controls.

Vacuum Bowl Cutters

Some Bowl Cutters can reduce the pressure inside the bowl or create a vacuum environment. Processing chicken or vegetables in a vacuum can enhance the binding with water, improve color and flavor, and achieve denser emulsions. Vacuuming can also promote protein extraction and reduce jelly sedimentation, improving product quality and extending shelf life.

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Hydraulic Piston Fillers

What Is a Hydraulic Piston Filler?

A Hydraulic Piston Filler is a device that utilizes hydraulic pumps to power the filling of foods, such as pastes, using a piston mechanism. This mechanism allows for the suction and extrusion of high-viscosity substances, making it ideal for filling viscous materials like ground meat and fish paste. It is commonly referred to as a hydraulic stuffer and falls under the category of volumetric fillers. The rapid filling capability of piston fillers makes them perfect for high-volume applications.

Applications of Hydraulic Piston Fillers

The primary applications of Hydraulic Piston Fillers are in food factories, meat processing plants, supermarkets, and butcher shops for sausage production. Casings for stuffing can be attached to the nozzle, allowing for sausage production. With additional attachments, they can also be used to shape hamburgers, meatballs, croquettes, and more.
Larger models can be used to stuff entire muscles into nets for products like hams, enabling the stuffing of prosciutto, rolled hams, and boiled hams. These fillers accommodate stretchable nets and general sausage casings.

Operating Principle of Hydraulic Piston Fillers

Mechanism

Most Hydraulic Piston Fillers feature a large cylinder with a hydraulic piston attached at the top.
The operation proceeds as follows:
Food to be filled is placed into the cylinder.
A piston is fitted at the top of the cylinder, and a casing is attached to the nozzle at the piston’s end.
When activated, the cylinder’s bottom rises, pushing the filling material upward to the top piston and then into the casing.
Filling into casings usually involves manual support. Consequently, the device’s switch is often a knee switch, allowing for hands-free operation.

Structure

The device is made of hygienic stainless steel, designed for easy piston removal and a screw-free bottom cylinder structure for straightforward cleaning. Some models feature corrosion-resistant coatings on cylinder parts. Many devices also use waterproof electrical boxes for the power and electrical circuits, enhancing durability.
Particularly in meat processing, piston fillers are designed to prevent the filling material from heating up, with some equipped with cooling fan kits to limit heat transfer.

Types of Hydraulic Piston Fillers

Hydraulic Piston Fillers are available in various sizes and capacities from multiple manufacturers, necessitating selection based on specific needs. Cylinder capacities range from small to large, with options like 14, 20, 25, 35, 50 liters, etc. Nozzle diameters can often be changed, with sizes like 12mm, 20mm, 30mm, and even up to 70mm to 200mm for larger models suited for hams.
Advanced models may include built-in pressure gauges and automatic depressurization as contents diminish. Some come with integrated speed regulators, allowing for manual speed adjustments. Models designed for mobility may be equipped with wheels.

Optional Attachments

Many Hydraulic Piston Fillers support a variety of optional attachments. For example, manual portioners can set quantities from 10 to 500 grams, and there are parts for shaping uniform patties of 100g, 80g, or croquette components. Some products feature attachment nozzles with vertical holes for producing skewered sausages (kebabs). These attachments are typically easy to disassemble and clean, similar to the main unit.

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Tracking and DF antennas

What Is a Tracking and DF Antenna?

A Tracking and DF (Direction Finding) antenna is designed for tracking and direction-finding purposes.

Tracking involves constantly monitoring and following a specific target or signal source. It involves keeping a constant watch on the target’s position and adjusting the antenna as necessary to track it. This technology is widely used in applications like wireless communication and radar systems, especially in radar systems where it can track aircraft, calculate their positions, and determine their velocities.

Direction finding, on the other hand, is the capability to measure the direction of a specific signal source. It involves receiving electromagnetic waves from the signal source and detecting or measuring the direction from which the waves arrive. This technology finds applications in tasks such as signal interception, locating the positions of radio stations, and tracking obstacles in wireless communication.

Antennas equipped with these functionalities are often available for separate purchase. However, some antennas are designed to possess both tracking and direction-finding capabilities simultaneously.

Applications of Tracking and DF Antennas

The applications of Tracking and DF antennas are diverse and include the following:

  • Aircraft: Control rooms for aviation traffic constantly monitor and assist aircraft by tracking their positions, altitudes, and speeds. Real-time tracking using these antennas provides information for air traffic guidance and collision avoidance, contributing to safe and efficient air transportation.
  • Drones: These antennas are used in drone technology to track and monitor the positions and movements of drones, essential for reconnaissance of terrains and surrounding environments.
  • Military: In military applications, Tracking and DF antennas are utilized to track and detect enemy aircraft, missiles, and ships, enabling early threat detection, enhancing national defense capabilities, and maintaining security.
  • Telecommunications Industry: In the telecommunications industry, these antennas help confirm the positions of base stations and radio transmitters. They are also used for monitoring unauthorized wireless communications. Additionally, they are employed in national security and criminal investigations to identify signal sources and intercept communications.

Principles of Tracking and DF Antennas

For tracking functionality, some antennas employ beamforming technology. This technology uses multiple antenna arrays to detect phase differences in received signals and finely adjust input signals. This allows for amplification of received signals to the maximum extent.

Direction finding often involves receiving signals at multiple points. By comparing signals received at various points, the direction of the signal source can be determined. Some antennas use phased-array antenna technology to control the phase of signals, aiding in pinpointing the direction of the signal source.

These antennas are designed based on various techniques, including beamforming technology, feedback control, and mathematical algorithms, to enable signal tracking or direction finding.

Choosing the Tracking and DF Antenna

When selecting a Tracking and DF antenna, it’s important to consider the following factors:

  • Frequency Band: The frequency band represents the range of frequencies over which the antenna operates optimally. Antennas are designed for specific frequency ranges, and choosing one that matches the frequency range of your application or communication system is crucial.
  • Maximum Gain: Maximum gain is a critical indicator of an antenna’s transmission and reception capabilities. A higher gain enhances signal sensitivity, which is especially important for long-distance communication or weak signal detection.
  • Waterproof and Dustproof Performance: Since antennas are often used outdoors, their waterproof and dustproof performance is essential. Waterproofing protects them from rain and humidity, while dustproofing safeguards against sand and dust. These qualities are often evaluated based on IP ratings.
  • Size: The size and mounting method of the antenna should be considered. In cases where installation space is limited, a compact antenna may be necessary. While tracking and direction-finding antennas are sometimes placed separately, purchasing an antenna with both functionalities is also an option.
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Directional antennas

What Is a Directional Antenna?

A directional antenna is an antenna capable of transmitting and receiving strong signals in a specific direction.

This type of antenna minimizes noise and interference from the surrounding environment, concentrating signals in a specific direction.

This enhances the stability and efficiency of communications, improving the quality of long-distance and wireless communications.

Use of Directional Antennas

1. Communication Systems

Directional antennas are used in mobile communication devices and base stations to improve signal quality and efficiency by focusing signals in specific directions. They help minimize interference within mobile networks. Directional antennas placed on communication towers transmit specific signals, dividing communication ranges.

2. Astronomy

In astronomy research, directional antennas, such as radio telescopes, receive electromagnetic radiation from space. This enables the capture of radio signals from sources like galaxies and cosmic background radiation, aiding in the study of celestial properties. Radio telescopes are essential for observing celestial bodies not visible in the visible light spectrum.

3. Aerospace

Aircraft and space shuttles use directional antennas for communication and navigation. For example, aircraft communication involves directional antennas communicating with ground control towers to receive location and weather information. Space shuttles utilize directional antennas for communication with Earth to navigate and control their operations.

Principles of Directional Antennas

Directional antennas exhibit high directionality due to their design and arrangement.

Many directional antennas use reflectors to concentrate radio waves in specific directions. For instance, parabolic antennas feature parabolic-shaped reflectors that gather signals and focus enhanced signals in a specific direction. Reflectors align wavefronts, minimize mutual interference, and enhance directionality.

Additionally, arranging antennas in specific configurations allows for signal direction control. For example, Yagi-Uda antennas adjust antenna orientation toward communication towers, enhancing signal directionality. This minimizes the risk of picking up unwanted signals and aids in noise reduction.

These factors combine to give directional antennas high directionality, enabling long-distance communication and noise reduction. They play a crucial role in various communication applications, including target detection.

Types of Directional Antennas

Directional antennas come in various types, including:

1. Parabolic Antenna

Parabolic antennas consist of large parabolic reflectors and feedhorns. The reflector concentrates radio waves in specific directions, resulting in high gain. They are commonly used in satellite communication and radar applications.

2. Yagi-Uda Antenna

 The Yagi-Uda antenna comprises elements such as reflectors, directors, and radiators. Radiators are the primary components, and when connected to multiple directors and a reflector, they direct signals in specific directions. Yagi-Uda antennas are typically used for television reception and amateur radio.

3. Horn Antenna

Horn antennas have a wide-mouthed waveguide structure and are mainly used in the microwave frequency range. They find applications in radar systems and communication.

4. Slot Antenna

Slot antennas feature slots cut into metal plates to radiate or receive radio waves in specific directions. They are commonly used as part of other antennas in radar and communication applications.

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Ion Chromatograph

What Is a Ion Chromatograph?

Ion Chromatograph is a chemical analysis instrument used for the separation and detection of cations and anions.

It is primarily used for the quantitative and qualitative analysis of ion components in aqueous solutions. Essentially, it involves introducing a sample solution into a specialized analysis component called a column, where ion components are separated using internal ion exchange resins and similar mechanisms. Ion Chromatography finds valuable applications in situations where ion analysis is necessary and is widely utilized in fields such as chemical research and environmental monitoring.

Ion Chromatographs are highly sensitive analytical instruments capable of detecting trace amounts of ion components. Furthermore, they possess the ability to selectively separate different ion species, allowing for precise extraction of specific components from complex mixtures. When combined with automatic samplers and detectors, the analysis process can be automated, making data collection more efficient.

Uses of Ion Chromatograph

1. Food Industry

Ion Chromatography is used to measure the levels of cations such as calcium and anions like nitrates in food products. It is employed for measuring salt content and is used as the basis for labeling nutritional information. It is also commonly used for the determination and quantification of trace elements like iron and zinc.

Additionally, it is utilized for the detection and quantification of food additives and preservatives, such as antioxidants, ensuring the quality of manufactured food products. This helps verify that additives and preservatives are present in the correct amounts.

2. Environmental Sector

Ion Chromatography is widely used in the detection and quantification of pollutants, including heavy metals, in soils and water. This enables the identification of pollution sources in the environment and allows for measures to be taken for environmental protection. It is used to monitor ion components in rivers, groundwater, and the atmosphere, assessing and addressing changes in the environment and their impact on health.

3. Pharmaceutical Industry

In the pharmaceutical industry, Ion Chromatography is employed for the testing and quality control of cations and anions in pharmaceutical products. This ensures product consistency and quality. It is used to analyze reaction intermediates and by-products generated during chemical processes, ensuring the purity and safety of the final products.

Additionally, Ion Chromatography is used in research related to biochemistry, measuring components like amino acids in biological samples. It is utilized for the analysis of enzyme reactions and metabolic pathways, making it valuable for studying the dynamics of ions within living organisms.

Principle of Ion Chromatograph

When using Ion Chromatography, a sample solution containing the ion components of interest is first introduced. Samples are often introduced using quantitative pumps and may involve automation of the entire system using auto-samplers.

The introduced sample solution enters a specialized column where ion exchange resins are filled, allowing for the selective capture of specific ions. Cation exchange resins capture cations in cation chromatography, while anion exchange resins capture anions in anion chromatography.

The separated ion components are then measured by a detector. Commonly used detectors include conductivity detectors and absorbance detectors, which quantitatively measure the ion concentrations. The measured data is analyzed by a computer, calculating and displaying the concentration of the target ion components.

Choosing an Ion Chromatograph

When selecting an Ion Chromatograph, it is important to consider the following factors:

1. Target Ion Species

It is essential to clearly define the ion components you want to analyze. Consider the types of ions you wish to measure, such as calcium or fluoride, as this will guide your choice of columns and detectors.

2. Detector

Depending on the ions you want to analyze, choose an appropriate detector. Common detection methods include conductivity detection and absorbance detection. Some detection methods may be susceptible to interference from other components.

3. Flow Rate

The flow rate of the Ion Chromatograph indicates the speed at which samples are measured. High flow rates are required for analyzing large sample volumes quickly, while low-flow instruments are suitable for high-sensitivity measurements. Choose an appropriate flow rate based on your analysis needs.

4. Accuracy

Accuracy in analysis is a crucial factor. To ensure analytical accuracy and reproducibility, verify the accuracy of the selected Ion Chromatograph. Higher-precision instruments are generally more expensive, so choose a product that offers the necessary level of accuracy for your requirements.

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Glass Railing

What Is a Glass Railing?

Glass railings, a type of handrail crafted from glass, find widespread use in architecture and interior design due to their unique characteristics.

Characterized by transparency, glass railing provide an unobstructed view of the surroundings, elevating the aesthetics of spaces and allowing ample natural light. Frequently composed of tempered glass for enhanced strength and durability, they are also shatter-resistant, simplifying maintenance and preserving their visual appeal.

Applications of Glass Railings

Due to their high transparency, glass railings are versatile in use. Examples include:

1. Commercial Facilities

  • Shopping malls utilize glass railings on balconies and staircases, offering a modern and luminous atmosphere.
  • Hotels employ decorative glass in balconies and lobbies to enhance views and create an inviting ambiance.
  • Art galleries and museums integrate glass railings in staircases and balconies for improved exhibit visibility.

2. Offices

  • Glass railings contribute to contemporary and clean aesthetics in office staircases and entrances, fostering a comfortable environment for employees.
  • The bright appearance can be advantageous for recruitment efforts.

3. Public Facilities

  • Airports and similar settings utilize glass railings to provide a spacious impression, particularly beneficial for attracting tourists.
  • Corrosion resistance makes them suitable for damp environments, such as public pools.

4. Residential Homes

  • Glass railings in homes serve as stair railings, brightening interiors and exteriors and contributing to a comfortable daily life.
  • They are also used in gardens and balconies to create relaxing spaces.

Characteristics of Glass Railings

  • – Glass railings predominantly use tempered glass, offering higher strength and safety as it shatters into granules upon breakage.
  • Transparent designs facilitate light transmission and maintain an open atmosphere, while frosted glass options cater to specific needs.
  • High corrosion resistance makes glass suitable for outdoor use, with optional anti-slip treatments for safety.

Selecting Glass Railings

Considerations when choosing glass railings include:

1. Size

  • Height should comply with architectural and safety standards, typically ranging from 90cm to 110cm.
  • Length is determined based on the installation site.

2. Thickness

  • Indoor and outdoor uses may require different thicknesses, with indoor typically 5cm to 12cm and outdoor often exceeding 15cm.

3. Design

  • Matching the building’s exterior and interior is crucial, with options including frameless or steel frame combinations.
  • Various glass designs, such as transparent panels, etching, or patterns, offer customization.
  • Color considerations include transparent or colored glass options to align with the overall building design and interior colors.

Understanding these considerations ensures the selection of glass railings that not only prioritize safety but also harmonize with the surrounding aesthetics.

データインティグリティシステム

データインティグリティシステムとは

データインティグリティシステムとは、製薬業界で求められているデータの完全性と信頼性を担保するために構築するシステムです。

製薬業界においては、行政当局より患者保護の観点から、医薬品開発、試験、認可、製造の各段階のあらゆるデータに対する完全性と信頼性を確保することが強く求められています。膨大なデータを一元的に管理し、データインティグリティーを担保するためのシステムが導入されています。

データインティグリティシステムの使用用途

データインティグリティシステムは医薬品の開発、試験、認可、製造などに係る全てのデータを正確に効率的に管理し、行政当局の審査や査察に的確に応えるために使用されます。

特に、患者保護の観点から、アメリカ食品医薬品局 や欧州医薬品庁などの行政当局が実施する厳格な審査プロセスに適応することが重要です。これらの審査ではデータの完全性や信頼性が厳しくチェックされ、データの改ざん防止が求められます。

2014年に日本がPIC/S (医薬品査察協定及び医薬品査察共同スキーム) に加盟したことにより、国内でも同様に厳しい審査基準が適用されるようになりました。医薬品だけでなく医療機器を製造する企業においても利用されており、業界全体にとって重要なツールとなっています。

データインティグリティシステムの原理

1. データインティグリティの要件

データインティグリティは製品 (医薬品) のライフサイクルを通して、データの完全性と信頼性を確保することです。

PIC/S等のガイドラインでは、データインティグリティを証明するためにはALCOAの原則に基づいていることを要求しています。ALCOAの原則とは、データの帰属性 (Attributable) 、判読性 (Legible) 、同時性 (Contemporaneous) 、原本性 (Original) 、正確性 (Accurate) の5つの要件で構成されます。

さらに、データインティグリティにはALCOA+という項目を増やした、より厳しいガイドラインも現れています。

2. データインティグリティシステムの役割

データインティグリティシステムは製薬業界のデータ整合性保証に重要な役割を果たします。紙の管理や個別部門の電子ファイル管理の不安を解消します。ALCOA原則に基づき、ファイル履歴保存、所有権確認、紙データの電子化、生体認証アクセス管理などを統一的に行うシステムです。

データインティグリティシステムの種類

データインティグリティシステムには、主要な目的別に分類することができます。

1. 検査データの収集・解析・管理

検査データの効率的な収集、解析、および管理を支援するために設計されています。様々な検査装置からデータを抽出し、大量の検査データを確認する際やデータの有効活用、不正行為の予防を強化したい場合に特に有用です。

2. 統計的工程管理 (SPC) 

SPCは「Statistical Process Control」の略で、製品の品質保証と工程管理の改善のために、各製造工程のデータを統計的に処理を行う方法のことです。多くの製造工程で発生する異常を見落とさないために使用したり、異常発生時の記録をスムーズに行うために使用されます。

3. データ解析

データ解析は、収集したデータを取り込んで自動化する場合や簡易的に解析を行いたい場合に使用されます。データレビューのために、解析した内容を監視・記録できるものもあります。

4. 検査・実績収集

製造現場の各センサーに収集された記録は、一般的に管理図を用いて可視化して管理します。検査記録や実績をデータ化するために使用されます。

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Wi-Fi Module

What Is a Wi-Fi Module?

Wi-Fi module is a component that consolidates all necessary parts for wireless LAN communication in accordance with Wi-Fi standards onto a single circuit board. It’s essential for enabling wireless communication between electronic devices.

To communicate effectively using wireless technology, devices must adhere to specific communication standards. The Wi-Fi standard, defined under IEEE (Institute of Electrical and Electronics Engineers) 802.11 specifications, is a standard for wireless LAN that facilitates high-speed wireless communication within a range of tens of meters.

Wi-Fi module includes all necessary components for Wi-Fi communication, such as wireless chips, antennas, peripherals, and software, integrated onto a single board. Incorporating a Wi-Fi module into electronic device development allows for efficient and rapid establishment of Wi-Fi communication capabilities.

Applications of Wi-Fi Modules

Wi-Fi modules are widely used in electronic devices that connect to Wi-Fi LANs.

As the standard for wireless LAN, Wi-Fi requires a wireless router to connect to the internet and manage communication within the LAN. Routers can be stationary, connected via a cable to the external network, or mobile routers that connect to a Wide Area Network (WAN) provided by mobile phone companies. Both types of routers use Wi-Fi modules for LAN-side communication.

Electronic devices that connect to the internet via wireless routers include computers, gaming consoles, TVs, and other internet-enabled home appliances, all incorporating Wi-Fi modules.

With the advancement of IoT (Internet of Things), various devices in factories, buildings, and commercial facilities are increasingly communicating with external entities via networks. Wi-Fi, being suitable for high-speed and high-capacity communication compared to other wireless technologies like Bluetooth, is increasingly integrated into IoT devices, especially those transmitting large amounts of data like video.

Most smartphones have the capability to connect to wireless routers. Some have integrated Wi-Fi modules, while others have Wi-Fi functionalities combined with the main communication module.

Principles of Wi-Fi Modules

Wi-Fi module is an electronic component that mounts wireless chips (semiconductors, LSIs), and peripheral circuits on a small circuit board, equipped with communication software. Simply integrating a Wi-Fi module with an antenna and connection terminals in an electronic device enables Wi-Fi communication.

Developing Wi-Fi-capable electronic devices with off-the-shelf Wi-Fi modules can significantly reduce development time compared to creating Wi-Fi chips and software for each device.

As technology advances, the demands for miniaturization and power efficiency in electronic devices have intensified. Sourcing Wi-Fi modules from external manufacturers allows electronics companies to allocate resources to other aspects of development. Module manufacturers continually research and develop smaller, more efficient modules, optimizing development resources for both parties.

Wi-Fi standards, introduced in the late 1990s, have undergone several revisions, leading to increased communication speeds. As of November 2023, there are six standards based on IEEE 802.11: IEEE 802.11a (Wi-Fi2), IEEE 802.11b (Wi-Fi), IEEE 802.11g (Wi-Fi3), IEEE 802.11n (Wi-Fi4), IEEE 802.11ac (Wi-Fi5), and IEEE 802.11ax (Wi-Fi6). Communication speeds have increased from 54Mbps in IEEE 802.11a to 9.6Gbps in IEEE 802.11ax. The frequency bands used have expanded from the 2.4GHz band to include the 5GHz band.

Devices operating in the same frequency band can communicate, even if they follow different standards, by matching the slower speed. However, devices using different frequency bands (2.4GHz and 5GHz) cannot communicate with each other.

Choosing a Wi-Fi Module

When selecting a Wi-Fi module, choose a frequency band suitable for the environment. The 2.4GHz band has longer reach and better obstacle penetration than the 5GHz band, which offers faster communication speeds. However, with the widespread use of Wi-Fi, communication speeds can vary depending on location and time.

Some modules come with development environments, while others do not, affecting the amount of development work needed.

In some cases, other communication modules may be more suitable than Wi-Fi modules. Technologies like Bluetooth, Zigbee, and NFC have shorter ranges and slower speeds but offer advantages in terms of size, power consumption, and cost. Their limited range can also be beneficial for security.

Choose the most suitable communication module based on application requirements, considering communication distance, speed, power consumption, and security.