EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of EN ISO 13408-3 testing. EN ISO 13408-3 specifies requirements and provides guidance on equipment, processes, programs and procedures for the control and verification of lyophilization as an aseptic process. It does not address the physical/chemical targets of a lyophilization process.
Lyophilization is a physical-chemical drying process designed to remove solvents from both aqueous and non-aqueous systems by sublimation and desorption. The product to be lyophilized must be identified and documented.
Product features should include, but are not limited to:
Once the specified lyophilization process has been applied, it meets the product's stated requirements for safety, quality and performance.
The design specifications of the equipment to be used to perform the required procedure within the specified allowable deviations should be established and documented.
Written regulations should be prepared that define how validation will be carried out. Regulations will be reviewed and approved and critical parameters and acceptance criteria determined. The design, installation, operation, performance and operations of the equipment are carried out by qualified personnel in accordance with approved regulations. Any deviations from regulations should be documented, investigated and corrected.
EUROLAB assists manufacturers with EN ISO 13408-3 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.
To get an appointment, to get more detailed information or to request an evaluation, you can ask us to fill in our form and reach you.
EUROLABreporting and certification activities, United Accreditation Foundation (UAF), Turkish Accreditation Agency (TÜRKAK) ve Enterprise Accreditation Foundation (EAF) based on the accreditation provided by the accreditation body. The Enterprise Accreditation Foundation (EAF) accreditation body is also a signatory of the United Nations (UN GLOBAL COMPACT) organization.
