Aseptic Processing: A Primer - Pharmaceutical Technology

Latest Issue

Latest Issue
PharmTech Europe

Aseptic Processing: A Primer
PharmTech speaks to Ray O'Connor from the National Institute for Bioprocessing Research and Training (NIBRT) for an overview of aseptic processing.

Pharmaceutical Technology Europe

Analytics and testing

Q PTE: Various analytics and testing are involved in aseptic processing, including sampling, validation, and identification. Can you talk about some of the major considerations manufacturers need to keep in mind for this part of aseptic processing?

O'Connor: Sampling is an important part that involves testing to determine whether your process is in control throughout manufacturing. Before approving a process, it must be validated, which requires an extensive battery of tests on the product, including characterisation, identification, and contamination minimisation. One key factor for taking samples of biologics is to ensure that the product is not contaminated while samples are taken, which could lead to false positives.

Samples are also taken after the product has been sterile-filtered for sterility testing. If the product does not pass sterility test, it will be a failed batch and will be rejected.


blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
| Weekly

FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
View Results
Eric Langerr Outsourcing Outlook Eric LangerTargeting Different Off-Shore Destinations
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAsymmetric Synthesis Continues to Advance
Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
Sean Milmo European Regulatory WatchSean MilmoExtending the Scope of Pharmacovigilance Comes at a Price
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Better Comms Means a Fitter Future for Pharma, Part 1: Challenges and Changes
Source: Pharmaceutical Technology Europe,
Click here