Aseptic Processing - Pharmaceutical Technology

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PharmTech Europe

Aseptic Processing
(Manufacturing.) Sterile and isolated production systems (espcially for parenteral dosage forms), including conventional cleanroom and restricted access barrier isolation systems (RABS) technology, supplies, and equipment.

The Role of Glasses in Aseptic Production: A Detail Often Ignored

October 2, 2006

Pharmaceutical Technology

Glasses are important when operating in a sterile environment, and it is necessary to ensure that they will stand up to repeated sterilization processes without introducing contaminants. The glasses were subjected to numerous steam sterilization cycles to assess durability and microbial reduction. Results showed that the glasses most widely available on the market have been refined by the manufacturer to satisfy pharmaceutical customer needs by withstanding repeated sterilization cycles and minimizing contaminating particle release.

Risk-Management Assessment of Visible-Residue Limits in Cleaning Validation

September 2, 2006

Pharmaceutical Technology

Before formal cleaning validation programs were instituted, visual inspection was the primary means of determining equipment cleanliness. The use of visual inspection is still typically a component of a cleaning validation program and for routine inspections of cleaning effectiveness, but the use of visual inspection as a sole criterion for equipment cleanliness has not been successfully implemented as a valid approach for cleaning validation.

Compounding Pharmacy Issues Recall, But Challenges FDA Decision

July 22, 2014

Unique Pharmaceuticals has issued a voluntary recall of sterile compounded preparations, but aired concerns about FDA?s recall demand.

Blow-fill-seal Technology Advances in Aseptic Filling Applications

June 18, 2014

Equipment and Processing Report

New advanced aseptic manufacturing technologies are available for filling liquid pharmaceuticals, including biologics.

ionHP Biodecontamination Technology for Aseptic Systems

May 12, 2014

The ionHP biodecontamination hydrogen peroxide-based sterilization technology is designed for use in aseptic enclosures.

Implementing QbD in Sterile Manufacturing

December 2, 2013

Pharmaceutical Technology

Industry experts discuss the application, challenges, and benefits of a quality-by-design approach to sterile manufacturing.

Best Practices for Restricted Access Barrier Systems in Aseptic Manufacturing

August 21, 2013

Equipment and Processing Report

RABS is a flexible barrier system that maximizes product control but minimizes operator interaction when best practices are followed.

Parenteral Drug Association Releases New Report on Manual Aseptic Processes

July 9, 2013

Report outlines recommended practices for control and evaluation of operations.

Aseptic Filling is the Next-Generation Application for Single-Use Systems

June 26, 2013

Pharmaceutical Sciences, Manufacturing & Marketplace Report

The benefits of single-use systems are being realized for downstream unit operations, including aseptic filling.

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Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
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Expedited reviews of drug submissions
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More stakeholder involvement
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View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
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