What is the difference between denatured ethanol (IMS) & Isopropyl Alcohol (IPA)?
Both are equally effective disinfectants so the choice is down to other factors. IPA dries more rapidly, but has a strong acrid smell and a lower occupational exposure limit than IMS. However IMS has a sweeter smell that some users may find unpleasant.
What is IMS?
IMS stands for Industrial Methylated Spirit. This does not mean that is contains methanol. It is also known as denatured ethanol. It is ethanol denatured with recognised denaturants.
Is there a greater risk of product contamination from IMS than undenatured ethanol?
There are many different denaturants of ethanol. They are usually present in trace quantities which are unlikely to adversely affect product quality.
Why is the concentration of alcohol used for surface disinfection 70%?
70% has been recognised as the optimum concentration for disinfectant properties for at least 40 years.
When should I use Premier Klercide 70/30 made with WFI rather than with deionised water?
Pharmaceutical facilities that manufacture sterile injections usually require alcohol made with Water for Injection to remove any risk of endotoxin contamination. Other sterile units, with less direct product contact usually use alcohol made with deionised water.
What is the difference between filtered & sterile alcohol?
Kleralcohol is filtered to 0.2 microns to remove all viable micro-organisms from the fluid. Premier Klercide 70/30 is also filtered but it is then terminally sterilised by gamma irradiation to ensure the fluid and all packaging are free from viable micro-organisms including bacterial spores.
What is the in-use shelf life of Premier Klercide 70/30 alcohols?
Premier-WFI Klercide 70/30 and Premier Klercide 70/30 are fitted with the Sterishield Delivery System, which has been validated to ensure that the contents remain sterile for three months. A technical report detailing the work, which includes the results from trials conducted with liquid nutrient, is available on request.
Why should I buy Premier Klercide 70/30 Sterile Alcohol, when I can make it myself?
Historically most major pharmaceutical manufacturers have purchased concentrated alcohol for dilution with their own in-house sterile water or WFI (water for injection). On paper this is a cheaper option than buying in a ready to use product.
However, over the past few years the regulatory authorities have taken a closer interest in the in-house production of alcohol for disinfection. They have become more demanding in the level of QC and validation that they expect, including the following areas of concern:
The time, effort and staff costs involved in the monitoring and the production of in-house alcohol for disinfection are significant, yet often overlooked. When these indirect costs are taken into account then the purchase of a fully validated ready to use sterile alcohol is cost effective.
The buying in of a fully validated product enables the cleanroom operation to concentrate on the core business, which can often increase capacity.
I find your 1 litre trigger spray bottles heavy to hold. Do you have an alternative?
Alcohol is also available in 4 litre containers fitted with the SteriShield Delivery System, with a remote trigger spray. This means there is no weight in the hand and the product remains sterile during use for at least 3 months.
Alternatively, Premier Klercide 70/30 sterile alcohols are also available in 500 ml bottles with the SteriShield Delivery System.
What is the length of tube on the 4 litre sprays?
The 4 litre trigger sprays have a tube length of 1 metre between the bottle and the trigger.
Are any of your biocides sporicidal?
Yes, Klercide-CR Biocide B, Biocide E and Biocide S are sporicidal in all their forms. Premier Klercide-CR Biocide C also offers some sporicidal activity and is free from residues. Tests have been carried out to demonstrate sporicidal efficacy. For a copy of the technical reports please contact us.
What are the active ingredients in each biocide?
Which biocides can I use with a mop and bucket system?
All of the concentrated biocides can be diluted for use with a mop and bucket system. For ease of use Klercide-CR Biocide X, Biocide Y, Biocide S and Biocide T have been specifically designed as convenient unit dose concentrates. These dilute in water of suitable quality, for use with mopping systems.
What is the dilution protocol for Klercide-CR Concentrates?
Klercide-CR Biocide A, Biocide B and Biocide D concentrates should be diluted 1 part concentrate to 3 parts water. A 5 litre container will make up to 20 litres of dilute biocide, which will be sufficient for most large cleanrooms.
What do you dilute Klercide-CR biocides with?
These products should be diluted with water of a suitable quality for the cleanroom environment. The water selection is usually one of the following:
Tap water is unlikely to be of a suitable quality for most cleanrooms and is not recommended.
Can I dilute the Klercide-CR biocide concentrates with hot water?
It is recommended that the biocides are diluted with water at room temperature. At extremes of hot and cold, the performance of the biocides has not been tested. Klercide-CR Biocide X and Biocide Y have been successfully diluted in water at 70 degrees centigrade with no adverse reactions observed.
Do your products contain anti-foaming agents?
Do I need to rinse off the biocides after the contact time?
Almost all biocides leave some degree of residue. For product contact surfaces it is best practice to wipe the area with alcohol or water of suitable quality to ensure complete removal, following the contact time.
'Shield Medicare offers a range of low residue biocides blended with Water for Injection. They are efficacious at very low concentrations, ensuring minimal residues are left. For further information, please see Premier-WFI Klercide-CR Sterile Biocide C and Permier-WFI Klercide-CR Sterile Biocide F.
How can I test a surface for biocide residues?
The tester needs to swab the surface with a suitable swab and then send this to a laboratory equipped with HPLC and GCMS equipment.
The laboratory will rinse the swab and concentrate the liquid in order to try to find a trace of the relevant chemical. If the surface has been rinsed and wiped the tester may be looking for parts per billion. Details of the traces for our biocides are contained in the relevant technical file.
What is the contact time?
The recommended minimum contact time required for all Klercide-CR Biocides is 5 minutes.
What can I use in place of aldehydes or sodium hypochlorite (bleach)?
These are very effective products, which are usually used to provide sporicidal activity. They can be replaced with Klercide-CR Biocide B, which is an excellent sporicide, non-toxic and non-corrosive. Klercide-CR Biocide B is available in a range of sterile and cleanroom presentations.
How often should I rotate the biocides?
There is no recommended timescale for rotation of biocides. No studies have been completed to prove rotation is necessary or to show which is the optimum rotation protocol. However many major customers rotate their biocides monthly. Our sales team will be pleased to help you determine what is best for your facility.
How often should I use a sporicidal agent?
Klercide-CR Biocide B and Biocide C are non-corrosive and non-toxic and so can be used as often as required. If bacterial spores are a regular problem, Klercide-CR Biocide B should be used routinely. If bacterial spores are an occasional problem, Klercide-CR Biocide B, Biocide E or Biocide S can be used as a corrective action.
What biocides can I use on my flexible film isolator?
Generally manufacturers of flexible film isolators say that alcohol should not be used to clean the plastic walls as it will reduce the life of the material. However, our biocides Klercide-CR Biocide A and Biocide B and Premier Klerclean neutral detergent can be used. Application is to spray onto the surface and wipe off after a few minutes. The Klercide Isolator Cleaning Tool can help to ensure the surfaces are effectively wiped.
For how long can I store Klercide-CR Biocide X and Y following dilution?
Klercide-CR Biocides X and Y are designed for single use only, with the contents of each 50 ml bottle being diluted to 5 litres. It is good practice to use the solution immediately to avoid any risk of contamination and to discard any remaining liquid at the end of each day.
Where this is not convenient, storage should be in a sealed container and its shelf life checked by appropriate validation work.
Do I need to rinse off the detergent after use?
Yes. Some bacteria are known to thrive in detergents. It is for this reason that we supply sterile Klerclean. Also detergents can interfere with the action of biocides reducing their efficacy.
How can I effectively clean my Isolator or laminar flow cabinet?
The Isolator Cleaning Tool is specifically designed to reach difficult areas of these cabinets. It is supplied sterile and is suitable for autoclaving. The individual cleaning pads are cleanroom packed, double bagged & gamma irradiated. Two forms of the pads exist, a 100% polyester version for the highest specification units, and a low particulate product.
What types of sterile disposable Mopheads are available?
There are two versions; a 100% polyester mophead for the highest specification cleanrooms & a low particulate product, which is suitable for use in cleanrooms up to Grade B (ISO Class 5).
How do I choose between a double or triple bucket system?
The choice will depend on the individual cleanroom environment, however the following points will help with the selection.:
Can the Cleaning Systems be autoclaved?
The double & triple bucket systems are completely autoclavable. The only exceptions are the sterile disposable mopheads and the sterile disposable mophead covers which are designed for single use only.
What is the best option when there is limited storage space?
Consider using Klerwipe Sterile Impregnated Mop Wipes. These convenient wipes are for use with the Klercide Autoclavable Mop Wipe Frames and they eliminate the need for a bucket system, concentrates and water. They are available impregnated with Alcohol, Biocides or Neutral Detergent for efficient cleaning of large surface areas.
Alternatively, the Klercide Cleaning System includes tailor made formats to suit the available space. For instance triple bucket systems can be supplied without the large handle & extra top buckets, so the trolley can fit under a worksurface. Alternatively, separate buckets & a simple wringer can replace the trolley completely when storage space is very limited.
When should I use a 100% polyester wipe rather than a low particulate wipe?
Lint free wipes are manufactured from 100% continuous knit polyester and the edges are laser sealed. These wipes are designed for use in the highest classification cleanrooms, such as Grade B (ISO Class 5) or better.
Low particulate wipes are made from a polyester/cellulose blend and are suitable for most cleanrooms, up to Grade B (ISO Class 5).
When should I use an impregnated wipe rather than a dry wipe?
Wipes impregnated with alcohol or biocides are particularly useful where there is a need to disrupt the surface biofilm, or when it is important to avoid introducing liquid spray into the air surrounding a critical product filling point. The impregnated wipe also avoids the need to use a spray and dry wipe, which can be difficult to manipulate and time consuming during transfer disinfection procedures.
Do you produce special sizes of wipes?
In addition to the standard range of wipes in our catalogue, we also supply wipes to specific sizes required by our customers. Please contact us about any special wipe requirements you may have.
How are your sterile Klerwipes packed?
The standard range of dry wipes is sold in packs of 100, supplied in 10 double bagged packs containing 10 wipes. This reduces wastage and minimises the risk of cross contamination.
When would I use wipes packed in VHP (vapourised hydrogen peroxide) impermeable packaging?
The reason for the special packaging is to reduce the aeration time required to remove all the vapour from a gassing isolator after a VHP gassing phase. It has been found that with the standard plastic packaging of wipes, a double evacuation cycle of the Isolator is required to remove all of the vapourised hydrogen peroxide. This is necessary as in some cases traces of hydrogen peroxide can have a detrimental effect on pharmaceutical products. Using the VHP impermeable packaging means only a single cycle is required to evacuate the gas. This saves a lot of time and money by improving the manufacturing efficiency. Other products can also be provided in VHP impermeable packaging. Please contact us for details.
What syringes can I have in Klerpacks?
The standard range of Klerpacks contains BD Luer Lok tipped syringes, since these are universally validated for use with syringe drivers. Other syringes, such as Sherwood can be supplied if required.
What pack sizes do the Klerpack Syringe Multi-packs come in?
In order to meet a wide range of customer needs, there are packs of 5, 10, 25 and 50 syringes. Each pack is supplied double bagged and gamma irradiated, in case quantities of 10 packs.
What other items can you pack into sterile Multi-packs?
In addition to syringes, we can supply a wide range of items such as needles, syringe hubs and chemo dispense pins.
Can you produce customised procedure packs?
We can produce customised packs containing a wide range of items to suit your specific requirements. We have considerable experience in sourcing items for such packs. Alternatively, we can work with free issued materials to produce the Klerpacks exactly to your specifications.
How will your Klerpacks be affected by VHP (Vapourised Hydrogen Peroxide) gassing systems used in many isolators?
Klerpacks are also available in foil packs, which are resistant to VHP. These packs are designed to be hung in the gassing isolator, and the absence of paper means aeration times can be reduced.
Do Klerpacks help reduce the extra time taken to wipe items before transferring them into an isolator or laminar flow cabinet?
Klerpacks are ideally suited to situations where transfer disinfection involves wiping as opposed to spraying only. As the inner bag is completely sterile non-contact transfer can be used, or where procedures demand, the bag can be wiped easily. This will save a considerable amount of technician time compared with wiping individual items.
Do the BD syringes contain latex?
No, they are completely latex free.
What chemicals are your latex, nitrile & vinyl gloves resistant to?
We have resistant charts for the most commonly used chemicals. In addition, we have information about less common compounds. Please contact Customer Services for further details.
In principle, nitrile gloves offer better overall protection and especially to agents that are cytotoxic.
Which glove should I use in each area?
Our range of gloves is clearly divided into different specifications, to suit the classification of each area. Sterile cleanroom gloves are for use in the most critical areas, especially where aseptic processing is taking place. Cleanroom gloves are suitable for most cleanrooms up to Grade B (ISO Class 5). Non-critical gloves are widely used in the lowest cleanroom grades or non-cleanroom environments.
Which are the best; nitrile or latex gloves?
The choice will depend on many factors, especially operator comfort. Latex gloves are generally easier to don and provide a much better fit. Nitrile gloves are usually chosen where there are problems associated with latex allergy or there is the need for better chemical resistance.
What length of gloves do you supply?
Sterile gloves are available in 300 mm and 375 mm sizes, where the longer cuff length prevents exposure of the critical wrist area. Non critical area gloves are either 255 mm or 300 mm long.
Do you supply other gloves outside the range shown in the catalogue?
Yes, we have developed specialist gloves to meet particular customer requirements. Please contact Customer Services with details of the specification you need.
When should I use a disposable tacky mat?
Tacky mats with 30 tear off sticky surfaces are most suitable for areas with low traffic, where the need to change is low. In most busy cleanroom environments it is more cost effective to use Dycem flooring, which can be cleaned at a frequency to suit your needs.
Which are more cost effective; Dycem Flooring or disposable tacky mats?
Dycem flooring is up to seven times more cost effective than disposable tacky mats. The initial outlay looks expensive but over the life of the mats the low cleaning and maintenance costs win through compared with disposable tacky mats.
This cost advantage is particularly important when the comparative performances are taken into account. There are several published studies that demonstrate Dycem flooring is up to seven times more effective than disposable tacky mats.
Is the higher tack level of a peel off mat an advantage?
Contamination on your feet and the wheels of trolleys is in layers and of varying sizes requiring multiple steps (at least 3 on a tack surface for 100% removal. Thus, as long as the tack level of the mat is greater than the donor (foot) the contamination touching the surface is removed. Very high tack surfaces are often avoided because they are uncomfortable and pull off over-shoes.
Doesn't cleaning Dycem flooring take longer than pulling a sheet from a peel off mat?
A properly designed Dycem flooring system is cleaned when the regular maintenance is scheduled. "Correctly" peeling an adhesive mat, only 4" at a time, from each corner rolled inward and bagging it in the middle, is slow and rarely done.
What special cleaners, rejuvenating chemicals and equipment are need to clean Dycem flooring?
Dycem can be cleaned with most detergents and bactericidal cleaners. Klercide 70/30 Alcohols and Klercide-CR Biocides are all suitable for use on Dycem flooring. Please check with us before using other cleaners.
Simply damp mop the floor and squeegee dry and the Dycem flooring is ready for immediate use. The minimal amount of liquid (damp mopping) followed by immediate drying with a squeegee allows you to clean part of a room or hallway without ever shutting down the area. We can provide specially designed cleanroom mops and a new specifically designed wet and dry vacuum cleaner.
How does Dycem work?
The unique Dycem polymer material has a naturally high tack, which along with its extremely smooth and flexible surface combine to offer the most effective properties for removing contamination from feet and wheels.
Can I use adhesive peel off mats along with Dycem flooring Clean-Zone to make a system even more effective?
Adhesive peel-off mats often have adhesive carry over. The adhesive is transferred from your feet to the Clean-Zone surface, making the cleaning process more difficult. Thankfully adhesive deposited on Dycem Clean-Zone does not reach the critical area. Since Dycem has been proven to remove more contamination on every step than peel-off mats, it is better to extend the length of the Clean-Zone to ensure 100% contamination removal.
What sort of contract manufacturing can you perform?
Shield Medicare has the capability to cleanroom manufacture liquid product as well as dry goods. This includes medical device assembly & packing and the production of contamination control products. To check if we can meet your requirements, please contact Sarah Anning at firstname.lastname@example.org.
Can you CE mark medical devices?
We offer the facility to produce the necessary design files to obtain the CE mark, prior to manufacture. We have the necessary ISO9001, BS EN ISO13485 & MDD93/42/EEC to be able to CE mark these products.
How quickly can you take on a new contract manufactured product?
In many cases we have to respond very rapidly to meet our customers' needs. For this reason we have developed systems that enable us to specify all the requirements of the job at the same time as we prepare a quotation for the work. Experience has shown that this can avoid unnecessary delays later on.
Can we audit your facilities to ensure they are suitable for our work?
We actively encourage our customers and potential customers to visit our facility in South Wales to perform audits to suit their needs. Indeed we expect most contract customers will want to visit at the earliest opportunity.
How long will my order take to arrive?
We try to maintain at least two weeks stock of all our main catalogue lines. For this reason we are able to meet most of the new or urgent requirements we receive.
UK Customers - Delivery is normally within 3 days from receipt of order. Where items will take longer than this our Customer Services Department will keep you informed of the expected delivery date.
International Customers - Our distributors normally hold sufficient stock locally to meet expected demands. For this reason they are able to offer a similar level of service in most cases. Please contact your local distributor, or our Customer Services Department to check delivery dates for any particular product.
What certification comes with the Cleanroom Contamination Control Products?
The Klercide range of Alcohols & Biocides comes with a Certificate of Analysis as standard. Certificates of Irradiation & Sterility are also provided when required. Certification for other products is supplied to meet particular customer specifications.
What if there is a problem with my order?
We make every effort to ensure orders are correctly delivered, on time. If there is any difficulty with an order please contact Customer Services who will resolve the matter promptly.
For invoicing queries please contact the Accounts Department.
© Shield Medicare 2008