Geneva Labs

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

262.723.5669

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Informational

Notices

Changes in USP Microbial Limit Test
USP Microbial Limit Test was revised on May 1, 2009 into two separate sections: USP Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests and Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms.

Testing of Glycerin for Diethylene Glycol

The Office of Compliance in the Center for Drug Evaluation and Research (CDER) provides Guidance for Industry concerning the “Testing of Glycerin for Diethylene Glycol.”

Now Available

Now available a closed system membrane filtration test of sterility utilizing the Millipore Steritest System for maximum assurance against a false negative response.

CGMP Manufacturing Practice Regulations for Finished Pharmaceuticals

Final Rule: CGMP Manufacturing Practice Regulations for Finished Pharmaceuticals. Released September 8, 2008. Effective December 8, 2008. Amendments have been made to the CGMP for finished pharmaceuticals. Included in the three areas targeted for change is Aseptic Processing, specifically §211.113(b), §211.67(a), §211.84(d)(6), and §211.110(a).

Newsletters/Articles

Browse our latest newsletters and articles, listed below. All documents are in PDF format, which will require a PDF reader, such as Adobe Acrobat Reader to view them. They are also available as Word Documents.

Please note: The following PDF documents will open in  your browser window. However, the DOC files will download to your computer. 

Toxicology / Biocompatibility

Sample Requirements for Biocompatibility Testing [ PDF | DOC ]

Microbiology

Antimicrobial Effectiveness Testing [ PDF | DOC ]

Special Projects

Environmental Monitoring [ PDF | DOC ]

Sterilization Process Validation

ANSI/AAMI/ISO 11137-2 ; Method to Substantiate 25 kGy for Gamma Sterilization [ PDF | DOC ]
Validation of the EtO Sterilization [ PDF | DOC ]

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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