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.
Consolidating Your Vendor Network: Why It Is Important To Work With A Laboratory That Offers A Range Of Servicesadmin 2018-05-10T07:13:26+00:00
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.
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.
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
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.
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?