İçerik Tekdüzeliği Avrupa Farmakopesi ve 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 […]

Ampul Testi için Laboratuvar Ekipmanları: ISO 9187 Uyumluluğu için Eksiksiz Bir Kılavuz

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, […]

Elastomerik Kapak için Delinme Testi: ISO 8871-5 ve USP 381 uyarınca Ampul Mühürlerinin Kalitesinin Sağlanması

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. […]