Glove Leak Test
21CFR800.20 requires testing of exam and surgeon’s gloves to confirm the glove quality for the protection of healthcare workers in order to reduce the risk of transmission of infectious and immunodeficiency diseases. Following the method given in this section of the CFR, gloves are inspected for visible defects and pinhole leaks.
Sampling of the lot should be performed by an individual or service independent of your company. Geneva Labs offers assistance with the sampling process for product located within a 100 mile radius of our facility. For product located outside of that perimeter, we offer detailed sampling instructions to the individual or service of your choice.
Process Validation for Reusable Medical Devices / Instructions for Use
As the cost of care rises, more healthcare facilities opt for equipment and supplies that are reusable. To ensure that your recommended processing instructions provide a clean and/or sterile product, our Special Projects laboratory can conduct validation studies which duplicate the instructions provided. Protocols for hospital sterilization cycles and cleaning efficacy are offered.
Stability / Accelerated Aging
The purpose of stability testing is to give assurance that the integrity and functionality of a product and its packaging remains effective over the stated life span of a device or pharmaceutical. Exposure to a variety of environmental temperature and humidity conditions, followed by appropriate testing, will provide data to support shelf-life or expiration dating.
Geneva Laboratories offers a wide range of storage conditions including extreme low temperature, refrigeration, and elevated humidity. By applying ICH/FDA and ASTM (Q10) guidance, our analysts will work with you to set up protocols using the best temperature and humidity conditions for your product.
USP chapters <797> & <1116>, ISO guidance documents (ANSI/AAMI/ISO 13485, ANSI/AAMI/ISO 11135-1), and the FDA ‘Aseptic Processing Guideline’ all recommend or require environmental monitoring as a part of the manufacturing process control. This monitoring should include sampling for viable and/or non-viable particulate. Air sampling, settling plates and surface sampling are typical options for monitoring of the manufacturing areas and personnel. Water systems can be monitored by tests for endotoxin (in-process LAL), total organic carbons (TOC), and the heterotrophic plate count (microbial count). Characterization of recovered organisms by colony morphology, gram stain morphology, or identification to species is recommended.
Please contact a customer service representative for further information.