FAQs

[Photograph: Washing]
Our specialist technicians have the experience and know-how to think their way through even the most challenging applications.

Frequently Asked Questions

We've listed some of the questions our potential and existing customers most often ask us. If you have a question that isn't covered here, please don't hesitate to contact us and we'll do our best to answer it.

  1. What is a cleanroom and why do I need to have my product packed in one? A cleanroom is an enclosed space in which the concentration of airborne particulate matter is controlled at specific limits, thus ensuring a precisely controlled (and clean) environment with minimal levels of environmental contaminants, such as dust and airborne microbes. Products processed within a cleanroom environment are therefore subject to the minimum risk of contamination (bioburden). Medical devices, and any product marketed as sterile, should be packed in a cleanroom of the correct classification. Cleanrooms are classified according to the number of particles per volume of air.
  2. Do I need to have my products washed? Many medical devices need to be washed before packing to remove any manufacturing dirt and to ensure that any contamination (bioburden) is reduced and the product is clean. Current HTM Best Practice Guidelines (including HTM 2030 and 01-05) recommend cleaning by thermal washing and disinfection.
  3. What is the difference between washing or thermal disinfection and ultrasonic cleaning? At Granton®, we have state-of-the-art facilities for ultrasonic cleaning as well as washing and thermal disinfection. Ultrasonic cleaning and washing or thermal disinfection are two different processes. Let's take ultrasonic cleaning first. This process is designed to remove manufacturing dirt and debris and to achieve a clean product. Typically, the ultrasonic cleaning process involves placing the product in an ultrasonic tank containing a suitable enzyme detergent cleaner. Ultrasonic cleaning uses high-frequency sound waves. After this process, the product is then rinsed and dried. Using this process may be suitable in certain circumstances, but it has many variables for example, is the tank temperature maintained at the optimum level to suit the detergent? How long do you leave the product in for? Is the rinse water clean? Am I leaving any residue on the instrument which might have an effect on the sterilization process? Is the process validated? It should also be noted that ultrasonic cleaners are not designed for disinfection; they are only designed to remove dirt and debris. Washing and thermal disinfection is a very different process offering its own benefits. Products cleaned in a washer-disinfector unit are subjected to a pre-programmed cycle. Typically, this cycle consists of a pre-wash stage where the instruments are continually sprayed with clean water, followed by a main wash stage using a solution of water and detergent. This is then followed by a final rinse stage where the product is rinsed with RO (Reverse Osmosis) water to eliminate the presence of bacteria and endotoxins. RO water is water that has been filtered many times and contains zero contaminants. To avoid re-contamination during the final rinse cycle, washed product must be rinsed with RO water. Finally, thermal disinfection then takes place where the temperature is raised to between 80°C and 90°C. There is then a final drying cycle. There are many benefits to washing and thermal disinfection as opposed to ultrasonic cleaning. Firstly, the process can be fully validated: our washer-disinfectors are independently validated to HTM 2030. Secondly, the process is recordable: our washer-disinfector units are fitted with a printer providing each batch of product with proof of a successful process. Thirdly, the process is repeatable: with correctly maintained and loaded units, the process achieves consistent results and, as the units are automatic and pre-programmed, human intervention is kept to a minimum. Fourthly, during the wash and thermal disinfection process, the product is both disinfected (which, as we've noted above, isn't true of ultrasonic cleaning) and rinsed with RO water, thereby ensuring zero residue is left on the product. Finally, and perhaps most importantly, washing and thermal disinfection is considered to be Best Practice. Current HTM Guidelines (including HTM 2030 and 01-05) recommend the use of thermal washing and disinfection. As we are all aware, in the healthcare arena, Best Practice provisions must be adhered to wherever reasonably practicable. By subjecting your product to washing and thermal disinfection, you are both complying with Best Practice and providing yourself with the peace of mind that you’ve done all you reasonably can to make sure your product is as clean as it possibly can be. This means that patients coming into contact with your product are exposed to the smallest possible risk of infection.
  4. Does my product need to be single or double packed?The usual rule of thumb here is to ask yourself if the product is going to be used within a hospital operating theatre. If it is, then it's normal to double pack the product. If you are unsure, we are happy to help and our technicians will be able to guide you through the process of pack design.
  5. How do I decide which method of sterilisation to use on my product?Sterility is a critical issue, so when dealing with the process of sterilisation it is important to work with an experienced, knowledgeable and skilled partner. We have many years of experience in this field and we can advise and assist you in selecting the best possible method of sterilisation for your product. The most common methods of sterilisation used for single-use medical devices are Gamma Radiation and Ethylene Oxide gas (EtO), although other methods (such as Steam or E-Beam) are available.When helping our customers decide on the optimal method of sterilisation, we will consider a range of factors. For example, what type of material the product is produced from - some plastics, for instance, discolour and go brittle after the Gamma process. Product and batch quantity will also have a bearing - the EtO process, for example, tends to be more suitable for pallet loads of product and/or bulky items, but the initial validations may be more expensive for EtO than for Gamma.We can outline the options available to you during our initial discussions.
  6. In the initial stages my volume will be quite small. Does this matter?No, we’re here to help you any way we can. We can literally pack as few as 10 items, if required. Each order is matched to your specific needs, and some of our biggest customers started with small quantities.
  7. How long will the process take?Our turnaround time can be as little as 7 days once all the process route and regulatory systems are in place. Lead times on initial orders can vary depending on the design of the pack and what, if any, validations are required prior to product launch.
  8. What can we pack?Our Cleanline service can be tailored to suit your needs. Typical situations catered for include: Size - from screws and burrs to implants and instruments. Material - from metals and plastics to dressings and soft products. Content - from single instruments to procedure packs and tray assemblies. Volume - from one offs to high volume runs. Customers - from small local businesses to multinational corporations.
 
Our work conforms to: ISO Class 7 (incorporating Class 5 zones), ISO 13485:2003, ISO 9001:2008