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Container Closure Integrity Testing
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--Method Development And Validation
--Personal Care Chemistry Testing
--Extractables and Leachables
--ANALYTICAL GAS TESTING
--USP 660 Pharmaceutical Glass Testing
--USP 661 Plastic Containers Testing
--USP 671 Container Performance Testing
--Elastomeric Closure Testing
--EP & JP Container Testing
--Biological Reactivity Testing
--Container Qualification Full Test List
--CONTAINER CLOSURE INTEGRITY
--Vacuum Decay Leak Detection
--Electrical Conductivity (HVLD)
--Helium Leak Testing (HeLD)
--Residual Seal Force (RSF)
--Mass Flow Leak Detection
--ASTM & ISTA Distribution Testing
--Pharmacuetical Package Testing
--Medical Device Packaging Testing
--Consumer Product Testing
--Shelf Life & Accelerated Aging Testing
--Packaging Materials Testing
--Package Integrity Testing
--Package Strength Testing
--Package Labeling Testing
--Cleaning Validations (Swabbing, Analysis)
--USP <61> : Microbial Enumeration Tests
--USP <51> Preservative Challenge Test
--USP <62> Testing for Specified Microorganisms
High Voltage Leak Detection (HVLD) Testing Using The EScan 625 Instrument
In this first part of a series of blogs discussing High Voltage Leak Detection (HVLD), I will provide a general overview of one of the more popular HVLD units, an EScan 625 manufactured by PTI Inspect
Extractables and Leachables
Extractable and leachable studies have become a hot topic within the Pharmaceutical industry. Some individuals consider Extractables and Leachables as one entity, but they are really considered two different studies.
How clean is clean? - Cleaning, sanitizing, decontaminating… are you at par with FDA guidelines?
Modern cleaning validation procedures must be implemented to prove that the equipment is reasonably free of any residue. It must be documented to be safe, causes no product quality concerns, and the process is contaminant-free in accordance with FDA, cGMPs, and USP guidelines.
Elemental Analysis from a Quality Standpoint
Quality Assurance Units must provide assurance that the validation process has produced the expected results as per the requirements of USP General Chapter <233> Elemental Impurities in accordance with <1225> Validation of compendial procedures
ASTM D4169 Distribution Simulation Testing
Let's take a moment to go into detail of one of the most widely used distribution simulation test methods, ASTM D4169 – Standard Practice for Performance Testing of Shipping Containers and Systems.
FDA Guidance on Method Validation – Part One
Method Validation effects the development and quality control testing of most products. Updated FDA guidance titled Analytical Procedures and Methods Validation for Drugs and Biologics
Assessing CCI at Ultra Low Temperatures
With the increasing utilization of ultracold frozen storage to maintain product potency, the question arises: how do we verify container closure integrity at these extremely low temperatures?
A Candid Look at the Contract Pharma Conference
A few months back I published a blog article on the value of attending Interphex. For the regular readers (I know there are few), you will recall that I started that article by simply stating my dista
Residual Solvents: Most Difficult and Demanding Test in the Pharmaceutical Industry
Pharmaceutical products should contain low levels of residual solvents as determined by safety data. The presence of residual solvents in pharmaceutical products needs to be determined through testing
Trends in CCIT Part III: The Rise of the Autoinjector
As development of biologics and biosimilars forges on, the autoinjector remains on the rise. Industry shifts to deterministic test methods translate to a need to develop and validate methods for autoinjectors
Effective Teamwork in a GMP Laboratory Environment
Three years ago, the executive management of Whitehouse Laboratories implemented a major reorganization plan. Over the previous ten years, the company had experienced many areas of growth to include e
Trends in CCIT Part II: Reactive vs Preventative CCIT Programs
CCIT programs in lifecycle of a product-package system; from development of the package, to stability, to analysis of package integrity after distribution cycles. As related to proposed revisions to USP 1207
Trends in CCIT Part I: Probabilistic to Deterministic
In the past four or so years working with clients to develop and validate container closure integrity (CCI) test methods, there have been a number overarching trends that have become readily apparent.
Navigating USP Updates
Available tools to navigate the USP flow of information that will help remain abreast of changes that may affect your organization
USP 661 Container Testing – Common Questions
Common concerns and questions regarding USP 661 Container Testing. Outline answers to ten common questions that the USP has received specific to the USP 661 chapter
The Value of Pharmaceutical, Biotechnology and Science Related Internship Programs
implementing an intern program for college students specific to engineers, chemistry, biology and material science students can lead to a mutually rewarding results
The Strategic Use of Outsourcing
Contract laboratories go beyond routine laboratory work and provide the consultancy support required to meet theses ever changing regulatory developments.
Defining Technical Services
Technical Services division performs testing in key service areas such as, Unit Dose, Mechanical Testing, Stability. Cleaning Validation, Extractable Leachable.
High Performance Liquid Chromatography (HPLC) Testing
High Performance Liquid Chromatography otherwise known as HPLC testing
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.
Container Qualification Testing – The Closure Dilemma
USP 661 and USP 671 general chapters. Qualification testing of a closure for a pharmaceutical use container so it meets the USP qualification process
Container Integrity Testing Part Four – Capping, Residual Seal Force & Laser Diffraction
In part three of this series on CCIT, two commonly used methods – Residual Seal Force and Laser Diffraction – will be reviewed.
Container Integrity Testing Part Three – Helium & Mass Extraction
In part three of this series on CCIT, two commonly used methods – Helium and Mass Extraction – will be reviewed.
Container Integrity Testing Part Two - Vacuum Decay and HVLD
In part two of this series on CCIT, two commonly used methods – Vacuum Decay and High Voltage Leak Detection – will be reviewed.
Part One – Current State of Container Integrity Testing
This series of articles will review the present state of Container Closure Integrity Testing, the various methods currently available, the factors for choosing the most optimal method and current regulatory guidelines under development.