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Process Validation is a systematic approach used in manufacturing industries, particularly those under stringent regulatory requirements, to ensure that a process consistently produces a product that meets its predetermined specifications and quality attributes.

At Medistri, we’re focused on using our resources to combat climate change. We believe our commitments are both ambitious and necessary. To achieve our objectives, we focus on scalable innovation. Designing and implementing new technologies, mobilising financing structures, and rapidly deploying renewable energy.

Medistri is attending Pharmapack 2024 in Paris, France from January 24 to 25, hosting a booth to cater client meetings, showcase its services and answer all questions.

Risk mitigation through testing in the biocompatibility scenario is a crucial step in the evaluation of medical devices. It involves assessing the biocompatibility of the materials and processes used in the device by taking a risk-based approach to their biological safety evaluations.

Measuring the bond strength of materials is a key factor in determining the reliability and durability of many products. By ensuring the adhesive strength meets the required standards, manufacturers can enhance product quality, improve customer satisfaction, and prevent potential failures or malfunctions.

The Burst Test, as defined by the International Organization for Standardization (ISO) in ISO 2758, is a globally recognized method for assessing the bursting strength of paper. This test, also known as the Mullen Test, is applicable to paper with bursting strengths ranging from 70 kPa to 1,400 kPa.

A Biological Evaluation Plan (BEP) is an essential step in the medical device production process. This plan is aligned with the ISO 10993, the international series of standards for the biological evaluation of medical devices.

Bubble leak testing is an important method in the medical packaging industry to detect critical leaks within packaging. This test is particularly useful for validating the integrity of packages and bags, which is necessary to maintain a sterile environment for the contents. This test involves submerging the package or bag in water and applying a small amount of pressure to the package. The presence of a continuous stream of bubbles indicates a leak and therefore a breach of the sterile barrier.

Making sure that the sterilization is done correctly is one of the main priorities in the medical device and packaging industry. All medical packaging, whether it is a single-use product or intended for resterilization and reuse, must be strong enough to be easily opened by healthcare providers while ensuring product sterility. To ensure that packaging achieves this delicate balance, many manufacturers follow test standards such as ASTM F88 to measure the tensile strength of adhesives used in medical device packaging.

Bacterial endotoxins can trigger severe inflammation and death if they enter the bloodstream, cerebrospinal fluid, or intraocular fluid. Accurate detection of endotoxin levels in medical products is therefore an important part of the sterility testing process. Evaluation of bacterial endotoxin pyrogens is included in the International Organization for Standardization (ISO)’s new standard for microbiological methods.