New range of sterile and filtered cleanroom disinfectants

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Timothy Lucas
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1 New range of sterile and filtered cleanroom disinfectants

Technical expertise, extensive processing capability and a well-deserved reputation for innovation, proven by awards from the cleanroom industry.

Fully accredited BS EN ISO 9001:2000 and BS EN ISO 13485:2003 accredited and holds the Medical Device Directive 93/42/EEC for the design, manufacture and distribution of

Regularly audited by the major pharmaceutical companies, who themselves have GMP accreditation.

2 Shield Medicare Company Profile Shield Medicare is a market leader in the supply of specialist contamination control products to pharmaceutical, biotechnology, healthcare and medical device industries worldwide. Experienced cgmp manufacturer 15 years experience of high quality cleanroom manufacture to cgmp standards. Technical expertise, extensive processing capability and a well-deserved reputation for innovation, proven by awards from the cleanroom industry. Operation of Grade C cleanrooms and Grade B aseptic suites. Fully accredited BS EN ISO 9001:2000 and BS EN ISO 13485:2003 accredited and holds the Medical Device Directive 93/42/EEC for the design, manufacture and distribution of sterile and non-sterile cleanroom products. Working towards 98/8/EC Biocidal Product Directive. Regularly audited by the major pharmaceutical companies, who themselves have GMP accreditation. Any customer is welcome to visit the sterile manufacturing facilities to carry out a supplier audit. Technical support available Specialist testing and quality laboratories operating to the principles of Good Laboratory Practice. Expertise and high levels of technical support through all stages of the specification and validation process. Product range available across the world through a network of carefully appointed distributors. Shield Medicare is a division of

Preventing Spore Contamination from Disinfectants Preserving cleanroom integrity demands the safe delivery of disinfectants, something often overlooked when using sterile disinfectants.

With a conventional trigger spray, contaminated air can be sucked back into the bottle, contaminating the liquid.

3 Preventing Spore Contamination from Disinfectants Preserving cleanroom integrity demands the safe delivery of disinfectants, something often overlooked when using sterile disinfectants. There are advantages to using trigger sprays to apply disinfectants, but not all trigger sprays protect the sterility of the contents. With a conventional trigger spray, contaminated air can be sucked back into the bottle, contaminating the liquid. The patented SteriShield Delivery System solves this problem because it operates as a closed system, preventing air being drawn back into the bottle and so eliminating the possibility of contaminating the liquid. The liquid is held inside a medical grade bag and all points of entry into the bag, including the dip-tube, are completely sealed. The system allows all the liquid to be dispensed from the bottle so there is no wastage. The adjustable trigger nozzle allows the liquid to be dispensed as a jet or a spray for optimum surface coverage. The system has been independently and rigorously validated to give an in-use shelf life of three months, so unused product does not need to be discarded. Full validation test data is available in technical report TR0403R. A product using the SteriShield Delivery System is designated by Validation work in the licensed pharmacy unit of the Queen Elizabeth Hospital in Birmingham, UK, identified that a standard trigger spray alcohol had been contaminated with fungal spores only eight hours after opening. Contamination Control at Your Fingertips, Pharmaceutical Manufacturing International, Autumn 1999

Selecting the right disinfectants Whichever disinfectants you select for your contamination control regime, they must be able to maintain the low levels of microbial contamination predefined for each

Many disinfectants have a broad spectrum of activity, especially against bacteria, but most are not effective against spores, so choosing the right sporicide is particularly important.

4 Selecting the right disinfectants Whichever disinfectants you select for your contamination control regime, they must be able to maintain the low levels of microbial contamination predefined for each class of cleanroom, according to EU standards. Many disinfectants have a broad spectrum of activity, especially against bacteria, but most are not effective against spores, so choosing the right sporicide is particularly important. Some disinfectants are so aggressive that they are harmful to health or equipment and unpleasant for operators to use. Shield Medicare disinfectants (biocides) are safe to use, effective and fast acting. They are compatible with alcohols, offering a wide range of options for rotation to meet each cleanroom s individual requirements. Standard best practice of a disinfect, wipe and rinse routine should always be used and note should be taken of the safety datasheet which gives conditions and chemicals to avoid for each product. Recommended limits for microbial contamination* Settle Plates Contact Plates Glove Print Air Sample (diam. 90 mm). (diam. 55 mm). 5 fingers Grade cfu/m 3 cfu/4 hours cfu/plate cfu/glove A < 1 < 1 < 1 < 1 B C D cgmp states that Disinfectants used in Grade A and B areas should be sterile prior to use. * Eudralex Vol 4 Good Manufacturing Practice, Annex 1: Manufacture of sterile medicinal products

How to choose disinfectants Every application has different requirements, so consider: What grade of cleanroom you

Which organisms are a problem, based on your environmental test results.

Whether a sporicide should be part of the rotational regime or for occasional action point use only.

Whether residues are acceptable. The safety of the disinfectant, eg toxic or corrosive.

5 How to choose disinfectants Every application has different requirements, so consider: What grade of cleanroom you are operating and therefore what microbial reduction is required. Which organisms are a problem, based on your environmental test results. Rotation of disinfectants to ensure all organism types are removed and to eliminate any risk of resistance. Whether a sporicide should be part of the rotational regime or for occasional action point use only. Contact time required to achieve desired kill and whether you can afford significant production down-time. Whether residues are acceptable. The safety of the disinfectant, eg toxic or corrosive. Whether the disinfectant is certified sterile and whether the disinfectant will remain sterile during use. Range of formats available, for example ready-to-use fluids, concentrate, impregnated wipes, mopping systems. Convenience and time taken to dilute concentrate solutions.

Advantages of Biocides Broad spectrum efficacy with sporicidal activity Fast acting, high quality disinfectants for cleanrooms and critical areas.

Safe and effective Shield Medicare biocides are all non-toxic and non-corrosive under normal use, so they can be used safely in most cleanroom environments.

Double bagged for easy transfer. Guaranteed spore free All sterile biocides, except Biocide S and Biocide T, are filtered to 0.

Helpful validation documentation A comprehensive technical file is available for each biocide, to shorten the validation process.

6 Advantages of Biocides Broad spectrum efficacy with sporicidal activity Fast acting, high quality disinfectants for cleanrooms and critical areas. The range will effectively control all types of microbial contamination, including troublesome spores. CEN and isolate tested Comprehensive test data is available. Safe and effective Shield Medicare biocides are all non-toxic and non-corrosive under normal use, so they can be used safely in most cleanroom environments. Ideal for a rotational regime Tested for compatibility, so no need for additional testing. Suitable for Grade A and B areas Cleanroom processed and sterile. Double bagged for easy transfer. Guaranteed spore free All sterile biocides, except Biocide S and Biocide T, are filtered to 0.2 micron and all are either gamma irradiated or aseptically processed to a validated procedure. Helpful validation documentation A comprehensive technical file is available for each biocide, to shorten the validation process. Range of presentations for ease of use The biocides are available in a range of formats to suit different applications, including trigger sprays, concentrates and impregnated wipes. Unique SteriShield Delivery System All trigger sprays incorporate Shield Medicare s unique SteriShield Delivery System, which ensures the contents remain sterile throughout use. Cleanroom friendly packaging The packaging materials are low particulate and are easy to spray and wipe for efficient transfer into clean areas.

Broad Spectrum Biocides Shield Medicare offers a unique range of broad spectrum biocides in a variety of ready-to-use or concentrate formats, including impregnated wipes.

Premier Klercide-CR Biocide X is a unit dose concentrate of the same formulation, to conveniently make up 5 litres of ready-touse product and reduce the risk of dilution errors.

Premier Klercide-CR Biocide D is a sterile amphoteric surfactant in a 1 litre trigger spray, 5 litre ready-to-use or 5 litre concentrate.

Biocide Y is available sterile or filtered. These four biocides are fully compatible with each other and suitable for rotation with alcohol. They are 0.

Premier Klercide-CR Biocide T is a sterile unit dose concentrate containing glucoprotamin, a unique chemical formulation that is especially effective against bacteria.

It is packaged in a Grade D (ISO Class 8) cleanroom in aluminium laminated polyethylene sachets which are double bagged and then gamma irradiated. It has a 2 year shelf life.

7 Broad Spectrum Biocides Shield Medicare offers a unique range of broad spectrum biocides in a variety of ready-to-use or concentrate formats, including impregnated wipes. Premier Klercide-CR Biocide A is a blend of a quaternary ammonium compound and a biguanide in a 1 litre trigger spray, 5 litre ready-to-use or 5 litre concentrate. Premier Klercide-CR Biocide X is a unit dose concentrate of the same formulation, to conveniently make up 5 litres of ready-touse product and reduce the risk of dilution errors. Both products are available sterile or filtered. Premier Klercide-CR Biocide D is a sterile amphoteric surfactant in a 1 litre trigger spray, 5 litre ready-to-use or 5 litre concentrate. Premier Klercide-CR Biocide Y is a unit dose concentrate of the same formulation, to conveniently make up 5 litres of ready-to-use product and reduce the risk of dilution errors. Biocide Y is available sterile or filtered. These four biocides are fully compatible with each other and suitable for rotation with alcohol. They are 0.2 micron filtered, filled and double bagged in a Grade C (ISO Class 7) cleanroom. For sterile product, the bottles are then gamma irradiated. They have a 2 year shelf life. Premier Klercide-CR Biocide T is a sterile unit dose concentrate containing glucoprotamin, a unique chemical formulation that is especially effective against bacteria. It makes up 8 litres of ready-to-use product and reduces the risk of dilution errors. It is packaged in a Grade D (ISO Class 8) cleanroom in aluminium laminated polyethylene sachets which are double bagged and then gamma irradiated. It has a 2 year shelf life. Suggested cleaning and disinfection regime Frequently, use neutral detergent to clean the area followed by alcohol to disinfect. Regularly, use a rotation of broad spectrum disinfectants If a specific spore problem is identified: use Biocide B or E to remove spores. The success of any contamination control regime is dependent on a range of environmental and operational factors and every facility must validate its own procedures to ensure it is meeting the cgmp guidelines for microbial limits, making adjustments as necessary.

Effective Sporicides One of the most difficult requirements in a life science cleanroom is the control of bacterial spores, which are particularly difficult to kill because they can lie dormant for

The study also showed that if the transfer disinfection procedure employed comprised of spraying solely with alcohol, only 27.

8 Effective Sporicides One of the most difficult requirements in a life science cleanroom is the control of bacterial spores, which are particularly difficult to kill because they can lie dormant for long periods. Spores can enter the cleanroom on people and on components at a surprisingly high rate. Research has shown that around 40% of consumables are contaminated with bacterial spores. The study also showed that if the transfer disinfection procedure employed comprised of spraying solely with alcohol, only 27.6% of the spores would be removed, so the regular use of a sporicide should be strongly considered. Alcohol does not kill spores Shield Medicare can offer a range of sporicidal disinfectants suitable for all areas of the cleanroom and to meet different sporicidal needs. They are excellent for routine spore prevention, or the more powerful sporicides, Biocide B and E, are suitable for action point use to remove troublesome spores. Features of Shield Medicare sporicides: Proven efficacy against a wide range of spores. Passes standard CEN tests for sporicidal activity - comprehensive test data is available. Short contact time (5-15 mins) even in conditions of heavy soiling. Non-toxic and non-corrosive under normal use. Premier Klercide-CR Biocide B is a broad spectrum disinfectant with excellent sporicidal activity. It is a unique blend of a stabilised chlorine dioxide and a quaternary ammonium compound. It is safe and pleasant to use and due to its faint odour it has high operator acceptance. It is 0.2 micron sterile filtered and double bagged under laminar flow in a Grade B (ISO Class 5) cleanroom. It is also available non-sterile, filtered to 0.2 micron in a Grade C (ISO Class 7) cleanroom and double bagged. 1 year shelf life for ready-to-use, 9 months for concentrate. Premier Klercide-CR Biocide B is available in a range of formats so is ideal for use in all areas of the cleanroom, including a ready to use trigger spray, concentrate solution for bucket systems, impregnated pouch wipes, or mop wipes.

Effective Sporicides Premier-WFI Klercide-CR Biocide C is a 6% spray grade hydrogen peroxide solution blended with Water for Injection, specifically designed for areas where a low level, safe

It is available in a 1 litre trigger spray and 5 litre ready-to-use, triple bagged for the highest grade areas.

2 micron sterile filtered in a Grade B (ISO class 5) cleanroom and have a 1 year shelf life.

9 Effective Sporicides Premier-WFI Klercide-CR Biocide C is a 6% spray grade hydrogen peroxide solution blended with Water for Injection, specifically designed for areas where a low level, safe sporicide with very low residues is required. Endotoxin levels are guaranteed to be below 0.25 EU/ml, making this sporicide ideal for product contact areas, isolators and RABS. It is available in a 1 litre trigger spray and 5 litre ready-to-use, triple bagged for the highest grade areas. Alternatively it is available blended with deionised water, Premier Klercide-CR Biocide C, in a 1 litre trigger spray and 5 litre ready-to-use, double bagged. Both products are 0.2 micron sterile filtered in a Grade B (ISO class 5) cleanroom and have a 1 year shelf life. Premier Klercide-CR Biocide E is an effective ready to use sporicide, a sodium hypochlorite solution providing 0.5% available chlorine. Particularly suitable where high level sporicidal activity is required at short contact times, it is available in a 1 litre trigger spray or 5 litre ready to use. It is 0.2 micron filtered, filled and double bagged in a Grade C (ISO Class 7) cleanroom before gamma irradiation. It has a 2 year shelf life. Premier Klercide-CR Biocide S is a unit dose concentrate, also based on 0.5% available chlorine, supplied in tablet form for safety and ease of handling. The concentrate consists of a pot of 17 tablets of sodium dichloroisocyanurate (NaDCC) in an effervescent base, which form a solution containing 0.5% (5000 ppm) available chlorine when diluted in 10 litres of water. Each tablet contains 5 g NaDCC in a total tablet weight of 10 g. Each pot of tablets is double bagged in a Grade D (ISO Class 8) cleanroom and gamma irradiated. It has a 2 year shelf life. Validation All products are supplied by a BS EN ISO 9001:2000, BS EN ISO 13485:2003 and European Medical Device Directive 93/42/EEC accredited company. Certificates of analysis, irradiation and sterility (as appropriate) available with every batch. Sterility tested to an approved pharmacopoeial method. Full supporting documentation available for all biocides.

Efficacy of Biocides Efficacy against a selection of organisms typically found in a pharmaceutical cleanroom* Biocide A/X Biocide B Biocide C Biocide D/Y Biocide E/S Biocide T Spores No Efficacy Good

niger Bacillus subtilis Bacteria Good Good Good Good Good Good Clostridium botulinium Clostridium perfringens Corynebacterium species Enterococcus faecium Enterococcus hirae Escherichia coli Gemella

Salmonella choleraesuis Salmonella entiritidis Serratia liquefaciens Serratia marcescens Staphylococcus aureus Staphylococcus capitis Staphylococcus epidermidis Staphylococcus hominis Staphylococcus

10 Efficacy of Biocides Efficacy against a selection of organisms typically found in a pharmaceutical cleanroom* Biocide A/X Biocide B Biocide C Biocide D/Y Biocide E/S Biocide T Spores No Efficacy Good Fair No Efficacy Good No Efficacy Bacillus cereus Bacillus coagulans Bacillus licheniformis Bacillus pumilis Bacillus sphaericus Bacillus subtilis var.niger Bacillus subtilis Bacteria Good Good Good Good Good Good Clostridium botulinium Clostridium perfringens Corynebacterium species Enterococcus faecium Enterococcus hirae Escherichia coli Gemella morbillorum Klebsiella pneumoniae Kytococcus sendentarius Listeria monocytogenes Micrococcus luteus Mycobacterium smegmatis Mycobacterium tuberculosis Proteus mirabilis Pseudomonas aeruginosa Salmonella choleraesuis Salmonella entiritidis Serratia liquefaciens Serratia marcescens Staphylococcus aureus Staphylococcus capitis Staphylococcus epidermidis Staphylococcus hominis Staphylococcus simulans Vancomycin res. Enterococci Fungi Fair Fair Fair Fair Good Fair Absidia corymbifera Aspergillus fumigatus Aspergillus niger Candida albicans Cladiosporium cladosporioides Mucor racemosum Penicillium compactum Penicillium expansum Penicillium notamum Saccharomyces rouxii Tricophyton interdigitale Viruses Fair Good Good Fair Good Fair Hepatitis B Herpes HSV-2 HIV Hong Kong Virus 68 Influenza A2 Poliovirus Rhinovirus * This is not an exhaustive list, but gives an indication of efficacy against different organism types. Each institution must validate a disinfectant to ensure efficacy against its specific wild isolates. Key Results from EN1040, EN1276, EN1650, EN13704, EN13697 and Shield Medicare Hard Surface Test Results from other laboratory testing Anecdotal evidence

Ordering Information Code Description Size Unit of Sale KCR4241 Premier Klercide-CR Sterile Biocide A Spray 1.0 litre 6 bottles x 1.0 litre KCR4251 Premier Klercide-CR Sterile Biocide A Capped 5.

0 litre KCR751 Klercide-CR Biocide A Capped 5.0 litre 4 bottles x 5.

0 litre KCR722 Premier Klercide-CR Sterile Biocide X Unit Dose Concentrate 50 ml 50 bottles x 50 ml KCR711 Klercide-CR Biocide X Unit Dose Concentrate 50 ml 50 bottles x 50 ml WPK2515 Klerwipe-CR

11 Ordering Information Code Description Size Unit of Sale KCR4241 Premier Klercide-CR Sterile Biocide A Spray 1.0 litre 6 bottles x 1.0 litre KCR4251 Premier Klercide-CR Sterile Biocide A Capped 5.0 litre 4 bottles x 5.0 litre KCR812 Premier Klercide-CR Sterile Biocide A Concentrate Capped 5.0 litre 4 bottles x 5.0 litre KCR701 Klercide-CR Biocide A Spray 1.0 litre 6 bottles x 1.0 litre KCR751 Klercide-CR Biocide A Capped 5.0 litre 4 bottles x 5.0 litre KCR8103 Klercide-CR Biocide A Concentrate Capped 5.0 litre 4 bottles x 5.0 litre KCR722 Premier Klercide-CR Sterile Biocide X Unit Dose Concentrate 50 ml 50 bottles x 50 ml KCR711 Klercide-CR Biocide X Unit Dose Concentrate 50 ml 50 bottles x 50 ml WPK2515 Klerwipe-CR Sterile Biocide A Low Particulate Pouch Wipe 200 x 200 mm 20 packs x 15 wipes WPM5015 Klerwipe-CR Sterile Biocide A Low Particulate Mop Wipe 420 x 250 mm 10 packs x 20 wipes KCR4242 Premier Klercide-CR Sterile Filtered Biocide B Spray 1.0 litre 6 bottles x 1.0 litre KCR4253 Premier Klercide-CR Sterile Filtered Biocide B Capped 5.0 litre 4 bottles x 5.0 litre KCR814 Premier Klercide-CR Sterile Filtered Biocide B Concentrate Capped 5.0 litre 4 bottles x 5.0 litre KCR705 Klercide-CR Biocide B Spray 1.0 litre 6 bottles x 1.0 litre KCR755 Klercide-CR Biocide B Capped 5.0 litre 4 bottles x 5.0 litre KCR8105 Klercide-CR Biocide B Concentrate Capped 5.0 litre 4 bottles x 5.0 litre WPK2525 Klerwipe-CR Sterile Filtered Biocide B Low Particulate Pouch Wipe 200 x 200 mm 20 packs x 15 wipes WPM5025 Klerwipe-CR Sterile Filtered Biocide B Low Particulate Mop Wipe 420 x 250 mm 10 packs x 20 wipes KCW6243 Premier-WFI Klercide-CR Sterile Filtered Biocide C Spray 1.0 litre 6 bottles x 1.0 litre KCW6255 Premier-WFI Klercide-CR Sterile Filtered Biocide C Capped 5.0 litre 4 bottles x 5.0 litre KCR4243 Premier Klercide-CR Sterile Filtered Biocide C Spray 1.0 litre 6 bottles x 1.0 litre KCR4255 Premier Klercide-CR Sterile Filtered Biocide C Capped 5.0 litre 4 bottles x 5.0 litre WPK2535 Klerwipe-CR Sterile Filtered Biocide C Low Particulate Pouch Wipe 200 x 200 mm 20 packs x 15 wipes WPM5035 Klerwipe-CR Sterile Filtered Biocide C Low Particulate Mop Wipe 420 x 250 mm 10 packs x 20 wipes KCR4244 Premier Klercide-CR Sterile Biocide D Spray 1.0 litre 6 bottles x 1.0 litre KCR4257 Premier Klercide-CR Sterile Biocide D Capped 5.0 litre 4 bottles x 5.0 litre KCR818 Premier Klercide-CR Sterile Biocide D Concentrate Capped 5.0 litre 4 bottles x 5.0 litre KCR725 Premier Klercide-CR Sterile Biocide Y Unit Dose Concentrate 50 ml 50 bottles x 50 ml KCR714 Klercide-CR Biocide Y Unit Dose Concentrate 50 ml 50 bottles x 50 ml WPK2545 Klerwipe-CR Sterile Biocide D Low Particulate Pouch Wipe 200 x 200 mm 20 packs x 15 wipes WPM5045 Klerwipe-CR Sterile Biocide D Low Particulate Mop Wipe 420 x 250 mm 10 packs x 20 wipes KCR4245 Premier Klercide-CR Sterile Biocide E Spray (Chloroclens) 1.0 litre 6 bottles x 1.0 litre KCR4259 Premier Klercide-CR Sterile Biocide E Capped (Chloroclens) 5.0 litre 4 bottles x 5.0 litre KCR718 Premier Klercide-CR Sterile Biocide S Concentrate Tablets (Chloroclens) 170 g 12 tubs x 170 g KCR720 Premier Klercide-CR Sterile Biocide T Concentrate (Inciclens) 20 ml 60 sachets x 20 ml KFS005 Klercide Fogging System Each KPSS20 Klercide Pressurised Spray System Each Shield Medicare Ltd cannot assume responsibility for product performance as the wide areas of use are beyond our control. Shield Medicare Ltd makes no guarantees, specific or implied, for the suitability of use. Purchasers and Users should verify that products are suitable for the intended purpose. The product range is continually being updated and improved, we therefore reserve the right to change, modify or withdraw any product or service without notice.

Shield Medicare Ltd Cheyenne House West Street Farnham GU9 7EQ UK Tel: +44 (0)1252

12 Shield Medicare Ltd Cheyenne House West Street Farnham GU9 7EQ UK Tel: +44 (0) Fax: +44 (0) KCO13E-4

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