Pacific BioLabs publishes several booklets and pamphlets which contain a combination of regulatory compliance guidance and information about PBL services. To view them online, they require the Adobe® Acrobat Reader, version 5.0 or greater.

The below booklets and brochures may also be available in hardcopy. Please contact us  to request hard copies of any of the booklets or other published materials.

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• Booklets
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    Assessing Biocompatibility - A Guide for Medical Device Manufacturers (PDF)
    Sterility Assurance Compliance - A Guide for Medical Device Manufacturers (PDF)
    Preclinical Toxicology - Points to Consider in Program Design (PDF)
    Preclinical Toxicology - Guidance For Industry - ICH Guidances (PDF)

• Pamphlets
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    Biomaterials and Medical Device Testing (PUB)
    Microbial ID Services (PUB)
    Microbiology and Sterility Assurance Testing (PUB)
    Toxicology Services (PUB)

• Presentations

  • Monitoring Controlled Environments - 2007 (PPT)
    Medical Device Sterilization and Validation: General Principles - 2007 (PPT)
    Ethylene Oxide Sterilization Validation - 2007 (PPT)
    Heat Sterilization Validation - 2007 (PPT)
    Radiation Sterilization Validation - 2007 (PPT)
    Selecting and Managing Contract Sterilizers and Testing Laboratories - 2007 (PPT)
    Assessing Biocompatibility: Practical Guide - 2006 (PPT)
    The Advantages of Genotypic Microbial ID - 2006 (PPT)
    Sterilization Overview - 2004 (PPT)
    Points to Consider in Preclinical Development - 2003 (PPT)
    Preclinical Pharmacology - 2000 (PPT)

    NOTE: These PowerPoint presentations were prepared by PBL technical experts for specific events. The information was current as of the date of the presentation. As technical information changes frequently, please check with PBL for updates before acting on any of the recommendations included in these presentations.

• List of Test Codes
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    Medical Device (PDF)
    Pharm/Biopharm (PDF)
    Other (PDF)

• Certifications
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    Certificate of Registration: ISO 13485:2003 (PDF)
    Certificate of Registration: ISO 9001:2008 (PDF)
    AAALAC Accreditation Letter ( (PDF)