BUSINESS
事業案内
One-stop response for the complete pharmaceutical production equipment
We provide integrated services including design, manufacturing, and after-maintenance, focusing on preparation equipment, cell culture equipment, and inactivation equipment related to pharmaceutical manufacturing.
Design with experience and technical expertise
All of Topsystem’s products are custom-made, so we place great importance on listening to our customers. In addition, to the ability to engineer solutions that meet customer requirements and needs, our designers have the ability to propose usability equipment. After our designers simulate the height and movement of an operator by using a 3D model, they will propose improved equipment that meets customer needs as well as takes into account operability, human traffic flow, safety, and maintenance.
Manufacturing in Search of Technology
No matter the specifications of the equipment we offer high quality production. That is what Topsystem’s manufacturing is all about. For example, clean weld lines with no weld burns, and full penetration so that the seams of pipes are almost undetectable. Equipment that handles pharmaceuticals is related to the people’s health, so a high level of precision is required. We take responsibility for each and every manufacturing process and continue to pursue further advances in our manufacturing skills.
Quality Control in Pursuit of Further Quality
We conduct a variety of inspections from independent stand point based on customer requirement. For example, welding penetration is checked with an endoscope and guaranteed with great precision. Furthermore, measuring instruments such as pressure gauges are calibrated annually under strict control. We can prove that our shipped products are of excellent quality.
Maintenance With Precision Care
We regularly visit our customer to perform maintenance that ensures the health and longevity of the equipment. Our maintenance team, which has the same level of know-how as the manufacturing department, makes precise proposals on when to replace parts according to the operating conditions. With our nationwide network of partner companies, we can respond quickly to customers in various regions from Hokkaido to Kyushu.
Precise Validation
We offer validation work from design to hand over of our products that validates , verifies, and records all processes as a document.
As this documentation is important for obtaining approval for pharmaceutical manufacturing, we confirm that our products meet the specifications provided by the customer and record each and every confirmed item on the document.
Global expansion
We are expanding our business to ASEAN countries by designing and manufacturing at factories in China and Indonesia.
In addition, employees from countries such as China, Vietnam, Sri Lanka, the United States, and Indonesia are active at the head office. We strive to create a work environment that welcomes diverse work styles.
Engineers with management skills
In any project, the project leader is responsible for process control and cost control. The project leader is a very important position that is not simply an engineer but that brings together and manages the departments involved in a project. Utilizing their communication and management skills, they lead our manufacturing process.
PRODUCTION
FLOW
生産フロー
At Topsystem, each product is custom-made to meet customer requirements. In the beginning, our sales staff will propose a plan in line with customer requirements, and work with the customer from the basic design of the equipment. Then, we provide an integrated system from design to manufacturing, inspection, validation, and after-sales maintenance. We provide an environment for tooling up the producing pharmaceuticals with one-stop system.
Sales
Sales in leading edge of the pharmaceutical industry
Every year, the pharmaceutical industry develops various kinds of new drugs and invests in facilities . In the situation, our sales personnel obtains information promptly and proposes solutions which meet the customers’ needs. The first priority is communicating with customers, so we always cultivate a knowledge of technical terms and the knowledge required to understand the customer’s needs.
In recent years, we have also been focusing on overseas business, and are engaged in a wide range of aggressive sales activities both in Japan and overseas.
Design・Fabrication
Design・Fabrication
We take into account operability, maintainability, and future expansion, and use our accumulated know-how from past achievements in our design process. Process design, mechanical design, Electrical instrumentation design, system design are aligned to provide better proposals in terms of both hardware and software. For manufacturing, we provide integrated manufacturing services, including pipe fabrication , Frame and stage fabrication, control panel manufacturing, skid fabrication and electrical instrumentation work. We take full responsibility for installation and on-site inspection at the customer’s factory.
Pharmaceutical Preparation Equipment
We propose, design, and manufacture preparation equipment and pharmaceutical water production equipment that are indispensable for the manufacture of pharmaceuticals, in accordance with customer needs. We have experience with preparation tanks which volume is from 25L to 14,000L.
Culture Equipment
Culture Equipment for and cell requires advanced technology (control system) that incorporates various factors such as temperature, concentration, and agitation into the design. We design and manufacture both the device itself and the system in an integrated manner. Our engineers have the expertise and know-how to propose equipment.
Wastewater and Inactivation Treatment Equipment
Hazardous wastewater (containing microorganisms and viruses) generated in manufacturing process of vaccine and drug requires appropriate treatment. Utilizing our many years of expertise, we provide Wastewater and Inactivation Treatment Equipment that meets effluent standard so that customers can safely discharge wastewater from their plants.
Instrumentation and Control Systems
Instrumentation and control systems are the cornerstone for the phermaseutical manufacturing process. We propose, design, and develop the workflow which meets the operational requiremnts or processes by customers.
Inspection and Validation Services
Inspection and Validation Services
Since pharmaceutical products are used in the human body, strict quality control is required for pharmaceutical manufacturing equipment. Using a high-performance endoscope, we thoroughly check the inside of the piping. In addition to the inspection of equipment, piping units, and electrical instrumentation, we also conduct FAT (Factory Acceptance Test), IQ (Installation Qualification), calibration, commissioning, and OQ (Operational Qualification) at the customer’s factory. Based on these records, we carry out validation work, which is indispensable for manufacturing equipment that complies with PIC/S-GMP. Validation involves documenting the production process of the equipment itself, from design to hand over, and proving that the equipment is in accordance with the User Requirement Specification (URS).
Maintenance
After-sales service
We propose the most appropriate maintenance program for your equipment. To ensure safe and stable operation of equipment , we perform inspections of equipment itself, Operation check of power equipment, and calibration of instrumentation.
A Nationwide Network of Partner Companies
We have a network of partner companies throughout Japan, from Hokkaido in the north to Kyushu in the south. We provide speedy maintenance services to customers all over Japan.
Periodic inspection and repair of Preparation Equipment
We suggest the replacement of parts that are subject to wear and tear based on the customer’s usage conditions such as gaskets for equipment and valves that are in constant operation.
