Reactive Leachables
The reactivity of leachables is an area of growing concern, particularly for therapeutic proteins and peptides. These...
Archives: Courses
Rubber Oligomers: The “Special Case” compounds: Formation, Structure Toxicity & Reactivity
Rubber oligomers, originating from rubber closures (vials) or plungers (e.g., syringes or cartridges), represent a class of...
Setting up Extractables & Leachables Studies for Small Volume Parenteral Applications
In this presentation at the 2022 Nelson Labs Virtual Symposium, we will cover the general principles of...
The Challenges in Toxicological Assessments for Small Volume Parenteral Packaging System Applications
This presentation at the 2022 Nelson Labs Virtual Symposium will focus on the typical toxicological challenges encountered...
The Necessity of Extractables and Leachables Qualifications for Lyophilized Drug Products: Some Fallacies Addressed.
When selecting and qualifying the primary packaging for lyophilized drug products (LDPs), a fundamental question arises: How...
A Structured Approach to Selection of Container Closure Materials for Small Volume Parenterals – Pipe Dream or Necessity
In the upcoming 2022 Nelson Labs Virtual Symposium, this presentation will emphasize the importance of selecting materials...
E&L Testing of Single-Use Systems for Production
In the 2022 Nelson Labs Virtual Symposium, this presentation will focus on the critical issue of leachables...
Manufacturing an SVP Drug Containment Solution: Quality by Design
The 2022 Nelson Labs Virtual Symposium will offer an in-depth look at the considerations necessary when choosing,...
Polymer-based, Pre-filled Syringes designed to Minimize the Aggregation Risk of Sensitive Biodrugs
Biopharmaceutical drugs offer new therapeutic solutions to numerous human diseases and conditions. However, these advanced therapies come...
Radiation Sterilization of SVPP: RTU and fill/finished. Do not default to 25 kGy – 40 kGy.
At the 2022 Nelson Labs Virtual Symposium, we will present examples of radiation sterilization for Ready-to-Use (RTU)...
Rubber Manufacturing and Composition of Pharma Rubbers
Rubber closures are a critical component in the primary packaging system of small volume parenterals (SVPs). At...
Combination Products and Parenteral Packaging: A Notified Body (EU) Perspective
This presentation at the 2022 Nelson Labs Virtual Symposium will provide a comprehensive overview of the considerations...
Combination Products and Parenteral Packaging a US Perspective
This presentation at the 2022 Nelson Labs Virtual Symposium will provide a comprehensive overview of drug delivery...
A Stepwise Approach to Deal with In Vitro Cytotoxicity Failures
Manufacturers are required to perform a biological evaluation of any medical device as outlined in ISO 10993-1....
FDA Medical Device Inspections in the Post Pandemic World
The FDA is ramping up its inspections of medical device manufacturing facilities. Are you ready? Since March...
2022 State of the Medical Device Industry Quality, Biocompatibility, and Changing Regulations
As another year unfolds with regulatory changes, updated mandates, and the ongoing impacts of the COVID-19 pandemic,...
Preservative Effectiveness Testing – Calling Attention to Burkholderia SPP
Controlling the growth of microbes within non-sterile formulations is critical for ensuring product safety and meeting regulatory...
On the Origin of Extractable Species
The universe of extractables is extremely diverse, encompassing a wide variety of materials used in the construction...
Testing and Risk Management Impacts Changing Medical Device
Change management, particularly related to a medical device’s design, is one of the most commonly cited issues...
Risk Assessment for Single Use Systems: USP 665 vs. BPOG
Disposable plastic components are increasingly popular in biopharmaceutical drug manufacturing systems due to their cost-effectiveness and reduced...