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Laboratory

Medical Device Shelf Life Testing

Medical devices are labeled with an expiration date that is supported by testing shelf-life data. Medical device manufacturers wishing to gather data on the shelf life of their products may subject their devices to long-term stability studies or accelerated aging studies. There are many different endpoints that can be used to assess the shelf life of a medical device, including sterility or package integrity, so it is important that endpoints and test methodology are decided upon before testing is begun.

Laboratory

Elemental and Trace Metal Analysis

Elemental and Trace Metal Analysis is a critical part of quality control and commercial release in the pharmaceutical and medical device industry. It involves the analysis of trace metals and other elements in raw materials, active pharmaceutical ingredients (APIs), excipients, and formulations to ensure product quality and purity.

Packaging

Compression Test

Compression tests are used to determine a material’s behavior under applied crushing loads, and are typically conducted by applying compressive pressure to a test specimen (usually of either a cuboid or cylindrical geometry) using platens or specialized fixtures on a universal testing machine.

Sterilisation

Steam Sterilisation Technology

Steam sterilisation technology exposes your products with saturated steam under pressure. Steam enhances the ability of heat to kill microorganisms by reducing the time and temperature required to denature or coagulate proteins in the microorganisms. Steam sterilisation cycles generally have three phases including conditioning, exposure and exhaust. Steam sterilisation is a simple but very effective method of decontamination.

Packaging

Introduction to Concentrated Impact Test

Concentrated Impact Test is a type of transit testing that is performed to make sure a package can withstand the rigors and environment of the distribution cycle. It is one of the most widespread impact testing methods for measuring the protective capacity of packaging.

Laboratory

Environmental Monitoring

Environmental monitoring is a crucial process that helps to assess the impact of human activities on the environment and take steps to minimize any negative effects. Failure to conduct environmental monitoring can result in a lack of understanding of the environmental impact of an organization’s activities, leading to potential harm to the natural environment and human health.

Sterilisation

Introduction to EO Sterilisation

At Medistri, whether you are a start-up or a large established company, you can track your products through the EO sterilisation process and have a clear overview of when your products are ready to leave our facilities. Medistri can ship your sterile products directly to your customers or to your distribution centre.

Packaging

Mechanical Handling Test

Mechanical handling refers to the use of machines and equipment to move, store, control, and protect materials, goods, and products throughout the process of manufacturing, distribution, consumption, and disposal. Mechanical handling tests are used to evaluate the ability of shipping units to withstand the stresses of manual and mechanical handling during the distribution process.

Laboratory

Residual Testing

Residual testing is a method of analysing the chemical residues that may remain on a medical device after it has been exposed to a sterilisation process. Residues can affect the biocompatibility, functionality and safety of the medical device, and potentially harm the patient or user. Therefore, it is important to ensure that the residues are within acceptable limits according to the relevant standards and regulations.

Microbiological Testing

For many years, healthcare quality has been enhanced by medical devices. These devices are made with strict safety and risk evaluation processes to ensure they work as intended and safeguard patients’ health. To maintain high quality control standards, manufacturers have to check their medical devices regularly. One of the methods to assess the safety of a device is to look for any harmful microorganisms that might infect the device. This is done by using microbiological tests.