How Raleigh Coatings Turn Concepts into Medical-Grade Products: Frequently Asked Questions
Our specialist wound care coating and conversion services provide a wide range of organisations with high-quality products for advanced wound care needs. We work with you from conception through to the finished product to meet your individual requests, while adhering to stringent quality management standards, both in-house and through the International Organisation of Standardisation (ISO).
The wound care industry requires a distinct and specialist partner to meet medical marketplace needs; our expert knowledge of this sector means we can develop a wide range of products to suit these requirements.
At Raleigh Coatings, we follow a five-phase process to understand your requirements and develop the best products. This process includes:
Phase 1: Enquiry – This stage involves an open discussion to understand your needs. It then goes on to outline the project and agree on timelines and further arrangements about packaging and transportation.
Phase 2: Samples – After the initial discussion, samples are created for evaluation. Any adjustments can be made before sign off, and costs are discussed more thoroughly.
Phase 3: Development Process– After samples have been agreed upon, we move onto the development stage. This may include a pilot line and mainline trials.
Phase 4: Operational Qualification – Once these trails trials have been successful, the next stage moves onto the manufacturing process and final confirmation of costs and quotes.
Phase 5: Performance Qualification – Once the other steps have been completed, this stage signs off the specification with you. This covers everything from production, perforation, conversion, packaging and transport. It also includes technical specifications and standards. Once both parties have signed off this stage, it cannot be changed, and the manufacturing process can begin.
Before you start the process, there are often several questions you may have about how we can develop your wound care dressing products.
In this blog, we cover some frequently asked questions to help you find out more about our wound dressing manufacturing processes and how we can fulfil your wound dressing product requirements.
What are the health and safety requirements for manufacturing a wound dressing?
There are specific standards that are required to manufacture a wound dressing to ensure consistently high standards are met throughout production. A particular aspect of these standards covers manufacturing in a clean room environment, and at Raleigh Coatings, we are proud to have ISO 14644 Class 7 Clean Room. This standard is in place to ensure the specific elements of wound dressing manufacture are upheld;
- Classification of air cleanliness
- Specifications for testing
- Metrology and test methods
- Design, construction and start-up
- Enhanced clean devices
What wound care products do we manufacture?
At Raleigh Coatings, we produce bi-laminate and tri-laminate silicone gel coated roll stock constructions for bordered and non-bordered dressings.
What materials can we use for your wound dressing?
We use a variety of raw materials in wound dressing manufacturing to ensure the highest quality medical grade products. The materials we use include:
- Silicone gel
- PU film carriers
- Acrylic pressure-sensitive adhesives
- Non-woven carriers
- Polyester carriers
Our medical coatings process also has delamination and relamination capabilities and includes full development facilities, including pilot line requirements.
What production lines do we manufacture products for the wound dressings market on?
Our wound care roll products are manufactured in Class 7 Clean Rooms on lines 1 and 3. We are also able to perforate and slit in clean room facilities . You can find out more about each line in the Phase 3 development stage here.
What is cleanroom coating? How does it differ from industrial coating?
In wound care manufacturing, it is vital to ensure each medical-grade product is produced in a clean and sanitary space. Our clean rooms are air-controlled and continually monitored to ensure containment levels are adhered to, so we consistently provide inclusion free coatings.
This process differs from industrial coatings, as there are stringent standards to be met at each phase of development.
What is the process of perforation?
Perforation in wound dressings is an integral part of the development process and ensures improved performance of the dressing. To perforate wound care products, mechanical perforation takes place in the manufacturing stages.
Our equipment is able to perforate wound dressings in a range of materials such as films, acrylic coated films and silicone gel coated products. The perforator is set to the requirements of the project and can range from 1.5mm – 3mm, however this can be adjusted to a larger measurement if required. Other factors of perforation include the pattern of the hole to ensure consistent open area.
The mechanical perforation process also ensures parameters are consistent, and tooling is used to cut holes cleanly. Our perforator also removes over 99% of all waste produced during the process.
What tests can we perform on your wound care product in our laboratory?
An essential part of the development process is ensuring our wound dressing products meet high standards and specific testing specifications. We assess all coated bi, tri and quad laminated products and perform several tests including:
- Stripping liner force and tack
- Moisture vapour transmission rate (MVTR)
What are the processes of reel-to-reel slitting and at what stage of manufacture is this process done?
The process of reel-to-reel slitting is an operation that involves cutting large rolls into narrower rolls. We can provide rewind slitting depending on your requirements.
The reel-to-reel slitting process can be performed before coating or post-coating. However, it is more common to use this process after coating, as this then goes on to produce smaller reels, which then moves on to the process of cutting into wound dressing sizes.
Which delamination and relamination services can we provide for your wound dressing?
At Raleigh Coatings, we provide both delamination and relamination services, depending on your specifications. In a delamination for example, you may need perforated liners to be replaced by fresh liners to change the type of wound dressing product. In a relamination case, there is the option to add additional films such as PU film to the acrylic side of the construction.
Our process is equipped to meet the needs of individual projects. Plus, our new delamination/relamination equipment ensures we are able to perform these requirements accurately and within the required standards.
What challenges do we face in wound dressing manufacture?
Our five-phase Raleigh Coatings process ensures we bring each customer high-quality medical-grade products for every project. Each stage in our development requires stringent testing and monitoring to meet industry standards and in-house quality management tests.
The wound dressing sector is continually evolving, and to keep ahead of the curve, we strive to ensure we innovate to bring top-quality products to our customers. There are challenges that the wound dressing manufacturing industry faces, so check out our next blog to see how we’re tackling these to improve our processes and specialist services.
For more information on how Raleigh Coatings can support your wound dressing requirements, and to find out more about our processes, contact our team on 01785 850 357 or email our Business Development Project Manager, Jenny Reeves ([email protected])