ASTM is one of the world's leading international quality organisations. The ASTM guidelines are an agreement between consumers, manufacturers, government agencies and scientists from over 140 countries on the implementation of packaging quality and testing requirements.
Heavy metal elemental analysis is the process of measuring the concentration and composition of metals in biological samples. Heavy metals can be toxic and essential for living organisms, depending on their dose and bioavailability. Therefore, it is important to monitor their levels in the environment.
The Toxicological Studies provide a consistent definition of the circumstances under which it is necessary to undertake studies on new drugs and/or devices. The recommendations take into account the known risk factors as well as the intended indications and duration of exposure. Following standards such as ISO 10993 also helps to uncover potential risks like carcinogenicity, genotoxicity and reprotoxicity. Additionally, following standards can increase sensitivity and reduce the number of animals required for overall safety evaluations.
Reprocessing and cleaning validation are essential processes in the medical device industry - it’s critical to ensure the safety and effectiveness of medical devices. These processes help to prevent the transmission of infections and ensure that devices function as intended. Both reprocessing and cleaning validation are subject to strict regulations to ensure that they are carried out correctly and effectively.
The validation of steam sterilization on products includes both physical and microbiological qualification processes. These processes are performed to ensure that the sterilization process is effective in deactivating microorganisms and providing a sterile product for later use.
Sterilisation is an important method that manufacturers widely use to keep medical devices safe for patient use. It is a considered a ‘cold’ sterilization technique and offers high compatibility with most materials used in the manufacturing & packaging of medical devices, such as plastics, polymers, metals and glass. For many medical devices, EO sterilisation may be the only method that effectively sterilizes without damaging the device during the sterilisation process.
Visual Inspection Testing provides a qualitative visual inspection to evaluate the appearance characteristics of unopened, intact seals in order to determine the presence of defects that may affect the integrity of the package. ASTM F1886 covers the determination of channels in the package seal down to a width of 75 μm (0.003 in.) with a 60 – 100 % probability.
Real-Time Ageing Tests are a great way to test the durability of a product. They can also be used to test how quickly an object will deteriorate, or even how long it takes for certain chemicals to break down. It's important that you follow all safety precautions when performing a real-time ageing test.
Sterilisation is a crucial process in the pharmaceutical industry to ensure the safety and efficacy of drugs and medical devices. Ethylene oxide (EO) sterilisation is one of the most widely used methods for sterilising pharmaceutical products. In this article, we will discuss the basics of EO sterilisation, its advantages and disadvantages, and its applications in the pharmaceutical industry.
Accelerated ageing tests are essential in determining the expected lifespan of materials and products in a shorter period of time. These tests are conducted to simulate the natural ageing process under extreme conditions, such as high temperature and humidity, to predict the performance and durability of the materials and products.