Search results for "contamination"
Article
Cleaning of Dedicated Equipment: Why Validation is Needed
…lla Marta
Cleaning of pharmaceutical equipment is essential to reduce the risk of product contamination and, as stated in relevant guidelines and as recognized by the pharmaceutical sector, this…
Article
QbD and PAT in Upstream and Downstream Processing
The design qualification and review is challenging the equipment design with special attention on CQAs such as contamination with germ and fibrillation.
Vanden Boom (Hospira): In the case of bi…
Article
Sources of Bioburden You Might Have Missed
There are, however, ways to shut the door on contamination.
The risk is most acute in the upstream process, which should not be a surprise. What better place for a bacterial contamination to gro…
Article
Evaluating E&L Studies for Single-Use Systems
Critical aspects and lessons learned
This experiment raised some difficulties within the execution and the analytics, and revealed some lessons learned:
• Due to the impact of contam…
Article
Microbiological Testing: Time is of the Essence
…ing is crucial for ensuring sterility, determining antimicrobial effectiveness, detecting microbial contamination or bioburden levels, analyzing endotoxins, and implementing environmental monitoring …
Article
Selecting the Right Viral Clearance Technology
Regulatory requirements vary by country, individual agency, the phase of development, and the contamination risk profile for a particular product, according to Strauss. Target clearance values also de…
Article
Risk Assessment and Mitigation in Biopharmaceutical Manufacturing
…red with solid-dosage manufacturing?
AstraZeneca: In biopharmaceutical manufacturing, microbial contamination is usually the greatest overall risk. The primary factors that affect the risk of mic…
Article
A Look Ahead at BioPharma Manufacturing and Regulation
MICROBIAL CONTAMINATION
BioPharm: Priority 3 of the August 2011 strategic plan calls for reducing microbial contamination of medical products. What specific goals does FDA have in this area?
…
Article
Updating Viral Clearance for New Biologic Modalities
In such cases, viruses are absent, and their presence would represent a contamination of the process, Berrie says.
For traditional downstream processing templates, such as monoclonal antibody (mAb…
Article
Improving mAb Manufacturing Productivity by Optimizing Buffer and Media Prep Process Flow
Single-use raw material delivery systems, in powder or liquid form, can help reduce the risk of contamination and minimize the need for frequent cleaning steps. Raw material quality control (QC) testi…