Science Library

Microtest offers a variety of papers on life sciences testing and pharmaceutical manufacturing.  Please download any title of interest.

Medical Device Testing

• FDA Updates Medical Device Endotoxin testing program (New Guidance) — by Steven Richter, Ph.D.
• Using Notebook Studies to Help Ensure a Successful Reusable Device Cleaning Validation — by Patrick Kenny
• Reusable Medical Device Cleaning Validation and Testing Requirements: An Industry Perspective — by Steven Richter, Ph.D.
• New Medical Device Polymer Biocompatibility Screening Test Using Zebrafish Embryos (Danio Rerio) — by Steven Richter, Ph.D.
• The New Scope of Reusable Device Cleaning Validation — by Patrick Kenny
• Five Steps to Validating the Cleaning Process of Medical Devices — by Patrick Kenny
• Medical Device Sterility Testing: Essential Things You Must Know — by Steven Richter, Ph.D.
• Package Validation Requirements for Medical Devices and Combinatory Products — by Steven Richter, Ph.D.
• Get With the Program: Having a solid package validation program can prevent failure of combination products — by Steven Richter, Ph.D.
• Reusable Medical Device Disinfection and Cleaning Validation Requirements — by Steven Richter, Ph.D.

Pharmaceutical & Biotech Testing

• Summary of Proposed Changes to 21 CFR 610: The New Scope of Biologics Sterility Testing — by James E.T. Gebo
• USP Microbial Examination of Non-Sterile Products: A Roadmap to the Regulations of the Non-Sterile Testing World — by James E. T. Gebo and Kimberly Kitch
• Dietary Supplements: A New Paradigm for Manufacturers — by Steven Richter, Ph.D.
• Pharmaceutical Sterility Testing: Essential Things You Must Know — by Steven Richter, Ph.D.
• Stability Program Management, Clinical Trial Materials: PTC When Using A Contract Stability Lab — by Alexander Mello and Jessica Labrie

Environmental Monitoring

• Disinfectant Qualifications: Insight and Perspective — by Deborah Ensign, Shawn Sherry, and Kate Bloomrose
• Six Steps to Qualifying Disinfectants — by Deborah Ensign
• Developing Environmental Monitoring Programs for the Ever-Changing Regulatory Landscape — by Steven Richter, Ph.D.
• The Microbial ID Breakthrough: How DNA Sequencing Services Help Prevent Catastrophic Cleanroom Shutdowns — by Dennis Champagne

Compounding Pharmacies

• Compounding Pharmacy Inspections: What You Must Know To Prepare for the FDA — by Steven Richter, Ph.D.

Contract Manufacturing

• Weathering the Storm of Regulatory Compliance in Aseptic Manufacturing — by Alex Mello
• Advanced Detection of Mycoplasmas: How Real-Time PCR Analysis Helps Save Time and Money for Biopharmaceutical Manufacturers — by Dennis Champagne
• Clinical Trial Material Production and Testing: Is Your CMO Providing Everything You Need? — by Alexander Mello

Combination Products

• Combination Products 2.0: Applying the New FDA Regulations — by Steven Richter, Ph.D.