- Challenge: The raw material collection bag attached to the mill came off, increasing work time
- Solution: Prototyped in 3 mm increments to prevent gaps at the bag connection point
- Result: Reduced work time per operation; overtime was eliminated
Key takeaways
- Per-operation time reduced from about 10-15 minutes to about 5-10 minutes.
- Bag detachment and powder blow-up risk was addressed by eliminating gaps at the connection point.
- Instead of a full equipment replacement (GMP burden), the team improved a single component through 3 mm-step prototypes.
Fine Chemical Manufacturer Z Company
Development and research of fine chemicals such as electronic materials and fragrances; contract manufacturing of pharmaceutical ingredients, etc.
Contents
- Production activities that require “absolute prevention of contamination”
- Work time dragged on while continuing to use existing equipment despite usability issues
- Shortened work time and eliminated chronic overtime by using a customized product
- “We considered dimensions very carefully, and we appreciate your support even with difficult requests.”
Production activities that require “absolute prevention of contamination”
MV: What kinds of products do you manufacture?
Customer: We are a company engaged in the development and research of what are known as fine chemicals, including electronic materials, fragrances, and pharmaceuticals.
We can accommodate a wide range of scales, from several kilograms to several thousand kilograms, and can manufacture from prototyping to full-scale production in accordance with customer requests.
We have a GMP-compliant production building with, for example, a Class 100,000 cleanroom, and MONOVATE products are mainly used there.
MV: Please tell us what is required in pharmaceutical manufacturing and what your company focuses on.
Customer: As MONOVATE also frequently manufactures equipment for pharmaceuticals, you may already know this, but above all we work with the understanding that we must never allow contamination.
To make that happen, we focus heavily on, for example, building production systems that prevent mistakes from occurring and on training and educating the employees involved in manufacturing.
For training and education, we take our time and carry it out for about six months until a worker can operate independently. Even so, it is not something simple enough to be fully mastered in six months, so even after training ends, operators support one another while carrying out production.
In this way, we work every day to ensure stable quality and highly reproducible production.
Work time dragged on while continuing to use existing equipment despite usability issues
Key point: A recurring bag detachment issue increased work time and created dust risk, but GMP procedures made a full equipment change difficult.
MV: How did you learn about our company?
Customer: We had already been using many of MONOVATE’s 20 L straight-sided stainless steel containers. They are clip-type containers equipped with a highly corrosion-resistant Teflon gasket.
Because it is pharmaceutical equipment, being able to choose a Teflon gasket is reassuring. The functionality is sufficient, and they are durable, so we reorder them regularly.
MV: Thank you for your kind words! This time, however, the item you introduced was not a straight-sided stainless steel container, but an update to a component we had previously delivered, correct?
Customer: Yes. It is a component attached to a piece of equipment called a mill.
This machine has a dedicated bag attached to collect the milled raw material, and the part is used like a joint to connect the machine and the bag.
Previous component
MV: What problems did you have with the previous component?
Customer: Pressure is applied when discharging the milled raw material, and depending on the power setting of the mill, the bag would come off or powder would blow up into the air.
We had asked you to manufacture the component according to the dimensions specified by our standards, and it was delivered exactly as requested, but the work situation was difficult.
MV: That could also lead to issues such as yield loss, dust, and the effort required for cleaning.
Customer: We kept thinking about how we could improve it, but we couldn’t come up with a good solution.
There is also the risk that changing equipment will change the output, and because this is manufacturing equipment related to pharmaceuticals, updating equipment requires preparing many documents and procedures in accordance with GMP ministerial ordinances. This was also a factor that made it difficult to casually replace equipment.
MV: We often hear similar voices from customers, so we understand very well. It is a necessary system to maintain the safe quality of pharmaceuticals, but it can be frustrating because we think, “We could propose something better…”
Shortened work time and eliminated chronic overtime by using a customized product
Key point: A small, targeted redesign (not a full replacement) delivered measurable time savings and removed the need for overtime.
The product adopted this time. The connection to the mill is elliptical, and the other side is a hopper with a perfect circular shape matched to the bag opening diameter.
MV: Under those circumstances, what led to the update of the component this time?
Customer: We had continued using it as-is for about five to six years while considering various options, but the on-site staff again proposed, “We really want to do something about it,” and we decided to consult MONOVATE.
(On-site operator) Milling work takes a lot of time, and on days when we had it, we always worked overtime. We would finish around 8 p.m., I suppose. That reduces our personal time. There are various household things we need to do as well, but it was hard to secure time.
In the meantime, as we kept using it, there were also conversations like, “Wouldn’t it be easier if we changed the dimensions here?” and that led to the proposal.
Based on the issue of the bag coming off the component, we received the request, “We want to fit the bag and the connection part perfectly,” and proposed prototyping. After confirming the size of the collection bag, we adjusted the dimensions of the connection part in 3 mm increments and created prototypes.
The customer checked which dimensions fit best, and we applied those to the final product.
Why it worked
- The team validated fit using the actual bag used in production, not an assumed specification.
- Small 3 mm-step changes made it easy for on-site staff to compare options and select the best-performing dimension.
- By updating only the connection component, the customer avoided a larger GMP-heavy equipment replacement.
MV: How has it been after delivery?
Customer: With the previous equipment, milling took about 10-15 minutes per operation, but after the update it was shortened to about 5-10 minutes. We can now finish work on time without overtime, which has been a great help.
MV: That’s great to hear. We are happy to receive such feedback, and it gives us a strong sense of fulfillment.
“We considered dimensions very carefully, and we appreciate your support even with difficult requests.”
MV: Our sales representative I worked with you on this update. How was your experience?
Customer: We are grateful to I. I ended up making many requests, but they helped us a great deal by responding in various ways.
We wanted to ensure the product collection bag could be set perfectly, so during the consideration stage we requested several prototypes for the bag connection section.
This was the key point of the update, so we examined it carefully, but since we received prototypes with dimensions changed in millimeter units, we were able to select one that fit perfectly. We are satisfied with the usability.
As with your prototyping support that we just discussed, we really appreciate that you can respond flexibly to our requests. This time we ordered for pharmaceutical-related equipment, but if we need any stainless steel containers for the chemical products side, we would definitely like to ask you again.
Also, we heard that MONOVATE has many pharmaceutical customers, so if you know anyone who is having trouble with pharmaceutical milling, we would be happy if you could introduce our company (laugh).
Editor’s Note
We are very pleased that our products were able to have a positive impact on the customer’s production and even their personal life. It is also a great pleasure that Z Company, who works daily with ingenuity to ensure reliable pharmaceutical manufacturing, uses our products and consults us about improvements.
We will continue striving to be a manufacturer that can make flexible proposals for customers’ challenges.
[Sales Comment]
The key point in this project was prototyping. The customer provided the bag they actually use, and we prototyped three types of nozzles to match it. The customer tested combinations of the bag and nozzle, and we manufactured the product with the specification that fit best.
We are a manufacturer that produces custom-made products tailored to each requirement. We will listen to your needs and propose the optimal solution. Even for shapes or specifications not listed in our catalog or on our website, please contact us first. We will start by determining feasibility.
We will propose improvements such as “updating hard-to-use equipment” and “reducing work time,” starting from a single unit
