What is a Sterile Barrier System?
A Sterile Barrier System (known as SBS) is often present (and mandated by regulation) in the medical packaging industry. It refers to minimum packaging that prevents contamination and helps to sterilize the finished product. The system must guarantee sterility throughout the whole supply chain from production through to the operation room. ISO 11607-1 specifies the requirements related to the compliance of the packaging for sterilised medical devices, including materials, sterile barrier systems and packaging systems.
Introduction to Cytotoxicity
Measuring the potential adverse effects of substances on living organisms is important to multiple industries. A property of the substance that needs to be known is its cytotoxic effect - whilst toxicity is a more general term for how harmful a substance is to living organisms, Cytotoxicity is a term that describes how toxic a substance is to cells.
Medistri SA's Earthwork & Construction Begins
In order to keep up with the growth expectations of our customers, we are pleased to inform that Medistri’s expansion will begin mid-March.
Bioburden testing is a fundamental microbiological analysis used to assess the level of microorganisms present on a medical device or other sterile product before it is sterilized. It involves collecting a sample from the product and then growing and counting any microorganisms present in the sample.
In Vitro Toxicology
In vitro toxicology is the study of the potential toxicity of chemicals, pharmaceuticals, and other substances by testing them on cells or tissues. In the early stages of development, this type of study is necessary for the medical device and pharmaceutical industry, as it allows for the identification of potential hazards and side effects.
2022 Carbon Emissions Report
At Medistri, we’re focused on offering great services and infrastructure for healthcare companies with the task of bettering our planet. We take responsibility for our services throughout their entire cycles—from sourcing materials, managing processes to forwarding the products to our customers. We focus on the areas where we can make the biggest difference for our planet: reducing our impact on climate change, conserving important resources and using safer materials. Millions of products pass through our Sterilisation infrastructure every year. Making adjustments to reduce our carbon impact can have a meaningful impact.
Introduction to EO Sterilisation Validation
Sterilization is the process of eliminating or reducing the number of microorganisms. It is a critical step in the manufacturing and packaging of medical devices and pharmaceuticals to ensure safe for use for patients. EO sterilization is a commonly used method of sterilization in the medical and pharmaceutical industries.
Great start to Pharmapack Europe 2023
We are very happy to come and visit our customers to discuss their 2023 and onwards objectives!
Introduction to Biocompatibility
In the medical device industry, biocompatibility evaluations are performed to assess the risk of harm to patients or users resulting from device contact with living tissue and bodily fluids. Standards such as ISO 10993 and USP Class VI provide a framework for evaluating the risk profile of a medical device, based on the nature of body contact and the duration of contact.
LAL & Bacterial Endotoxin
The LAL (Limulus Amebocyte Lysate) testing, also known as bacterial endotoxin testing, is an in vitro assay used to detect the presence and concentration of bacterial endotoxins in drugs and biological products, and is an important part of pharmaceutical microbiology.