Blogs

Categories

Select a Sub-Category

Films and Coatings
Pharmaceutical Packaging Components
Prefillable Systems
Self Injection Devices
Vial Containment Solutions
Washing and Sterilization
Reconstitution and Transfer Devices

Select a Sub-Category

Analytical Lab Services
Contract Manufacturing
Fill-Finish
Regulatory Support

Select a Sub-Category

Cell and Gene Therapy Packaging
Drug Development Process
Regulatory Challenges
Transitioning to Combination Products

Select a Sub-Category

Corporate Development
ESG/Sustainability
One West Team (Employee Culture)
Our Culture of Giving (Philanthropy)
Research and Development

Previous Blogs

By Sok-Tiang Koh

二月 15, 2019

The level of particles in parenteral pharmaceutical formulations is a critical quality attribute. This is no surprise; the clinical consequence of their presence can be very severe, including fatality. In the major pharmacopeia, from the US, Europe, and Japan, there is a specified limit for particles in the final parenteral formulation. Moreover, these pharmacopeia specify two methods for measurement – light obscuration (LO) and microscopic particle count (MPC).