EO Sterilisation & Packaging
It is critical when evaluating packaging materials that the risks from sterilisation methods are assessed. Different types of sterilisation methods impact materials and products in different ways.Medistri’s team has gathered more than a decade of experience working with the world’s most innovative healthcare companies and helping them scale globally.
Our Environmental Commitment
At Medistri, we have invested our resources in finding smarter systems, protocols & validation methods to reduce, optimise and eliminate EO emissions. Since our foundation in 2006, we’ve been focused on using our resources to establish sustainable infrastructure. We believe our commitments are both ambitious and necessary.
Phtalates Testing and Analysis
Medistri can perform phthalate trace level detection analysis and screening of products and materials especially made of polyvinyl chlroride (PVC). These regulations require some industries to heavily & regularly monitor the presence an amount of these specific compounds. They have been established to monitor either low percentage or part per million (ppm) levels.
The Infrastructure behind millions of product
Founded in 2006, Medistri has been focused on building infrastructure for the healthcare industry. Companies of every size, from startups & university projects to Fortune 500 companies use our services to save time, scale and focus on what they do best.Medistri reduces the barriers to healthcare product development & scalability.
Development of Medical Devices Testing Stack
Patient safety is predicated on the medical device’s specific structural materials and also on a comprehension of the compounds and residuals that might be produced or recognised throughout the supply chain. Medistri’s laboratory team aggregates all data, outlines findings, and recommend risk management proposals in a transparent, detailed, and precise manne — Allowing you to bring your safe product to market quickly.
Extractables & Leachable’s (E&L) Testing for Pharmaceuticals
Extractables and leachables (E&L) studies are now a crucial component of product release. Medistri’s Laboratory provides GMP-compliant leachables method validation for use in GMP stability testing and storage programs and are able to support a variety of closure or drug delivery systems.
Sub-Visible Particle Testing
Medistri’s laboratory performs medical device particulates testing on injections, parenteral infusions and medical devices as particulate matter is produced through various sources during processing. Particulate matter in injections and parenteral infusions consists of mobile undissolved particles, other than gas bubbles, unintentionally present in the solutions.
Contract Steam Sterilization Services
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.
Ethylene Oxide Residual Analysis
Because of its broad material compatibility, ethylene oxide (EO) is frequently used to sterilize medical equipment. It’s possible for EO to leave a residue on the material being sterilized. The following are the residues that may remain following sterilisation:
- Ethylene Oxide (EO) is a possible byproduct of processing.
- Ethylene Chlorohydrin (ECH) is a potential by product of EO’s interaction with free chloride ions.
- Ethylene Glycol (EG), a byproduct that may result from the interaction of EO with water.
Ethylene Oxide (EO) Sterilization Validation
Prior to beginning routine ethylene oxide sterilisation, a product with a sterile claim needs to complete a validation process to ensure the Sterility Assurance Level claimed is met according to ISO 11135.
An Ethylene Oxide (EO) Sterilization Validation is designed to assist the manufacturer in the development of a sterilization process that delivers the appropriate sterility assurance level and ensures repeatability for each product type developed.
