Latest range of highest quality sterile and filtered cleanroom alcohols

Transcription

1 Latest range of highest quality sterile and filtered cleanroom alcohols

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

3 Contamination Control Sources of contamination Contamination can enter the cleanroom on raw materials, packaging, personnel, equipment and cleaning/disinfection products. Research has shown that up to 60% of consumable items passed into the cleanroom are contaminated with bacteria and 40% with spores.* The transfer of materials into and out of the unit is one of the greatest potential sources of contamination. Eudralex Vol 4 Good Manufacturing Practice, Annex 1: "Manufacture of sterile medicinal products" Preventing contamination Disinfect all items passed into the cleanroom spray & wipe protocol recommended. Operators must wear gowns, caps, masks, gloves or overshoes and disinfect hands regularly according to the grade of cleanroom. Reduce the amount of paper in the cleanroom, including paper packaging. Ensure that disinfectants are sterile and spore free and remain sterile throughout use. Train and educate staff about the easy spread of contamination, manipulation techniques, the importance of validated procedures and the correct way to clean/disinfect. Research has shown that spray and wipe is the most effective method of removing bioburden during the transfer process, especially for spores, and this is becoming widely accepted as best practice by hospitals and industry.* Validation of liquid disinfection techniques* % Reduction of organisms Spray 70% IMS Wipe 70% IPA Spray & Wipe S.aureus B.subtilis * Validation of liquid disinfection techniques for transfer of components into hospital pharmacy cleanrooms, Hospital Pharmacist Sept 2001, M G Cockcroft et al. Dealing with contamination Implement a cleaning regime incorporating a neutral detergent to remove soiling. Disinfect all surfaces with alcohol and disinfectant of suitable quality. Use a dedicated sporicide if spore contamination is detected. We recommend using a sporicide such as Klercide-CR Biocide B or Biocide E on a regular basis to prevent spore contamination from occurring. Validate the procedure.

4 Selecting the Right Alcohol Whichever grade of alcohol you select for your contamination control regime, it must be able to maintain the low levels of microbial contamination predefined for each class of cleanroom, according to EU standards. Alcohols have a broad spectrum of activity against bacteria, fungi and viruses, are quick drying and leave little or no residue, so are ideal for product contact areas. Shield Medicare offers IPA (isopropyl alcohol), denatured ethanol (IMS) and Pharma Ethanol which is ethanol denatured with IPA. All contain 70% alcohol which is the industry standard when using alcohol as a disinfectant. Points to consider Whether the alcohol needs to be sterile according to the grade of cleanroom. Whether the alcohol will remain sterile during use. Whether the spray is adjustable. Whether the packaging is appropriate for a cleanroom. Whether the quality of the product can be guaranteed check the manufacturer s credentials. Method of application. Safety issues such as the likelihood of inhalation. Consistent surface coverage. Wastage and disposal. EC GMP Annex 1 Manufacture of Sterile Medicinal Products Recommended limits for microbiological monitoring of clean areas during operation 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

5 Selecting the Right Alcohol Sterile or non-sterile? 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 Shield Medicare IPA and denatured ethanol (IMS) alcohols are available in three grades: Premier-WFI Klercide 70/30 alcohols (sterile with highest specification water for injection EP) are ideal for Grade A and B areas where low levels of endotoxins are required and they are particularly suitable for product contact areas. Guaranteed spore free. Premier Klercide 70/30 alcohols (sterile with deionised water) are suitable for all grades of cleanroom, including A and B areas. Guaranteed spore free. Kleralcohol or Klercide-125 alcohols (0.2 micron filtered with deionised water) should only be used in Grade C, D or unclassified cleanrooms and are not suitable for product contact areas. Minimising operator exposure Consideration should be given to the method of application to minimise operator exposure to the alcohol vapour and meet health and safety requirements. For example, the amount of spraying required for transfer disinfection can be reduced through the use of the Klerpack range of sterile multi-pack components, rather than transferring individual items. Also, the use of low particulate alcohol impregnated wipes provides a convenient method of application without spraying alcohol into the atmosphere. Note: alcohols are not effective against bacterial spores, so it is important to use sterile alcohols to ensure that spores are not introduced into the cleanroom. If spores are found then a sporicide such as Premier Klercide-CR Biocide B, Biocide C or Biocide E / S must be used to remove them and routine use of a sporicide would be a wise precaution.

6 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 as the entire contents can be used. 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

7 Advantages of Alcohols Suitable for Grade A and B areas Cleanroom processed and sterile. Triple bagged or double bagged for easy transfer. Guaranteed spore free All sterile alcohols are filtered to 0.2 micron and gamma irradiated. Unique SteriShield Delivery System All trigger sprays incorporate Shield Medicare s unique SteriShield Delivery System, which ensures the contents remain sterile throughout use. CEN tested Full test data available including EN1276, EN1650 and EN Helpful validation documentation A comprehensive technical file is available for each alcohol, to shorten the process when validation is required. Range of presentations for ease of use The alcohols are available in a range of sizes and formats to suit different applications, including trigger sprays, aerosols and a wide range of impregnated wipes. Cleanroom compatible packaging The packaging materials are low particulate and are easy to spray and wipe for efficient transfer into clean areas. Validation Manufactured by a BS EN ISO 9001:2000, BS EN ISO 13485:2001 and European Medical Device Directive 93/42/EEC accredited company. Certificates of analysis, irradiation, sterility and quantitative endotoxin levels <0.25 EU/ml available with every batch (as appropriate). Sterility tested to an approved pharmacopœial method. In use sterility guaranteed by the SteriShield Delivery System, validated for three months. 2 year shelf life (aerosols 3 years). Full supporting documentation available.

8 Sterile Alcohols Premier-WFI Klercide 70/30 is a sterile spore free 70/30 alcohol, either IPA, denatured ethanol (IMS), or Pharma Ethanol (ethanol denatured with IPA) blended with the highest specification water for injection (EP). This range is suitable for product contact areas where low endotoxin levels are required. Endotoxin levels are guaranteed to be below 0.25 EU/ml. All formats are gamma irradiated to a validated procedure to guarantee a spore free alcohol. All formats are 0.2 micron filtered, filled and triple bagged under Grade B (ISO Class 5) Laminar Air Flow in a Grade C (ISO Class 7) cleanroom. In-use sterility of the trigger sprays is guaranteed for at least 3 months with the SteriShield Delivery System, while the in-use sterility of the aerosol is also validated to be at least 3 months. Trigger and capped formats have a 2 year shelf life and the aerosol has a 3 year shelf life. Premier Klercide 70/30 is a sterile spore free 70/30 alcohol, either IPA or IMS (denatured ethanol) blended with deionised water, suitable for Grade A and B areas. It is 0.2 micron filtered, filled and double bagged in a Grade C (ISO Class 7) cleanroom before irradiation using a validated process to ensure a spore free alcohol. All trigger sprays are fitted with the SteriShield Delivery System to ensure the sterility of the contents is preserved throughout use.

9 Filtered Alcohols Kleralcohol is a cleanroom filtered 70/30 alcohol, either IPA or denatured ethanol (IMS) blended with deionised water. It is suitable for areas where sterile alcohol is not required. It is 0.2 micron filtered, filled and double bagged in a Grade C (ISO Class 7) cleanroom. All trigger sprays are fitted with the SteriShield Delivery System to ensure the integrity of the contents is preserved throughout use. Klercide-125 is a cleanroom filtered 70/30 denatured ethanol (IMS) blended with deionised water and containing 0.125% hydrogen peroxide. The small amount of hydrogen peroxide ensures there are no spores in the bottle components by the time the product reaches the customer (after 50 hours the hydrogen peroxide is no longer active). Suitable for areas where sterile alcohol is not required it is 0.2 micron filtered, filled and double bagged in a Grade C (ISO Class 7) cleanroom. Shield Medicare s Alcohol Range Product Name Composition Format Sizes Available Wipes Available Areas of Use Alcohol 360 ml Aerosol 500 ml with SDS 1 litre with SDS 5 litre with SDS 5 litre capped Sachet Pouch Tub Mop Grade A Grade B Grade C/D Unclassified Premier-WFI IPA with WFI Sterile Y Y Y Y Y Y V V S N Klercide 70/30 IPA Premier-WFI Klercide Ethanol denatured Sterile Y Y Y V V S N 70/30 Pharma Ethanol with IPA, with WFI Premier-WFI Denatured Ethanol Sterile Y Y Y Y Y V V S N Klercide 70/30 IMS with WFI Premier Klercide IPA with DI water Sterile Y Y Y Y Y Y Y Y V V S S 70/30 IPA Premier Klercide Denatured Ethanol Sterile Y Y Y Y Y Y Y Y V V S S 70/30 IMS with DI water Kleralcohol IPA IPA with DI water Filtered Y Y Y N N V V Kleralcohol IMS Denatured Ethanol Filtered Y Y Y N N V V with DI water Klercide-125 Denatured Ethanol Filtered Y N N V V with 0.125% H 2 O 2 Key = Sterile with Water for Injection V = Very suitable = Sterile with deionised water S = Suitable = Filtered with deionised water N = Not suitable Y = Yes

10 Accessories and Wipes Klercide LAF and Isolator Cleaning Tool A special autoclavable tool with sterile disposable covers, which aids the cleaning and disinfection of isolators and laminar flow cabinets. Klercide Hands Free Dispensers Convenient wall-mounted or bench-mounted hands free dispensers are available for all Klercide 70/30 5 litre trigger sprays. A wall-mounted adaptor is also available for Klercide 70/30 aerosols. The extended lever allows operators to disinfect their hands using their arm or elbow, to prevent cross contamination. Klerwipe 70/30 Sterile 70% Alcohol Impregnated Pouch Wipes Sterile 100% polyester pouch wipes impregnated with Klercide 70/30 IPA blended with water for injection, for high grade and product contact areas, 200 mm x 200 mm, triple bagged in a convenient, resealable, non-shedding pouch. Sterile low particulate pouch wipes, 200 mm x 200 mm, impregnated with either Klercide 70/30 IPA or denatured ethanol, double bagged in a convenient, resealable, non-shedding pouch. Controlled and efficient application of the alcohol that reduces operator exposure by minimising droplets in the air. Klerwipe Sterile Impregnated Mop Wipes Sterile low particulate 420 mm x 250 mm wipes impregnated with either Klercide 70/30 IPA or denatured ethanol, designed to fit onto a choice of lightweight autoclavable mop frames. Efficient way of applying alcohol to large areas, while minimising operator exposure. Impregnated sachet and tub wipes are also available, see table on previous page, as well as a wide range of 100% polyester and low particulate dry wipes for use with trigger spray alcohols.

11 Ordering Information Code Description Size Unit of Sale KW2002 Premier-WFI Klercide 70/30 Sterile IPA Aerosol 360 ml 24 cans x 360 ml KW2004 Premier-WFI Klercide 70/30 Sterile IPA Spray 500 ml 12 bottles x 500 ml KW2006 Premier-WFI Klercide 70/30 Sterile IPA Spray 1.0 litre 6 bottles x 1.0 litre KW2008 Premier-WFI Klercide 70/30 Sterile IPA Spray 5.0 litre 4 bottles x 5.0 litre KW2012 Premier-WFI Klercide 70/30 Sterile IPA Capped 5.0 litre 4 bottles x 5.0 litre KW2205 Premier-WFI Klercide 70/30 Sterile Pharma Ethanol Spray 1.0 litre 6 bottles x 1.0 litre KW2207 Premier-WFI Klercide 70/30 Sterile Pharma Ethanol Spray 5.0 litre 4 bottles x 5.0 litre KW2211 Premier-WFI Klercide 70/30 Sterile Pharma Ethanol Capped 5.0 litre 4 bottles x 5.0 litre KW2001 Premier-WFI Klercide 70/30 Sterile Denatured Ethanol Aerosol 360 ml 24 cans x 360 ml KW2003 Premier-WFI Klercide 70/30 Sterile Denatured Ethanol Spray 500 ml 12 bottles x 500 ml KW2005 Premier-WFI Klercide 70/30 Sterile Denatured Ethanol Spray 1.0 litre 6 bottles x 1.0 litre KW2007 Premier-WFI Klercide 70/30 Sterile Denatured Ethanol Spray 5.0 litre 4 bottles x 5.0 litre KW2011 Premier-WFI Klercide 70/30 Sterile Denatured Ethanol Capped 5.0 litre 4 bottles x 5.0 litre KL1002 Premier Klercide 70/30 Sterile IPA Spray 500 ml 12 bottles x 500 ml KL1004 Premier Klercide 70/30 Sterile IPA Spray 1.0 litre 6 bottles x 1.0 litre KL1008 Premier Klercide 70/30 Sterile IPA Spray 5.0 litre 4 bottles x 5.0 litre KL1009 Premier Klercide 70/30 Sterile IPA Capped 5.0 litre 4 bottles x 5.0 litre KL1011 Premier Klercide 70/30 Sterile Denatured Ethanol Spray 500 ml 12 bottles x 500 ml KL1013 Premier Klercide 70/30 Sterile Denatured Ethanol Spray 1.0 litre 6 bottles x 1.0 litre KL1015 Premier Klercide 70/30 Sterile Denatured Ethanol Spray 5.0 litre 4 bottles x 5.0 litre KL1016 Premier Klercide 70/30 Sterile Denatured Ethanol Capped 5.0 litre 4 bottles x 5.0 litre KL302 Kleralcohol IPA Spray 1.0 litre 6 bottles x 1.0 litre KL303 Kleralcohol IPA Spray 5.0 litre 4 bottles x 5.0 litre KL304 Kleralcohol IPA Capped 5.0 litre 4 bottles x 5.0 litre KL311 Kleralcohol Denatured Ethanol Spray 1.0 litre 6 bottles x 1.0 litre KL312 Kleralcohol Denatured Ethanol Spray 5.0 litre 4 bottles x 5.0 litre KL313 Kleralcohol Denatured Ethanol Capped 5.0 litre 4 bottles x 5.0 litre KL125 Klercide-125 Denatured Ethanol with H 2 O 2 Spray 1.0 litre 6 bottles x 1.0 litre KHFD05 Klercide Sterile Hands Free Dispenser for 5 litre trigger Each KBMD05 Klercide Sterile Bench Mounted Hands Free Dispenser for 5 litre trigger Each KHSA01 Klercide Hand Held Spray Adaptor for Aerosols Each KWMA01 Klercide Wall Mounted Spray Adaptor for Aerosols Each Key = Sterile with Water for Injection = Sterile with deionised water = Filtered with deionised water 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.

12 Shield Medicare Ltd Cheyenne House West Street Farnham GU9 7EQ UK Tel: +44 (0) Fax: +44 (0) KCO10E-3