Three Point Bending Flexural Test: Understanding the Key Principles and Applications

The three point bending flexural test is a crucial test in material science and engineering, often used to evaluate the strength, flexibility, and resistance of materials under bending stress. This test is particularly important in fields such as packaging, pharmaceuticals, and materials testing, where the durability and performance of materials like paperboard, plastics, and glass […]

Ampoule Break Strength Testing Machine: Essential for Parenteral Drugs Packaging

The ampoule break strength testing machine plays a pivotal role in ensuring the quality and safety of parenteral drugs packaging. This testing is vital for evaluating the strength and integrity of ampoules used in medical applications, where the ability to break cleanly and safely is crucial. In this article, we will explore the importance of […]

Vacuum Decay Leak Testing Solution for Pharmaceutical Package Integrity

Vacuum Decay Leak Testing Solution for Reliable Package Integrity A vacuum decay leak testing solution plays a critical role in modern pharmaceutical and medical packaging quality assurance. Sterile products rely on intact container–closure systems to maintain sterility, protect physicochemical properties, and ensure patient safety throughout their lifecycle. Even microscopic leaks can compromise product quality by […]

Understanding Hydrolytic Resistance of Glass Grains and ISO 720

Hydrolytic Resistance of Glass Grains: Understanding ISO 720 Testing The hydrolytic resistance of glass grains is an important quality characteristic for glass used in pharmaceutical packaging, such as ampoules and vials. ISO 720 provides the testing standards to evaluate this property, which is crucial for ensuring the chemical durability of glass when it comes into […]

Ampoule Break Strength Test and ISO 9187 Requirements for Glass Ampoules

Ampoule Break Strength Test in Pharmaceutical Packaging The ampoule break strength test plays a critical role in pharmaceutical quality control, especially for injectable drugs packaged in glass ampoules. Ampoules must open easily and cleanly at the point of use, while still maintaining sufficient mechanical strength during filling, sterilization, transportation, and handling. An imbalance in break […]

Ampoule Leak Test and the Role of the Ampoule Leak Testing Machine

Ampoule Leak Test and the Role of the Ampoule Leak Testing Machine Introduction Ampoule leak testing is a critical procedure used to ensure the integrity of ampoules, which are sealed containers used for storing pharmaceuticals, vaccines, and other sensitive materials. These glass containers must remain airtight to protect their contents from contamination, oxidation, and degradation. […]

Sisu ühtsus Euroopa farmakopöa ja ISO 9187

Sisalduse ühtlus Euroopa farmakopöa on ravimite kvaliteedikontrolli põhiline aspekt, mis tagab, et iga ravimvorm sisaldab toimeaine ettenähtud kogust kindlaksmääratud piirides. Ampullides süstitavate ravimite puhul on ühtlus oluline mitte ainult tõhususe, vaid ka patsiendi ohutuse seisukohast. Järgides farmakopöastandardeid ja ISO 9187, saavad tootjad [...]

Laboriseadmed ampullide testimiseks: ISO 9187 nõuetele vastavuse täielik juhend

Sissejuhatus Ravimitööstuses on ampullide terviklikkuse ja kasutatavuse tagamine oluline patsiendi ohutuse ja tootmise tõhususe seisukohast. Usaldusväärsed laboriseadmed ampullide testimiseks mängivad olulist rolli selliste kvaliteediparameetrite hindamisel nagu purunemisjõud, hüdrolüütiline vastupidavus ja lõõmutamise kvaliteet. Üks kõige autoriteetsemaid standardeid selles valdkonnas on ISO 9187, [...]

Elastomeerse sulguri läbitorkamise katse: Ampulli tihendite kvaliteedi tagamine vastavalt ISO 8871-5 ja USP 381 nõuetele.

Elastomeersete sulgurite läbitorkamise test: Ampullide tihendite kvaliteedi tagamine vastavalt ISO 8871-5 ja USP 381. Elastomeersete sulgurite terviklikkuse säilitamine on ravimipakendite puhul kriitilise tähtsusega. Elastomeersete sulgurite läbitorkamise katse on põhiline kvaliteedikontrolli protseduur, mis tagab, et ampullides ja viaalides kasutatavad kummist korgid vastavad rangetele ohutus- ja toimivuskriteeriumidele. Alates [...]

Kuidas teha elastomeersete sulgurite läbilaskvuse teste vastavalt ISO 8871-5 ja USP 381 nõuetele

Kuidas teha elastomeersete sulgurite läbilaskvuskatset vastavalt ISO 8871-5 ja USP 381. Elastomeersete sulgurite läbilaskvuskatsel on oluline roll ravimipakendite valideerimisel. Elastomeersed sulgurid - näiteks ampullides ja viaalides kasutatavad kummist korgid - peavad võimaldama nõela hõlpsat läbitungimist, säilitades samal ajal plommi terviklikkuse. Selles artiklis uurime, kuidas [...]