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--ANALYTICAL GAS TESTING
--Container Qualification Test List
--Medical Device Packaging
--Shelf Life & Accelerated Aging
--CONTAINER CLOSURE INTEGRITY
--Electrical Conductivity (HVLD)
--Helium Leak Testing (HeLR)
--Residual Seal Force (RSF)
--Mass Flow Leak Detection
The Value of Attending the Interphex Conference
Three key observations as to why Interphex is a must attend event. Interphex will bring over 12,000 global pharmaceutical and biotechnology professionals together in New York
Choosing a Distribution Test Method
In a recent article, we reviewed and discussed key concerns when selecting a test partner for package testing. Oftentimes, Life Science manufacturers struggle with packaging system development a
Qualifying “Excipient” Gases (Nitrogen, Carbon Dioxide, Oxygen) In the Drug Manufacturing Process
Qualifying Excipient Gases In the Drug Manufacturing Process. Steps to minimize and eradicate the possibility for the introduction of contaminated substances
Considerations When Choosing a Partner for Medical Device or Package Testing
In a recent article, we reviewed and discussed key components of cGMP and ISO 17025 quality systems and the role they play in the world of contract laboratory testing as it relates to pharmaceutical,
A Review of Gas Chromatography (GC) Testing
A review of the basic operation of the GC instrument for a better understanding of this commonly used test method.
The Value of ISO 17025 and cGMP Quality System Standards
Key areas to focus on when qualifying an outsourcing partner are Good Manufacturing Practices (GMP), and ISO 17025 quality standards.
An Overview of ISO 11607 Testing
Key components to the ISO 11607 procedure. ISO 11607 is the principle guidance for validating terminally sterilized medical device packaging
Are You Qualifying Your Dose Cups?
The Proper Approach to Volume Verification Testing of Metered Drug Delivery Devices
USP 671 Permeation – Clarification on Changes
Pending changes effective December 14, 2014 and insights into how industry companies may utilize the procedures to insure they meet the regulatory (FDA) requirements
Stability Testing – Overview and Update
Stability testing and monitoring in the drug development and manufacturing process. A critical step applicable to Food and Drug Administration (FDA) regulated products.
Updates on Container & Package Testing
Pending United States Pharmacopeia (USP) changes for container and package systems.
Syringe Qualification Testing
The USP 661 and USP 671 general chapters are effective in outlining the test requirements for a plastic container and a package system.