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Contract Manufacturing

EXPERT CONTRACT MANUFACTURING SERVICES

Overview

With over 50 years of expertise in contract manufacturing for the medical device and wound care industries, Brightwake is recognised as a global leader in delivering high-quality, market-ready solutions. Our contract manufacturing services are built on a foundation of extensive industry knowledge, advanced manufacturing capabilities, and a commitment to excellence. We offer a complete suite of services that cover the entire product lifecycle, from concept development and design to large-scale production and distribution.


Our experience in the medical device industry means we understand the complexities and regulatory challenges that our clients face. This is why we provide turnkey solutions that not only streamline the manufacturing process but also ensure that every product complies with global regulatory requirements. Whether you are developing a new product or looking to optimise an existing one, Brightwake has the expertise, resources, and capabilities to bring your vision to life.

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Our state-of-the-art cleanroom facilities are equipped with the latest technology to ensure precision, efficiency, and scalability in manufacturing. We work closely with our clients to ensure that every aspect of the product, from design to final packaging, meets the highest standards of quality and safety. By partnering with Brightwake, you gain access to a team of experts dedicated to transforming your concepts into commercially viable products that stand out in the competitive healthcare market.

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Coating, Casting and Lamination

ADVANCED COATING AND LAMINATION FOR MEDICAL DEVICES

Overview

Brightwake offers cutting-edge coating, casting, and lamination services tailored to the unique needs of the medical device industry. Our capabilities include the application of medical-grade adhesives, silicone coatings, and anti-microbial and bioactive coatings to a wide range of substrates, ensuring that your products deliver the performance and reliability required in critical healthcare applications.


Our adhesive coating solutions encompass a variety of materials, including silicone gels, hydrocolloids, hydrogels, and acrylics. These coatings are engineered to provide the optimal balance of tack, adhesion, and comfort, making them ideal for applications where skin contact is involved. Additionally, our expertise in silicone coating allows us to produce medical-grade silicones that offer superior biocompatibility and durability. In the realm of bioactive coatings, we excel in applying materials such as antimicrobial agents and bioactives that enhance the healing process.

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These coatings are particularly beneficial in wound care products, where they help to prevent infection and promote faster healing. Our lamination processes are equally advanced, enabling us to create multi-layered composite materials that combine different substrates and adhesives to achieve the desired performance characteristics. 

Whether you need a material with enhanced breathability, moisture management, or barrier properties, our lamination capabilities ensure that your product meets all necessary criteria. By partnering with Brightwake, you gain access to a team of experts who are committed to delivering innovative solutions that not only meet but exceed the expectations of the medical device industry.

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High-Performance Technical Textiles for Medical and Wound Care Applications

PRECISION TEXTILE MANUFACTURING 

Overview

At Brightwake, we excel in the production of woven and knitted technical textiles, meticulously crafted to address the specific demands of the medical device and wound care industries. Our textile manufacturing process is driven by innovation, enabling us to develop high-performance products that meet the unique specifications of each client.


Our expertise extends across a diverse range of yarn materials, allowing us to produce advanced technical textiles incorporating alginate, carboxymethylcellulose (CMC), and silver to create specialised properties such as antimicrobial, increased absorption, enhanced durability, breathability, and moisture management. These technical textiles are further refined through advanced processes like reinforcement, quilting, and multi-layer fabric development. This approach enables us to deliver solutions tailored to complex medical applications, ensuring that each product not only meets but exceeds industry standards.

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Whether the requirement is for woven textiles used in wound dressings or knitted fabrics designed for compression garments, Brightwake has the capability and technology to deliver. Our commitment to precision and quality ensures that every textile product is crafted with the utmost care, meeting the stringent demands of the healthcare sector.

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Advanced Cutting Techniques for High-Precision Medical Components

PRECISION CUTTING AND SLITTING

Overview

Brightwake offers a comprehensive range of precision cutting and slitting services, designed to meet the exacting standards of the medical device industry. Our cutting capabilities include ultrasonic cutting, laser cutting, rotary-die cutting, and die-press cutting, each selected to ensure the highest level of accuracy and quality.


These advanced cutting techniques are essential in the production of medical components, where precision directly impacts the performance and safety of the final product. Our cutting services are not only about achieving the correct dimensions but also about ensuring that the materials maintain their integrity throughout the process. This is particularly critical in applications such as wound care dressings and medical devices, where even the smallest deviation can affect product efficacy.

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In addition to standard cutting services, we offer slitting capabilities that allow for the precise division of materials into narrower widths. This is particularly useful for applications requiring custom-sised components or materials prepared for further processing. By leveraging our cleanroom cutting and slitting expertise, clients can be assured that their products will meet the highest standards of precision and quality, ready for further assembly or direct use in medical applications.

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Production Sewing for Durable and Reliable Medical Textiles

CUT AND SEW

Overview

Brightwake’s cut-and-sew manufacturing services are integral to the production of high-quality medical textiles and devices. Our approach combines traditional handcraft with modern automation, ensuring that every product is manufactured with precision, consistency, and durability.
 

We employ a variety of sewing techniques, including stitch bond, lockstitch, binding, bar tack, flag stitch, box stitch, and overlock stitching. Each method is chosen based on the specific requirements of the product, ensuring that the final result is not only functional but also durable and reliable. Our automated sewing equipment allows us to maintain elevated levels of precision across large production runs, ensuring consistency in every batch.

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The versatility of our cut-and-sew capabilities means we can handle a wide range of medical products, from complex wound care dressings to compression garments and other specialised medical textiles. By combining our expertise in material selection, design, and sewing, Brightwake delivers products that meet the stringent demands of the healthcare industry, ensuring safety, efficacy, and comfort for the end-user.

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Seamless Bonding Solutions for Medical Devices and Textiles

RF WELDING

Overview

Brightwake offers advanced RF (Radio Frequency) welding services, providing strong, reliable bonds for medical films, coated textiles, and flexible components without the use of adhesives or heat. This technology is particularly valuable in the production of medical products where the integrity of seams and bonds is critical to product performance.


RF welding works by using electromagnetic energy to generate heat within the material, allowing it to bond at a molecular level. This process results in clean, neat seams that are both strong and flexible, ideal for applications such as wound care dressings, pressure relief mattresses, inflatable medical devices, pharmaceutical flexible containment, DVT devices, heating and cooling devices, automotive seating components, and other products that require watertight or airtight seals.

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Our expertise in RF welding is complemented by our ultrasonic welding capabilities, allowing us to offer a comprehensive range of bonding solutions. These processes are crucial for ensuring the durability and reliability of medical products, especially in environments where they are exposed to stress, moisture, or other challenging conditions.
By integrating RF welding into our manufacturing process, Brightwake ensures that every product we produce meets the highest standards of quality and safety, ready for use in critical medical applications.

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High-Speed Converting Assembly and Packaging for Medical Devices

CONVERTING AND ASSEMBLY

Overview

Brightwake’s cleanroom converting and assembly services are designed to meet the diverse and complex needs of the medical device industry. Our advanced capabilities allow us to handle everything from the conversion of basic medical components to the assembly of intricate, multi-layered devices. We specialise in high-speed, high-precision manufacturing that ensures consistent quality and reliability across all products.


Our automation engineers play a crucial role in developing and implementing tailored automation systems that streamline the converting and assembly processes. These systems integrate a variety of technologies, including high-precision cutting, lamination, adhesive application, and component placement, to ensure that every product is manufactured to the highest standards. This level of automation not only increases production efficiency but also reduces the risk of errors, ensuring that every product meets the stringent requirements of the medical device industry.

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By leveraging our converting, assembly, and packaging services, you can enhance your product development process and ensure that your products are manufactured, assembled, and packaged to the highest standards of quality and safety.

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Automated Assembly for Medical Devices

MEDICAL DEVICE ASSEMBLY

Overview

Brightwake’s cleanroom medical device assembly services are designed to ensure that your products are manufactured, assembled, and packaged with the highest levels of precision and quality. Our state-of-the-art cleanroom facilities and automated assembly lines are equipped to handle a wide variety of medical devices, from simple components to complex, multi-layered products.


Our automated assembly processes are designed to maximise efficiency and consistency, ensuring that every product meets the exacting standards of the healthcare industry.

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We utilise advanced technologies, including precision cutting and converting equipment, to ensure that every component is assembled accurately and efficiently. This level of automation not only improves production speed but also ensures that every product is manufactured to the highest standards of quality and safety.


By partnering with Brightwake for your assembly needs, you can be confident that your products are being manufactured and packaged in compliance with the highest standards of safety and quality.

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Comprehensive Formulation, Fill and Finish Services

FORMULATION, FILL AND FINISH

Overview

Brightwake’s formulation, fill, and finish services are designed to provide a complete solution for the development and production of stable, effective medical products. Our expertise in formulation allows us to combine ingredients in precise proportions, ensuring that every product delivers consistent, predictable results.


Our formulation services cover a wide range of applications, from the creation of wound care products to the development of topical treatments and biomedical coatings. We work closely with our clients to understand their specific needs and develop formulations that meet their requirements. Our state-of-the-art laboratories are equipped with the latest technologies, allowing us to conduct comprehensive testing and quality assurance at every stage of the formulation process.

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Once a formulation has been developed, our fill and finish services ensure that the product is prepared for market. We offer cleanroom formulation, fill, and finish technology, provides an efficient, and cost-effective method for packaging liquid and semi-liquid products. Our formulation, fill, and finish lines are capable of handling a wide range of container sizes and formats, ensuring that your products are ready for distribution in a timely and efficient manner.


By offering a complete range of formulation, fill, and finish services, Brightwake provides a seamless solution for the development and production of medical products that meet the highest standards of quality and efficacy.

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Customised Packaging Solutions for Sterile and Retail Medical Devices

PACKAGING

Overview

Brightwake’s cleanroom packaging services are designed to meet the diverse needs of the medical device industry, ensuring that every product is ready for market in the most efficient and effective way possible. Our packaging solutions are comprehensive, covering everything from sterile packaging for medical devices to customised packaging for retail distribution.


Our packaging lines are equipped to handle a wide range of materials and formats, allowing us to tailor our services to the specific requirements of each product. This includes the use of specialised packaging materials that maintain sterility, as well as retail packaging that enhances the product’s market appeal. Our experience in the medical sector means we understand the importance of maintaining product integrity and safety during packaging, which is why we adhere to the highest standards of quality control throughout the process.

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In addition to packaging, we also provide labelling and compliance services, ensuring that all packaging meets regulatory requirements and is ready for global distribution. Whether you need a simple, sterile package for a single-use medical device or a complex, multi-component packaging solution for retail, Brightwake has the expertise and capabilities to deliver.
 

By partnering with Brightwake, you gain access to a comprehensive cleanroom packaging service that not only prepares your products for the market but also enhances their value and appeal in a competitive marketplace.

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ISO-Certified Testing and Quality Assurance

LABORATORY AND MICROBIOLOGY TESTING

Overview

Brightwake’s ISO 13485-accredited laboratories provide a comprehensive range of testing, inspection, and quality assurance services to ensure that all our products meet the highest standards of safety and performance. Our laboratories are equipped with state-of-the-art analytical and microbiology testing equipment, allowing us to conduct a wide range of tests, from basic quality checks to complex microbiological analyses.


Our testing capabilities include bioburden testing, which measures the microbial load on a product, and endotoxin testing, which ensures that products are free from harmful bacterial toxins. We also offer sterility testing to confirm that products meet all regulatory requirements for sterility, making them safe for use in critical medical applications.

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In addition to our microbiology testing services, we also provide material testing to assess the physical and chemical properties of materials used in medical devices. This includes tests for strength, durability, and biocompatibility, ensuring that every material used in our products meets the necessary standards for medical use.


By providing a comprehensive range of testing and quality assurance services, Brightwake ensures that every product we manufacture is safe, effective, and compliant with all relevant regulatory requirements.

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Global Sterilisation and Supply Chain Management

STERILISATION AND LOGISTICS

Overview

Brightwake partners with leading sterilisation providers to offer a full suite of sterilisation services, ensuring that our products are sterile, safe, and ready for market. Our sterilisation services include ethylene oxide sterilisation, gamma irradiation, and electron beam sterilisation, each of which is selected based on the specific needs of the product and its intended use.


Our expertise in global supply chain management ensures that our products are delivered to our customers efficiently and effectively, no matter where they are located. We manage complex supply chains that span multiple countries and continents, ensuring that products are manufactured, sterilised, and delivered in compliance with all relevant regulatory requirements.

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By partnering with Brightwake, you gain access to a global network of sterilisation providers and supply chain experts who are dedicated to ensuring that your products are safe, effective, and ready for market.