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What Challenges Do We Face in Wound Dressing Manufacture?

Our experience and expert knowledge in the wound care industry make us one of the sector’s most established and trusted companies. Despite our reputation as being one of the wound dressing field’s leading organisations, we still have to overcome a number of hurdles on a daily basis.

We never want to let our standards slip, which is why we embrace these hurdles. To find out what challenges we face and how we face them, be sure to read on.

Challenge no.1: The need to provide a unique service

It is not possible to offer a one-size-fits-all service in the wound care sector. To retain our position at the top of this industry, it’s essential that we provide each individual customer with a bespoke service that is tailored around their unique needs. Anything less, and we wouldn’t be able to provide the optimised service that we have become known for.

Offering a blanket service would be much easier than offering a unique one, that much is for certain. Nevertheless, we strive to manufacture wound dressing products in as bespoke a fashion as possible by following a five-phase process. This helps us to understand the individual requirements of our customers and ultimately develop the best products on the market.

Our five-phase process aids us as we take on the challenge of providing a unique service to each and every customer. It helps us get right to the heart of each individual matter, and it allows us to make the most out of the time we are afforded with our consumers. Here is the exact process that we follow:

Phase 1: Enquiry — We hold an open discussion with our customers to understand their needs, outline a project timeline, and make arrangements with regards to packaging and transportation

Phase 2: Samples — We discuss samples with our customers so that we can attain a better idea of what adjustments need to be made and what prices need to be set

Phase 3: Sample development — We develop our samples while still remaining in close contact with the customer (we may run a pilot line and/or mainline trials at this stage to ensure that the customer in question is 100% happy with our service)

Phase 4: Operational Qualification — Once the customer is happy to proceed, we confirm our final quotes, set our final costs, and move on to the manufacturing process

Phase 5: Performance Qualification — The production, perforation, conversion, packaging, and transport specification are signed off, and we start the manufacturing process

Challenge no.2: Our sector is constantly evolving

All industries undergo changes from time to time, but it’s safe to say that our field undergoes more than most. The wound care sector is in a constant state of flux, simply because there are always new technologies and materials being introduced into the wound care market. In our bid to consistently provide wound dressing products that are befitting of the day, we strive to keep ahead of the curve at all times.

In the fast-paced sector that we work in, this is no mean feat. Our laboratory is constantly abuzz. The expert workforce that we employ stops at nothing to ensure that our products meet high standards and specific specifications.

We assess a whole host of coated bi, tri, and quad laminated products on a daily basis. Some of the specific tests that we perform include:

• Adhesion
• Stripping linear force and tack
• Moisture vapour transmission rate (MVTR)

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])

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
• Operations
• 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:

• Adhesion
• 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])

The Wound Care Market Trends to Expect in 2020

The products available for more advanced wound care are designed to a) provide more extensive pain relief for patients, and b) improve healing times. For chronic wound conditions, those products are very useful for not only speeding up the time it takes to heal but also resulting in fewer treatment costs. The wound care market continues to grow, but what trends can those in the industry expect to see in 2020 and beyond? The changing face of the global population and the rise of specific conditions means that the wound care market is set to face significant growth in the coming years. Here are the main reasons for that, and why the sector is set to go through some dramatic changes over the next few years.

Ageing Issues

People are living longer than ever. Advances in medicine, as well as rises in quality of life, means that the elderly population is growing faster than it ever has before. It is expected that over the next 50 years, there will be an elderly population of up to 8.6 million in the UK, which is roughly the number of people that live in London. That increase in the number of elderly people means that they will be more vulnerable to chronic conditions, and the wound care market is set to rise significantly over the next decade for that reason alone. As wound care specialists continue to take advantage of rapid technological developments, evidence-based treatments are set to become the new normal for those in the sector.

The Diabetes Factors

As one of the more common wound-causing diseases, diabetes is proving very challenging to medical professionals. As many as one in ten UK residents are now having to live with the limiting factors of Type 2 diabetes, and that number is growing exponentially with age. Diabetes can cause serious and chronic wounds, with ulcers on the feet being particularly prevalent. These can quickly lead to the need for amputation, and the rates of necessary amputations are steadily rising. As the geriatric population continues to grow, diabetes, in particular, looks set to become one of the major growth factors for the wound care market.

Tech Advances and Growing Awareness

More people are now aware of the available treatments when it comes to wound care. This means that there is expected to be significant growth in demand for those products designed and manufactured by established and professional Wound Care product specialists. The continued development of overseas trade means that the potential market is growing for those that sell wound care products to medical facilities all around the world. Although growth may be slower in those countries with fewer financial resources, the continued drop in production costs could alleviate that issue and lead to even further growth.

Medical facilities are using proven wound care products in growing numbers, not just in the UK but around the world. As we start to see more significant trends in geriatric care and the profitability of additional markets, the wound care sector looks set to see more profitability and further growth in 2020 and beyond.

Why Choose A Solvent Acrylic PSA?

The Benefits

Solvent acrylic PSAs are the adhesives of choice for durability and long-term applications; they provide the widest range of expedient performance properties, including better chemical, water and heat resistance over almost all other adhesive types.

The molecular structure of an adhesive determines the way in which it performs in different circumstances. Solvent-based acrylic adhesives feature a number of crosslinking mechanisms, whereas water-based adhesives typically do not. One such effect of crosslinking is an increased resistance to chemicals and other solvents; most water-based adhesives lack this connective ability, resulting in them being more susceptible to poor end-use performance when exposed to solvents.

Through testing and modifications, adhesive technologists are able to use solvent acrylic adhesives to deliver precise polymer performances to meet almost all adhesive needs. This wide breadth of possibility in customisation of solvent acrylic adhesives enables the option of combining positive characteristics with minimal sacrifice to overall performance properties.

Advantages of using formulated/customised solvent acrylic adhesives include:

• Outstanding chemical resistance

Well-suited for use in environments where chemical exposure is a possibility.

• Performance properties retained at a wide range of temperature extremes

This adhesive type performs well at high and low temperature extremes, making it well suited to being used in a diverse scope of locations and conditions.

• Longevity and durability

Solvent acrylic adhesives are usually the best option for an application that requires long-term wear and durability against the elements.

Things To Consider

Tack Level

Tack is the measure of force required to remove an adhesive tape from a substrate immediately after initial application, with very minimal effort. Solvent acrylic PSAs’ tack levels can be manipulated to range from low, to medium, to high tack.

Skin Adhesion

Skin adhesion is measured through testing the bond strength between the adhesive and the substrate. Pressure is applied to the adhesive and is then left to wet-out onto the substrate (adhesive dwell). Adhesion generally continues to increase for a period of time after the initial application, typically 24 hours. For this reason, a peel test, in which adhesion is tested through the force required to ‘peel’ the adhesive from the substrate, is often performed at different periods of time to show any differentiation.

Solvent acrylic PSAs are suitable for use in the medical industry where skin contact is required; many also meet ISO10933 test standards.

Biocompatibility ISO10933 Test

A series of tests designed to provide assurance that the materials used in the manufacture of a medical device are appropriate and safe for use.

The type of testing performed on the material/adhesive is determined by the intended use, duration of contact on the skin and the condition of the intended patient.

The ISO guidance documents for biocompatibility ISO 10993, offer the direction needed to determine which test methods are most appropriate.

Colour

The clear appearance of a solvent acrylic PSA is well suited to medical requirements.

Substrate

Solvent acrylic PSAs can be applied to a variety of substrates, including PU films, polyester films, non-woven carriers, PET & PP scrims, foams and papers.

MVTR

Moisture vapour transmission rate (MVTR) is a measure of the passage of water vapour through a substance; it is an incredibly important factor to be considered in order to control moisture levels in a wound dressing. The higher the MVTR reading, the more moisture that can pass through the adhesive.

A number of solvent acrylic PSAs have high MVTR ratings, making them ideal adhesives to be used in the construction of a wound dressing as they enable moisture from the wound to escape.

Solvent Acrylic PSAs are both gamma and EtO sterilisation stable:

Gamma sterilisation stable

The substance is exposed to gamma rays as a method of sterilisation or decontamination. The gamma rays are a form of electromagnetic radiation of very short-wave lengths; these rays act as a source of ionising energy that destroys bacteria and pests.

EtO sterilisation stable

Ethylene oxide (EtO) is a gas that acts as a powerful alkylating agent. The sterilisation process disrupts the DNA of microorganisms, preventing them from reproducing, therefore destroying all known viruses, bacteria and fungi and insuring safe, sterile products.

The process of EtO sterilisation consists of four primary variables: gas concentration, humidity, temperature and time. The substance is first brought to the necessary temperature and moisture content, it is then placed in an enclosed chamber where all air is removed and controlled amounts of steam and EtO are introduced.  The final stage requires the substance to enter a high velocity aeration room, where gas residuals are lowered to the required levels for a period of at least 48 hours.

Thickness

The coat weight thickness is dependent on the solid content, viscosity and end use of the solvent acrylic adhesive system; on average coat weights range from 10-100gsm.

Selecting The Right Manufacturer

With customers requesting complex combinations of performance characteristics, it is important that the manufacturer understands the properties of the adhesive and has broad experience of the application of an adhesive onto a substrate.

The manufacturer is also required to have a knowledgeable technical team who have experience in handling solvent acrylic PSAs; understanding where to source the adhesive, how to laminate the construction, how to coat and how to dry. All of the adhesive’s characteristics can be lost if just one step in the process is done incorrectly, highlighting the importance of choosing the right manufacturer to build your construction.

For information on how Raleigh can support you in your solvent acrylic PSA coating requirements, contact our team on 01785 850 357 or email our Business Development Manager, Julian Watkins.

Why perforation is important in silicone gel wound dressings

There is a drive in the wound care industry to constantly improve the performance of a wound dressing; we have found that perforation in silicone gel wound dressings plays a very important part in this development.

It is already recognised that silicone gel wound dressings show improved performance over more conventional wound dressings in the following areas:

• Immobilisation of the wound
• Prevention of contamination
• Reduction in the risk of bacterial infection
• Absorption of any drainage of wound exudate
• Oxygen entry and water vapor escape
• Atraumatic removal
• Cosmetic covering

The action of perforating a silicone gel dressing further improves performance. To realise these improvements, manufacturers need to understand the following 5 factors that can maximise the effectiveness of a perforated wound dressing:

1. Open Areas

Accuracy in meeting design requirements of perforation in silicone gel wound dressings during the manufacturing process is vital in allowing wounds to heal at the required rate; this is achieved by ensuring that the perforation pattern reaches an open area of 17%-20%.

This percentage range allows exudate to be drawn away from the wound into the absorbent level, whilst maintaining moisture levels of the wound surface at the required rate for optimal healing.

2. Perforated Hole Size

Not only is the open area of the perforation pattern important, but manufacturers must also understand the importance of achieving precise cuts and consistent hole size in the perforation pattern. This is critical because it ensures that the exudate is removed, leaving the blood to carry on with the healing process.

To achieve this consistency in hole size, expert manufacturing tooling is used to cut each hole cleanly, removing debris to ensure the perforated product functions with 100% efficiency.

3. Pattern of Perforation

Consistency of quality throughout the wound dressing construction is important to ensure performance parameters are achieved. This is evident in the perforation pattern, which should feature a consistent pattern throughout all the dressing.

Keeping to this standard enables maximum yield and repeatability, guaranteeing that the same high level of performance is achieved with every individual wound dressing

4. Perforation Quality

Expert coaters for the wound dressing marketplace will always take into careful consideration the choice of carrier for the dressing, so as to avoid any complications or impinge on the ability to perforate the substrate, factors which would result in an inferior dressing.

Only through the use of the highest quality materials and through production in an ISO 14644 class 7 clean room environment will manufacturers be able to produce the highest medical grade dressings for the healthcare market.

5. Waste Removal

During the manufacturing process of precision perforation, it is vital that waste created by the perforation process is removed.

Any perforator should be able to remove 99%+ of all waste produced during the perforation process. This careful extraction minimises the risk of any waste ending up in the wound itself. This process also enables the perforated sections to remove exudate from the wound consistently.

Meeting Medical Grade Standards with Raleigh Coatings 

High quality raw materials, precision perforation and clean room coating & conversion environments are vital for superior silicone gel wound dressings. As market leaders in silicone gel coating, Raleigh Coatings are committed to the whole process, ensuring the final finished product delivered to customers meets the demanding specifications required.

For more information about the coating and conversion options that Raleigh can support you in, contact our team on 01785 850 357 or email our Business Development Manager, Julian Watkins.

Solving your coating challenge is our business

At Raleigh Coatings, we thrive on helping customers realise the potential of their most ambitious ideas.

Our technical team is trained and experienced in dealing with all enquiries, no matter how unusual they may seem and no matter what size the request.

Our customers come to us from a range of industries interested in our ability to produce exceptional quality coatings; including medical tape, graphic film and specialist labels.

However, our most exciting challenges come from novel coating ideas that need to be produced with completely new formats.

How we meet your bespoke coating requirements

Bespoke custom coating is our chance to really shine and defines us as industry leaders.

By utilising state-of-the-art technologies and unrivalled expertise, we are able to break down the complexities of the process; with the aim of making the coating understandable and goals achievable.

Starting with the initial enquiry, we will talk with you about your vision and end goals, understanding your needs and concerns. Then we take your concept and develop it through the expertise of our technical team in a specially equipped laboratory.

The construction is then trialled through a pilot line to test, inspect and adjust to achieve the right results. Following approval of the process, the product is then transferred and produced as a finished coated product on the main line.

The end result? The realisation that your innovative idea is now a reality.

New coating techniques are not just the only solutions we provide for our customers. Here’s a sample of questions that can help you decide if Raleigh Coatings is the match you’ve been looking for.

Do you only coat adhesives?

No, we can also coat with any solvent based coating. We also offer silicone gel coating services using our clean room based line.

I’m struggling with ideas for which substrates / carriers to use?

Simply talk to us. We are happy to help. We have a broad experience working with non-wovens, films (polyester, polypropylene, polyurethane) and a variety of papers. Using our experience with these materials we can help guide you through the selection process.

What if my substrate requires higher surface energy?

We have a vast experience with chemically treated films and can also corona treat inline onsite; both of which are used to promote adhesion to substrates.

What if my product requires coating in class 7 clean room environment?

Then you’re in luck. We have 2 clean room coating lines that meet the ISO 14644 class 7 requirements for both acrylic and silicone gel coating.

My product requires onward conversion / slitting, can you help?

Yes we can, by using our reel to reel slitting facilities. This means that we can take your jumbo rolls and cut them down to narrow width rolls.

Do you have further conversion services?

Yes, we also have partnerships with product conversion companies so that we can fully satisfy all your conversion needs.

How can you advise and assist with silicone gel coating for wound care products?

As the UK’s leading specialist in medical adhesive coatings, we have developed a strong expertise in exacting the conditions that silicone gel coating requires. We also have very strong relationships with key gel manufacturing suppliers that support our ability to provide accurate and specialist advice when it comes to wound care product coatings.

Do you only flood coat?

No, we also offer stripe coating of acrylic P.S.A.

Can I vary my coat weights?

Yes, we can flood coat from 10gsm – 100gsm in acrylic P.S.A and also from 50gsm – 500gsm in silicone gel.

Our commitment to providing solutions for your most complex coating requirements is evident not only in our approach, but our reputation as unrivalled technical experts in the field of custom coating. 

For further queries it may be helpful to visit our frequently asked question⁶ page, or contact our team by calling 01785 850 375 or email our Business Development Manager, Julian Watkins at [email protected].