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New range of sterile and filtered cleanroom disinfectants
Shield Medicare Company Profile
Shield Medicare is a market leader in the supply of specialistcontamination 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
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 unitof the Queen Elizabeth Hospital in Birmingham, UK, identified that a standard trigger spray alcohol had been contaminated with fungalspores only eight hours after opening.”Contamination Control at Your Fingertips, Pharmaceutical Manufacturing International, Autumn 1999
Preventing Spore Contaminationfrom Disinfectants
“
Selecting the right disinfectants
Whichever disinfectants you select for your contamination controlregime, they must be able to maintain the low levels of microbialcontamination 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 PrintAir Sample (diam. 90 mm). (diam. 55 mm). 5 fingers
Grade cfu/m3 cfu/4 hours cfu/plate cfu/glove
A < 1 < 1 < 1 < 1
B 10 5 5 5
C 100 50 25 –
D 200 100 50 –
“cGMP states that “Disinfectants used in Grade A and B areas should besterile 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 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.
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.
Advantages of Biocides
Broad Spectrum Biocides
Shield Medicare offers a unique range of broad spectrum biocides in avariety 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 BiocideX 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. 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, useneutral detergent to
clean the areafollowed by alcohol
to disinfect.
Regularly, use a rotationof broad spectrum
disinfectants
If a specific spore problem
is identified: useBiocide B or E toremove 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.
One of the most difficult requirements in a life science cleanroom is thecontrol of bacterial spores, which are particularly difficult to killbecause 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.
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.
Alcohol does not kill
spores
Effective Sporicides
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*
Spores No Efficacy Good Fair No Efficacy Good No EfficacyBacillus cereus
Bacillus coagulans
Bacillus licheniformis
Bacillus pumilis
Bacillus sphaericus
Bacillus subtilis var.niger
Bacillus subtilisBacteria Good Good Good Good Good GoodClostridium botuliniumClostridium perfringensCorynebacterium speciesEnterococcus faeciumEnterococcus hiraeEscherichia coliGemella morbillorumKlebsiella pneumoniaeKytococcus sendentariusListeria monocytogenesMicrococcus luteusMycobacterium smegmatisMycobacterium tuberculosisProteus mirabilisPseudomonas aeruginosaSalmonella choleraesuisSalmonella entiritidisSerratia liquefaciensSerratia marcescensStaphylococcus aureusStaphylococcus capitisStaphylococcus epidermidisStaphylococcus hominisStaphylococcus simulansVancomycin res. Enterococci
Fungi Fair Fair Fair Fair Good FairAbsidia corymbifera
Aspergillus fumigatus
Aspergillus niger
Candida albicans
Cladiosporium cladosporioides
Mucor racemosum
Penicillium compactum
Penicillium expansum
Penicillium notamumSaccharomyces rouxiiTricophyton interdigitaleViruses Fair Good Good Fair Good FairHepatitis BHerpes HSV-2HIVHong Kong Virus 68Influenza A2PoliovirusRhinovirus
Key
Results fromEN1040,EN1276,EN1650,EN13704,EN13697and ShieldMedicare HardSurface Test
Results fromother laboratorytesting
Anecdotalevidence
* This is not an exhaustivelist, but givesan indicationof efficacyagainstdifferentorganismtypes. Eachinstitutionmust validate a disinfectantto ensureefficacyagainst its specificwild isolates.
Biocide A/X Biocide B Biocide C BiocideD/Y
Biocide E/S Biocide T
Shield Medicare Ltd cannot assume responsibility for product performance as the wide areas of use are beyond our control. ShieldMedicare Ltd makes no guarantees, specific or implied, for the suitability of use. Purchasers and Users should verify that products aresuitable 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.
Ordering Information
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
Code Description Size Unit of Sale
Shield Medicare Ltd Cheyenne House West Street Farnham GU9 7EQ UKTel: +44 (0)1252 717616 Fax: +44 (0)1252 715269 [email protected] www.shieldmedicare.com
KC
O13E-4