SPP COP E-Letters

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E-Letters

E-Letters are topic-specific, electronic newsletters published four times per year by ISPE's global Communities of Practice (COPs).  The content for E-Letters is submitted by professionals working in the pharmaceutical industry and is a resource by which to share best practices, regulatory news, technical articles and innovative solutions to real world problems.

*COPs are now an ISPE Member-only benefit, therefore some E-Letter content can be accessed only if you are an ISPE Member. Join ISPE today to continue accessing all E-Letter content and other valuable resources that will assist you in being more effective at your job.

January 2013

Survey Says Most See Benefits of Vacuum Hold Tests for Lyophilization
A survey by ISPE’s Sterile Products Processing (SPP) and Engineering Standards Benchmarking (ESB) communities indicate that most people involved in the use of lyophilization for sterile products manufacturing see the benefits of using Vacuum Hold Tests as part of the overall control strategy for the process. More.

ISPE Aseptic Conference Explores Latest in Aseptic Processes
The ISPE Aseptic Conference, to be held 4 – 5 March 2013 in Baltimore, Maryland, USA, will present the latest in aseptic processes, including making disposables work for your process, the latest in barrier isolation and containment technologies, cleaning and sterilization. More.

Updated Sterile Product Manufacturing Guide Available
The ISPE Baseline® Guide: Sterile Product Manufacturing Facilities (Second Edition), replaces the original Guide and integrates and consolidates international practical solutions that address sterile manufacturing technological advances since the original Guide’s release in 1999. More.

October 2009

RABS History and Trends – 2009 Preliminary Data
Barrier isolation history and trends 2008 final data was published in Pharmaceutical Engineering magazine’s May/June 2009 issue.

Webinar to Focus on Electron Beam Sterilization Tunnels in the Pharmaceutical and Medical Device Industries
In-line sterilization tunnels using electron beams have become a reality since the development of low and medium accelerators small enough to fit into self-shielded units for integration in production lines. A live ISPE Webinar on 1 December will examine the many advantages of these systems for the pharmaceutical and healthcare industries. Read more.

Case Study: New Parenteral Production Facility
Challenges and lessons learned from a new parenteral production facility in Switzerland were presented at the 18th Annual Barrier Isolation Conference. The facility included a vial filling line (liquid) in isolator technology, vial filling line (liquid and lyophilized) in RABS/isolator technology, bulk syringe filling line in isolator technology, and formulation and support facilities. Read more ( 3 MB) .

What the SPP Community is Discussing Right Now
Glycol near aseptic suites, recombinant and non-recombinant finished product, sampling for sterile powder, and air powder monitoring in aseptic powder fill continue to be hot topics of discussion on the SPP COP site. Read more.

April 2009

Top 5 Citations from US FDA Sterile Drug Product Inspections
What were the top five citations from US FDA Sterile Drug Product Inspections in 2008? These and other findings from the FDA are included in a presentation by Tara Gooen delivered at the ISPE Tampa Conference in March. Read more ( 4 MB) .

Annex 1 Implementation Challenges
A presentation by Gordon Farquharson explores the management and implementation of the revision to Annex 1 EU GMP. Read more ( 1 MB) .  

Crystal Clear Aseptic Filling
An article in a Pharmaceutical Engineering supplement presents a case study on Aseptic Technologies’ GMP Manufacturing Site for Aseptic Filling, Category Winner of the 2009 Facility of the Year Award for Equipment Innovation. Read more ( 16 MB) .

Advancing the Aseptic Powder Filling Process
An article in a Pharmaceutical Engineering supplement presents a case study on the Aseptic Powder Filling Facility 4, a project by GlaxoSmithKline Manufacturing that captured an Honorable Mention in the 2009 Facility of the Year Awards competition. Read more ( 16 MB) .

What the SPP Community is Discussing Right Now
Issues in aseptic media fill guidelines, support filtration validation, and endotoxin and bio-burden are some of the current hot topics under discussion on the SPP COP site. Read more.
 


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