ISO 80369-7 is the newly published standard that replaces the ISO 594 series of standards. The ‘Part 7’ standard is specifically [...]
Amazingly, since the 1990’s the risk of misconnection of fittings for medical device and drug delivery systems has been evident [...]
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.
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
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.