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. […]

Sisällön yhdenmukaisuus Euroopan farmakopea ja ISO 9187.

Sisällön yhdenmukaisuus Eurooppalainen farmakopea on olennainen osa lääkkeiden laadunvalvontaa, sillä sen avulla varmistetaan, että kukin lääkemuoto sisältää aiotun määrän vaikuttavaa ainetta määritellyissä rajoissa. Ampulleissa olevien injektoitavien lääkkeiden osalta tasalaatuisuus on ratkaisevan tärkeää paitsi tehon myös potilasturvallisuuden kannalta. Noudattamalla farmakopeastandardeja ja ISO 9187 -standardia valmistajat voivat [...].

Laboratoriolaitteet ampullitestausta varten: ISO 9187 -vaatimusten noudattamisen täydellinen opas

Johdanto Lääketeollisuudessa ampullien eheyden ja käytettävyyden varmistaminen on potilasturvallisuuden ja tuotannon tehokkuuden kannalta välttämätöntä. Luotettavat laboratoriolaitteet ampullien testausta varten ovat elintärkeitä laatuparametrien, kuten murtovoiman, hydrolyyttisen kestävyyden ja hehkutuslaadun, arvioinnissa. Yksi tämän alan arvovaltaisimmista standardeista on ISO 9187, [...]

Puncture Test for Elastomeric Closure: Ensuring Quality of Ampoule Seals per ISO 8871-5 and USP 381

Puncture Test for Elastomeric Closure: Ensuring Quality of Ampoule Seals per ISO 8871-5 and USP 381 Maintaining the integrity of elastomeric closures is critical in pharmaceutical packaging. The puncture test for elastomeric closure is a fundamental quality control procedure that ensures rubber stoppers used in ampoules and vials meet stringent safety and performance criteria. From […]

Miten elastomeeristen sulkimien läpäisevyystestit suoritetaan ISO 8871-5:n ja USP 381:n mukaisesti?

Miten elastomeeristen sulkimien läpäisevyystestit suoritetaan ISO 8871-5:n ja USP 381:n mukaisesti Elastomeeristen sulkimien läpäisevyystestillä on tärkeä rooli lääkepakkausten validoinnissa. Elastomeeristen sulkimien, kuten ampulleissa ja injektiopulloissa käytettävien kumitulppien, on mahdollistettava neulan helppo tunkeutuminen ja säilytettävä samalla tiivisteen eheys. Tässä artikkelissa tarkastelemme, miten [...]