BlogCategory: Technical Services

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
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.
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.
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
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
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
Available tools to navigate the USP flow of information that will help remain abreast of changes that may affect your organization
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.
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
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,
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
Stability testing and monitoring in the drug development and manufacturing process. A critical step applicable to Food and Drug Administration (FDA) regulated products.
The USP 661 and USP 671 general chapters are effective in outlining the test requirements for a plastic container and a package system.