Aseptic Processing - Pharmaceutical Technology

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PharmTech

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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.

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.

Will Aseptic Connectors Make Production Outside of the Cleanroom Possible?

June 12, 2013

Pharmaceutical Sciences, Manufacturing & Marketplace Report

Aseptic connectors provide the flexibility and robustness needed for modern parenteral manufacturing operations.

The Next Generation in Aseptic-Filling Equipment

May 22, 2013

Pharmaceutical Sciences, Manufacturing & Marketplace Report

Adoption of single-use systems and more flexible systems drive innovation.

Isolator Technology for Aseptic Filling of High Potent Products

April 18, 2013

PIERRE FABRE MEDICAMENT PRODUCTION has 22 years experience in isolator technology for aseptic filling of high potent freeze-dried injectable products.

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Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatcchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
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