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SUPPORTING cGMP COMPLIANCE ACROSS THE GLOBE, EXPORTING EXCELLENCE WORLDWIDE
CLEANROOM PRODUCTS Contamination Control for Critical Environments
2
Micronclean Consumables Catalogue
BIG BLUE
The Micronclean Big Blue Handbook is a complete 125 page resource for operating a cGMP cleanroom in accordance with guidelines. It is available to buy from Waterstones or Amazon for ÂŁ70.00 or you can receive a free copy with your first Micronclean purchase order over ÂŁ500 in value. There are some useful extracts of the book throughout this catalogue to provide practical advice and guidance on how to appropriately use the Micronclean products that are on offer. We hope that you find this information useful.
Micronclean Consumables Catalogue 3
Contents
Micronclean’s Standard Product Range Dry Wipes 06
Micro Denier / Polyester / Quilted Polyester / Polycellulose / Melded Nylon
Pre-Saturated Wipes 08
Tub Wipes / Pouch Wipes / Polyester / Polycellulose / Polypropylene
Cleaning Agents 10
Trigger Sprays / Bulk Containers / IPA / IMS / Neutral Detergent / Biocides
Mopping Systems 12
Pre-saturated Disposable System / Triple Bucket System
Cleaning Equipment 17
Isolator Cleaning Tool & Bonnets / Cleanroom ULPA Vacuum Cleaner
Permanent Garments 20
Coveralls / Lab Coats / Hoods / Overboots / Undergarments
Disposable Clothing 22
Coveralls / Boilersuits / Lab Coats / Aprons / Sleeve Protectors / Hoods
Gloves 24
12” or 16” / Latex / Nitrile / Vinyl / Bulk Packed / Sterile - Hand Specific Pair Packed
Headwear 26
Face Masks / Pouch Masks / Beard Snoods / Mob Caps
Footwear 27
Overshoes / Overboots / Cleanroom Shoes & Clogs
Stationery 30
Cleanroom Paper / Pens / Note Books
Packaging 31
Sterile Bags / Grip Seal Bags / Irradiation Indicators / Cleanroom Tape
Entry Mats 33
Peel off Sticky Mats / Permanent Tack Flooring and Mats
Cleanroom Cleaning 34
Decontamination Cleans / VHP / Routine Maintenance
4
Micronclean Consumables Catalogue
Big Blue Book
Creating a Cleaning Plan and SOP’s Disinfectant Impregnated Wipes Preparing a Cleaning Plan In order to properly maintain your cleanroom and ensure consistent optimal performance a cleaning plan should be created. The plan will provide clear information when discussing requirements with cleaning suppliers, and for developing cleaning standard operating procedures (SOPs) and a staff training programme. Any changes to the cleanroom facility or its function must be assessed using the cleaning plan and a new revision of the plan produced when required with traceability of the changes implemented. A cleaning plan will be a useful reference when cleaning validations and re-qualifications are performed and is also essential for customer or compliance audits. The cleaning plan will define; • What is to be cleaned • How the cleaning will be carried out • When the cleaning is to be carried out • Who is responsible for cleaning When producing a cleaning plan the different cleanliness zones and areas of greatest risk to product should be detailed. Locations of manufacturing equipment, dedicated cleaning equipment e.g. connection points for built-in vacuum system and garment issue and disposal points should be shown.
Any areas of notable hazards, first aid boxes and emergency exits must be clearly identified. The cleaning plan will include details of the cleaning equipment and chemicals and the associated dilution and application rates specific to the production unit.
••
Cleaning must start with the cleanest area and finish with the
••
Cleaning follows the air pressure cascade in a series of
••
In a cleanroom cleaning starts at the point furthest from the
••
Cleaning is carried out in a series of steps starting with the
microscopic particulate.
sterile packs.
by use SOP procedure Louth wareho s the release zone as per and Baxter ure define the amber This proced certificate(s) mity are product in a irradiation inspects ate(s) of confor Supervisor plus the gamm clean certific Warehouse ent record eted Micron 1. The Louth use movem the compl Louth wareho mance and 202. The of confor ss. certificate(s) reviews the Healthcare ment at Skegne department QA depart of the QA sent to the a member n, documentatio of the above 2. On receipt dose of specifically:um n, es a minim documentatio d and indicat been receive This proce correctly ents have completed dure defin has been types docum ed es the certificate • All four release been achiev a irradiation 1. The Louth procedure 35kGy has • The gamm ly four um dose of correctly by the Warehous ted correct across the and maxim completed 202. The QA depa reconcile 25kGy has been been comple rtment Louth ware e Superviso numbers ent record mity has for Com r inspe Healthcar tion order house ate of confor • The movem cts prod pliance movement e certifi ties and irradia clean certific uct in the 100 steril quanti cate(s) Micron record al file sent to the t codes, • The amber of confo e pack plus the QA depa s. zone as clean technic rmance codes, produc TD-2.1). gamm rtment per Louth and the • The batch per the Micron reference at Skeg completed a irradiation ed code as warehous (document ness. 2. ments approv On t, receipt docu e SOP Micronclea certificate(s) curren of the batch t code is a and Baxte document oft the abov n certifi e the release • The produc e docu r cate(s) ation, spec mentation may preclud of confo of the produc that ts release ifical rmity are ise , a mem ly:d inciden to author ber of no reporte ent form the QA • All four • There are the movem departme types docu d, QA sign nt • satisfie The gamm reviews ment are the to Q \ Louth use. a irradiation s have been listed in (2) and save 25kGy Louth wareho 3. If the criteria certificate received document form to the name. and maximum scan the the file has • mity, the The been comp move and return dose of number as ates of confor 35kGy tion order • The Micro ment record has clean certific has been leted correctly r plus irradia the Micron been comp and indic achieved PRODUCTnclean certifi lot numbe and date • The ates a minim leted FINISHED batch code 4. QA sign the Baxter cate of of conformity correctly have a green um dose certificate C of C, using s, prod doc clean carton will uments uct code warehouse of has been plus the Micron • The s, quan Record each completed tities and Movement of the carton product correctly Green Zone. irradiation of the signed d to the side (document code is a curre appropriate order num 5. On receipt SE label applie mity and nt, appr rred to the refer confor FOR RELEA bers recon ence TD-2 • There oved code ate ofare t is then transfe APPROVED cile acros .1). as per the clean certific no repor and the produc s the four ted incid Micronclea mance, Micron conformity of confor ents that n techn 3. If the certificate may precl ical care criter file Health 25). ia listed ude the and retur the Baxter (appendix release n the form in (2) are satisfi ate on file 6. QA retain of the batch tion certific ed, QA to the Louth irradia a sign gamm the move warehous 4. QA sign ment form e. and date02/10/09 to autho warehous Date: the Micro rise relea e C of C, se of the ton /09 nclean certifi using the product cates of Philip Borring Date: 02/10 Baxter conformity lot num Issued by: n 5. On recei ber , Simpso scan pt le plus the docu 04 irradiation APPROVED of the signe by: Michel ment and Issue No.: d Move order num Authorised ment save to conformity FOR RELEASE ber as 1 of 1 Q \ Louth label appli Record each the file and the Page: carton name. ed to the product will have is then side of a green transferre the carto 6. QA retain FINIS n plus d to the the Baxte the Micro HED PRODUCT appropria gamma r Healthcar nclean irradiation te Gree certificate e certifi n Zone certificate cate of . of on file conforman (appendix ce, Micro 25). nclean certificate of confo rmity and Issue No.: 04 Page: Issued by: 1 of 1 Philip Borri Authorise ngton d by: Michelle Date: Simpson 02/10/09 Date: 02/10/09
Quality SOP QU 05 Sterile Mop: Sto 9 rage & Handlin g
least clean area.
cleanrooms from the highest pressure to the lowest pressure.
exit and works towards the exit.
removal of visible contamination followed by the removal of
••
When a chemical sanitiser is used the correct concentration,
••
No cleaning equipment or products must be specified which
volume and surface contact time must be clearly stated.
will produce particulate contamination or leave harmful
residues. ••
Cleaning operations which have the potential to cause
identified and confined to non-critical areas.
contamination e.g. emptying garment discard bins, must be
••
Any staff involved with cleaning must be properly trained and
••
Any cleaning operations involving hazardous materials must be
equipped.
identified and all aspects of cleaning and disposal clearly
described.
QU035 ure Quality SOP : QA Release Proced cide Sterile Bio 100 Compliance
will apply to all plans.
035 04
ment for the QA depart
The order, frequency and methods of cleaning will also be chosen to suit each unit however the following principles of cleanroom cleaning
059 09
••
All cleaning activities need to be appropriately recorded. The
and retained for future reference.
cleaning records need to be reviewed on a scheduled frequency
A cleaning plan may provide sufficient information for a small operation, however it is usually beneficial to produce SOP’s (Standard Operating Procedures) for each cleaning task, which will provide detailed
instructions for anyone performing a cleaning task and also forms part of basic staff training.
5
Micronclean Consumables Catalogue / January 2016
Micronclean Consumables Catalogue 5
Pre-Saturated Wipes
Disinfectant Impregnated Wipes
The Micronclean Cleanroom Product Portfolio is designed to aid cGMP compliance in your critical environment.
The combined range is the most respected and comprehensive offering of Cleanroom Contamination Control Consumables, meeting the complex operational demands of your cleanroom. Micronclean supplies a wide range of diverse products for cleanroom environment. We understand the critical importance of continuity of supply and the consequent requirement to hold high levels of stock for core products.
This catalogue showcases the ÂŁ1.8m of standard items that are stocked in our new warehouse.
We will shortly be relaunching our website at www.micronclean.com, giving customers the ability to place orders and giving access to technical datasheets and product information.
The unsurpassed technical knowledge of the Micronclean team allows us to support our customers and provide the solutions to any technical and service challenges. We undertake site audits, product demonstrations and provide comprehensive quotes to structure the most appropriate product supply to customers.
CLEANING Contamination Control for Critical Environments
6
Micronclean Consumables Catalogue
WhiteGuard ISO 3 & 4 Polyester Wipes 1 WhiteGuard 3 2 WhiteGuard 3
3 WhiteGuard 11 4 WhiteGuard 5
WhiteGuard 3 High performance 100% knit continuous filament Polyester, ultra low linting wiper with laser sealed edges to trap particulate and contain moisture. Widely used in Semiconductor, Pharmaceutical, Aerospace & Medical device industries Also available with Ultrasonically sealed border edges.
WhiteGuard 5 Microdenier wipes constructed from continuous filament blended nylon and polyester with ultrasonic sealed edges. High yarn-to-dust contact surface area plus wedge-shaped cross section ensure excellent wiping efficiency. Widely sed in lens and screen manufacture.
Dual Layer WhiteGuard 11 Cleanroom laundered, two-ply quilted, 100% continuous-filament polyester knitted in a double-knit interlock pattern. Two-ply construction offers high sorbency capacity with ultrasonic sealed border edges to prevent particle and fibre release. High grade spill control.
1
2
3
4
Non Sterile Code
WNTG05012 WNTG05011 WNTG04009 WNTG05009
WNMD04009
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Sterile Code WSTG03012
WSTG05009 WSTG02009 MHPELN50S WSPW60300
Description
WhiteGuard 3 Wipes 12” x 12” (300 x 300mm) 120gsm WhiteGuard 3 Wipes 12” x 12” (300 x 300mm) 140gsm WhiteGuard 3 Wipes 11” x 11” (280 x 280mm) 120gsm WhiteGuard 3 Wipes 9” x 9” (228 x 228mm) 135gsm WhiteGuard 3 Wipes 9” x 9” (228 x 228mm) 120gsm WhiteGuard 3 Wipes 9” x 9” (228 x 228mm) 120gsm WhiteGuard 5 Wipes 9” x 9” (228 x 228mm) 220gsm WhiteGuard 11 Wipes 12” x 12” (300mm x 300mm) 240gsm WhiteGuard 11 Wipes 12” x 12” (300mm x 300mm) 240gsm
Size
12” x 12” 12” x 12” 11” x 11” 9” x 9” 9” x 9” 9” x 9” 9” x 9” 12” x 12” 12” x 12”
ISO
ISO4 ISO3 ISO4 ISO3 ISO3 ISO3 ISO4 ISO3 ISO3
Pack Qty 150 50 150 100 150 10 100 50 20
Case Qty 10 x 150 10 x 50 10 x 150 10 x 100 10 x 150 20 x 10 10 x 100 4 x 50 5 x 20
As a guide to customers, Micronclean has indicated the highest classification of cleanroom each product would typically be used in.
Micronclean Consumables Catalogue / January 2016 7
WhiteGuard
ISO 5 & 6 Polycellulose Wipes 1 WhiteGuard 2 2 WhiteGuard 7
Poly-Cellulose, WhiteGuard and GuardWipe Poly-Cellulose Wipes Poly-Cellulose wipes are specifically designed to deliver a combination of cleanliness and absorbency; combining the low linting characteristics of Polyester coupled with the high liquid retention rates of cellulose.
WhiteGuard 2 45% Polyester, 55% Cellulose blend, WhiteGuard has excellent absorbency, with low linting properties. Available in a variety of sizes and pack formats, WhiteGuard is a multipurpose wipe for ISO5+ clean areas.
WhiteGuard 8 (formerly Pharmawipes) Designed for tightly controlled applications focussing on cleanliness and particulate control within ISO5 Pharmaceutical manufacturing or compounding environments.
Industrial Wipes WhiteGuard 6 Aggressive Melded Nylon wiper with a diamond textured surface to provide good abrasion. Ideal for machine cleaning, degreasing and spill control in clean industrial areas. Poly-Cellulose Wiper Roll WhiteGuard 7 Highly absorbent, low linting polycellulose wiper roll with perforated edges. Ideal for support areas where particulate control is necessary, especially where a high volume or density of wipes are required. Well suited to lab applications and low grade cleanroom production facilities. 400 sheets per roll, blue or white.
Non Sterile Code
WNWG04012 WNWG04009 WNWG06009 WNMN04016 WNMN04012 WNMN04008 WNPW81010 WNPB81010 WNCS93012 WNCS93009
Sterile Code WSWG04012 WSWG04009
WSCS93012 WSVW12012 WSCS93009 WSVW11009
2
1
Description
WhiteGuard 2 12” x 12” (300mm x 300m) Flat Packed WhiteGuard 2 12” x 12” (300mm x 300m) Flat Packed WhiteGuard 2 9” x 9” (228mm x 228m) Flat Packed WhiteGuard 2 9” x 9” (228mm x 228m) Flat Packed WhiteGuard 6 10” x 16” (254 x 405mm) Flat Packed WhiteGuard 6 12” x 12” (300mm x 300mm) 203gsm WhiteGuard 6 10” x 8” (254 x 203mm) 203gsm WhiteGuard 7 Roll White 400 sheets per roll WhiteGuard 7 Roll Blue 400 sheets per roll WhiteGuard 8 12” x 12” (300mm x 300mm) Flat Packed WhiteGuard 8 12” x 12” (300mm x 300mm) C-Folded WhiteGuard 8 9” x 9” (228mm x 228mm) Flat Packed WhiteGuard 8 9” x 9” (228mm x 228mm) C-Folded
As a guide to customers, Micronclean has indicated the highest classification of cleanroom each product would typically be used in.
Size
12” x 12” 12” x 12” 9” x 9” 9” x 9” 10” x 16” 12” x 12” 10” x 8” 10” x 15” 10” x 15” 12” x 12” 12” x 12” 9” x 9” 9” x 9”
ISO
ISO6 ISO5 ISO5 ISO6 ISO7 ISO7 ISO7 ISO6 ISO6 ISO5 ISO5 ISO5 ISO5
Pack Qty 100 100 100 300 100 100 100 1 1 25 x 4 10 x 10 300 10 x 100
Case Qty
20 x 100 10 x 100 10 x 100 16 x 300 10 x 100 10 x 100 10 x 100 2 x 1 Roll 2 x 1 Roll 17 x 25 x 4 14 x 10 x10 8 x 300 27x10x10
www.micronclean.com
8
Micronclean Consumables Catalogue
VeriGuard
1
Pre-saturated Wipes
With a comprehensive range of substrates, disinfectants and formats, Micronclean can meet all of the Cleanroom requirements for pre saturated wipes Substrates VeriGuard 1 - Polypropylene Most abrasive, lightweight and costeffective, available in tub and bulk pack pouch formats. VeriGuard 2 - Poly-Cellulose Highly absorbent 55% cellulose, low linting 45% Polyester, strong, absorbent multifunctional wipe. VeriGuard 3 - Polyester Heavy density, thermally sealed edges to trap particulate and retain cleaning solution. High grade fabric.
Disinfectants IPA 70% isopropanol alcohol blended with 30% DI or WFI. IMS 70% denatured ethanol blended with 30% DI or WFI. Alpha Quaternary Ammonium rotational biocide. Beta Amine based rotational biocide with sporicidal action, non-corrosive.
3
1 2 3 4
VeriGuard 1 VeriGuard 2 VeriGuard 8 VeriGuard 9 Silver Pack
Packaging Formats Tub Lower grade clean areas, For high volume usage, aggressive and intricate cleaning (especially equipment and parts) and long lasting alcohol retention. Double bagged. Pouch Full range of substrates and alcohols available in pouch format, varied pack sizes, re-sealable adhesive flap.
2
4
Non Sterile Code
WNVG05020 WNVG04023 WNVG09023 WNVG06030
Sterile Code
WSVG05020 WSVG07020 WSVG04023 WSVG09023 WSVG06030 MCZSLA50S WSAP01009 WSBT02009 WSCW91009 WSCW92009 WSCW96ZZZ WSCW97ZZZ
Description
VeriGuard 1: Polypropylene IPA/DI Tub Wipe 18gsm VeriGuard 1 Polypropylene IMS/DI Tub Wipe 18gsm VeriGuard 2: Poly-cellulose IPA/DI Pouch Wipe Z-Fold 68gsm VeriGuard 2: Poly-cellulose IMS/DI Pouch Wipe Z-Fold 68gsm VeriGuard 15: Polyester IPA/WFI Pouch Wipe V-Fold 132gsm VeriGuard 10: Polyester IPA/WFI Pouch Wipe Stacked 132gsm VeriGuard 8 Poly-cellulose with Alpha Biocide C-Fold 68gsm VeriGuard 8 Poly-cellulose with Beta Biocide/Sporicide C-Fold 68gsm VeriGuard 8 Poly-cellulose IMS/WFI Z-Fold 68gsm VeriGuard 8 Poly-cellulose IPA/WFI C-Fold 68gsm VeriGuard 9 Silver Pack Polypropylene Viscose IPA WFI 23gsm VeriGuard 9 Silver Pack Polypropylene/Viscose IMS/WFI 23gsm
Size
8” x 8” 8” x 8” 9” x 9” 9” x 9” 12” x 12” 12” x 12” 9” x 9” 9” x 9” 9” x 9” 9” x 9” 8” x 9” 8” x 9”
ISO
ISO5 ISO5 ISO4 ISO4 ISO3 ISO3 ISO4 ISO4 ISO4 ISO4 ISO5 ISO5
Pack Qty Case Qty 200 200 100 100 15 50 15 15 15 15 200 200
12 x 200 12 x 200 8 x 100 8 x 100 30 x 15 5 x 50 10 x 15 10 x 15 40 x 15 40 x 15 8 x 200 8 x 200
As a guide to customers, Micronclean has indicated the highest classification of cleanroom each product would typically be used in.
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Micronclean Consumables Catalogue
9
Big Blue Book
Cleanroom Wiping Technique
1
Quarter Fold Wiping Technique When using wipes to decontaminate critical areas it is good practice to fold the wipe to provide eight separate cleaning faces. This practice is to ensure particle containment rather than dispersal and also ensures the wipe is used to its full potential, providing efficiencies and cost savings.
2
The wipe should be used in single overlapping strokes with a maximum of eight passes (one for each folded face) per wipe (as shown in the sequence of illustrations 1-5). This technique will maximize particle removal and the surface area covered will depend on the size of the wipe and the quantity of liquid absorbed.
3
NOTES:
• When wipes are being used to apply a sanitising solution care should be taken to ensure that sufficient chemical is transferred to the surface from the wipe and that it is evenly distributed. Adequate disinfection will not take place without the correct application of sanitiser.
4
• When used for absorbing spills a dry wipe is simply removed from the container and applied to the spilled liquid. Once absorbed into the wipe the wipe is discarded in a safe manner according to the area procedures. A further dry wipe should then be used to wipe over the area and remove any residual moisture. • If cleaning or sanitising chemicals are to be applied to dry wipes the chemical should be dispensed onto the wipe and not onto the surface to be cleaned. This minimises the possibility of chemical aerosols contaminating the cleanroom. • If pre-wetted wipes are used then care should be taken to ensure that once opened the wipes container is re-sealed between uses to stop loss of impregnant through evaporation.
5
10 Micronclean Consumables Catalogue
CleanGuard Alcohols and Detergents
1
Alcohols CleanGuard 1 IPA 70% Isopropanol Alcohol with 30% Water for Injection (WFI), sterilised by Gamma Irradiation. Available in 500ml or 950ml Trigger Sprays, or 5L bulk containers. CleanGuard 2 IMS 70% Denatured Ethanol with 30% Water for Injection (WFI), sterilised by Gamma Irradiation. Available in 500ml or 950ml Trigger Sprays or 5L bulk containers.
CleanGuard 5 Non Ionic Detergent with Isopropanol and Deionised Water for the effective cleaning of sensitive components, equipment or areas that must avoid aggressive acid or alkaline chemicals. Available as 1L Trigger Spray.
Each triggers’ hold up volume is less than 0.3% significantly better than any other product. Demineralised Water CleanGuard 6 DI Water An 0.2 micron filtered Demineralised Water for the effective dilution of solutions and chemicals, and for cleaning applications in the micro-electronics industry. Available in 1L Trigger Sprays, 5L and 25L Bulk RTU Containers. 1 CleanGuard 1 IPA 2 CleanGuard 2 IMS
Non Sterile Code
ZNND81001 ZNDI82005
QUALITY TODAY - INNOVATION TOMORROW
2
Sterile Code
ZSAL64499 ZSAL64950 ZSAL64005 ZSAL65499 ZSAL65950 ZSAL65005 ZSDI82005
Description
CleanGuard 1 Trigger Sprays IPA / WFI CleanGuard 1 Trigger Sprays IPA / WFI CleanGuard 1 RTU IPA / WFI CleanGuard 2 Trigger Sprays IMS / WFI CleanGuard 2 Trigger Sprays IMS / WFI CleanGuard 2 RTU IMS / WFI CleanGuard 5 Trigger Spray Low Ionic Neutral Detergent CleanGuard 6 RTU Litre DI Water
Size
500ml 950ml 5 Litre 500ml 950ml 5 Litre 1 Litre 5 Litre
ISO
ISO4 ISO4 ISO4 ISO4 ISO4 ISO4 ISO5 ISO5
Pack Qty Each Each Each Each Each Each Each Each
Case Qty 24 15 2 24 15 2 6 1
As a guide to customers, Micronclean has indicated the highest classification of cleanroom each product would typically be used in.
Micronclean Consumables Catalogue 11
CleanGuard Biocides & Sporicides
1
2
Delivery Formats Unit Dose Concentrated unit dose for dilution in DI water or WFI. Most suited to mopping applications where active ingredient efficacy is paramount. Single use only. Trigger Sprays Available in 500ml and 950ml, our comfortable and easy to use trigger heads, provide the best application directly onto surfaces. Each triggers’ hold up volume is less than 0.3% significantly better than any other product on the market. Integral gore filter, hermetically sealed and cleanroom double bagged.
4
Rotational Disinfection System CleanGuard 3 Beta CleanGuard 3 Beta is the rotational cleanroom cleaner/ disinfectant agent to complement CleanGuard 4 Alpha. This product is a complex blend containing a unique amine based structure, blended with fully non-toxic, biodegradable detergent. The formulation does not contain any hazardous aldehydes or chlorine generating components. The formulation is highly effective as a cleaner and disinfectant against bacteria, mycobacteria, fungi, viruses and spores. The mode of action exhibited by CleanGuard 3 Beta has been shown to be via disruption of the RNA of the microorganisms and prevents resistance being built up. It is safe to use on any surface and is odourless and colourless. Sterile Code
ZSBT04005 ZSBT02500 ZSBT06001 ZSAP03005 ZSAP01500 ZSAP05001
CleanGuard 4 Alpha A synergistic blend of quaternary ammonium compounds, CleanGuard 4 Alpha is a highly effective, colourless, odour-free, non-staining, non-tainting one step disinfectant / detergent for the cleaning and disinfecting of all hard surfaces including metal, glass, plastics, rubbers and polymers. The mode of action for CleanGuard 4 Alpha is via denaturing of micro-organism proteins and effects on the metabolic pathways. CleanGuard 4 Alpha is a broad-spectrum biocide and is effective against bacteria and fungi. 1 2 3 4
5 Litre RTU Bulk container with pre-mixed solution ready for direct application.
3
CleanGuard 3 Beta Trigger Spray CleanGuard 4 Alpha Trigger Spray CleanGuard 4 Alpha 5 Litre RFU CleanGuard 3 Beta Unit Dose
Description
CleanGuard 3 Beta RTU Sterile CleanGuard 3 Beta Trigger Spray Sterile CleanGuard 3 Beta Unit Dose Sterile CleanGuard 4 Alpha RTU Sterile CleanGuard 4 Alpha Trigger Spray Sterile CleanGuard 4 Alpha Unit Dose Sterile
As a guide to customers, Micronclean has indicated the highest classification of cleanroom each product would typically be used in.
Size
5 Litre 500ml 250ml 5 Litre 500ml 50ml
ISO
ISO3 ISO3 ISO3 ISO3 ISO3 ISO3
Pack Qty Each Each Each Each Each Each
Case Qty 2 6 10 2 6 10
www.micronclean.com
12
Micronclean Consumables Catalogue
PureGuard
Pre-saturated Mopping System: Hardware Bucketless Mopping System The PureGuard Mopping System is a fully validated bucketless process designed to reduce contaminants from the cleanroom and improve cGMP compliance. PureGuard eliminates exposed chemical and soiled water from your cleaning process, whilst also removing the need for operators to mix/dilute cleaning chemicals. The system utilises pre-dosed disposable micro-fibre mops that are tested and validated for a 15M2 coverage of floors, walls and ceilings. The mops are evenly and uniformly dosed in an ISO4 filling area, clean packed, double bagged and sterilised by Gamma Irradiation.
Telescopic handle Sprays and wipes storage area
Mop pack storage for use
Sprays and wipes storage area
Mop dispenser
Soiled mop collector
Cleanroom compatible wheels
Product Code
MTSS01001 MFSS79226 MHSS02001 MHPC79322
Description
PureGuard Stainless Steel Complete Trolley System with Basket Attachment Low Profile Stainless Steel Mop Frame, swivel hinge with locking nut Stainless Steel Fixed Length Handle 142cm Telescopic Polymer Handle, extendable from 86.5cm to 160cm
Mop frame and handle storage
Size
Universal 10 x 40cm 142cm 86.5 - 160cm
ISO
ISO4 ISO4 ISO4 ISO4
Pack Qty Each Each Each Each
Case Qty Each Each Each Each
Micronclean Consumables Catalogue
PureGuard
Pre-saturated Mopping System: Wipes Mops Disinfectant Impregnated Dry Mops Mops can also be provided dry. Dry mops can be dosed onsite with alternative cleaning agents, however these will have to be validated independently to qualify the appropriate coverage.
Disposable Mop Material Short Pile Microfibre Designed for cleanroom applications up to ISO Class 4, this very low shedding polyester microfibre mop has fully bound edges and due to the polyester reservoir holds enough disinfectant to provide 15M2 cleaning and application coverage. Gamma irradiated. The rear side of the mop has 2 pockets to enable a secure fit and hands free connection with the stainless steel mop frame.
Pre-saturated Mops: Cleaning Agents Mops are uniformly dosed to achieve 15M2 coverage with any of the following cleaning agents: CleanGuard Alpha CleanGuard Beta CleanGuard IPA
CleanGuard IMS
CleanGuard Neutral Detergent
Sterile Code
MSMA04016 MSMA01016 MSMB04016 MSMB01016 MSME04016 MSME01016 MSMI04016 MSMI01016 MSMS04016 MSMN01016 MSMD01016
Description
PureGuard 4 Mops dosed with Alpha Individually packed PureGuard 4 Mops dosed with Alpha Stack packed PureGuard 3 Mops dosed with Beta Individually packed PureGuard 3 Mops dosed with Beta Stack packed PureGuard 2 Mops dosed with IMS Individually packed PureGuard 2 Mops dosed with IMS Stack packed PureGuard 1 Mops dosed with IPA Individually packed PureGuard 1 Mops dosed with IPA Stack packed PureGuard 5 Mops dosed with Neutral Detergent Individually packed PureGuard 5 Mops dosed with Neutral Detergent Stack packed PureGuard 6 Mops Dry Stack Packed
Size
420 x 130mm 420 x 130mm 420 x 130mm 420 x 130mm 420 x 130mm 420 x 130mm 420 x 130mm 420 x 130mm 420 x 130mm 420 x 130mm 420 x 130mm
ISO
ISO4 ISO4 ISO4 ISO4 ISO4 ISO4 ISO4 ISO4 ISO4 ISO4 ISO4
Pack Qty 1 10 1 10 1 10 1 10 1 10 1
Case Qty 60 x 1 8 x 10 60 x 1 8 x 10 60 x 1 8 x 10 60 x 1 8 x 10 60 x 1 8 x 10 60 x 1
As a guide to customers, Micronclean has indicated the highest classification of cleanroom each product would typically be used in.
www.micronclean.com
13
14
Micronclean Consumables Catalogue
PureGuard How the system works
PureGuard mops are delivered in packs of 10 mops, these are cleanroom decontaminated and impregnated with CleanGuard rotational disinfectants and gamma irradiated.
Stage 1
Remove the outer bag and insert the mop pack into the dispenser attached to the trolley.
Stage 2
Using the system’s cleanroom cutter, open the mop bag.
Stage 3
Each mop can process an average of 15M2 of cleanroom surface.
Place your next order of mops with Micronclean. Simple, safe and compliant, reducing SOP’s and eliminating the chance for cross contamination or operator dilution errors.
PureGuard Mopping System
Once all the soiled mops have been placed into the cleanroom waste sack, seal with a cable tie and remove from the trolley.
Stage 10
Micronclean Consumables Catalogue
PureGuard
How the system works
The opened bag is then stretched over the special spring action arms. This action ensures unimpeded access to the ‘stack’ of mops.
Stage 4
Once a mop is used, a single click on the mop frame releases the used mop into the Cleanroom waste sack. Process starts again.
Stage 9
The stainless steel mop frame is released by un-clipping the hinge, the mop frame can then be lowered into the open bag and engaged into the mop end pockets.
Stage 5
Floor mopping is best approached with the mop head adjusted to move in two planes, so an overlapping sinusoidal action is made.
Stage 8
Once the mop frame is engaged, a light push locks the hinge and the mop and frame are now connected and ready to use without having to touch the mop with gloved hands.
Stage 6
Each mop within the pack will effectively cover 15M2 depending on levels of contamination. Wall and ceiling use is easiest with mop head set to move in one plane only.
Stage 7
Watch a demo of the PureGuard System on Micronclean’s YouTube Channel
www.micronclean.com
15
16
Micronclean Consumables Catalogue
VeriClean
Triple BucketImpregnated Cleaning System Disinfectant Wipes VeriClean Triple Bucket System The VeriClean Triple Bucket System captures and isolates contaminants, ensuring unsoiled delivery of cleaning and sanitizing agents. No more re-applying of soiled water and weakened solutions, experienced with old-style mopping. Each component of the VeriClean System plays an important role in delivering the highest level of cleanliness; The innovative swivel mop frame uniformly and precisely applies cleaning and sanitizing agents onto floors, walls and ceilings. The unique wringing mechanism, exerts force evenly across the whole surface of the mop, extracting the maximum volume of soiled contaminants. VeriClean is compatible with gamma, ETO & autoclave sterilization - up to 121° C for 30 minutes. System Includes: Stainless Steel Trolley with Autoclaveable Casters, Wringer, 3 15L buckets with SS handles, 1 Telescopic Polymer Mop Handle with low profile Stainless Steel Mop Frame. Available with wire basket handle attachment and 4 x 6 Litre pails (as pictured). Mop Handles Stainless Steel Fixed Length 142cm fixed length handle made from 304 stainless steel with tig welded end cap and fixing hole to attach to mop frame. Polymer Telescopic Telescopic mop handle extendable from 86.5 to 160cm made from high quality, lightweight polyester and composite materials, fixing hole to attach to the mop frame, twist lock to adjust length and lock in place, durable and chemically resistant. Stainless Steel Mop Frame Manoeuvre on floors, walls, ceilings and confined areas such as corners and steps, also permits ‘S’ motion mopping. Low profiled styainless steel for cleaning under benches, equipment and hard to reach surfaces. Continual surface contact at any angle, accurately balanced and non-flipping. Quick release frame-locking mechanisk enables easy replacement of contaminated mops.
Product Code
GL79218 ZNHAN320F MFSS79226 MHSS79232 MHSS02001
Description
VeriClean Triple Bucket System inc Mop Frame & Handle VeriClean Wire Basket Attachment & 4 x 6L Pails (To fit on GL79218) Stainless Steel Mop Frame Telescopic Polymer Handle Fixed Length Stainless Steel Handle
Size
45 Litre 24 Litre 10 x 40cm 86.5 to 160cm 142 cm
ISO
ISO4 ISO4 ISO4 ISO4 ISO4
Pack Qty Each Each Each Each Each
Case Qty Each Each Each Each Each
Micronclean Consumables Catalogue
Disinfectant Impregnated Wipes
Cleaning Equipment
Hardware for the maintenance of Critical Environments
Isolator Cleaning Tool A quick and efficient tool for the cleaning of compounding isolators, biological safety cabinets, laminar flow hoods, pass boxes, transfer hatches, air showers and other mini-environments. The Micronclean Isolator Cleaning Tool is made from durable 304 stainless steel and has a 360 degree swivel head. Handle made from smooth aluminium.
Isolator Cleaning Bonnet Made from dual layer continuous filament 100% polyester, the Micronclean Isolator Cleaning Bonnet is designed to be easily applied to the Isolator Cleaning Tool and is laundered prior to use. The Polyester material ensures a high wiping performance, that is durable and low linting, whilst the dual layer provides absorbency. Sterilised by Gamma Irradiation. Tested to ASTM-D-629.
Nilfisk GM80CR Cleanroom Vacuum Lightweight, portable and quiet, the GM 80CR is perfect for use in cleanrooms, research labs and other critical environments. Four-stage filtration system includes a 10 litre paper bag, main filter, microfilter and ULPA exhaust filter. A conductive hose and accessories provide ESD protection. Included Accessories Detachable Trolley, 10 foot, 32MM Conductive Plastic Hose, 2 Straight Stainless Steel Wands, Floor Nozzle, Conductive Dust Brush, Conductive Crevice Nozzle, Utility Nozzle, Tool Caddie, 30 foot Power Cord and a pack of 5 Paper Bags. ASTM-D-629. Product Code
VCSS80230 VCPB80ZZZ ZSPW12ZZZ ZNSS01035 ZNSS01061
Description
Nilfisk GM80CR Cleanroom Vacuum Cleaner with Ulpa Filter Nilfisk GM80CR replacement paper bags - Pack of 5 Isolator Cleaning Bonnets Sterile Isolator Cleaning Tool - Short Handle Isolator Cleaning Tool - Long Handle
Size
10 Litre 10 Litre Universal 35cm 61cm
ISO
ISO4 ISO4 ISO4 ISO4 ISO4
Pack Qty Each Each Each Each Each
Case Qty Each 5 Bags 20 x 1 1 1
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18
Micronclean Consumables Catalogue
Big Blue Book
Selection of Cleanroom Garments Disinfectant Impregnated Wipes and Change Frequency Garment Systems and Changing Frequency Cleanroom clothing acts as a mobile filter for the wearer and the basic rule is that more cover = more contamination control. Some published guidance is available and The Institute of Environmental Sciences and Technology, Contamination Control Division, have produced a useful Recommended Practice; IEST-RPCC003.3ref 1 This document addresses the gowning of personnel as an important aspect of cleanroom contamination control and gives guidance on the selection, specification, maintenance and testing of clothing for use in aseptic and non-aseptic cleanroom conditions. It provides recommendations on the types of clothing appropriate for different ISO 14644-1ref 2 classified areas and recommends change frequencies for these areas, as shown in the table below.
TYPE 5
TYPE 6
ANTISTATIC EN1149-1
NUCLEAR PARTICLE
CHEMICAL PROTECTION
BIOHAZARD EN14126
Clothing protection symbols
IEST-RP-CC003.3 clothing recommendations at different ISO classifications Apparel Type
8 and 7
6
AS AS Inner suit R R Hair cover AS AS Woven gloves AS AS Barrier gloves AS AS Facial cover AS AS Hood AS AS Powered headgear R AS Frock AS R Coverall AS AS Two piece suit R AS Shoe cover AS R Boot AS AS Special footwear 2 per week 3 per week Frequency of change
ISO 14644-1 Air Cleanliness Class 5 5 Aseptic 4
R R AS AS R R AS AS R AS AS R AS Daily
AS R NR R R R AS NR R NR NR R AS Per entry
R R NR R R R AS N R NR NR R AS Per entry
3
2 and 1
R R NR R R R AS NR R NR NR R AS Per entry
R AS NR R AS AS R NR R NR NR R AS Per entry
Key: R = Recommended, NR = Not Recommended, AS = Application Specific. Tables adapted and reprinted from IEST-RP-CC003 with permission from the Institute of Environmental Sciences and Technology (IEST). Copyright by IEST, www.iest.org
Micronclean Consumables Catalogue / January 2016 19
Mopping: Dry
Low linting data logging and recording material
CLOTHING Contamination Control for Critical Environments
20 Micronclean Consumables Catalogue
BodyGuard
Launderable Cleanroom Garments 1
2
Cleanroom Garments High Performance Barrier Fabrics Micronclean has been providing critical garment services within the UK for over 30 years. This experience has allowed the development of a range of cleanroom garments to exceed the stringent needs of all types of cleanroom users. Micronclean’s cleanroom fabrics have been independently performance validated for their whole lifecycle to ensure compliance. Sterilisation Micronclean Cleanroom Garments are designed to withstand sterilisation via steam or irradiation and are validated for optimum performance Autoclave: 80 Cycles Gamma Irradiation: 50 Cycles
3
4
1 Coverall with Collar 2 Coverall with Collar, Hood & Overboots 3 Lancer Coat 4 Tunic & Trousers Short Sleeve
Non Sterile Code
F11WF5505JGB SC2WF5505JGB 400WF5505JGB T01WF5505JGB C91WF5505JGB MR9MU9NB
Description
Cleanroom Coverall with Integral Hood, Mono Filament Polyester ESD Grid, Sky Blue Cleanroom Coverall with Mandarin Collar, Mono Filament Polyester ESD Grid, Sky Blue Cleanroom Hood with press studs, Mono Filament Polyester ESD Grid, Sky Blue Cleanroom Overboots with toggles & press studs, Mono Filament Polyester ESD Grid, Sky Blue Cleanroom Lancer Coat with zip & polyester cuffs, Mono Filament Polyester ESD Grid, Sky Blue Cleanroom long sleeve press studs Tunic & Trousers with drawstring, 100% Polyester Navy Blue
Size
XS - XXL XS-XXL XS - XXL XS - XXL XS - XXL XS - XXL
ISO
ISO4 ISO4 ISO4 ISO4 ISO4 ISO5
Pack Qty Each Each Each Each Each Each
As a guide to customers, Micronclean has indicated the highest classification of cleanroom each product would typically be used in. QUALITY TODAY - INNOVATION TOMORROW
Micronclean Consumables Catalogue
21
Big Blue Book
Correct Cleanroom Gowning Technique
Cleanroom Gowning Technique Humans pose the greatest contamination threat to any clean environment, so It is vitally important that proper gowning technique is employed to ensure complete coverage of the operator and to minimise contamination of the donned garments. Every critically controlled environment should implement a suitable gowning procedure; below is an example procedure for an ISO4 Cleanroom. Cleanroom Gowning Video Available on the Micronclean YouTube channel 1
2
3
4
8
7
6
5
9
10
11
12
ONE: Wash hands thoroughly, scrubbing nails, use alcohol hand rub.
NINE: Remove coverall from sterile pouch, roll the garment arms and
THREE: Take 3 steps with each foot on entry mat entering the airlock.
and insert into coverall leg, repeat with second leg, pull up to the waist
TWO: Don disposable mob cap, overshoes & beard snood if required. FOUR: Put undergarments on, tunic, trousers & footwear if required. FIVE: Don cleanroom gloves and rub gloved hands with alcohol rub.
SIX: Select packaged garment set, check sterility indicator and packaging integrity, place on step-over bench and open.
SEVEN: Open Cleanroom Hood, hold on inside, don and fasten. EIGHT: Fasten Face Mask, ensure coverage of mouth and nose.
legs up, touching only the internal surfaces of the coverall. Raise one leg and insert arms. Cross legs and zip to top, tuck hood into collar.
TEN: Sit on the step-over bench, lift one leg and don overboot, place on the clean side over the bench and fasten, repeat with second boot. ELEVEN: Don sterile gloves, only touching inside glove surfaces.
TWELVE: Discard packaging into bin. Check appearance in the mirror, ensure whole body is covered, add goggles if required.
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22 Micronclean Consumables Catalogue
DuPont Tyvek™
Disposable Garments & Accessories 2
DuPont Tyvek Garments Tyvek Classic Xpert The brand-new and enhanced Tyvek® Classic Xpert provides wearers with greater liquid and particulate protection as well as an innovative design for optimal safety. Drawing on decades of experience in the field, the Tyvek® Classic Xpert garment now offers enhanced protection against a range of threats, from water-based chemical liquid splashes, asbestos, pharmaceutical and radioactive particulates to biological hazards. Chemical protective clothing category III, type 5B and 6B. Tyvek Classic Type 5/6 Coverall.
Washed Tyvek Laundered and packed within Micronclean’s ISO 14644-1 Class 4 cleanroom laundry facility: • Decontaminated hooded coveralls meet Class I of standard IEST-RP-CC003.3 • Anti-static treatment • Low linting • Zip fastening with no flap • Elasticated cuffing at wrists and ankles • Integrated socks
3
Tyvek Industry A range of disposable garments and accessories for the cleanroom and lab industries manufactured from Tyvek and clean packed. Including: Lab & Howie Coats Over Boots & Shoes 1 Sleeve Protectors Boilersuits Hoods
1 Tyvek® Lab Coat 2 Tyvek® Classic Xpert 3 Tyvek® Lab Coat
Non Sterile Code
DNWH07SML-XXL
DNWH09SML-XXL
Sterile Code
Description
DSWH08SML-XXL
Tyvek Classic Xpert Coverall
DSWH31MED-XXL
GL74940A (10) GL70382
DNWH24ZZZ
DNWH06SML-XXL
Tyvek Classic Xpert Coverall Washed Coverall with Integral feet (Bunny Suit) Tyvek Lab Coat with Collar zip front
Tyvek Sleeve Protectors elasticated cuffs DSWH24ZZZ
DSWH06SML-XXL
Tyvek Hood
Tyvek Apron, head loop and waist ties
Tyvek Boilersuit with Collar, elasticated cuffs and ankles
Size
S - XXL S-XXL M - XXL S - XXL Universal Universal Universal S - XXL
ISO
ISO5 ISO5 ISO5 ISO5 ISO5 ISO5 ISO5 ISO5
Pack Qty Each Each Each Each Pair Each Each Each
Case Qty 25 50 20 50 100 100 50 25
As a guide to customers, Micronclean has indicated the highest classification of cleanroom each product would typically be used in. QUALITY TODAY - INNOVATION TOMORROW
Micronclean Consumables Catalogue
23
SureGuard
Disposable Apparel for Clean Environments
SureGuard Type 5&6 Category III SureGuard disposable apparel is the first defence in protecting your environment from airborne particulate and your operators from the environment. Offering Category III chemical protection this low linting barrier fabric provides customers an economical alternative. SureGuard micro porous fabric is manufactured from Polypropylene with a Polyethylene laminate, affording high levels of cleanliness with a superior tensile strength. Water vapour transmission rates exceed those of other disposables providing superb comfort and breathability. CE marked to Type 5 & 6, SureGuard provides a cost effective option for disposable apparel without sacrificing quality.
Non Sterile Code
DNWH04SML-XXL DNWH10SML-XXL
Sterile Code
DSWH04SML-XXL DSWH13SML-XXL
SureGuard Garments SureGuard is manufactured from two materials bonded together. The first material is a specially designed polypropylene textile that makes the material strong and hard to puncture. The second material is a film that has very small holes in it to allow the garment to breathe.
The Polyethylene film ensures that the outside of the suit is resistant to most chemicals and will not wet out. The interior material transports perspiration away from the wearer unlike other similar products where moisture pools and drips.
These holes will not permit chemicals to pass through but will permit air and water vapour to permeate; creating a safe and comfortable garment.
Description
SureGuard 1 Anti-static Hooded Coverall SureGuard 2 Anti-static Coat SureGuard 3 Hooded Coverall with Integral Feet
As a guide to customers, Micronclean has indicated the highest classification of cleanroom each product would typically be used in.
Size
S - XXL S - XXL S - XXL
ISO
ISO5 ISO5 ISO3
Pack Qty 1 1 1
Case Qty 25 25 25
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Micronclean Consumables Catalogue
SkinGuard
Non Sterile Examination Gloves
Boxed Gloves SkinGuard 2 Powder free boxed nitrile examination gloves for use in low grade clean areas and laboratories. Made from Carboxylated Butadiene Acrylonitrile (XNBR) with a textured surface. 150 per Box / Beaded Cuff / Hypoallergenic ASTM D3578-95 EN 374 - 3 N 374 - 2 EN 455-1 & 2
1
3
Bulk Packed Gloves SkinGuard 10 12” Natural Latex ambidextrous gloves, with beaded cuff and a textured surface. Bulk packed.
With a thickness of 6.5mil (±1) and a tensile strength of 3335 psi / 23 mpa, SkinGuard 10 combines durability with dexterity for increased operator protection and sensitivity. SkinGuard 11 & 12 12” White Nitrile ambidextrous gloves with beaded cuff and textured surface, provide operator comfort and flexibility. SkinGuard 11 is suitable for ISO4 applications, achieving a liquid particle count (LPC) of <600 at 0.5µ, whilst SkinGuard 12 is designed for ISO 6 areas achieving <1600 LPC at 0.5µ. Product Code
GNNB02SML-XLG GNLN10XSM-XLG GNNW11SML-XLG GNNN12SML-XLG GNVW13SML-XLG GSLN52SML-XLG
Description
2
Kimtech Pure G3 NXT 12” White Nitrile ambidextrous gloves with textured fingertip and beaded cuff, suitable for processes requiring strength and puncture resistance.
1 Kimtech Pure GX NXT 2 SkinGuard 10 3 SkinGuard 13
SkinGuard 2: Blue Nitrile Boxed 9” Ambidextrous Glove SkinGuard 10: Natural Latex 12” Ambidextrous Glove SkinGuard 11: White Nitrile 12” Ambidextrous Glove SkinGuard 12: White Nitrile 12” Ambidextrous Glove SkinGuard 13: Opaque Vinyl 12” Ambidextrous Glove Kimtech Pure G3 NXT: White Nitrile 12” Ambidextrous Glove
SkinGuard 13 Vinyl ambidextrous bulk packed gloves for use in a wide range of applications, including micro-electronics and food preparation and a range of non-critical applications. 100 per pack / Anti-static Powder free / Easy to don ASTM D3578-95 EN 374 - 3 N 374 - 2 EN 455-1 & 2 Size
S-XL S-XL S-XL S-XL S-XL S-XL
ISO
ISO7 ISO5 ISO5 ISO6 ISO4 ISO5
Pack Qty 150 100 100 100 100 100
Case Qty 10 x 150 10 x 100 10 x 100 10 x 100 10 x 100 10 x 100
As a guide to customers, Micronclean has indicated the highest classification of cleanroom each product would typically be used in.
QUALITY TODAY - INNOVATION TOMORROW
Micronclean Consumables Catalogue 25
1 1 2 3 4
SkinGuard
Kimtech Pure G3 SkinGuard 1 Isolator Gloves SkinGuard 6
Sterile Surgeons Gloves Protection & Dexterity for Critical Environments
3
SkinGuard 1 A sterile, powder free, polychloroprene glove designed to provide unrivalled performance, providing protection from chemicals, cytostatic drugs and biological agents while offering a high level of wearer comfort. This is achieved by graduated thickness, which provides fingertip sensitivity without compromising the level of protection provided. The glove also incorporates surface treatment for improved donning and grip. Advanced technology produces an exceptionally soft and pliable material combined with excellent strength and integrity. The hand-specific shape of the glove is ergonomically designed for comfort and to minimise hand fatigue.
2
Kimtech Pure G3 Sterling 12” Grey Nitrile hand specific gloves with textured fingertip and beaded cuff, suitable for processes requiring strength and puncture resistance.
Pair Packed Gloves SkinGuard 5 12” Natural Latex hand specific gloves, with beaded cuff and a textured surface. Packed in pairs.
SkinGuard 6 12” White Nitrile hand specific gloves with beaded cuff and textured surface, provide operator comfort and flexibility.
With a thickness of 6.5mil (±1) and a tensile strength of 3335 psi / 23 mpa, SkinGuard 5 combines durability with dexterity for increased operator protection and sensitivity.
SkinGuard 6 is suitable for ISO3 pharmaceutical, medical and healthcare applications, particularly suited to processes that require sustained periods of wear.
Product Code
GSPG31065-90 GSLN05060-90 GSNW06060-90 GSNW07060-90 GSNN57065-90
4
SkinGuard 7 As above but with a 16” glove length for increased resistance and less chance of glove slippage.
Description
SkinGuard 1: Green Polychloroprene 12” Hand Specific Glove (STERILE) SkinGuard 5: White Latex 12” Hand Specific Glove (STERILE) SkinGuard 6: White Nitrile 12” Hand Specific Glove (STERILE) SkinGuard 7: White Nitrile 16” Hand Specific Glove (STERILE) Kimtech Pure G3 Sterling: Grey Nitrile 12” Hand Specific Glove (STERILE)
As a guide to customers, Micronclean has indicated the highest classification of cleanroom each product would typically be used in.
Gauntlet & Isolator Gloves Micronclean offer a range of isolator gauntlets available in a variety of different materials, lengths and port sizes suitable for use in fixed and mobile isolator units. Our range of products, manufactured under an ISO9001:2008 quality system include the following materials; Polyurethane / CSM / Neoprene Natural /Rubber Latex / Butyl All gauntlets individually tested and QC checked. Gauntlets can also be clean processed, clean packed and Irradiated. Size
6.5 - 9.0 6.0 - 9.0 6.0 - 9.0 6.0 - 9.0 6.5 - 9.0
ISO
ISO4 ISO4 ISO5 ISO5 ISO3
Pack Qty 10 Pairs 10 Pairs 10 Pairs 10 Pairs 30 Pairs
Case Qty
5 x 10 Pairs 20 x 10 Pairs 20 x 10 Pairs 20 x 10 Pairs 30 x 10 Pairs
www.micronclean.com
26
Micronclean Consumables Catalogue
FaceGuard
Face and Head Coverings Wipes Disinfectant Impregnated 1 Beard Snood 2 Duckbill Pouch Style Facemask 3 FaceGuard 2 with Ear Loops
Pleated Face Masks FaceGuard 1, 2 & 3 FaceGuard Pleated 3-Ply ES Face Masks, cleanroom manufactured and packed. Ultrasonic bonding ensures a cleaner mask by reducing contamination & outgassing. Filter centre layer manufactured from 18 gsm high density meltblown polypropylene. Inner and outer layer made from 17 gsm combined polymer ES. FaceGuard 1 with ties.
Faceguard 4 FaceGuard Pouch Mask is designed to provide the wearer with additional comfort from an increased internal breathing chamber. Additional particle containment is offered from the extended neck veil. Outer and Inner layer made from 20gsm thermal calendared polypropylene, filter layer made from 20gsm melt blown polypropylene. Particle filtration efficiency 98% @ 0.3µ
FaceGuard 2 with ear loops.
Bacteria filtration efficiency 99% @ 3µ
FaceGuard 3 with head loop.
Particle filtration efficiency 97.6% @
Beard Snoods Beard Masks are made from soft spunbond nonwoven fabric. These hygienic masks have soft elastic ear-loops offering comfortable and effective barrier protection. They are available in white and one size fits all. Mob Caps Pleated Mob Caps made from soft, thermally bonded polypropylene with enclosed, double elastication around the edge. Complete hair covering, one size fits all. Available in White or Blue. Also available Spunbond Polypropylene balaclava style hood for complete head covering.
0.1µ
Bacteria filtration efficiency 95.1% @ 3µ
2 1
Non Sterile Code
MNTW01100 MNTW01020 MNEW01100 MNEW01020
MNHW01100 MNHW01020 MNHW04010 MNWH01ZZZ HNWH01ZZZ
3
Sterile Code
MSTW01020
MSEW01020
MSHW01020 MSHW04020
MSWH52ZZZ
Description
FaceGuard 1 Mask with Ties FaceGuard 1 Mask with Ties individually packed FaceGuard 1 Mask with Ties individually packed FaceGuard 2 Mask with Ear Loops FaceGuard 2 Mask with Ear Loops individually packed FaceGuard 2 Mask with Ear Loops individually packed FaceGuard 3 Mask with Head Loops Universal FaceGuard 3 Mask with Head Loops individually packed FaceGuard 3 Mask with Head Loops individually packed FaceGuard 4 Pouch Facemask with Headband FaceGuard 4 Pouch Facemask with Headband Individually Packed FaceGuard 5 Beard Snoods - White FaceGuard 6 Double Elastic Mob Cap CR Classic Face Mask with Ties - White sterile 9”
As a guide to customers, Micronclean has indicated the highest classification of cleanroom each product would typically be used in.
ISO
ISO5 ISO5 ISO5 ISO5 ISO5 ISO5 ISO5 ISO5 ISO5 ISO5 ISO5 ISO5 ISO5 ISO4
Pack Qty 50 20 20 100 20 20 100 20 20 50 20 100 100 20
Case Qty 20 x 50 50 x 20 15 x 20 10 x 100 50 x 20 25 x 20 10 x 100 50 x 20 25 x 20 10 x 50 25 x 20 5 x 100 10 x 100 10 x 20
Micronclean Consumables Catalogue
27
TuffGuard
Strong and Durable Disposable Footwear Disinfectant Impregnated Wipes 2 1
3
TuffGuard 2 Blue Polythene Overshoes The most cost-effective end of the disposable footwear market, Micronclean’s Blue Polythene overshoes have undergone stringent quality checks to ensure that they are the most durable polythene overshoe available. Available in a 14” or 16” length cover, Heavy Duty polythene also available.
Tyvek Overshoes & Overboots Tyvek overshoes and overboots consist of a tyvek upper area with a Tyvek or a PVC sole. The benefit of using Tyvek lies in it’s breathability properties, and combined with a PVC sole you have a high performance shoe in terms of particle retention and non slip combined with a highly comfortable product for the wearer. Additional benefits of Tyvek product is that they have ESD properties, can be laundered or irradiated and has the additional benefit of being antistatic
4 1 2 3 4
Product Code
SNBL01016 SNBL31014 SNBL31016 SNWH81006 SNWH83016 SNWH82009 SNWH81016 SNRE81009 SNWH03016
Description
TuffGuard 3 TuffGuard PVC Overshoes TuffGuard PVC overshoes are manufactured from 100 micron Gauge PVC, with an extra strength seam. The TuffGuard range of overshoes are the strongest and most durable disposable footwear product on the market. The textured surface of the overshoe give them superior non-slip properties, and the range of size options ensure a shoe cover that fits a wide range of shoe sizes. Available in Red or White and also available in a heavy duty 175 micron for more demanding environments.
TuffGuard 3 Tyvek Overboot TuffGuard 2 Tyvek Overshoes
TuffGuard 1 Heavyweight Blue Polythene Overshoe TuffGuard 2 Blue Polythene Overshoes TuffGuard 2 Blue Polythene Overshoes TuffGuard 3 White 100 micron gauge PVC Overshoes TuffGuard 3 White 100 micron gauge PVC Overshoe TuffGuard 3 White 100 micron gauge PVC Overshoes TuffGuard 3 White 100 micron gauge PVC Overshoes TuffGuard 3 Red 100 micron gauge PVC Overshoes TuffGuard 6 Anti-Slip White Overshoes
Size
16” 14” 16” 6” x 14” 6” x 16” 9” x 14” 9” x 16” 9” x 16” 16”
ISO
ISO6 ISO6 ISO6 ISO5 ISO5 ISO5 ISO5 ISO5 ISO5
Pack Qty 100 100 100 500 500 500 500 500 100
Case Qty 10 x 100 20 x 100 20 x 100 1 x 500 1 x 500 1 x 500 1 x 500 1 x 500 10 x 100
As a guide to customers, Micronclean has indicated the highest classification of cleanroom each product would typically be used in.
www.micronclean.com
28
Micronclean Consumables Catalogue
TuffGuard
Cleanroom Shoes and Clogs 1 2
Toffeln Cleanroom Footwear TuffGuard Autoclaveable Safety Clog: Purposely designed for cleanrooms and sterile areas. Unisex white flexible clog with adjustable heel strap Autoclavable to 130°C, Integrated 200J safety steel toe cap, Antistatic, CE Marked, Conforms to EN ISO 347. Toffeln Steri-Klog: Long-lasting, strong thermoplastic, washable, unisex clog with non-slip sole, side vents and adjustable strap over the bridge. Can be autoclaved at temperatures of up to 134°C making them an ideal choice for visitors and short-stay personnel. The footbed shape allows feet to spread naturally.
Toffeln Proflex Shoes: An electro static dissipative shoe made from ‘Action-Breathe’ uppers, a high-tech S2 material, stronger than leather, highly resistant, durable, waterproof and breathable. The Pro Flex Shoes are washable and also have a non slip sole for added safety. Toffeln Safety Lite Shoes: Safety Shoes with an ergonomically designed foot shape provides room for feet to spread naturally, and a wider safety steel toe-cap prevents toes from being pinched. Electro static dissapative protection is provided by anti-static soles, high grade materials have been carefully selected to give an enhanced level of comfort and extra protection is provided by the slip-resistant soles.
4
3
1 2 3 4
Description
Size
Toffeln Safety Lite Shoes White
3, 4, 5, 6, 7, 8, 9, 10, 11
Product Code SNWH350 (Add 03 for size 3 to 11 for size 11)
Toffeln Steri-Klog White
SNWH340 (Add 03 for size 3 to 11 for size 11)
Toffeln Comfy Lite Safety Shoes White
SNWH440 (Add 03 for size 3 to 11 for size 11) SNWH360 (Add 03 for size 3 to 11 for size 11)
Toffeln Safety Lite Cleanroom Shoes Toffeln Pro Flex Cleanroom Shoes Toffeln Steri-Klog TuffGuard Autoclaveable Safety Clog
TuffGuard Autoclaveable Safety Clog White
3, 4, 5, 6, 7, 8, 9, 10, 11
Pack Qty 1 Pair
Case Qty 1 Pair
3, 4, 5, 6, 7, 8, 9, 10, 11
1 Pair
1 Pair
3, 4, 5, 6, 7, 8, 9, 10, 11
1 Pair 1 Pair
1 Pair 1 Pair
Micronclean Consumables Catalogue / January 2016 29
Mopping: Dry
Low linting data logging and recording material
CONSUMABLES Contamination Control for Critical Environments
30
Micronclean Consumables Catalogue
GuardMark Cleanroom Stationery
GuardMark 4 Munising LP Paper Munising LP readily accepts inks and laser printing without smudging. It features high opacity, good heat stability, chemical and moisture resistance and can be photocopied, sterilised or shredded. It also accepts standard printing inks and requires no special procedures for printing other than those needed to keep the paper free from contamination.
GuardMark 1 Pens Anti-static Pens with a low ionic ink, clean packaged in 12s and double bagged. Available in Black and Blue, can be sterilised by Gamma Irradiation. GuardMark 2 Sterile Marker Pen Sterile marker for writing on glass, metal and plastic. Polypropylene Barrel with Polyester nib, black permanent ink, can even write on wet surfaces, water and alcohol resistant. 3
1 2
1 2 3 4
4
GuardMark 3 Paper GuardMark paper is a 72GSM paper designed for use in cleanrooms and controlled environments. With ultra low particle and fibre generating properties, low ionic content and excellent IPA resistance, GuardMark is a hard wearing clean paper. Compatible with most inks for writing without smearing and in addition an excellent heat resistant material for laser printing and use in photocopiers. GuardMark is ROHS compliant and can be sterilised by Autoclave or Gamma Irradiation. Available in White, Blue, Green, Yellow and Pink.
GuardMark 4 Munising Paper GuardMark 1 Pens GuardMark 2 Sterile Marker Pens GuardMark 3 Cleanroom Paper
Non Sterile Code
ZNBK01012 ZNBL01012
ZNWH04072 ZNBL04072 ZNPI04022 ZNGR04022 ZNYE04022 ZNWH04225 ZNBL04225 ZNWH04018
QUALITY TODAY - INNOVATION TOMORROW
Sterile Code
ZSBK01012 ZSBL01012 ZSBK03010
ZSWH04225 ZSBL04225 ZSWH04018
Description
GuardMark 1 Cleanroom Pens Black GuardMark 1 Cleanroom Pens Blue GuardMark 2 Sterile Marker Pens GuardMark 3 Cleanroom Paper White 72 GSM GuardMark 3 Cleanroom Paper Blue 72 GSM GuardMark 4 Munising Cleanroom Paper Pink 22lbs GuardMark 4 Munising Cleanroom Paper Green 22lbs GuardMark 4 Munising Cleanroom Paper Yellow 22lbs GuardMark 4 Munising Cleanroom Paper White 22.5lbs GuardMark 4 Munising Cleanroom Paper Blue 22.5lbs GuardMark 4 Munising Cleanroom Paper White 18lbs
Size
A4 A4 A4 A4 A4 A4 A4 A4
ISO
ISO4 ISO4 ISO4 ISO5 ISO5 ISO4 ISO4 ISO4 ISO4 ISO4 ISO4
Pack Qty 12 12 1 250 250 250 250 250 250 250 250
Case Qty 10 x 12 10 x 12 10 x 1 10 x 250 10 x 250 10 x 250 10 x 250 10 x 250 10 x 250 10 x 250 10 x 250
As a guide to customers, Micronclean has indicated the highest classification of cleanroom each product would typically be used in.
Micronclean Consumables Catalogue 31
GuardPack
Supporting Consumables 1 Sterile Grip Seal Bags 2 Cleanroom Packing Tape 3 Irradiation Indicators
Cleanroom Packaging Sterile Grip Seal Bags 75 micron (300 gauge) polythene bags with a gri seal opening, clean packed and sterilised by gamma irradiation. Sterile Waste Sacks Low density polyethylene (LDPE) 25 micron (100 gauge) cleanroom waste sacks, sterile. Tape Micronclean offer a range of Tapes for use in cleanrooms, from vinyl construction tape for temporary partitioning and sealing, to wafer shipping tape and specialist tapes for the semiconductor and Healthcare industries. Available in varied colours and sizes. Clean packed, also available sterile.
Cleanroom Labels Low Temperature Labels Low temperature labels are designed for use with product that must be labelled and stored in fridges or freezers, with a maximum temperature of minus 40 degrees celcius. A6 backing sheets with 2 across and 10 down 45mm x 12mm white labels. TSE and Pthalate free. Clean packed and sterilised by gamma irradiation. Barcode Labels Pre-printed sterile barcode labels with a pre-determined sequence, 16 labels per flat sheet, perforated down the centre. Also available on a reel upon request.
Irradiation Indicators Gammatex irradiation sterilisation indicators are Class 1 process indicators, manufactured in compliance with ISO 11140-1:2005 “Sterilisation of health care products - Chemical indicators”. Gammatex gamma sterilisation indicators undergo a simple yellow to red colour change when exposed to gamma radiation. They are used in the industry as qualitative process indicators for the gamma irradiation sterilisation process. Processed labels can also be retained as part of a quality control validation record.
3
1
2
Non Sterile Code
BSPE01250
Sterile Code
Description Sterile Polythene Waste Sack 26 x 44”
Size
ISO
BSPE81230
Sterile Grip Seal Polythene Bag 8 x 12”
127 x 203mm 203 x 304mm
ISO4
BSPE58300
ZNPY01012 TNWH31ZZZ
BSPE91430 TSWH31ZZZ ENV200CC BCL200CC
Sterile Grip Seal Polythene Bag 5 x 8”
Sterile Grip Seal Polythene Bag 9 x 14”
Gammatex Irradiation Indicator Stickers on a Reel Cleanroom Wafer Shipping Tape 1” White
Sterile Cleanroom Low Temperature Labels Flat Sheet Sterile Cleanroom Printed Barcode Labels Flat Sheet
As a guide to customers, Micronclean has indicated the highest classification of cleanroom each product would typically be used in.
660 x 1117mm
228 x 356mm 12mm
ISO4
Pack Qty Case Qty 10 x 10 10
ISO4
100
ISO4 ISO4
33metres length ISO4 12 x 45mm 15 x 30mm
ISO4 ISO4
100
10 x 100
100
10 x 100
5000 1
200 200
10 x 100 1 Roll
24 (72: Sterile) 20 x 200 10 x 200
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32
Micronclean Consumables Catalogue
GuardTack
Tacky Rollers
Tacky Rollers Tacky Rollers are designed to easily remove dust and particulate from cleanroom surfaces such as walls, ceilings and other hard to reach areas. Tacky rollers are a popular cleaning tool for controlled environments used as a time saving alternative to traditional mop systems, with an anti-microbial agent they also provide long-lasting protection against bacterial growth. They can also be used as an effective tool to remove particulate from sensitive components in electronics manufacturing.
1 2
Tacky rollers are produced on a plastic inner core and contain perforated film or foam tear-away sheets that are easy to remove, exposing the next clean sheet. Foam Roller Refills A polyethylene foam, used for textured or uneven surfaces, the foam refill adapts to the surface that it is rolled over, ensuring surface contact and particle collection. Available in 9” or 18” Widths.
3
Film Roller Refills 3mil Polyethylene Film Roller refills, used for flat surfaces. Available in 9” or 18” Widths. Tacky Roller Handles Heavy Nickel coated metal handle and plastic grip. Tacky Roller Extension Handles Metal extension pole for tacky roller mop handles. Ideal for hard to reach places in the cleanroom such as walls and ceilings. The Tacky Roller Mop Extension Pole is extendable from 122cm to 244cm’. 1 Film Tacky Roller 2 Foam Tacky Roller 3 Tacky Roller Extension Handle
Product Code GL80420 GL80427 GL80424 GL80425 GL80422 GL80423 GL80421
Description GuardTack 9” Tacky Roller Handle GuardTack 9” Foam Roller - 40 sheets GuardTack 9” Film Roller - 180 sheets GuardTack 18” Tacky Roller Handle GuardTack 18” Foam Roller - 20 sheets GuardTack 18” Film Roller - 40 sheets Extension Pole to fit 9” and 18” Tacky Roller Handles
Size 9” 9” 9” 18” 18” 18” 122 - 244cm
ISO ISO5 ISO5 ISO5 ISO5 ISO5 ISO5 ISO5
Pack Qty Each
Case Qty Each
Each
9
Each Each Each Each Each
9
Each 9 9
Each
As a guide to customers, Micronclean has indicated the highest classification of cleanroom each product would typically be used in. QUALITY TODAY - INNOVATION TOMORROW
Micronclean Consumables Catalogue 33
GuardTack
Entry Mats: Controlling foot borne and wheel borne contamination
1
2
GuardTack Disposable Peel off Mats GuardTack Mats are the ideal way to control footborne or wheel borne contamination in areas of transfer from lower grade to higher grade areas and environments. Manufactured from a Low Density Polyethylene, 30 sheets per mat, with a pressure sensitive adhesive that contains a spore growth retardant to ensure there can be no bacterial growth on the mat. Available in Low Tack (4 mats per case) or Medium Tack (8 mats per case), in White, Blue or Grey with numbered tabs to denote remaining sheets. 1 White Tacky Mat 2 Blue Tacky Mat
White
ANWH08026 ANWH08018 ANWH08336 ANWH04026 ANWH04018 ANWH04336 ANWH04036 ANWH04122
Blue
ANBL08026 ANBL08018 ANBL08336 Cut to size ANBL04026 ANBL04018 ANBL04336 ANBL04036 ANBL04236
Grey ANGY08018 ANGY08336 ANGY04026 ANGY04018 ANGY04336
GuardTack Permanent Matting GuardTack Mats are a permanent, washable, tack regenerating floor covering designed specifically for the removal of between 98100% of even the finest foot and wheel borne contamination. Available in widths of 1.2m and for larger mats a vinyl weld creates a contamination free seam. Adhesive backed for easy self installation and ridged edging safety trim. Description
Can be applied as a floor covering or used as a permanent mat (framed on request). No peel off layers meaning no risk of static damage. Just mop, rinse, squeegee and let dry. 100% of the tack is regenerated when cleaned properly. Multiple applications: Inside and outside Cleanroom areas, air showers, gown rooms and entry / hallways.
GuardTack 1 26” x 45” Peel off Mat Medium Tack GuardTack 1 18” x 45” Peel off Mat Medium Tack GuardTack 1 36” x 36” Peel off Mats Medium Tack GuardTack 1 Permanent Matting GuardTack 2 26” x 45” Peel off Mat Low Tack GuardTack 2 18” x 45” Peel off Mat Low Tack GuardTack 2 36” x 36” Peel off Mat Low Tack GuardTack 2 36” x 45” Peel off Mat Low Tack GuardTack 2 18” x 22” Peel off Mat Low Tack GuardTack 2 24” x 36” Peel off Mat Low Tack
As a guide to customers, Micronclean has indicated the highest classification of cleanroom each product would typically be used in.
Size
26” x 45” 18” x 45” 36” x 36” 1.2m width 26” x 45” 18” x 45” 36” x 36” 36” x 45” 18” x 22” 24” x 36”
Pack Qty 30 30 30 Each 30 30 30 30 30 30
Case Qty 8 8 8 Each 4 4 4 4 4 4
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34
Micronclean Consumables Catalogue
CleanTeam
Cleanroom Maintenance Cleaning Team Disinfectant Impregnatedand Wipes The Micronclean Cleaning Team are a dedicated unit specially trained for environment decontamination. They have been maintaining controlled environments since 2001 and operate worldwide, serving a variety of clean industries. The service that they offer provides customers with: 1. 2. 3. 4.
Assurance of environment compliance to GMP guidance and standards Improved environment performance and reduced maintenance costs An audit ready facility in time for external review & internal validation Fully documented process for compliance with ISO9001 & 14001
The Micronclean cleaning service is offered as a bespoke solution to customers; with each environment undergoing a free of charge, full survey prior to any clean. This attention to detail ensures that each and every clean undertaken meets the stringent standards that Micronclean and their customers demand, and that the service achieves the desired objectives it has been comissioned to meet.
Industries Served: • • • •
Pharmaceutical Medical Device Healthcare Aerospace
• • • •
Semiconductor Optical / Laser Laboratory Veterinary
Quality Assurance Cleaning SOPs For each clean carried out a Clean Plan will be drawn up for approval. This document includes site plans and defines the cleaning procedures and materials to be used. Creating site-specific plans in this way provides a defined work schedule and outlines clear expectations and outcomes. Micronclean operators work to Standard Operating Procedures (SOPs) and full training records are available for all staff.
Training All cleaning staff are trained to key GMP requirements. Staff training includes good hygiene practice, cleanroom gowning technique and cleanroom cleaning methods. Specific staff training requirements for customer sites will be considered during the planning phase of a clean.
Clean Documentation On completion of a site clean a Clean Record will be issued. The Clean Record contains a copy of the site Clean Plan, the results of pre- and post-clean environmental monitoring carried out, the batch information for all cleaning materials used and details of any deviations from the approved cleaning procedures, with a corrective action plan as appropriate. 035 04 QU035 ure Quality SOP : QA Release Proced cide Sterile Bio sterile packs. iance 100 for Compl department by the QA use SOP procedure Louth wareho s the release zone as per and Baxter ure define the amber This proced certificate(s) mity are product in a irradiation inspects ate(s) of confor Supervisor plus the gamm clean certific Warehouse ent record eted Micron 1. The Louth use movem the compl Louth wareho mance and 202. The of confor ate(s) ss. certific s the Healthcare ment at Skegne ment review QA depart QA depart er of the sent to the memb a n, documentatio of the above 2. On receipt cally:dose of specifi um n, es a minim documentatio and indicat received correctly This proce ents have been completed types documdure defin ate has been certifices the • All four achieved has been relea a irradiation se proce ly 1. The Louthum dose of 35kGy • The gamm ly four correctdure by ted correct across the and maxim Ware been completed the 25kGy202. The record hashous rs reconcile been comple QAnumbe departme Superviso ent Louth ware econfor mity has nt for Com tion order of r inspe Healthcar certific atehous • The movem cts prod plian ce equanti ties and irradia move e clean certifi uct in the ment recor file 100 steril cate( sent to codes, • The Micron technical ambe e pack the QAproduct s) of confo d plus Micron clean codes, r zone ce TD-2.1). s. rmance departme thethe gamm • The batch as per and ent referenas per Louth nt at Skeged code a irrad the comp (docum iation certifi warehous ments t, approv ness. 2. On leted Microbatch docu recei code is a curren e SOP cate(s) of the nclea of the abov and Baxte t productpt docu n certifi the release • The mentation producr e docu preclude cate(s) the may of ment that , specifical ts ation, a ise release of conformity d inciden ly:member ent form to author are no reporte of the QA • There • All are the movem four types departme d, QA sign nt revie • The gamm docu are satisfie ment in (2) ws save to Q \ Louth s have a irradiation wareho criteria listed beenuse. ent andthe 25kG 3. If the to the Louth the docum ythe certificate received andform name. scan file maxi return has been of conformity, • The mum dose r as the and move of 35kG certificatescompleted tion order numbe • The Micro ment recor irradiacorre Micronclean y has been CT ctly and date thed has been comp number plus nclea achieved and indic FINISHED PRODU of n certifithe Baxter lot leted • The QA sign 4. batch code using cate of ate a greenates a minim conformity correctly will have use C of C, um dose clean certific s, prod doc wareho each carton uments uct code the Micron of has been ent Record s, quan carton plus comp • The prod Movem of theleted tities and correGreen Zone. uct code of the signed d to the side irradiation receipt (docu appropriate ctly is a curre label applie 5. Onment mity and RELEASEnt, appr transferred to the order num FOR refer ate of confor VED bers recon ence • There oved code t is then APPRO produc clean certific are no and theTD-2 cile acros .1). as per the reported mance, Micron s the four Micro conformity incidents nclean ate of confor certific 3. If the that techn may precl dix 25). ical file Healthcare criteria ude the listed the Baxter (appen and retur release QA retainin (2) arecertificate on file n 6. the of the batch tion satisfied, form irradia a to QA sign the Louth gamm the move warehous 4. QA sign ment form /09 e. and date to autho Date: 02/10 warehous the Micro rise e C of C, nclean ton release of 02/10/09 using the certificates theDate: Philip Borring product Baxter by: of confo lot num Issued n 5. On recei rmity le Simpso ber plus , Michel pt the docu No.: 04 by: scan irradiation APPROVED of the Issue signed ment and Authorised Movement order num save to conformity FOR RELEASE 1 of 1 Reco ber as Q \ Louth rd each the file and the Page:label appli carton name. ed to the product will have is then side of a green transferre the carto 6. QA retain FINIS n plus d to the the Baxte the Micro HED PRODUCT appropria gamma r Healthcar nclean irradiation te Gree certificate e certifi n Zone certificate cate of . of on file conforman (appendix ce, Micro 25). nclean certificate of confo rmity and Issue No.: 04 Page: Issued by: 1 of 1 Philip Borri Authorise ngton d by: Michelle Date: Simpson 02/10/09 Date: 02/10/09
Quality SOP QU 05 Sterile Mop: Sto 9 rage & Handlin g
059 09
Micronclean Consumables Catalogue
35
Disinfectant Impregnated Wipes
Decontamination Cleans Routine Cleans VHP Decontamination
Each of these services are fully tailored to the needs of the controlled environment and the exact customer requirement: 1. Decontamination Cleans
2. Routine Cleans
3. VHP Decontamination
This level of clean can be applied during or after any cleanroom construction or renovation project, following a major spill or within any environment that requires indepth and sustained attention; especially for soil removal and particulate build up.
This category of clean is carried out at a regular interval whether weekly, bi-weekly, monthly, bi-monthly etc., and can be carried out within your own time parameters or those established after consultation as being appropriate for your needs.
Micronclean carry out Dry Vapour Phase decontamination cleans for the control of healthcare-associated infections or the eradication of micro-organisms such as bacteria, fungi or yeast from controlled environments.
It also applies to post-shutdown cleaning and any decontamination after planned and/ or emergency maintenance, and is especially useful prior to inspection, audit or validation.
Regular cleans are designed to help maintain an already stable and fully functional facility. This type of clean is carried out in accordance with your own cleaning regime and methods and is designed to help maintain good practice within a cleanroom.
VHP decontamination is an effective bactericide, fungicide, virucide and sporicide, providing up to and including a 6 log kill against pathogens such as MRSA and c-difficile .
The Decontamination Clean is specifically designed to remove heavy bioburden and large amounts of particulate, and to rapidly increase the performance and cleanliness of the controlled environment.
Cleaning can be carried out in accordance with your own gowning and transfer methodology and all our staff are highly trained to provide the best quality clean of your facility.
Micronclean provide decontamination of equipment and facilities using the BioGen DVHP generator. Our highly trained engineers follow strict procedures to ensure complete, fully validated decontamination. Fully validated results, confirmed via Biological Indicators prove that VHP vapour phase decontamination is an effective bactericide, virucide and sporicide AND is biodegradable, leaving no residue.
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STEWARDSHIP KNOWLEDGE INNOVATION EXCELLENCE
SUPPORTING cGMP COMPLIANCE ACROSS THE GLOBE, EXPORTING EXCELLENCE WORLDWIDE
Product Development
RESEARCH DEVELOPMENT & TESTING UNIT
This catalogue represents the standard range of products stocked for immediate dispatch from the UK warehouse. However Micronclean also operate an RD&T Unit that are focussed on creating innovative new products and solutions to serve our customers worldwide. If there is a product that you require but cannot see it in this catalaogue please call us today, we will be more than happy to put the team to work finding or creating a bespoke product or solution that meets the need of your application and environment.(MOQ applies).
QUALITY TODAY - INNOVATION TOMORROW
Micronclean Ltd Roman Bank / Skegness / Lincolnshire PE25 1SQ/ United Kingdom Tel: +44 (0)1754 767377 Email: sales@micronclean.com Web: www.micronclean.com MPC/03/2016