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Great start to Pharmapack Europe 2023

We are very happy to come and visit our customers to discuss their 2023 and onwards objectives!

Laboratory

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.

Laboratory

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.

Packaging

ISTA Packaging Standards

At Medistri, you can validate your packaging according to ISTA 2A, ISTA 3A, ASTM D7386, ASTM D4169. Should you fully validate your packaging system or should you simply test one particular characteristic of your sterile barrier system, Medistri laboratory is accredited and highly experienced for the most common test method provided in ISO 11607-1.

Sterilisation

EO Sterilisation Load Variables

At Medistri, we believe in delivering the highest quality services to our customers. In the sterilisation process of medical devices using ethylene oxide (EO), it is important to carefully consider several variables to ensure that the process is effective.

Schedule a meeting with Medistri at Pharmapack 2023

Medistri is attending Pharmapack 2023 in Paris, France from February 1 to 2, hosting a booth to cater client meetings, showcase its services and answer all questions.

Medical Device

Medical Device Biological Evaluation Plan

At Medistri, we aim to address these issues by using a scientifically sound risk-based approach to determine the most appropriate testing methods for each device. That’s why we follow the guidelines outlined in ISO 10993–1:2018 and the FDA’s guidance document on the use of this standard, which require a structured biological evaluation plan as part of a risk management process in accordance with ISO 14971

Laboratory

Total Organic Carbon (TOC)

Organic contaminants in medical devices can cause adverse reactions in patients, reduce the effectiveness of the device, or cause the device to malfunction. TOC analysis can identify and quantify these contaminants, allowing manufacturers to ensure that their medical devices meet regulatory requirements and industry standards.

Elemental and Trace Metal Analysis for Pharmaceuticals

For pharmaceutical manufacturers, Elemental and Trace Metal Analysis is an important step towards development, quality control, and release. Medistri’s in-house GMP laboratory works with it customers to design pharmaceutical organic and inorganic elemental analysis.

Sterilisation

Medistri to Welcome it's Fifth Sterilization Line

Medistri, a leading provider of contract sterilization & laboratory services for healthcare companies, is excited to announce the arrival of its fifth sterilization line this week. The new chamber will be used primarily for the sterilization of pharmaceutical & medical devices coming from multiple countries. It will be fully operational and ready to use by the beginning of 2023.