The fundamental rules of the game have changed for product development and production in the pharmaceutical industries. Today, manufacturing must meet growing productivity demands for speed and economy while improving output. Production must manage multiple change overs, smaller runs, and costlier ingredients as they run headfirst into the cost containment initiatives. This is due to the needs of newly covered and emerging patient populations, greater competition, and general belt tightening.
In this climate, “cost leadership” has become a mandate. Although poring over the cost of raw of materials has historically been the primary focus, the approach has shown limited cost effectiveness over the long term, particularly if the use of lower-cost materials results in less efficient manufacturing and reduced product performance.
We believe a more effective and new approach must include a “total cost in use” paradigm, with one key method: improve capsule-filling productivity and performance. This will increase yields, speed up filling, and reduce downtime. In addition to producing more products faster for customers of various channels, these improvements will reduce manufacturing costs and time for faster market delivery and higher profits. In fact, our work in this field has shown the combined savings realized by higher yields, faster machines, and reduced downtime can allow a manufacturer to recoup some three-quarters of the money spent on empty capsules used in production. Intrigued?
QbD: Plan Ahead to Achieve Efficiencies in Capsule-Filling and Manufacturing Costs
Inaugurated by Joseph M. Juran and the foundation of Six Sigma methodologies, Quality by Design (QbD) avows that quality can be planned and that encountered problems are related to how the quality was planned from the beginning.
When applying the concept to encapsulation productivity, matching the various dosing options of the capsule filler to the characteristics of your product is first and foremost. Also key is formulating your product to the intended dosing style used during commercialization. Thus, manufacturing efficiencies and profitability lie at the intersection of the formulation, equipment, and capsule. This thinking during development helps prevent potential development pitfalls and cost inefficiencies.
As examples, consistent weight control might be hard to attain when a powder that is difficult to compress is paired with a dosing style that uses a tamping technology. Conversely, bulk density and lubricity are important product characteristics to be considered during formulation to maximize success across a range of dosing styles.
A New Paradigm for Capsule-Filling Efficiencies: Speed, Yield, & Downtime
With the right recipe of formulation, equipment, and capsule, the cost of producing products can be cut by increasing production speed, improving yield, and reducing downtime. These three drivers of cost are often connected and generating an improvement in one may very well lead to a secondary benefit in the others.
Increasing speed – The faster something can be produced on a machine, the less it costs. The manufacturing cost of a product is less when more products can be manufactured with the same equipment and people as before – to include amortization of cost of utilities and fixed costs like rent and insurance.
Improving Yield – The fill material in the capsule accounts for most of the cost associated with an encapsulated product, not the empty capsule. Savings generated from yield improvements are due to fewer losses to starting materials and the time and energy saved in producing fewer filled capsule that cannot be sold. Even a small improvement in yield can generate considerable savings. Yield improvements have been the most widespread aim of capsule-filling operations.
Reducing Downtime – The longer production is stopped to clean a machine or get it to work properly, the more it costs to make a product. Dramatic improvements in downtime can be realized through appropriate early-stage fit of formulation, capsule, and capsule-filling equipment – and ongoing preventive maintenance of the capsule-filling equipment.
All three areas of potential improvement can generate savings. In a 2013 review of more than 29 customer case studies in which Capsugel Technical Service Engineers worked to improve capsule-filling efficiencies, savings in the three areas were quantified, as follows:
> Increased speed – Average speed increase of 36% per hour
> Increased yield – Average increase of 6%
> Reduced downtime – Average reduction of 128 minutes in an 8-hour shift, for an average downtime improvement of 73%.
When viewing the savings of all three areas, the 29 companies saved a combined aggregate about $2.8M through improvements in productivity – or $96,718 on average. With an average capsule spend of $128,843, this represents a 75% recovery of the cost for the capsules simply by implementing the improvements. We calculate that these 29 customers could save an additional combined aggregate savings of more than $2N if and when they implement a host of other improvements that have been proposed.
Stories of Capsule-Filling Improvements & Savings
Following are some examples of specific solutions to unique situations assisted by Capsugel’s Technical Service Engineers.
Case Study A: The $972K Impact of Reducing Waste and Increasing Speed
Problem: Excessive issues with poorly joined capsules were experienced after fill and closing due to the nature of the product and the setup of the filling machine. The company had to reduce the speed of the machine by 10,000 capsules per hour to reduce the level of poorly joined caspules to 2.2%
Solution: Capsugel reviewed the machine and recommended adjustments to the closing setup. The gap between the capsule and the upperclosing mechanism was too large. Once adjusted to the improved setting, the machine could run at full speed without the presence of poorly joined capsules.
Result: The company realized a $972,488 impact annually. This impact comprised the effect of producing 10,000 more capsules per hour with the same equipment and people. The savings were also helped by a significant reduction in the waste associated with the poorly joined capsules.
Case Study B: The $305K Impact of Improving Yield
Problem: A new pharmaceutical product was being filled at three different strengths. But the company was experiencing low yield due to weight variation for all three strengths on a machine it had been using for years. It also experienced a financial hit from waste from filling failures of the expensive product.
Solution: Capsugel re-trained veteran employees and new employees on the production line as to how to handle the capsules and set the machine to successfully achieve the proper fill weight.
Results: The yield increased by 1% for two different strengths and 2% for the third strength, for a cumulative impact of $240,817. The dollar amount is substantial despite the relatively minor yield increase because of the costly nature of the product. By eliminating the waste from filling failures, the company also could realize additional potential product sales of a cumulative $64,259.
Case Study C: The $487K Annual Impact from Cutting Downtime and Reducing Losses of Yield
Problem: Capsules were not separating at the proper location during runs so they could be filled with powder. Yields were suffering and the capsule-filling machine kicked out non-separated capsules that accounted for more than 7% of wasted empty rotations.
Solution: Capsugel discovered that the capsule bore – the hole in which the capsule sits throughout the filling process – was dirty. The dirty bore prevented the capsule body from separating. Production time was also lost because runs had to be stopped so that the machine table could be cleaned of the powder fills that slipped around the un-separated capsules and through the bore. The capsules could separate properly if the bore was cleaned once per hour, but that would mean the machine would have to be stopped and production time would still be lost. Capsugel recommended that the ingredients be reformulated with different excipients so the bores would not become dirty. The company is working on the reformulation solution.
Results: Upon immediate, thorough cleaning of the capsule bore, capsules now separated 99.5% of the time, but downtime for bore cleaning was still experienced. By reformulating the ingredients as a long-term solution, however, the company is projected to realize a $399,924 annual savings due to cut in yield losses and $87,456 annual savings by reducing down time one hour per eight-hour shift for cleaning of the bore and machine table.
Measurement of Savings: Capsule-Filling Efficiency Report Documents Success
To unlock pathways for greater efficiency, Capsugel Technical Support Service Engineers have consulted on equipment purchase for fill products, process flow evaluations, training on equipment adjustments – and more – from the beginning of the process to the end.
As we’ve shown, improvements are important. Equally critical are measuring the financial gains of the improvements. Existing metrics of filling-room performance tend to measure the negative impacts when established standards such as yield and downtime are not met, but those metrics fall short of quantifying the business impact. Capsugel Technical Service Engineers have developed a “savings calculator” that aggregates all cost drivers, including labor and overhead, to more accurately compute financial savings. Measurement of the drivers of a business is a powerful tool for maximizing profits and critical to success.
These savings reports can help to substantiate key maintenance and to sidestep pointless costs as well. They allow manufacturers to better justify and obtain resources to make the changes that would improve productivity of their capsule-filling operations.
Case Study D: ROI Investment via Capsule-Filling Efficiency Report
Problem: One company experienced various defects after encapsulation. A Capsugel inspection determined that excessively worn segments on the machine needed to be replaced.
Solution: Capsugel’s Capsule-Filling Efficiency Report revealed that the financial impact of the losses far exceeded the cost of replacing the segments.
Result: Armed with the business case, the company’s production team justified the cost of replacing the parts with their internal stakeholders.
There isn’t one type of equipment for every situation. The entire filling process needs to be designed from formulation to production to ensure a quality product that is produced efficiently. Understand the different types of capsule-filling systems and the type of fill that works best in each. Determine the optimal setup and combination during early development – a move to QbD – to reduce future costs by increasing the potential production speed and yield while avoiding downtime. Improving in these categories after development can also help to deliver continued financial savings. n
About the Author
John Davidson, Six Sigma Black Belt, is the Manager of Quality Engineering Services with Capsugel. Mr. Davidson is an engineering graduate from the Georgia Institute of Technology. Today, he manages a team of Quality and Technical Service Engineers who work with hundreds of pharmaceutical companies across North and Central America to improve operational efficiencies.