SAGE In Vitro Fertilization Quality Control


SAGE Media - Quality and Consistency at it best!


All SAGE products are held to tight production tolerances and rigorous quality control methodologies for product acceptance. Inherent with this are  the validated design and production process specifications, ensuring consistent product quality and reliability.

Sterility- All SAGE IVF devices are single use. Single use, disposable, and packaged sterile. Ethylene Oxide sterilization method is used with a Sterility Assurance Level (SAL) of 10-6.  The sterilization process is in compliance with ANSI/AAMI/ISO 11135 - Validation and Routine Control of Ethylene Oxide Sterilization Requirements, EN550 Validation and Routine Control of Ethylene Oxide Sterilization, and ANSI/AAMI/ISO 10993-7 - Ethlyene Oxide Sterilization Residuals.

Toxicity Testing- Following sterilization all devices undergo stringent toxicity testing. Devices are made from non-toxic biocompatible medical grade polymers meeting USP VI medical grade materials standards and are latex free. Materials are tested to a stringent 2 cell mouse embryo assay (MEA) batch tested after sterilization with an acceptance level of >80% and performed by an independent expert laboratory. Certificates are available on request.  Endotoxin testing is performed using Limulus Ameobocyte Lysate (LAL) with a pass level of 0.5 EU/ml.  Catheter ink markings are also non-toxic biocompatible and use a proprietary "pad print" process to ensure complete adhesion and elimination of "rub-off" common to other methods of catheter marking.


SAGE Media™

SAGE Assisted Reproduction Products™ has served as the premier resource for a comprehensive line of innovative media products, SAGE Media™, that reflect consistent quality, reliability, and exceptional value.  Its core competencies and resources have been, and still are, specifically aimed at IVF culture media and andrology products used in IVF laboratories worldwide. SAGE operates a state-of-the-art FDA registered medical device manufacturing and distribution facility in Pasadena, CA. All IVF products are produced in compliance with FDA current Good Manufacturing practices (cGMP’s). SAGE’s company wide Quality Management System complies with the requirements of ISO 13458.

Focus is placed on optimizing every step in manufacturing, quality assurance, and safety testing to ensure products meet or exceed current Quality System Requirements (QSR) and are continually validated. The result for our customers is consistent and reliable performance for all SAGE Media™ products.

Ongoing research and development led by renowned scientists in media development
A rigorous quality assurance methodology that delivers quality and consistency
Exclusive use of one-cell mouse embryo bioassay (MEA)
All phases of media production, testing, and distribution are performed internally, facilitating our complete control over product quality and reliability

Validation of Sterility Assurance Level (SAL) for the aseptic filling of liquid products through:

Initial performance qualifications
Periodic re-qualification tests which conform to stringent international standards
 

Quality Control Testing Program

Incoming raw materials are held in quarantine until QC tested for toxicity via one cell MEA testing
Endotoxin levels are tested using LAL gel clot method
IVF culture media are tested for pH and osmolality prior to filling
Materials and products are removed from the aseptic filling suite, and all horizontal surfaces are disinfected to continually maintain sterility
Finished products are tested for defined attributes (Finished Product Specification) and sterility prior to distribution
 

State-of-the-art environmental monitoring before, during, and after each filling procedure

Sterilization filters are washed with purified water before every use and are integrity tested before and after each filling process.  A testing failure after filling procedure results in immediate discarding of filled product
Surface bioburden is sampled with agar (RODAC) touch plates used on all participating personnel
Air bioburden is sampled by Reutgers Centrifugal Air Sampler (RCS unit) and laser particle counter (CLIMET)