Evaluating Equipment Utility and Innovation - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Evaluating Equipment Utility and Innovation
Pharmaceutical Technology's survey of manufacturing equipment and trends shows satisfaction with utility and innovation in most solid-dosage and parenteral drug-manufacturing equipment.


Equipment and Processing Report

Pharmaceutical Technology’s annual equipment and manufacturing survey gained the industry’s perspectives on trends in finished drug-product manufacturing and equipment. Respondents in both solid dosage and parenteral drug manufacturing were generally satisfied with the utility of existing equipment and the pace of innovation in meeting manufacturing needs. Most employ quality by design (QbD) to some extent, but respondents identified a range of challenges in implementing QbD. This article is excerpted from an article in the April 2013 issue of Pharmaceutical Technology, which further details trends in high-potency/high-containment manufacturing, process analytical technology (PAT), and continuous manufacturing.

Solid-dosage equipment
The survey showed that existing solid-dosage equipment is generally meeting needs. Areas noted by more than 20% of respondents as needing significant improvement, however, included process control/automation, powder transfer/materials handling, and feeding/dispensing (see Figure 1). When asked if innovation is keeping pace with current and future needs, responses were similar, with the same three areas indicated as lacking solutions by 20% or more of respondents. Tablet compression stood out as a strongly innovative area, with 96% of respondents indicating that innovation is “excellent” or “good” for this equipment.

Parenteral equipment
Users of parenteral equipment, likewise, are generally satisfied with existing equipment, as shown in
Figure 2. Process control/automation and vials/cartridges fill–finish equipment, however, were two areas noted by 20% or more of respondents as needing significant improvement. In all segments, nearly 80–90% of respondents said that the pace of innovation was “good” or “excellent”.

QbD
Almost half of respondents indicated that their company applies QbD principles for both new and legacy products, and another 32% apply QbD to all or select new products (see Figure 3). Only 22% of respondents do not apply QbD at all. Approximately 72% identified better process understanding as a benefit of QbD. Participants were invited to choose all answers that applied, and they indicated other benefits of QbD as increased efficiency/reduced waste (48%), reduced costs (44%), shorter process times (35%), streamlining regulatory review (32%), and improved ease of making changes (29%). Only 6% of respondents felt that there are no challenges or barriers to implementing QbD. More than half noted lack of knowledge and training as a problem.

Respondents’ profiles
Pharmaceutical Technology’s Equipment and Manufacturing Survey targeted individuals in production and engineering. The survey was conducted by email in February 2013 and had 193 respondents. Nearly 30% were from innovator pharmaceutical companies, 28% from generic-drug companies, 20% from contract manufacturers, and 10% from consumer healthcare companies making over-the-counter products. The remaining respondents included excipient and raw material suppliers (7%) and equipment or machinery vendors (5%). About half of the respondents were involved with solid-dosage manufacturing and the other half in parenteral drug manufacturing. The majority of respondents (79%) were from companies with under $1 billion in revenue. Nearly 7% were from companies with between $1 billion to 10 billion in revenue, almost 7% were from companies with $10 billion to 50 billion in revenue, and the remainder (8%) were from companies with over $50 billion in revenue.

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
28%
Attracting a skilled workforce
28%
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 WatchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
Report: Pfizer Makes $101 Billion Offer to AstraZeneca
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
Source: Equipment and Processing Report,
Click here