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The Pacific BioLabs Blog

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The Pacific BioLabs Blog | blog.pacificbiolabs.com Reviews
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Preclinical and GMP Testing News, and CRO Information
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3 info
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5 in medical device
6 tagged cleaning
7 disinfection
8 cleaning validation
9 cleaning validations
10 reusable device
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The Pacific BioLabs Blog | blog.pacificbiolabs.com Reviews

https://blog.pacificbiolabs.com

Preclinical and GMP Testing News, and CRO Information

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1

FDA Publsihes New Draft Guidance on Combination Products — The Pacific BioLabs Blog

http://blog.pacificbiolabs.com/pacificbiolabs/2015/2/27/fda-publsihes-new-draft-guidance-on-combination-products

The Pacific BioLabs Blog. Methods and News in Preclinical Testing, Analytical Chemistry, and Microbiology. The Pacific BioLabs Blog. The Pacific BioLabs Blog. FDA Publsihes New Draft Guidance on Combination Products. For anyone in the medical device or pharmaceutical fields, it's important to stay up to date on current Good Good Manufacturing practices. The guidance can be found on the FDA website: cGMP Guidance for Combination Products. Written by Aaron Burke. February 27, 2015.

2

PBL Announces New QA Department Manager — The Pacific BioLabs Blog

http://blog.pacificbiolabs.com/pacificbiolabs/2015/4/16/pbl-announces-new-qa-department-manager

The Pacific BioLabs Blog. Methods and News in Preclinical Testing, Analytical Chemistry, and Microbiology. The Pacific BioLabs Blog. The Pacific BioLabs Blog. PBL Announces New QA Department Manager. PBL is pleased to announce that Haihong Bao has joined as the new Quality Assurance Manager. Haihong brings more than 10 years of experience working in CRO environments, including 5 years QA management experience focusing on toxicology, analytical chemistry, and bioanalytical studies and reports.

3

Evaluation of Immunogenicity and Allergic Reactions to Medical Device Materials and Combination Products — The Pacific BioLabs Blog

http://blog.pacificbiolabs.com/pacificbiolabs/medical-device-immunogenicity

The Pacific BioLabs Blog. Methods and News in Preclinical Testing, Analytical Chemistry, and Microbiology. The Pacific BioLabs Blog. The Pacific BioLabs Blog. Evaluation of Immunogenicity and Allergic Reactions to Medical Device Materials and Combination Products. Collagen - an example of a biological material used as part of medical devices. Complex and Novel Materials Require More In-Depth Testing. However, it has become more common to see devices comprised of engineered biomaterials (such as stents co...

4

Why Understanding Bioburden and Sterilziation is Key to Medical Device Development — The Pacific BioLabs Blog

http://blog.pacificbiolabs.com/pacificbiolabs/2015/4/30/why-understanding-bioburden-and-sterilziation-is-key-to-medical-device-development

The Pacific BioLabs Blog. Methods and News in Preclinical Testing, Analytical Chemistry, and Microbiology. The Pacific BioLabs Blog. The Pacific BioLabs Blog. Why Understanding Bioburden and Sterilziation is Key to Medical Device Development. Pacific BioLabs and Nutek. A contract sterilizer specializing in e-beam irradiation). Understanding How Bioburden and Sterilization Affect Medical Devices. Pacific BioLabs performs medical device testing including sterilization validation services. April 30, 2015.

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ISO Certification

http://www.pacificbiolabs.com/iso.asp

Guide to Testing Regs. In Vitro Tox: Cytotoxicity. LAL and Pyrogen Testing. Contact Lens Solution Testing. Characterization of Pharmaceuticals and Biologics. EPA / OPPTS Testing. Stages of Drug Development. In Vivo Testing Overview. Categories of Preclinical Studies. GLP and Device Studies. Analytical Testing of Biomaterials. Lab Service Request Forms. QUALITY SYSTEMS: ISO Certification. Pacific BioLabs is ISO Certified as a Testing Services Supplier. Why Become ISO Certified? International Standards wer...

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Our Partners

http://www.pacificbiolabs.com/partners.asp

Guide to Testing Regs. In Vitro Tox: Cytotoxicity. LAL and Pyrogen Testing. Contact Lens Solution Testing. Characterization of Pharmaceuticals and Biologics. EPA / OPPTS Testing. Stages of Drug Development. In Vivo Testing Overview. Categories of Preclinical Studies. GLP and Device Studies. Analytical Testing of Biomaterials. Lab Service Request Forms. OUR PARTNERS AND PROVIDERS. Is a contract research organization providing detection strategies of drug and drug candidates at microdose levels. Is designe...

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Professional Affilitations

http://www.pacificbiolabs.com/affiliations.asp

Guide to Testing Regs. In Vitro Tox: Cytotoxicity. LAL and Pyrogen Testing. Contact Lens Solution Testing. Characterization of Pharmaceuticals and Biologics. EPA / OPPTS Testing. Stages of Drug Development. In Vivo Testing Overview. Categories of Preclinical Studies. GLP and Device Studies. Analytical Testing of Biomaterials. Lab Service Request Forms. Pacific BioLabs maintains affiliations with numerous professional associations including:. American Society for Microbiology ( ASM.

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Pacific BioLabs History

http://www.pacificbiolabs.com/history.asp

Guide to Testing Regs. In Vitro Tox: Cytotoxicity. LAL and Pyrogen Testing. Contact Lens Solution Testing. Characterization of Pharmaceuticals and Biologics. EPA / OPPTS Testing. Stages of Drug Development. In Vivo Testing Overview. Categories of Preclinical Studies. GLP and Device Studies. Analytical Testing of Biomaterials. Lab Service Request Forms. Pacific BioLabs was founded in 1982 as Northview Pacific Labs (NVP), the West Coast division of Northview Biosciences, Inc. To further expand its capabili...

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Testing Process

http://www.pacificbiolabs.com/testing_process.asp

Guide to Testing Regs. In Vitro Tox: Cytotoxicity. LAL and Pyrogen Testing. Contact Lens Solution Testing. Characterization of Pharmaceuticals and Biologics. EPA / OPPTS Testing. Stages of Drug Development. In Vivo Testing Overview. Categories of Preclinical Studies. GLP and Device Studies. Analytical Testing of Biomaterials. Lab Service Request Forms. QUALITY SYSTEMS: PBL Testing Process. 551 Linus Pauling Drive Hercules, CA 94547 - San Francisco Bay Area Tel: 510.964.9000.

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Facility

http://www.pacificbiolabs.com/facility.asp

Guide to Testing Regs. In Vitro Tox: Cytotoxicity. LAL and Pyrogen Testing. Contact Lens Solution Testing. Characterization of Pharmaceuticals and Biologics. EPA / OPPTS Testing. Stages of Drug Development. In Vivo Testing Overview. Categories of Preclinical Studies. GLP and Device Studies. Analytical Testing of Biomaterials. Lab Service Request Forms. PBL FACILITY - SUPPORTING GREAT SCIENCE. Commissioned in 2000, all major building systems and equipment have been validated to cGMP and GLP standards....

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Archive Policy

http://www.pacificbiolabs.com/archivefeeschedule.asp

Guide to Testing Regs. In Vitro Tox: Cytotoxicity. LAL and Pyrogen Testing. Contact Lens Solution Testing. Characterization of Pharmaceuticals and Biologics. EPA / OPPTS Testing. Stages of Drug Development. In Vivo Testing Overview. Categories of Preclinical Studies. GLP and Device Studies. Analytical Testing of Biomaterials. Lab Service Request Forms. Archive options are available at the time of sample submission on the Laboratory Service Request (LSR). Discard (after one year) – Non-GLP Default. Extend...

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News

http://www.pacificbiolabs.com/news.asp

Guide to Testing Regs. In Vitro Tox: Cytotoxicity. LAL and Pyrogen Testing. Contact Lens Solution Testing. Characterization of Pharmaceuticals and Biologics. EPA / OPPTS Testing. Stages of Drug Development. In Vivo Testing Overview. Categories of Preclinical Studies. GLP and Device Studies. Analytical Testing of Biomaterials. Lab Service Request Forms. July 21, 2016. PBL Analytical Chemist presents poster at Stanford. July 21, 2016. Seeking Beta Testers for PBL's New Client Portal! June 1, 2015. New Blog...

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Continuous Improvement

http://www.pacificbiolabs.com/improvement.asp

Guide to Testing Regs. In Vitro Tox: Cytotoxicity. LAL and Pyrogen Testing. Contact Lens Solution Testing. Characterization of Pharmaceuticals and Biologics. EPA / OPPTS Testing. Stages of Drug Development. In Vivo Testing Overview. Categories of Preclinical Studies. GLP and Device Studies. Analytical Testing of Biomaterials. Lab Service Request Forms. QUALITY SYSTEMS: Continuous Improvement. 551 Linus Pauling Drive Hercules, CA 94547 - San Francisco Bay Area Tel: 510.964.9000.

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SOP Manual

http://www.pacificbiolabs.com/sop.asp

Guide to Testing Regs. In Vitro Tox: Cytotoxicity. LAL and Pyrogen Testing. Contact Lens Solution Testing. Characterization of Pharmaceuticals and Biologics. EPA / OPPTS Testing. Stages of Drug Development. In Vivo Testing Overview. Categories of Preclinical Studies. GLP and Device Studies. Analytical Testing of Biomaterials. Lab Service Request Forms. QUALITY SYSTEMS: SOP Manual. More than 20 SOPs). More than 15 SOPs). More than 5 SOPs). More than 100 SOPs). Manual plus 10 SOPs). More than 40 SOPs).

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