Geneva Labs

FDA Registered, GMP/GLP Compliant  and Accredited to ISO/IEC 17025:2017

262.723.5669

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Special Projects

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.

Environmental Monitoring

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.

News

USP <55> Revision Effective August 1, 2016, USP <55> Biological Indicators-Resistance Performance Tests requires testing of four (4) paper carriers (i.e. spore strips) to be tested individually to verify the total viable spore count … Read More

Download a Test Request Form

Geneva Labs Test Request Form GMP Non-GLP

Geneva Labs Test Request Form GLP Spec Form

 

Our Mission

Geneva Laboratories, Inc. seeks to provide testing services that promote patient well-being while certifying patient safety by offering accurate, reliable and cost-effective testing to the medical industry and building long-term relationships with our testing sponsors based on trust and service.

1.262.723.5669

custservice@genevalabs.com

Hours

Monday through Thursday 8 am to 4 pm
Friday 8 am to 12 pm
Beginnning June 7

News

USP <55> Revision Effective August 1, 2016, USP <55> Biological Indicators-Resistance Performance Tests requires testing of four (4) paper carriers (i.e. spore strips) to be tested … Read More

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