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
Which of the following business challenge poses the greatest threat to your company?
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
Building a sustainable pipeline of products
30%
Attracting a skilled workforce
27%
Obtaining/maintaining adequate financing
14%
Regulatory compliance
30%
View Results
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
Medicare Payment Data Raises Questions About Drug Costs
FDA Wants You!
A New Strategy to Tackle Antibiotic Resistance
Drug-Diagnostic Development Stymied by Payer Concerns
Obama Administration Halts Attack on Medicare Drug Plans

Click here