PROJECT STORY

Disposable Wear for Sterile Rooms That Can Be Put On and Taken Off Without Touching the Wear Surface

The BioClean-D Drop-down with Mask, disposable wear with integrated hood and mask, was developed for the most advanced environment in pharmaceutical companies. This is a new type of wear for sterile rooms that can be put on without touching the outside of the garment and without the hem and the sleeves touching the floor. This type of garment has not become standard in Japan but is expected to be indispensable in the future.

Pharmaceutical production, physical and chemical research, research equipment and materials

Exceptional Quality

Gain Customers’ Trust Through Sales Solving Their Problems
In the era of 100-year lifespans, there is an urgent need to develop new drugs so that everyone can lead a healthy and vigorous life. The Lab Pharm Team (referred to below as LAB Team), dealing with the products required in each process from development to manufacturing, such as regenerative medicine and cosmetics, mainly in pharmaceutical companies, is engaged in businesses that are looking one more step ahead of the times.

The LAB Team was born in 1998. At that time, each company in the pharmaceutical industry was very conservative from the perspective of technology leakage prevention, but at the same time, those companies themselves had few opportunities to obtain new information. Therefore, we at the LAB Team persistently aimed to develop new users of our products in the pharmaceutical industry, and at the same time, by specializing in the life science industry, we could provide new information and opportunities in line with the industry. We grasped user needs that had been hidden until then by directly interviewing a person in charge of the manufacturing site and confirming the situation, which enabled us to develop and propose products that would meet the needs of each site in the industry.   

Meanwhile, each company had different needs, and the market for such products was not large from a business viewpoint. Therefore, we, as the LAB Team, while aiming to develop this market for which other companies could not accommodate easily, searched for manufacturers that could produce high-quality products in small batches in both Japan and overseas. In addition, in order to reduce the user management tasks for product users, we provided lot-by-lot sampling inspection reports and sterilization reports, a first in the industry in Japan. 

We did not talk about the ideal on paper but visited users’ sites to listen to their opinions directly and to find the cross point with new products, mainly made in Europe and the United States. This has been achieved only by the LAB Team of Harada Corporation, a trading company, because we, the LAB Team, know about the actual sites. The LAB Team currently deals with a wide variety of products, including not only decontaminants, sterile gloves, and disposable wear but also autoclavable wear, which can be used repeatedly. The range of products we are handling is so wide that we can be regarded as a comprehensive supplier of products for operators in aseptic areas.

Unprecedented and Revolutionary Disposable Wear for Sterile Rooms
In the general space where we live, a countless number of various fine particles, such as pollen, bacteria, dust, mold, hair, and dandruff, are floating. The human body is likewise covered with countless bacteria and dust. Therefore, when entering an aseptic area, you wear special clothing to contain the bacteria and dust on your body and, furthermore, to prevent fine particles from being brought into the area. However, because the bacteria and dust are not allowed to adhere to the clothing while you are putting it on, you must put on the clothing without touching the clothing surface.  

Drop-down is a system that eases such difficulty in putting on the clothing. We have dealt with BioClean-D Drop-down with Mask, which is a product incorporating that system, since 2018. This product does not require a user to touch the surface of the clothing from the time it is taken out of the package to actually wearing it.

Being disposable is also one of the features. In the past, the clothing for sterile rooms was repeatedly used by having it cleaned by a specialized contractor. The control of cross-contamination risks from deposits and a number of washes was needed, too. The Drop-down system has helped to solve these issues. 

Originally, we introduced this product into the Japanese market as early as around 2017, as we believed that there would be the demand not only in the pharmaceutical industry but in an advanced medical environment, such as regenerative medicine. We proposed this product to many customers at that time, but we were not able to come to an agreement regarding cost. Thus, we failed to enter the Japanese market. However, under increasingly strict aseptic control every year, the number of companies concerned about bacteria adhering to the surface of sterile room wear is growing. In recent years, the demand for the product has gradually increased. We feel that our product meets the needs of the times.



Develop Something Convenient for the Japanese
The design of BioClean-D Drop-down, which cab be worn without touching the surface of the clothing, was revolutionary. However, because of that very feature, users who were unfamiliar with it were reluctant to wear it. Another reason for user resistance was that the design for Westerners did not match the Japanese physique. We needed to modify the design to introduce this clothing according to Japanese specifications. 

It was in 2017 when we began to study the Japanese specifications to match any Japanese body type by adding a mask to the hood to make it an integrated hood and mask design. We changed the design around the eye area so that no skin would be exposed when a user put on goggles after wearing the clothing. Moreover, we improved the forehead area because this part was too exposed when a user was seated and because the fabric was stretched to the back of the head, the neck, and the back. We also added specific hooks to resolve the difficulty of putting on the clothing due to the physique difference in inseam dimensions between Westerners and Japanese. As such, while considering the details repeatedly, we negotiated with the overseas manufacturer directly. However, they were reluctant to develop their product for the limited existing market in Japan, giving us reasons such as the increased labor and costs for special Japanese specifications. 

After repeated negotiations, we eventually visited the manufacturer and explained why we needed Japanese specifications and the future market expansion for this product, by which we managed to convince them. We began development at last. Then, after repeatedly preparing samples and modifying the details, BioClean-D Drop-down with Mask for the Japanese market was completed.

Business Development Focusing on the Future
BioClean-D Drop-down with Mask boasts high-quality, but there are not many users who have decided to adopt it. Even though it has excellent functionality, users would not replace their product in use with ours easily. However, based on the analysis of the situation in Europe and the United States, we are confident that the wave for this product will eventually come. In fact, when we visit pharmaceutical companies with the test results by a third-party organization as well as samples, we receive high evaluations from the persons in charge. 

In addition, contamination control measures by pharmaceutical companies are becoming stricter every year. Such changes are progressing even in the software in parallel with capital investment. Therefore, the LAB Team has begun to get engaged, not to mention the introduction and development of new products, not only in sales but also in consultant business for contamination measures. Our aim is to comprehensively take users’ issues and solve them all, providing the latest information and the ways to handle issues through joint consultation with overseas companies that implement advanced initiatives. 

The future where Harada Corporation’s BioClean-D Drop-down with Mask will play an active role behind the launch of epoch-making new drugs is just around the corner.