Taiyo Pharmaceutical Industry, Contract Manufacturing Plant Takayama City, Gifu, Japan

Taiyo Pharmaceutical Industry Co (Taiyo Yakuhin) is one of the foremost contract pharmaceutical manufacturing and packaging companies in Japan. The company is well known for the manufacture of generic vitamins and antibiotics but has recently gained ground by manufacturing refillable and pre-filled syringes of medication for the parenterals market.

The company has been producing generics and OEM products for the last 40 years. The company, like many other Japanese companies, believes passionately in the principle of Kaizen (constant improvement) and value engineering, and this has been the reason for its success.

The company is located in Takayama City, Gifu, Japan, and its main business consists of two major enterprises: contract production for external parties, and the production of generic products.

In early 2004 Taiyo announced it was planning to increase its contract manufacturing operations since in the wake of new Japanese government legislation it was made easier for firms to produce drugs for third parties on a contract basis. The demand for contract manufacturing services in Japan increased after the revision of the Pharmaceutical Affairs Law came into effect in April 2005.

Following this, Taiyo announced that it intended to increase the contract manufacturing business from ¥2.3bn in 2002 to ¥7bn for the fiscal year ending 31 March 2005, as part of a broader plan to nearly double group sales to ¥32.bn.

In order to achieve this, the firm needed to increase its capacity to make antibiotics, particularly cephems and penems, at the facility in Takayama, and also needed to add a new production line for injectable drugs.

EXPANSION AND CONSTRUCTION

Following the corporate decision to expand, the next step was to choose a site for the expansion. The obvious choice for the company was the 110,000m² Takayama City campus (500 employees) where there was already a basic infrastructure for generics and contract manufacture.

The basic design of the new facilities (unit factory building) at the plant was started in late 2002 and completed by February 2005; construction work on new buildings was started in mid-2003 and completed in July 2005. Plant outfitting was started in May 2005 and completed by March 2006. Validation was started in July 2005 and completed by August 2006.

Manufacturing began in December 2006. In early 2007 the new plant was awarded the ‘Facility of the Year Award 2007’ for equipment innovation. The first vaccine-filled syringes were manufactured in September 2007 at a rate of 900,000 per week. The production is exclusively for the Japanese market.

The six-floor Unit Factory Building and the $40m pre-filled syringe (PFS) Manufacturing Line took up a floor space of 11,744m². The construction budget amounted to ¥4.58bn and the equipment cost for the primary work was ¥3.29bn and ¥4.85bn for the secondary work.

STRATEGY AND MANUFACTURE

The company was recognised for the project (as part of the contract manufacturing facilities expansion) to manufacture (filling and packaging) six types of pre-filled syringes. Since the company has established the new facility manufacturing as a successful project they have also started producing pre-filled syringes with high-speed type isolators as a new derivation for the important parenteral drug market. This is consistent with a low cost strategy and in accordance with its mid- to long-term management strategy.

The pre-filled syringes (PFS) line at its Unit Factory Building PFS manufacturing facility produces a total of six products, including four plastic syringe containers and two glass syringe containers. In addition to the in-house syringe project, two other manufacturing lines have been successfully completed and now produce pre-filled syringes equipped with high-speed type isolators.

The facility is believed to be the first in the industry capable of producing and filling glass syringes in-house (1ml and 2.25ml). The main product for the glass syringes is influenza vaccine but the company is in the process of planning the use of the two glass lines to fill other products into syringes under a contract basis. The company is receiving a great many orders to fill products into glass syringes.

A spokesperson for Taiyo said: "The most important aspects of the services we provide to customers and markets are the provision of high quality products…and the stable supply of products. By doing the syringe manufacturing and filling in-house tremendous costs can be saved; syringes cost only a fifth of what they used to.

Our products are low in price, easy for nurses to use and create little burden on patients. This includes pre-filled syringe preparations in various doses, which reduces the risk of contamination by foreign substances, and ease of use."

INNOVATION AND COST SAVING

Taiyo has also introduced an innovative packaging by packing the syringes in Tyvec pillows and also putting them through a hydrogen peroxide decontamination process while they are on the line. The company is dedicated to cost saving and actually collects cheaper electricity at night (off-peak), storing it in electrical storage batteries for use in the day.

The company is proud of the fact that there are no transportation costs to worry about from supplier factories for packaging material or for ready-made syringes. Glass tubing to produce syringe barrels is received in large cost-effective shipments from a German company. As everything is done in-house, the factory does not have such a great effect on the environment as it would were it receiving shipments of syringes and packaging materials every day.

CONTRACTORS

The designers of the production facilities (glass and plastic syringe lines) were Horiuchi Architectural Associates. The design of the production equipment was carried out in-house by Taiyo’s own team in conjunction with consultants. Construction management for the new unit factory building was carried out by Kashima Construction KK.

Other contractors and consultants for the project included Daiichi Jitsugyou KK, Itochu Foodec KK, Clean Mechanical KK, KK Airex, Sakura Seiki KK, Winkler & Co Ltd, Groninger KK, Systech Ushijima, Murata Seiko KK, Hitachi Information & Control Solutions Ltd, SIG, IWK, KK Haginoya Machinery and SPAMI KK Kit.

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