Vetter's New Commercial Line Validated for cGMP Filling - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Vetter's New Commercial Line Validated for cGMP Filling


RELATED ARTICLES

More in GMPs/Validation

A new filling line at Vetter's Ravensburg Vetter South facility is fully validated and ready for cGMP filling after successful media-fill completion, with a customer project underway, the company announced in a press release. The line's capacity ranges from mid- to large-volume batch sizes, with a maximum filling speed of 800 presterilized syringes per minute. The line currently fills 1-mL, standard-format syringes, and additional formats will be added in the future.

The line was designed to exceed cGMP requirements. It uses Restricted Access Barrier Systems (RABS) and fully automated transfer of sterile, packed tubs throughout the filling process to minimize human contact. Novel disinfection techniques include a spray disinfection tunnel for bagged tubs that was codeveloped by Vetter and the equipment manufacturer.

The line also includes an end-to-end track-and-trace system that features automated disposal of rejects and sample removal following the filling process. Fully automated, in-line control of syringe closures uses a three-dimensional scanner prior to filling to minimize API loss and reduce risk of contamination. An in-line, automatic weighing system monitors filling quantities.

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

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

Survey
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
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerRelationship-building at Top of Mind for Clients
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerRisk Reduction Top Driver for Biopharmaceutical Raw Material Development
Jill Wechsler Regulatory Watch Jill Wechsler Changes and Challenges for Generic Drugs
Faiz Kermaini Industry Insider Faiz KermainiNo Signs of a Slowdown in Mergers
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
Sandoz Wins Biosimilar Filing Race
NIH Translational Research Partnership Yields Promising Therapy

Click here