Evaluating Equipment Utility and Innovation

Image: STEVE ALLEN, getty imagesPharmaceutical 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. Responses also indicated trends in high-potency/high-containment manufacturing, process analytical technology (PAT), and continuous manufacturing.

Solid-dosage equipment

Figure 1: Utility of existing solid-dosage equipment in meeting needs (% of respondents).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

Figure 2: Utility of existing parenteral equipment in meeting needs (% of respondents).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”.

High-containment/high-potency manufacturing

Just over half of respondents that are involved in high-containment/high-potency manufacturing had seen an increase in activity in this area in the past year. Approximately one quarter of respondents said system setup/changeover was the most challenging factor in high-containment/high-potency manufacturing, while another quarter identified getting materials into or out of the contained system during production as the most challenging. Others identified air flow (10%), air-flow changes (10%), environmental issues (10%), containment (10%), personnel protection (7%) and ergonomics (3%) as the most challenging factor in high-containment/high-potency manufacturing.

QbD

Figure 3: Application of quality-by-design (QbD) principles to manufacturing processes (% of respondents).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. Approximately 42% indicated clarity of regulatory guidance as a barrier. Only about one-third of repondents chose, respectively, lack of management buy in, availability of software, or availability of equipment as barriers to QbD implementation.

PAT

Figure 4: Current and future use of process analytical technology (PAT) (% of respondents).Over half of respondents indicate that they use PAT, which is an increase from last year’s survey that found only 40% of respondents incorporating PAT (1). When asked to indicate the primary drivers for using PAT (multiple answers permitted), nearly half of respondents chose increased efficiency/reduced waste; others chose better process understanding (44%), reduced costs (33%), and shorter process times (31%). Almost 10% indicated that their company mandates use of PAT, and nearly 6% said their customers request it. Sterile manufacturing/aseptic processing and lyophilization are areas of potentially strong growth for the use of PAT. As shown in Figure 4, 14% of respondents in these areas use PAT now, but an additional 50% plan to implement PAT in the coming year. Compared to the other categories, a higher percentage in solid-dosage manufacturing (22–26%) already use PAT, but a lower percentage (24–25%) plan to add PAT in the coming year.

Continuous manufacturing

Continuous manufacturing is still a new technology, but is being considered as an alternative to traditional batch processes for solid-dosage manufacturing. Respondents indicated (multiple answers permitted) multiple barriers to implementing continuous processes, including:

• lack of equipment (46%)
• insufficient expertise (42%)
• cost (36%)
• concern over regulatory acceptance (29%)
• insufficient PAT (23%)
• lack of appropriate documentation systems (15%).

Nearly all agreed, however, that technology will continue to evolve and use of continuous processing will increase.

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 to $10 billion in revenue, almost 7% were from companies with $10 to $50 billion in revenue, and the remainder (8%) were from companies with over $50 billion in revenue.

Reference

1. P. Van Arnum, Pharm. Techol. 36 (4) 50-60 (2012).