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Jennifer Markarian is manufacturing editor of Pharmaceutical Technology.
PharmTech’s 2016 survey shows general satisfaction with existing solid-dose and parenteral manufacturing equipment, and slow adoption of continuous manufacturing processes.
Pharmaceutical Technology’s annual survey asks finished drug-product manufacturing equipment users in both parenteral and solid-dosage manufacturing about how equipment is meeting their needs and how new technology and initiatives are shaping the industry. Respondents were from diverse companies that manufacture products around the world (see Sidebar).
Pharmaceutical Technology’s Equipment and Manufacturing Survey targeted individuals in production and engineering. The survey was conducted by email in May through July 2016 and had 132 respondents. Approximately 35% were from innovator pharmaceutical companies, 32% were from generic-drug companies, and 18% were from contract manufacturers. The remaining respondents (fewer than 6% each) included consumer healthcare companies making over-the-counter products, equipment or machinery vendors, excipient and raw material suppliers, and consultants. Respondents included solid-dosage manufacturers (60%), parenteral drug manufacturers (30%), and those who participate in both areas (10%). Companies represented by the survey manufacture products in: the United States (61%), Canada (23%), Mexico/Central/South America (24%), Europe (53%), Asia (38%), and other regions (11%), which included Africa and Russia; respondents could choose more than one region.
Survey results suggest that, as in past years, equipment users are typically satisfied with existing equipment and with the level of innovation in most equipment areas. Although continuous solid-dosage manufacturing is viewed as a crucial area for innovation and is being used to some extent, significant commercial growth in use of this technology has not yet materialized. Equipment metrics are widely used and seen as valuable. The following summarizes some of the findings from the 2016 survey.
Respondents who use solid-dosage equipment indicate relatively high satisfaction with the equipment they are currently using. As shown in Figure 1, in six categories (mixing/blending, encapsulation, tablet compression, feeding/dispensing, granulation, coating, and packaging), 90% or more said equipment utility was "excellent, completely satisfied" or "good, but see areas for improvement." More than 80% of respondents indicated that packaging and powder transfer/materials handling were excellent or good. In-process testing/process analytical technology (PAT), integration with manufacturing and business systems, and process control/automation ranked slightly lower, with 65–70% of respondents indicating excellent or good performance. These rates of satisfaction are similar to rates in the past two years surveyed (1, 2). Satisfaction with innovation in all the areas surveyed paralleled the respondents’ satisfaction with current equipment.
Continuous solid-dosage manufacturing. Approximately 40% of the respondents who use solid-dosage equipment indicated that they employ continuous processing either overall or in select unit operations. In past years, most respondents indicated that they expected continuous manufacturing to advance. In an open-ended question in this year’s survey, nearly 10% of all respondents listed continuous manufacturing as the most important area for innovation in pharmaceutical manufacturing. The percentage of respondents using the technology, however, is the same as in 2014 (1). Cost (e.g., to invest in needed equipment) was noted by 72% of respondents as a barrier to implementing continuous manufacturing. Other barriers selected by respondents (multiple answers allowed) included insufficient expertise to adapt processes (45%), insufficient PAT available in the market to enable continuous processing (41%), concern over regulatory acceptance (39%), lack of equipment available in the market (33%), and lack of appropriate documentation systems in place (30%).
As shown in Figure 2, satisfaction with equipment used in parenteral manufacturing was generally good; 80% or more respondents indicated "excellent" or "good" for all categories except one. More than one-third of respondents noted significant problems with existing equipment in the area of integration with manufacturing and business systems. More than 90% of respondents were satisfied with the level of innovation in most areas. Two areas where some noted a lack of innovative solutions to problems were in system integration (15% of respondents) and process control and automation (13%).
Respondents in both solid-dosage and parenteral manufacturing who use containment for high-potency drug production employ various strategies, and combinations of strategies, including personal protective equipment (63%), dedicated production areas (55%), restricted area barrier systems (55%), and isolators (47%). When asked to choose the one most challenging area for high-containment/high-potency, responses were diverse, as shown in Figure 3.
Measuring and tracking equipment and operational effectiveness is strongly supported by equipment users, as indicated by those surveyed in 2015 (2) and 2016. More than 90% of respondents to the 2016 survey believe that metrics and trend analysis enhances the ability to improve equipment operation. More than three-quarters of respondents work in a company culture that encourages use of manufacturing metrics, and 78% use trend analysis to evaluate equipment performance. Nearly 60% have metrics to measure unplanned downtime or equipment failure.
Just under half of survey respondents, in both solid-dosage and parenteral equipment areas, were aware of equipment failures that had led to significant downtime or quality problems in the past year. Contamination or cleaning problems were the most frequently indicated root cause of failure indicated by 48% of solid-dosage manufacturers responding and 58% of parenteral manufacturers responding. Other causes of failure included utilities and process validation (approximately one-third of respondents each) and nonconformance (approximately 20%); equipment age was also noted as a root cause.
This year respondents were asked for the first time to reveal how various initiatives would improve equipment uptime or efficiency. Approximately 90% of respondents thought preventive maintenance, investing in new equipment, more metrics and management focus on equipment, and/or renovating facilities would have some or significant positive effect. Approximately 80% also indicated that more regulatory focus on equipment or switching to continuous manufacturing would help. Other factors that respondents thought would improve efficiency or uptime included improved automation or software upgrades and lean manufacturing concepts.
PAT, which measures characteristics of in-process materials, is an enabling tool for continuous manufacturing, process automation, and even equipment metrics and continued process improvement (3). In the five equipment areas surveyed (see Figure 4), 24–45% of respondents use PAT and another 25–33% plan to implement PAT use in the coming year. Although these responses indicate growth, use and intended use of PAT among survey respondents has not shown a significant increase but has been consistent for the past three years.
When asked to identify the most important areas for innovation in pharmaceutical manufacturing, several respondents listed continuous manufacturing and PAT. Automated processes and real-time release were also noted, along with process efficiency, lean manufacturing, and operational excellence. Several other respondents indicated quality control or quality assurance improvements as the most crucial, including enhanced methodology and rapid microbial testing. Others noted streamlined R&D, regulatory changes, cleaning, and maintenance as key. Although no respondents listed “internet of things (IoT)”, IoT does play a role in several of these areas.
1. J. Markarian, Pharm. Technol. 38 (7) 28-31 (2014).
2. J. Markarian, Pharm. Technol. 39 (8) 24-28 (2015).
3. S. Haigney, Pharm. Technol. 40 (6) (2016).
Vol. 40, No. 8
Pages: 16–19, 27
When referring to this article, please cite it as J. Markarian, "Measuring Equipment and Manufacturing Trends," Pharmaceutical Technology 40 (8) 2016.