The updated table below describes the current series of ISO 80369 Series of standards and when they came online:
In package performance protocols, these vibration forces are incorporated into a regimen of other transport hazards such as handling (shock), compression, and environmental temperature and humidity extremes.
ASTM D 4169-14 is the current FDA approved consensus standard. The typical test regimen for medical device package testing is distribution cycle 13 (DC 13).  The test intensity levels are most co
Whitehouse Laboratories is one such location that provides all of the testing and validation services that any medical or pharmaceutical manufacturer needs to ensure the efficacy of their products, and the safe delivery to their end use.
The debate in the industry is which standard to use for compliance with the ISO 11607 standard.
Significant product and package responses and interactions during shipment can be severe and may lead to package or product failure. Identification of critical frequencies and the nature of package stresses can aid in minimizing the effect of these occurrences.
Is critical in the package development and design process to assess the ability of the sterile barrier system to resist the vibratory forces in the transport environment
The nebulous aspect of vibration is that most of the damage caused by vibration forces is not known to have occurred until the product is delivered and about to be used for its intended use.
Often in the microbial examination of products, physical issues occur that force adaptations to the sample preparation. Some of these challenges include viscosity, the need for mixing or blending to a
The microbiological examination of products can often prove challenging when the product is antimicrobial. This is often by design, but can also be inherent to the excipients, inherent to the active p
Suitability Testing is integral to any Microbiological test system. Suitability testing demonstrates that the test system and methodology are suitable for the intended purpose and compatible with the
Controls, Validation, and Challenges of Bioburden Testing, Microbial Limits Testing, or Microbial Examination of Non-sterile products
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
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.
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.
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
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.
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
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 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
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
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
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
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
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.
Available tools to navigate the USP flow of information that will help remain abreast of changes that may affect your organization
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
implementing an intern program for college students specific to engineers, chemistry, biology and material science students can lead to a mutually rewarding results
Contract laboratories go beyond routine laboratory work and provide the consultancy support required to meet theses ever changing regulatory developments.
Technical Services division performs testing in key service areas such as, Unit Dose, Mechanical Testing, Stability. Cleaning Validation, Extractable Leachable.
High Performance Liquid Chromatography otherwise known as HPLC testing
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
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 In the Drug Manufacturing Process. Steps to minimize and eradicate the possibility for the introduction of contaminated substances
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 the basic operation of the GC instrument for a better understanding of this commonly used test method.
Key areas to focus on when qualifying an outsourcing partner are Good Manufacturing Practices (GMP), and ISO 17025 quality standards.
Key components to the ISO 11607 procedure. ISO 11607 is the principle guidance for validating terminally sterilized medical device packaging
The Proper Approach to Volume Verification Testing of Metered Drug Delivery Devices
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 and monitoring in the drug development and manufacturing process. A critical step applicable to Food and Drug Administration (FDA) regulated products.
Pending United States Pharmacopeia (USP) changes for container and package systems.
The USP 661 and USP 671 general chapters are effective in outlining the test requirements for a plastic container and a package system.
USP 661 and USP 671 general chapters. Qualification testing of a closure for a pharmaceutical use container so it meets the USP qualification process
In part three of this series on CCIT, two commonly used methods – Residual Seal Force and Laser Diffraction – will be reviewed.
In part three of this series on CCIT, two commonly used methods – Helium and Mass Extraction – will be reviewed.
In part two of this series on CCIT, two commonly used methods – Vacuum Decay and High Voltage Leak Detection – will be reviewed.
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.