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


Single-use filtration and fill–finish technologies can be used as part of a lean manufacturing strategy to boost production, and reduce manufacturing waste and costs.


(IMAGE SOURCE/GETTY IMAGES)
Single-use manufacturing solutions can accelerate production, improve flexibility, and reduce costs and waste–benefits that are well-aligned with lean process initiatives. Based on principles largely developed by Toyota, lean manufacturing seeks to identify and eliminate waste in manufacturing processes to reduce the cost of bringing a product to market (1). Focusing on creating more value with less work, lean manufacturing generally focuses on reducing eight specified wastes (see Table 1).


Table 1: Eight types of wastes targeted by lean process initiatives.
Implementing single-use filtration and fill–finish systems can deliver lean process improvement efficiencies and eliminate waste from the manufacturing workflow. Single-use systems can speed up production processes, reduce the risk of deviations, maintain consistency and have a positive impact on the bottom-line.

Delivering value with single-use filtration

Single-use filtration systems can deliver value in a number of ways. However, it is particularly beneficial if the single-use system has a modular structure that is replicable and scalable across different geographies, as this means the filtration assembly can keep pace with changing product, scale and site requirements.

Lean processing

As will be demonstrated later in a fill–finish case study, single-use assemblies can reduce processing time by as much as 50% through decreased preparation and set-up times. A number of elements drive these reductions, such as:

  • modular manifold designs mean they can be built on site and scaled as required
  • bags can be designed such that filling processes eliminate the need for operator handling
  • sterile filtration assemblies can facilitate technology transfer between early development, late development and commercial manufacturing
  • innovations in disconnection technology can reduce the time required to make sterile disconnection compared with the time taken by traditional tube sealers.

Before implementing single-use technologies, a thorough assessment of the current processes and opportunities for improvement should be conducted and objectives should be clearly defined. It is also important to pilot solutions and conduct performance testing in a laboratory setting before a definitive solution is finalised. Technology experts should also review process parameters, such as flow rate and pressuredrop requirements, and recommend the appropriate filter membrane and size when designing filtration subassemblies. Hands-on testing prior to installation will also give operators a greater degree of confidence than a typical new processing setup might usually foster, and will also give them the opportunity for real-time feedback, which will enable the solution to be better adapted to their actual process.


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
24%
Attracting a skilled workforce
29%
Obtaining/maintaining adequate financing
15%
Regulatory compliance
32%
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