Assembly - Racer Technology

For all of our customers

Each of our customer (be it low or high volume) will be assigned an assembly line dedicated for their product. This personalised approach ensures quality control, and efficiency throughout the manufacturing process. We understand the importance of tailor-made solutions, and our dedicated assembly lines are a testament to our commitment to meeting the specific needs and standards of each customer. Your product’s journey from assembly to completion will be handled with precision and care, guaranteeing the highest quality and satisfaction.

Full Turnkey Assembly

As part of our dedication as the leading contract manufacturer, we have a comprehensive system that caters to full-turnkey assembly. This ensures full traceability as we fully handle the manufacturing for our customers. Part of this engagement includes procuring other components to complete the product. These includes PCBA, metal stamping, screw components and liquid silicone rubber (LSR).

Clean Room Assembly Line

Our ISO Class 7 and 8 clean room allows us to plan and optimise our processes and mainly used for medical manufacturing. Work flows are strategically placed with guided processes in an orderly manner. In both ISO 7 and ISO 8 cleanrooms, maintaining cleanliness is essential to prevent contamination of products or processes within the controlled environment. Factors such as air filtration, gown procedures, air pressure differentials, and monitoring systems are critical to meeting the cleanliness standards of each classification.

We place careful emphasis on the criticality of cleanliness and the processes to ensure the desired level of cleanliness is constantly achieved. Our cleanroom design and maintenance is also aligned with industry standards and regulatory requirements.

Sterilisation

We have two types of sterilisation to choose from

ETO Sterilisation

Ethylene Oxide (ETO) Sterilisation uses a gas called ethylene oxide to kill bacteria and other harmful organisms.

Regulatory Landscape for ETO Sterilizers in Germany: Compliance and Standards

Gamma Sterilisation

Gamma sterilisation involves using high-energy gamma rays to kill microorganisms on the devices. It is a powerful and effective method, suitable for a wide range of materials.

Is Gamma Sterilization the Best Choice for Your Medical Device? - Life Science Outsourcing, Inc.

Sterilisation is a vital step in medical device manufacturing to ensure patient safety, prevent infections, comply with regulations, and maintain the quality and efficacy of medical devices throughout their lifecycle.

Patient Safety:
- The primary and most critical reason for sterilisation is to ensure patient safety. Medical devices come into direct contact with patients, and any microbial contamination can lead to infections or other adverse effects.
Infection Prevention:
- Sterilization prevents the transmission of infectious agents, including bacteria, viruses, and fungi, from medical devices to patients. This is crucial in preventing healthcare-associated infections (HAIs).
Regulatory Compliance:
- Regulatory bodies, such as the FDA (Food and Drug Administration) in the United States and similar agencies worldwide, have stringent guidelines and requirements for the sterilisation of medical devices. Compliance with these regulations is essential for market approval and ensuring the safety and efficacy of medical devices.

Process Validation Protocol

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Process Validation protocol (IOPQ) and FATP certifies a traceability system to assure the accuracy and perfection of the flow and storage of raw materials, WIP and finished products. This provides our customers with access to our web-site of inventory control. All our process are well-documented and it’s also our task to provide world class quality components, which involves our top management, down to our delivery men. Our dedication to continued training and improvement has earned our customers satisfaction with great success.

See our dedication to process validation here.