MPL Product Portfolio Presentation
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Transcript of MPL Product Portfolio Presentation
Presented by: Micronclean Products Ltd Mark Wheeler -‐ International Sales & Marketing Manager
cGMP Compliant Products for Cleanroom use
Micronclean have a vast range of stock products and also develop bespoke products and solutions for customers requirement
Cleanroom Products Overview
Permanent GarmentsBespoke Cleanroom Garments Designed for your application
Cleanroom Footwear
Disposable ClothingCoveralls, Lab Coats, Aprons, Sleeve Protectors, Hoods. Overboots & Overshoes
GlovesLatex, Nitrile and Vinyl. 12 & 16”
Sterile and Non Sterile.
CleaningDisinfectants & Biocides
Cleanroom Wipes Mopping Systems
AccessoriesStationery, Labels & Packaging
Face Masks & Goggles Overshoes & Mob Caps
Providing full clothing and PPE for complete compliance up to GMP Guidance for Pharma Grade A
Permanent Cleanroom Garments
HoodBalaclava style hood, one piece with stud fastening on the rear of the hood for adjustment, long fabric drape around the neck to tuck into coverall.
Under GarmentsProduced from an extremely light non shedding sand-‐washed polyester, designed for optimum wearer comfort and breathability, with excellent particulate data. Draw string or elasticated waist, V neck or howie style.
BootsLong length to just under knee, elasticated or toggle tie top fastening, straps over heel and bridge for close contact to min imise s l ippage. C leanroom Polyurethane soles, reinforced attachment to uppers.
Fabric95% Polyester interwoven with 5% Carbon Fibre Yarn to create an extremely clean non shedding fabric with an anti-‐static 5mm grid giving complete ESD properties. Manufactured in an ISO5 environment, Clean processed through an ISO4 laundry process and packaged in an ISO4 Cleanroom. Suitable for up to 50 wash & Irradiation cycles.
CoverallFully customisable Cleanroom Coveralls with reinforced overlocked seams, stitched using non-‐shedding polyester yarn, made to UK, EU & US sizing charts. GMP compliant.
Available Options: Collar style: Mandarin with Press Stud fastening Front fastening: Covered Zip or Press Studs Cuffs: Elasticated, Press Stud fasteners or Ribbed lycra Ankle: Elasticated or Press Stud fasteners Additions: Internal Pockets, Company Logo, Wearer Name Colours: White, Sky Blue, Navy Blue
SureGuard Cleanroom Clothing for use in ISO5+ Areas and applications concerned with cross contamination
Disposable Cleanroom Garments
SureGuard FabricSureGuard is a Medical non woven dual layer fabric made of a polypropylene laminated with a polyethylene film.
This is a unique dual-‐laminate construc\on that offers a high tensile strength and toughness that is also so^ and easy to work with. SureGuard fabric provides a fluid and par\culate barrier to protect operators without sacrificing mobility and comfort. Garments constructed of SureGuard fabric are strong and durable, and offer outstanding comfort, breathability, so^ness, and wearability. SureGuard is lightweight and resistant to tears and punctures.
SureGuard is a low lin\ng fabric with excellent par\cle and fibre shedding data, it is light-‐weight and resistant to punctures and tears. The fabric will repel oil, grease, blood, water and has good break through data for a comprehensive range of chemicals (Data available).
SureGuard Cleanroom Clothing for use in ISO5+ Areas and applications concerned with cross contaminationDisposable Cleanroom Garments
HoodsBalaclava style hood, one piece with elasticated opening to position comfortably against the face, long fabric drape around the neck to tuck into coverall.
Lab Coats, Aprons, SleevesLab Coats: Collar, zip front, zip cover, elasticated cuffs Aprons: Full frontal coverage, mid shin length, fixation ties at the rear and neck loop. Sleeves:
Over BootsLong length to just under knee, elasticated top fastening, elasticated ankle for close contact to minimise slippage. PVC non-‐slip sole.
CoverallSureGuard Category III Type 5/6 hooded coveralls with elasticated cuffs, elasticated ankles, zip front with zip cover and reinforced seams at stress points.
Available Options: -‐ Sterilised by Gamma Irradiation -‐ Available without hood as boiler suit
Sterile GMP CoverallSureGuard hooded coverall with reinforced stitching at the seams, zip front with zip cover, elasticated cuffs with 2” thumb loops, Integrated overboots with non slip blue PVC soles, fixation ties over the ankle and the bridge of the boot. Pharmaceutical Grade Compliance: -‐ Aseptically folded and Double Bagged -‐ Packed in an ISO4 Cleanroom -‐ Sterilised by Gamma Irradiation
Micronclean’s range of Gloves for Sterile Manufacturing Applications SkinGuard Sterile Gloves
CuffA beaded cuff, made from extra material tightly rolled and pressed gives extra grip against the arm.
MaterialLatex is still the most dextrous and sensitive material for product contact. Nitrile is compliant with allergy guidelines given and is cheaper.
Cleanroom ProcessedGloves a re washed 3 t imes w i th bacteriostat detergents in an ISO4 washer and dried using HEPA filtered air. Packaged in an ISO4 Cleanroom.
SterileSterilised by Gamma Irradiation, hand specific, aseptically folded, pair packed in internal pouch, 20 individual pouches per pack, 10 packs per case, total= 200 pairs.
Length12” is the industry leader however some applications are switching to a 16” glove. the longer length delivers improved grip against the wider surface area of the arm providing less slippage and increasing resistance.
FingertipsTextured fingertip gives greater grip whilst increasing durability to minimise punctures.
For Critical Environments – ISO4 & 5, Sterile Manufacturing of Pharmaceuticals & Medical Devices.
SkinGuard Sterile Gloves
SkinGuard 512” Latex Gloves, Hand Specific, Washed, Aseptically Folded, Pair Packed, Gamma Irradiated
SkinGuard 612” Nitrile Gloves, Hand Specific, Washed, Aseptically Folded, Pair Packed, Gamma Irradiated
SkinGuard 716” Nitrile Gloves, Hand Specific, Washed, Aseptically Folded, Pair Packed, Gamma Irradiated
Cleanroom FootwearCleanroom Shoes & ClogsSteri-‐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. ESD Cleanroom 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. Cleanroom Shoes are washable and also have a non slip sole for added safety.
TuffGuard PVC Overshoes
TuffGuard PVC overshoes are manufactured from .100 micron Gauge PVC, with an extra strength ultra sonic welded seam. The TuffGuard range of overshoes are the strongest and most durable disposable footwear product on the market. The textured embossed 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. -‐ Will not tear when operators step on sticky mats -‐ Will not break or tear during use or application -‐ Available in 5 colours: White, Red, Blue, Green and Yellow
FaceGuard Pouch Mask: A more user friendly mask that has a ‘Duck Bill’ shaped outward surface combining greater operator comfort with a reduced chance of contamination. Particles are pushed into the mask and travel down into the neck veil and into the garment, containing them and preventing their entry into the atmosphere.
Features -‐ 20” long veil attached to the underside of the mask to direct and trap
particulate generated from the mouth within the cleanroom garment. -‐ Clean packed individually and double bagged in an ISO4 environment.
Sterilised by Gamma Irradiation. -‐ Enclosed adjustable metallic nose grip for operator comfort and reduced
slippage, elasticated head bands for secure and comfortable fit to head.
Accessories
Compliance 100 Alcohol delivery system is an industry leader in performance, sterility and efficacy of Alcohol in useAlcohols
Trigger Spray0.2 micron filter on the air intake valve of the trigger head ensures larger particulate cannot enter the bottle vessel and affect the efficacy of the alcohol or cleaning agent within. This ensures that the sterile field is not compromised and sterility in use is tested and specified as 90 days.
5 Litre RTU (Ready to Use)Bulk containers filled in an ISO4 Cleanroom, ideal for mopping or large batch mixing. Double bagged and irradiated for use in Pharmaceutical, Healthcare and Medical Device applications.
Compliance 100 IPA (Isopropanol Alcohol)70% IPA blended with 30% Water for Injection (WFI), processed in an ISO4 Cleanroom, double bagged and Irradiated by Gamma Sterilisation. Available Options: -‐ 500ml or 950ml Trigger Spray -‐ 5 Litre RTU (Ready to Use) capped container -‐ Pre-‐saturated Wipes and Mops
70% IMS blended with 30% Water for Injection (WFI), processed in an ISO4 Cleanroom, double bagged and Irradiated by Gamma Sterilisation. Available Options: -‐ 500ml or 950ml Trigger Spray -‐ 5 Litre RTU (Ready to Use) capped container -‐ Pre-‐saturated Wipes and Mops
Compliance 100 IMS (De-natured Ethanol)
Micronclean present a safe and effective dual action biocide and sporicide disinfection systemRotational Biocide System + Sporicide
Features & Benefits-‐ Non Corrosive: Safe to use on stainless steel -‐ Odourless: Provides far greater operator comfort -‐ Sterility: Sterile in use for 90 days after opening -‐ Cost Saving: No need for an additional sporicidal
agent as Beta contains an active sporicide.
Validation Support GuideProvided alongside the Compliance 100 Rotational Disinfection System is a 75 page validation guide that provides technical information, sterilisation and sterility data, test data including broth fill test and corrosion study, dwell times and chemical resistance.
In Field StudyAlso included is an independent ‘In Field’ Study conducted by Professor Tim Sandle which concludes that the Compliance 100 Rotational Biocides provide the most effective disinfection system on the market.
Compliance 100 Alpha (Biocide)
Compliance 100 Alpha is a synergistic blend of quaternary ammonium compounds which is a highly effective detergent and broad spectrum disinfectant suitable for regular use in cleanrooms and controlled environments. Effective against bacteria, mycobacteria and fungi. Replaces the following disinfectants: -‐ Shield Klercide A, D, F & X -‐ Tristel Diamond & Platinum
Compliance 100 Beta is a blended disinfectant containing dodecylamine based structures, solvents and non-‐toxic, biodegradable detergent. Compliance 100 Beta is a highly effective detergent and broad spectrum disinfectant suitable for use in cleanrooms and controlled environments. Effective against bacteria, mycobacteria, fungi, viruses and spores. Replaces the following disinfectants: -‐ Shield Klercide B, E, S & Y -‐ Tristel CrySpore
Compliance 100 Beta (Sporicide)
High Quality 100% Polyester Cleanroom Wipes: Vertically Integrated Manufacturing ProcessCleanroom Wipes
Available Options-‐ Sterile: Gamma Irradiation Process -‐ Pack Size: Small Session packs (10,20,25), Stack
Packed (50,100) or Bulk Packed (150,300) -‐ Alternative Edges: Ultrasonic Border, Heat Sealed -‐ Sizes: Available any size, standard sizes:
9”x9” (228x228mm), 12” x 12” (300x300mm)
Material Close Up
Edge Options
TrueGuard PS Polyester (ISO 3 - 5)
High quality 100% Polyester Cleanroom Wipers made with continuous filament thread finished with laser sealed edges. Excellent particle retention data & zero fibre shedding, good, even retention and application of disinfectant. Designed for surface cleaning in high end applications within Pharmaceutical, Optical, Aerospace & Microelectronics. Triple processed through a Cleanroom washing machine, washed with low ionic bacteriostat, dried using a HEPA filtered dryer, clean packed and double bagged in an ISO4 Cleanroom.
A Two-‐Ply Quilted 100% Polyester Wiper constructed from continuous filament thread, knitted in a double-‐knit interlock pattern with a four sided ultrasonically sealed border edge. TrueGuard Q combines outstanding cleanliness and low extractable with extremely high absorbency and durability. This Quilted Polyester wipe is the best all-‐round wipe available for high grade Cleanroom applications, especially for spill control and high volume liquid application.
TrueGuard Q Quilted Polyester (ISO 3 - 5)
TrueGuard PS TrueGuard Q
Laser Sealed Ultrasonically Sealed
High Quality 100% Polyester Cleanroom Wipes: Vertically Integrated Manufacturing ProcessCleanroom Wipes
Available Options-‐ Sterile: Gamma Irradiation Process -‐ Pack Size: Small Session packs (10,20,25), Stack
Packed (50,100) or Bulk Packed (150,300) -‐ Sizes: Available any size, standard sizes:
9”x9” (228x228mm), 12” x 12” (300x300mm)
Alternative Format
Technical DataFull Technical Data available, providing Helmke Drum Particle Test and Orbital Shake Fibre Release Results. Certificates of Irradiation also available upon request.
WhiteGuard Poly-Cellulose (ISO 5 - 7)A Non-‐woven spun-‐laced blend of 45% Polyester & 55% Cellulose form this low linting and highly absorbent multipurpose cleanroom wiper that can be utilised for a number of cleaning processes; including surface wiping, spill control and application of cleaning solutions. Also available as Sterile Session Packs for Pharmaceutical Applications.
Melded Nylon Wipes, thick gauge Heterofil Polyamide calendared to give an abrasive textured diamond pattern. GuardWipes are an extremely durable wiper with an absorbent nature, used extensively in Industrial settings for spill control and for the cleaning and removal of Oil and Grease. Available in 3 sizes: 9x9”, 10x8” and 10x16”, stack packed in 100’s.
GuardWipes Melded Nylon (ISO 6 - 8) WhiteGuard Roll200 WhiteGuard wipes on a perforated core-less wiper roll, clean packed.
Materials100% Polyester wipes with continuous filament knitted thread, pre-‐impregnated with either 70% IMS (Denatured Ethanol) or 70% IPA (Isopropyl Alcohol) with 30% WFI (Water for Injection).
PackagingPolypropylene pouch, manufactured in an ISO4 environments with resealable adhesive label. Wipes are available flat packed, C-‐Folded or Z-‐Folded. Double bagged.
Biocidal Pre-impregnationAlso available impregnated with: -‐ Alpha: Biocide -‐ Beta: Biocide + Sporicide
Pre-‐Saturated Pouch WipesISO 4-‐6: Sterile Polyester Wipes impregnated with Alcohols or Biocides ISO 5-‐ 7: Poly-Cellulose Wipes impregnated with Alcohols or Biocides
Biocidal Pre-impregnationAlso available impregnated with: -‐ Alpha: Biocide -‐ Beta: Biocide + Sporicide
Materials45% Polyester with 55% Cellulose wipes pre-‐impregnated with either 70% IMS (Denatured Ethanol) or 70% IPA (Isopropyl Alcohol) with 30% WFI (Water for Injection).
PackagingPolypropylene pouch, manufactured in an ISO4 environments with resealable adhesive label. Wipes are available flat packed, C-‐Folded or Z-‐Folded. Double bagged.
Materials45% Polyester blended with 55% Cellulose. 70% IMS (Denatured Ethanol) with 30% WFI (Water for Injection).
PackagingLDPE tub and lock tight lid with perforated opening and flip top cap. Wipes are impregnated and packed into a cleanroom grade easy tear LDPE plastic bag enclosed in the tub.
SterilityAvailable Sterile by Gamma Irradiation Certificates of Irradiation available upon request, validation support available
Pre-‐Saturated Tub WipesISO 4-‐6: Sterile Poly-Cellulose Wipes impregnated with 70% IMS & 30% WFI ISO 7: Polypropylene Wipes impregnated with 70% IPA & 30% DI Water
SterilityAvailable Sterile by Gamma Irradiation Certificates of Irradiation available upon request, validation support available
PackagingLDPE tub and lock tight lid with perforated opening and flip top cap. Tubs are double bagged.
Materials100% Polypropylene Wipes on a perforated roll pre-‐saturated with 70% IPA (Isopropyl Alcohol) & 30% DI (De-‐ionised Water).
VeriClean Mopping SystemVeriClean Triple Bucket System
The VeriClean Triple Bucket System is an easy-‐to-‐use engineered solution specifically designed for use in cleanrooms. Manufactured without drilled holes the fully welded stainless steel trolley frame and wringer provide completely smooth surfaces, removing the opportunity for particle settlement, entrapment and ingress. 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 sanitising 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. The VeriClean System captures and isolates contaminants, ensuring unsoiled delivery of cleaning and sanitising agents. No more re-‐applying of soiled water and weakened solutions, experienced with old-‐style mopping. VeriClean is compatible with gamma, ETO & autoclave sterilisation -‐ up to 250° F (121° C) for 30 minutes. Also available as a Double Bucket System. Blue buckets as standard, White, Red and Green available upon request.
VeriClean Mopping System3D Map of the VeriClean Triple Bucket System VeriClean Triple Bucket System
The VeriClean Triple Bucket System is an easy-‐to-‐use engineered solution specifically designed for use in cleanrooms. Manufactured without drilled holes the fully welded stainless steel trolley frame and wringer provide completely smooth surfaces, removing the opportunity for particle settlement, entrapment and ingress. 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 sanitising 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. The VeriClean System captures and isolates contaminants, ensuring unsoiled delivery of cleaning and sanitising agents. No more re-‐applying of soiled water and weakened solutions, experienced with old-‐style mopping. VeriClean is compatible with gamma, ETO & autoclave sterilisation -‐ up to 250° F (121° C) for 30 minutes. Also available as a Double Bucket System. Blue buckets as standard, White, Red and Green available upon request.
VeriClean Mopping SystemSoftware & Consumables VeriClean Triple Bucket System
Mop Frame Manoeuvre on floors, walls, ceilings and confined areas such as corners and stairs -‐ also permits “S” motion mopping. Low profiled stainless steel mop frame for cleaning under fixtures and hard to reach surfaces. Continual surface contact at any angle, accurately balanced and non-‐flipping. Quick release frame-‐locking mechanism, enables easy replacement of contaminated mop or sponge head.
Telescopic Mop Handle Made of high quality polyester and composite materials; lightweight, durable, chemically resistant, extends 34” to 62”. Stainless Steel Wringer Exert and distribute pressure evenly over the whole surface, providing effective control of moisture content in mop heads.
Buckets 15 Litre Interlocking Buckets made from Low Density Polyethylene (LDPE) with Stainless Steel Handles.
Mops Blue PU Foam with 100% Polyester Covers: Most cost effective cleanroom compatible solution, good absorbency, low linting. Micro-‐Fibre Mops: More expensive upfront, can be laundered, not as absorbent but more durable and less chance of snagging.
MaterialLow Density Poly Ethylene (LDPE) with high tack adhesive (Medium tack adhesive available for users wearing CPE Overshoes).
Design30 peel-‐off sheets with a numbered corner tab. Adhesive backing sheet to adhere to the floor.
Sizes & ColoursAvailable in Blue, White or Grey. -‐ 18” x 45” (460mm x 1140mm) -‐ 26” x 45” (660mm x 1140mm) -‐ 36” x 36” (915mm x 915mm) -‐ 36” x 45” (915mm x 1140mm)
Material
Permanent, washable, tack regenera\ng mat designed specifically for the removal of even the finest footborne/wheelborne contamina\on.
DesignChemical Resistance to most chemicals. Bacteria Resistance: Prevents common bacteria (tested on pseudonomas aerugonosa & staphylococcus aureus.)
Sizes & ColoursCustom cut sizes, new vinyl weld creates a contamina\on free seam. Any size or shape available. Standard in-‐stock colour Navy Blue.
Contamination Control MatsDisposable: Peel off tacky sheets contain foot/wheel borne contaminants Permanent: Tack regenerating mats and flooring, installed anywhere onsite
Munising LP Paper (High Grade)67 gsm paper saturated with synthe\c polymer fibres to minimised par\cle genera\on. Material does not promote electro-‐sta\c discharge. Suitable for Autoclave Sterilisa\on. Laser printer and photocopier compa\ble. Available in White, Blue and Green.
GuardMark Paper (Medium)72 gsm cleanroom paper, low particle and fibre release data. Double Bagged cleanroom packed in an ISO5 area. Available in White, Blue, Green, Yellow
NotebooksManufactured with Munising LP Paper Available in A4, stapled or spiral bound. Lined or Plain, Clean Packed. Available Sterile by Gamma Irradiation.
Cleanroom PensLow ionic ink Cleanroom Pens, LDPE barrel
available in Black and Blue, individually clean packed in ISO 4 environment.Available Sterile
Cleanroom Tape1” & 2” width ultra clean tape, for use in ISO4+ environments, clean packed. Web cleaning system dissipates the static layer, allowing both sides of the label stock to be cleaned.
Cleanroom LabelsCritical environment labels are designed for use in Semiconductor, Data Storage, Biotechnology, and Pharmaceutical cleanrooms. Manufactured from 100% synthetic face-‐stocks, liners, and cores; avoiding particulate contamination issues that arise from coated paper products.
Cleanroom StationeryPaper: High and Medium grade Paper for use in controlled environments Accessories: Range of ancillary stationery items for use in Cleanrooms
GMP Packaging manufactured in an ISO4 environmentCleanroom Packaging
Available Options-‐ Format: Standard unsealed or grip seal -‐ Sterility: Available Sterile by Gamma Irradiation -‐ Sizes: Available in any size, standard sizes:
9”x9” (228x228mm), 12” x 12” (300x300mm)
Also Available
Technical DataFull Technical Data available, providing details of outgassing, particle release and physical properties. Certificates of Irradiation also available upon request.
Cleanroom LDPE Bags (ISO 4+)Cleanest grade Low Density Polythene Cleanroom bags manufactured in various different sizes, from 60 -‐ 300 micron gauge, produced in an ISO4 environment. Ideal for: -‐ GMP Pharmaceutical Packaging -‐ Medical Device Packaging -‐ Product transfer between areas
Cleanroom Labels (ISO 4+) Autoclave PouchesBreathable side of the pouch made from permeable Tyvek, alternate side is a transparent polythene film for visual inspection.
Critical environment labels are designed for use in Semiconductor, Data Storage, Biotechnology, and Pharmaceutical cleanrooms. Manufactured from 100% synthetic face-‐stocks, liners, and cores; avoiding particulate contamination issues that arise from coated paper products.
Address: Micronclean Products Ltd Suite 2 Rookery House The Guineas Newmarket Suffolk, CB8 8EQ, UK
www.micronclean.com
Contact: Mark Wheeler International Sales & Marketing Manager
T: +44(0)7876 899 822 E: [email protected]