While working as a manufacturing manager producing filled capsules, I often desired to see how other companies in the industry were operating. What types of equipment were used, and with what modifications? What approaches were taken to overcome formulation, equipment, and environmental challenges? What could I learn and employ from the practices of other companies?
After a decade of working in a singular environment, the last half decade of my life has involved traveling to manufacturing sites throughout the United States and Canada, in both pharmaceutical and nutritional industries. It is a wonderful opportunity to see the diverse manufacturing environments, ranging from multi-national corporations, to small, storefront production. In this continuing experience, I have come to believe in several core fundamentals which are practiced by the most successful manufacturing companies, in both pharmaceutical and dietary supplement markets. Adhering to these fundamentals will provide an environment for optimized machine time and product yield. This article will focus on topics of Equipment Selection, Designed Downtime, Teamwork, and Manufacturing Engineering Techniques which will assist the reader in maximizing resources in their capsule filling department.
A successful operation begins with proper equipment selection. I will use a sports analogy to illustrate. Consider the implications if World Cup Soccer officials decided that a finals game would be played using an American football instead of a soccer ball; with the players, the field, and goals remaining the same. Would the millions of world-wide viewers be able to appreciate the game as expected?
Obviously, the game would be changed in every aspect, beginning with the wobble of the ball in the game opening pass. The perfectly groomed playing field and the most talented soccer players in the world would struggle to overcome the challenge imposed by using the wrong equipment. While an event of this magnitude may be unlikely in the sports world, there are similarities which translate directly to our industry, as I witness people struggling to optimize the wrong equipment for their game.
An example from my past
A medium sized nutritional company made the decision to invest in the newest technology on the market to absorb an increase of business in the solid dose department. The decision was made to purchase the first machine of its kind ever manufactured. The concepts behind the machine were quite attractive, boasting a decrease in changeover time and ease of operator interface. Because the technology was new, it was also quite expensive. For this reason, management determined to purchase the smallest model of the equipment available, planning to run the machine continuously at the highest rated capacity.
It was not long before employees were placed on extended shifts, and working weekends and holidays to make up for unplanned deviations. The equipment was operating at every possible moment with little time given to preventative maintenance. While employees were burning out, the machine began to falter also. Both electrical and mechanical failures occurred at ever increasing rates. As the company sought support from the machine manufacturer, information came forward that this model of equipment was not designed for continuous operation, but was built for research and development work. The investment was made and damage to the equipment was done. It was two years of overworking personnel and machine before arrangements were made for a trade-in of appropriate sized equipment.
This unfortunate experience cost the company in forms of customer business, excessive overtime pay for employees, and general morale of all involved in its use. Couldn’t more consideration have been given to the demands that would be placed on both equipment and personnel when the purchasing decision was being made? Much of data and information was available at the time of purchase and could have foretold the impending disaster.
Many equipment purchasing decisions are made using only parts of a necessary equation. These may include: What is the best price we can get for a capsule filling machine? Where can I get a machine the quickest? How easy is it to operate? In some instances, decisions are made solely upon the recommendation of the sales representative for the equipment! While some of these factors are important, they fulfill only pieces of an overall, longer term picture.
Fight the urge to make price and availability your first qualifiers for an equipment purchase. The first consideration should be, what is the best technology for your application? In capsule filling, there are several technologies available, each having unique advantages. If you are running powders, there are tamper, dosator, and auger filling options. Each of these technologies exist because of advantages they offer. Consider the characteristics of the product you will be running, comparing this to the equipment capabilities. Prior to making a purchase, work with the equipment vendors in performing factory test runs, using your more challenging products. It is best for you to be present during these runs; you will observe which machine works most naturally with your products. Does the machine run immediately within its operating capability, or is special tweaking or modification involved? Establish a rating system to include set-up, operating, and clean-up times, product quality, and yield. Like the World Cup example, ensure the equipment will measure up to the application.
Not to be overlooked is the impact that the new equipment will have to existing operations. For some companies, they find strength in utilizing only one filling technology, and one equipment vendor. They access benefits including focused training and equipment knowledge, simplified parts inventories, and fewer standard operating procedures. However, other companies find strength utilizing diverse technologies, being capable of producing a wider range of products with fewer excipients and product re-work. When purchasing new equipment, determine if the need for simplicity or diversity is greater, and plan accordingly.
The need to consider the issue of equipment reliability and support, while very often overlooked, cannot be overstated. When your brand new capsule filling machine crashes for the first time (it will happen), and the replacement part you need is not in your spare parts kit, what is the availability of the part? If the OEM part is not available for eight weeks, is the machine common enough that parts can be found elsewhere? This may mean borrowing a common part from a company in your area.
What if the technologically driven machine is having an electrical problem which is difficult for your technician to troubleshoot; how will you be supported? Are experienced OEM technicians available by phone which can effectively walk you through troubleshooting exercises? Are the technicians supporting your time zone, and do they speak your language fluently? If problems remain unresolved, how quickly will they be onsite to resolve your issue? Is the machine common enough to the industry that you can receive additional support from other sources? Many capsule suppliers offer incredible support through training, repair and preventative maintenance assistance. The best industry support can be offered when the capsule filling machine is readily seen and common throughout the industry.
The task of optimizing equipment uptime in manufacturing is arguably one of the great challenges faced by production leaders in our day. It is a common occurrence in manufacturing to see extreme efforts made to maximize uptime on equipment that is not correctly sized for the run in the first place. If the appropriate size of equipment is purchased at the onset, production has the greatest opportunity for success, without jeopardizing the well being of both personnel and equipment.
A model can be used to determine how factors can be combined mathematically to aid in making the best possible decision. The structure of this simple Excel® model combines the average production run size, with the machine capacity of each given size, projected uptime for the equipment once production has started, and a standard product changeover time.
According to the structure of this model, the “y” machine would be the most effective choice for the given average. These and similar models can be effective tools employed by business owners and management to aid in determining the appropriate size of equipment for their application. Utilizing this type of tool, they will not have to rely too heavily on equipment vendors, who at times may be influenced by the prospect of higher sales, and may not be familiar with knowledge which belongs to the company selecting the equipment.
Business author Stephen Covey1 uses the story of the Goose and the Golden Egg to illustrate a valuable lesson in production capability. In the story, a farmer excitedly discovers his pet goose is laying an egg of pure gold every day. After a time of contentedness, the wealthy farmer’s greed for more gold overtakes him, and he decides to be-head the poor creature to remove all of the eggs inside. Not only does he find the goose empty, but he has destroyed the source of the golden eggs.
Many companies are like the farmer in this story, cutting the daily effectiveness and life of equipment through neglect in preventative maintenance and necessary repair while trying to realize greater production. I frequently visit companies who do not allocate downtime for maintenance unless the machine becomes inoperable because of a breakdown. This pattern of neglect will lessen the life of equipment, and will ultimately cost more unplanned downtime than a machine which is regularly maintained.
The effort which is involved in planning and implementing a preventative maintenance program will provide optimized machine performance during production, helping to prevent costly and untimely shut-down during critical production runs. If your preventative maintenance program is lacking, here are a few tips to consider:
Specific equipment maintenance information is generally provided in your equipment manual. While some manuals are very specific, some are equally vague. If you need additional assistance, a great resource can be the Technical Service team of your current capsule vendor. It may be helpful for you to request their assistance in setting up your program, helping you with the first few rounds of machine service.
Failure to maintain your equipment and replace necessary parts will lessen your opportunity for success each time you begin a production run. This also greatly complicates troubleshooting efforts when product problems arise, passing the burden of resolution to unfortunate capsule filling machine operators.
Complexities of machine issues are often compounded by other factors including challenging formulations, and issues of empty capsule quality. Each component of formulation, filling machine and empty capsule play a critical role in determining the ultimate goal of quality in capsule filling.
Let the following Venn diagram represent major factors contributing to possible failure in your capsule filling operation.
While weakness in any area of formulation, equipment or capsules can be enough to cause finished capsule defects and efficiency issues, consider the implication when you combine two or even three weaknesses together! As a new capsule filling machine operator, I remember catching handfuls of capsules as they discharged from the machine, sometimes seeing several defect types occurring simultaneously. It can be a great challenge to troubleshoot issues while running a challenging formulation, using worn tooling, and filling into capsules of questionable quality.
For the greatest opportunity of success in capsule filling, each area of the matrix should be carefully examined and planned in advance:
For dietary supplement manufacturers, the new cGMP regulations assign greater responsibility to the manufacturer to ensure quality compliance of their suppliers. It is therefore critical that you understand and trust the supply chain and manufacturing environment of your capsule supplier.
Another important factor which should never be overlooked in capsule filling is machine performance of capsules. Savings realized in an initial purchasing transaction can be quickly reversed through raw material loss and downtime when using poor quality capsules. At a grocery store, there are some items which are nearly always bought in recognized brand. This is because duplication of overall performance and value is very difficult, and where satisfaction in the end result is paramount. In these instances paying a little extra is generally worth the end cost. It is my experience both as a manufacturer and a technician, that using high quality capsules is not an area of compromise.
By taking special care to ensure formulation, equipment and empty capsules are optimal, you provide the greatest opportunity for efficiency and quality in your capsule filling department!
Manufacturing Engineering Techniques
While Continuous Improvement initiatives such as Six Sigma and Lean Manufacturing are on the rise and unquestionably invaluable, you do not need a special degree to study improvement in your department. Some of the greatest improvement engineers may be your operators, your technicians, and other department leadership. Improvements made from within offset the requirement for, and impact of external forces on your operation. Internally driven improvement will also lead to greater efficiencies and product quality, making your team hero’s in the eyes of business owners and customers! Here are some ideas:
One company leader I am acquainted with charged each production employee to be a manufacturing engineer in their area. Employees brought forth improvement ideas which were approved, implemented and rewarded. Ideas which were not implemented were still valued and praised by this leader, providing an environment which bred acceptance and creativity. While the value of each change was important, the additional value realized was in training the mind of each employee to look for better ways of doing their job. After a time, looking for ways to improve quality, reduce waste, and maximize production was inherent in production areas, with employees naturally working toward continuous improvement.
I invite you to consider the topics outlined in this article, determining what may be most useful in your operation, and committing resources to make improvement. Outfit your world class team by providing the proper equipment. As a company, treat the equipment as it were the goose laying golden eggs for you. With management, formulators, purchasing, maintenance, and operators working together synergistically they will find success in resolving quality and efficiency issues, effectively leading the company to the greatest opportunities for success!
1 Covey, S. (1989). Seven habits of highly effective people.
New York: Simon and Schuster