医療および医薬品試験

NTT-01 針靭性試験機

Introduction to Needle Resistance to Breakage Ensuring needle resistance to breakage is a critical part of medical device safety and reliability, particularly for hypodermic needles. Breakage during use can lead to serious injury, contamination, or product failure. The NTT-01 Needle Toughness Tester by Cell Instruments offers a precise, ISO 9626 solution for verifying the mechanical strength of stainless-steel needle tubing. Why Needle Resistance to Breakage Testing Matters In the realm of medical device manufacturing, especially for needles and catheters, mechanical failure during use poses significant risks. Needle resistance to breakage must be validated to ensure patient safety and product integrity. According to ISO 9626:2016, stainless steel needle tubing used in […]

NTT-01 針靭性試験機 続きを読む "

SLT-02 シリンジリークテスター

Syringe leak testing is a crucial process in ensuring the quality and safety of hypodermic syringes used in various medical and pharmaceutical applications. The syringe leak testing machine plays an essential role in detecting air leakage past the plunger stopper and ensuring the integrity of the syringe’s seal. What is Syringe Leak Testing? Syringe leak testing is performed to verify that the syringe’s plunger stopper and seals do not allow air to leak past them under specific pressure conditions. This test ensures that syringes are free from leaks that could compromise their functionality, particularly for applications where precision and sterility are paramount, such as insulin injections or vaccines. In the

SLT-02 シリンジリークテスター 続きを読む "

SPPT-01 シリンジ陽圧式気密試験機

Ensuring the integrity of disposable syringes is critical for patient safety and product quality in pharmaceutical and medical device manufacturing. Among the most important assessments is the syringe liquid leak test, particularly at the plunger stopper under compression. This test verifies whether any leakage occurs when the plunger is subjected to both axial and radial forces under controlled conditions. Cell Instruments offers an advanced solution to perform this test with precision and repeatability—the SPPT-01 Syringe Positive Pressure Tightness Tester. Syringe Liquid Leak Tester – ISO 7886-1 For laboratories and manufacturers seeking compliance with ISO 7886-1 Annex D, the SPPT-01 Syringe Positive Pressure Tightness Tester by Cell Instruments provides a fully

SPPT-01 シリンジ陽圧式気密試験機 続きを読む "

SSR-01 シリンジ摺動抵抗測定器

Break Loose and Glide Force Testing In syringe performance evaluation, break loose and glide force testing plays a crucial role in assessing the smoothness and reliability of the plunger movement. This test determines the force required to initiate and maintain the motion of the syringe piston, ensuring consistent drug delivery and patient safety. Cell Instruments, a leading manufacturer of materials testing equipment, provides advanced break loose and glide force testing machines designed according to ISO 7886-1 standards. These instruments help manufacturers, laboratories, and quality control professionals ensure that their syringes meet international quality and performance requirements. ISO 7886-1 and Syringe Performance The international standard ISO 7886-1 specifies the requirements and

SSR-01 シリンジ摺動抵抗測定器 続きを読む "

LT-03 リークテスター

I. Introduction of Bubble Leak Test Equipment 1. Definition and Purpose of the Equipment Bubble Leak Test Equipment is a crucial instrument used to detect leaks in various packaging materials. This method identifies leaks by immersing the package in a liquid and applying a vacuum to observe if bubbles form, indicating a breach. The primary purpose of this equipment is to ensure the integrity and safety of packaged products, preventing contamination and preserving quality. 2. Importance in Various Industries Bubble Leak Test Equipment is vital across multiple industries, including packaging, medical devices, and pharmaceuticals. In the packaging industry, it ensures that products are securely sealed, preventing spoilage and damage. In

LT-03 リークテスター 続きを読む "

TS-01 チューブ剛性試験機

Introduction to Syringe Tube Stiffness Tester For professionals in medical device manufacturing, syringe tube stiffness plays a critical role in ensuring the reliability, safety, and usability of hypodermic needles. The Syringe Tube Stiffness Tester, specifically designed to evaluate the stiffness of stainless steel needle tubing, provides a reliable method for quality control and standard compliance. This instrument, such as Cell Instruments’ TS-01, is indispensable for meeting the requirements outlined in ISO 9626. Stiffness is directly linked to mechanical integrity. Tubing that lacks appropriate stiffness may bend, break, or deform during use—posing risks of injury, inaccurate dosing, or contamination. Conversely, overly rigid tubing may fail to provide adequate flexibility, leading to

TS-01 チューブ剛性試験機 続きを読む "

FPT-01 摩擦剥離試験機

The Friction Peel Tester is an advanced instrument designed to assess two critical properties in material testing: the Coefficient of Friction (COF) and peeling force. These tests are essential for industries involved in packaging, medical devices, pharmaceuticals, textiles, adhesives, and beyond. Ensuring that products meet friction and peel standards guarantees functionality, safety, and performance. The Friction Peel Tester offers a precise, versatile, and reliable solution for both COF tests and peel tests, enabling manufacturers to improve their quality control processes and develop superior products. Key Features and Benefits of the Friction Peel Tester The Friction Peel Tester combines dual testing capabilities in one efficient device, making it ideal for a wide range of materials, including plastic films, paper, textiles, and adhesive

FPT-01 摩擦剥離試験機 続きを読む "

GHS グラジエント ラボ用ヒートシーラー

Gradient Laboratory Heat Sealer Principle Gradient Laboratory Heat Sealer operates by applying heat, pressure, and time to a sample of packaging material. These three variables—heat, pressure, and time—are adjustable, allowing users to simulate a wide range of packaging conditions. The ability to control these parameters is crucial for manufacturers who need to optimize sealing processes for different materials. One of the key features of advanced Gradient Laboratory Heat Sealers is the gradient sealing function. A Gradient Heat Sealer allows for multiple temperature settings to be tested simultaneously across a single sample. This capability speeds up the testing process, enabling manufacturers to determine the optimal sealing parameters without the need for

GHS グラジエント ラボ用ヒートシーラー 続きを読む "

GHR-01A ガラス粒子耐加水分解性試験機

The Sampler for Glass Grain Hydrolytic Resistance Test is an essential instrument in the testing and evaluation of glass materials used in pharmaceutical and medical packaging. This test helps determine how well glass resists degradation when exposed to water, ensuring that pharmaceutical products remain safe and effective throughout their shelf life. The hydrolytic resistance of glass is crucial, particularly in packaging such as ampoules, vials, and infusion bottles, where even minimal interaction between the glass and its contents can compromise the stability and safety of medications. The GHR-01A Glass Grain Hydrolytic Resistance Tester is designed to provide accurate and efficient testing according to international standards such as ISO 719 and ISO

GHR-01A ガラス粒子耐加水分解性試験機 続きを読む "

GLT-01 グロスリークバブルテスター

I. Introduction to the Gross Leak Bubble Tester In quality assurance of sterile and sealed packaging, detecting large breaches that compromise product integrity is crucial. The gross leak bubble tester is a highly effective, visual inspection method for identifying such defects. Commonly used in industries like food, pharmaceuticals, and medical device packaging, this method helps verify seal strength and barrier integrity before products reach the end user. The test follows a simple principle: by immersing the package in water and applying internal air pressure, visible bubbles will form if a leak exists. This intuitive approach, standardized by ASTM F2096, makes gross leak detection both accessible and highly accurate. II. How

GLT-01 グロスリークバブルテスター 続きを読む "

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