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. […]

Content Uniformity European Pharmacopoeia and ISO 9187

Content uniformity European pharmacopoeia is a fundamental aspect of pharmaceutical quality control, ensuring that each dosage form contains the intended amount of active ingredient within defined limits. For injectable drugs in ampoules, uniformity is crucial not only for efficacy but also for patient safety. By adhering to pharmacopoeial standards and following ISO 9187, manufacturers can […]

Lab Equipment for Ampoule Testing: A Complete Guide to ISO 9187 Compliance

Introduction In the pharmaceutical industry, ensuring the integrity and usability of ampoules is essential for patient safety and production efficiency. Reliable lab equipment for ampoule testing plays a vital role in assessing quality parameters such as breaking force, hydrolytic resistance, and annealing quality. One of the most authoritative standards in this domain is 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 […]

How to Perform Penetrability Tests for Elastomeric Closures According to ISO 8871-5 and USP 381

How to Perform Penetrability Tests for Elastomeric Closures According to ISO 8871-5 and USP 381 The penetrability test for elastomeric closure plays a vital role in pharmaceutical packaging validation. Elastomeric closures—such as rubber stoppers used in ampoules and vials—must allow for easy needle penetration while maintaining sealing integrity. In this article, we explore how to […]

The Importance of Ampoule Leak Testing for Product Integrity and Consumer Safety

Ampoule leak testing plays a vital role in guaranteeing the integrity of these sealed glass containers, which are commonly used to store sensitive products such as medications, chemicals, food and beverage extracts, and cosmetics. This essential quality control step helps prevent contamination, spoilage, and other safety concerns that could arise due to leaks or defects. […]