Achieving Lean Processing With Single-Use Systems - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Achieving Lean Processing With Single-Use Systems


Pharmaceutical Technology Europe


The single-use assembly consisted of a filter module connected to a 50L header bag, a pump line and needle assembly. For the isolator extension, a Getinge LaCalhene alpha port was added to the current restricted access barrier to permit the sterile transfer of fill lines and needles through the connection to the mating single-use Getinge LaCalhene beta bag. The flowpath was selfcontained and had limited assembly, increasing operator safety and reducing contamination risk. The hard piped filling module was replaced by a roll-up peristaltic pump skid to add flexibility to the existing line, which can now run fixed setups with time pressure, as well as single-use assemblies through an alpha beta connection for new products.


Table 2: Comparison between a traditional and a single-use fill–finish process at a pandemic flu vaccine manufacturing facility.
The comparisons between the traditional and single-use fill finish processes at this manufacturer are shown in Table 2. Overall, the campaign fill time was reduced from 36 h to 12 h. In the new configuration, the rate-limiting factor in manufacturing became the preparation of the drug formulation rather than the facility.

The new process required less than six months to commission, and in the 85 million doses filled to date, there have been zero contaminations. Equipment utilisation increased from 35% to 82%, and there was a significant drop in energy use due to the elimination of CIP/SIP.

Conclusion

A growing number of pharmaceutical and biopharmaceutical companies are exploring the potential of single-use systems to deliver lean process improvements. The main drivers for adoption are rapid facility start-up, flexible operations, and elimination of the chemical, utility and labour requirements for cleaning.

When incorporated as part of a larger, overall strategy to reduce waste and process time, improve process consistency and facilitate technology transfer, single-use systems can deliver measureable benefits and impact the bottom line.

Vikas Gupta is Merck Millipore Group Product Manager, Mobius Single-use Products and Services.
Tel. +1 781 533 3264

References

M. Holweg, Journal of Operations Management 25(2), 420–437 (2007).


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
20%
Attracting a skilled workforce
28%
Obtaining/maintaining adequate financing
12%
Regulatory compliance
40%
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
Source: Pharmaceutical Technology Europe,
Click here