MPL Product Portfolio Presentation by Micronclean Ltd

cGMP Compliant Products for Cleanroom use

Presented by:

Micronclean Products Ltd

Mark Wheeler -‐ International Sales & Marketing Manager

Cleanroom Products Overview Micronclean have a vast range of stock products and also develop bespoke products and solutions for customers requirement

Permanent Garments Bespoke Cleanroom Garments Designed for your application Cleanroom Footwear

Disposable Clothing Coveralls, Lab Coats, Aprons, Sleeve Protectors, Hoods. Overboots & Overshoes

Gloves Latex, Nitrile and Vinyl. 12 & 16” Sterile and Non Sterile.

Cleaning Disinfectants & Biocides Cleanroom Wipes Mopping Systems

Accessories Stationery, Labels & Packaging Face Masks & Goggles Overshoes & Mob Caps

Permanent Cleanroom Garments Providing full clothing and PPE for complete compliance up to GMP Guidance for Pharma Grade A Fabric 95% 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.

Coverall Fully 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

Hood Balaclava 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 Garments Produced 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.

Boots Long length to just under knee, elasticated or toggle tie top fastening, straps over heel and bridge for close co nta c t to m i n i m i s e s l i p p a ge . C l e a n ro o m Polyurethane soles, reinforced attachment to uppers.

Disposable Cleanroom Garments SureGuard Cleanroom Clothing for use in ISO5+ Areas and applications concerned with cross contamination

SureGuard Fabric SureGuard 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).

Disposable Cleanroom Garments SureGuard Cleanroom Clothing for use in ISO5+ Areas and applications concerned with cross contamination Coverall SureGuard 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 Coverall SureGuard 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

Hoods Balaclava 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, Sleeves Lab 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 Boots Long length to just under knee, elasticated top fastening, elasticated ankle for close contact to minimise slippage. PVC non-‐slip sole.

SkinGuard Sterile Gloves Micronclean’s range of Gloves for Sterile Manufacturing Applications

Sterile Sterilised by Gamma Irradiation, hand specific, aseptically folded, pair packed in internal pouch, 20 individual pouches per pack, 10 packs per case, total= 200 pairs.

Fingertips Textured fingertip gives greater grip whilst increasing durability to minimise punctures.

Length 12” 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.

Cleanroom Processed G l o v e s a re w a s h e d 3 t i m e s w i t h bacteriostat detergents in an ISO4 washer and dried using HEPA filtered air. Packaged in an ISO4 Cleanroom.

Material Latex is still the most dextrous and sensitive material for product contact. Nitrile is compliant with allergy guidelines given and is cheaper.

Cuff A beaded cuff, made from extra material tightly rolled and pressed gives extra grip against the arm.

SkinGuard Sterile Gloves For Critical Environments – ISO4 & 5, Sterile Manufacturing of Pharmaceuticals & Medical Devices.

SkinGuard 5

SkinGuard 6

SkinGuard 7

12” Latex Gloves, Hand Specific, Washed, Aseptically Folded, Pair Packed, Gamma Irradiated

12” Nitrile Gloves, Hand Specific, Washed, Aseptically Folded, Pair Packed, Gamma Irradiated

16” Nitrile Gloves, Hand Specific, Washed, Aseptically Folded, Pair Packed, Gamma Irradiated

Cleanroom Footwear Cleanroom Shoes & Clogs 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. 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

Accessories 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.

Alcohols Compliance 100 Alcohol delivery system is an industry leader in performance, sterility and efficacy of Alcohol in use

Compliance 100 IPA (Isopropanol Alcohol)

Trigger Spray

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

0.2 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.

Compliance 100 IMS (De-natured Ethanol) 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

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.

Rotational Biocide System + Sporicide Micronclean present a safe and effective dual action biocide and sporicide disinfection system

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 (Sporicide) 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

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 Guide Provided 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 Study Also 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.

Cleanroom Wipes High Quality 100% Polyester Cleanroom Wipes: Vertically Integrated Manufacturing Process

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.

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

TrueGuard Q Quilted Polyester (ISO 3 - 5) 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 PS

TrueGuard Q

Edge Options

Laser Sealed

Ultrasonically Sealed

Cleanroom Wipes High Quality 100% Polyester Cleanroom Wipes: Vertically Integrated Manufacturing Process

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.

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 WhiteGuard Roll

GuardWipes Melded Nylon (ISO 6 - 8) 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.

200 WhiteGuard wipes on a perforated core-less wiper roll, clean packed.

Technical Data Full Technical Data available, providing Helmke Drum Particle Test and Orbital Shake Fibre Release Results. Certificates of Irradiation also available upon request.

Pre-‐Saturated Pouch Wipes ISO 4-‐6: Sterile Polyester Wipes impregnated with Alcohols or Biocides

ISO 5-‐ 7: Poly-Cellulose Wipes impregnated with Alcohols or Biocides

Materials

100% 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).

45% Polyester with 55% Cellulose wipes pre-‐impregnated with either 70% IMS (Denatured Ethanol) or 70% IPA (Isopropyl Alcohol) with 30% WFI (Water for Injection).

Packaging

Polypropylene pouch, manufactured in an ISO4 environments with resealable adhesive label. Wipes are available flat packed, C-‐Folded or Z-‐ Folded. Double bagged.

Biocidal Pre-impregnation

Also available impregnated with: -‐ Alpha: Biocide -‐ Beta: Biocide + Sporicide

Pre-‐Saturated Tub Wipes ISO 4-‐6: Sterile Poly-Cellulose Wipes impregnated with 70% IMS & 30% WFI

ISO 7: Polypropylene Wipes impregnated with 70% IPA & 30% DI Water

Materials

45% Polyester blended with 55% Cellulose. 70% IMS (Denatured Ethanol) with 30% WFI (Water for Injection).

100% Polypropylene Wipes on a perforated roll pre-‐saturated with 70% IPA (Isopropyl Alcohol) & 30% DI (De-‐ionised Water).

Packaging

LDPE 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.

LDPE tub and lock tight lid with perforated opening and flip top cap. Tubs are double bagged.

Sterility Available Sterile by Gamma Irradiation Certificates of Irradiation available upon request, validation support available

VeriClean Mopping 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 System 3D Map of the VeriClean Triple Bucket System

VeriClean Mopping System Software & 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.

Contamination Control Mats Disposable: Peel off tacky sheets contain foot/wheel borne contaminants

Material Low Density Poly Ethylene (LDPE) with high tack adhesive (Medium tack adhesive available for users wearing CPE Overshoes).

Design 30 peel-‐off sheets with a numbered corner tab. Adhesive backing sheet to adhere to the floor.

Sizes & Colours Available 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)

Permanent: Tack regenerating mats and flooring, installed anywhere onsite Material Permanent, washable, tack regenera\ng mat designed speciﬁcally for the removal of even the ﬁnest footborne/wheelborne contamina\on.

Design Chemical Resistance to most chemicals. Bacteria Resistance: Prevents common bacteria (tested on pseudonomas aerugonosa & staphylococcus aureus.)

Sizes & Colours Custom cut sizes, new vinyl weld creates a contamina\on free seam. Any size or shape available. Standard in-‐stock colour Navy Blue.

Cleanroom Stationery Paper: High and Medium grade Paper for use in controlled environments 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

Notebooks Manufactured with Munising LP Paper Available in A4, stapled or spiral bound. Lined or Plain, Clean Packed. Available Sterile by Gamma Irradiation.

Accessories: Range of ancillary stationery items for use in Cleanrooms Cleanroom Pens Low ionic ink Cleanroom Pens, LDPE barrel available in Black and Blue, individually clean packed in ISO 4 environment.Available Sterile

Cleanroom Tape 1” & 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 Labels 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.

Cleanroom Packaging GMP Packaging manufactured in an ISO4 environment

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+) 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.

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 Autoclave Pouches Breathable side of the pouch made from permeable Tyvek, alternate side is a transparent polythene film for visual inspection.

Technical Data Full Technical Data available, providing details of outgassing, particle release and physical properties. Certificates of Irradiation also available upon request.

Contact: Mark Wheeler

International Sales & Marketing Manager

T: +44(0)7876 899 822 E: mark.wheeler@micronclean.com

Address:

Micronclean Products Ltd Suite 2 Rookery House The Guineas Newmarket Suffolk, CB8 8EQ, UK