Simple Solutions for USP Compliance

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About USP USP chapter describes the conditions, practices and quality standards for compounded sterile preparations (CSPs) of drugs and nutrients. To reduce the chance of contamination during the compounding and packaging of these products, compounding pharmacists must now perform critical operations in a cleanroom. A cleanroom, as defined in USP , is a room in which the concentration of airborne particles is controlled to meet a specified airborne particulate cleanliness class. Microorganisms in the environment are monitored so that a microbial level for air, surface, and personnel gear are not exceeded for a specified cleanliness class. Depending on the nature of the operation, work is performed in different cleanroom classes. Recommended Action Levels for Microbial Contamination

ISO 14644-1:1999* Process Area

Classification

Direct Compounding ISO Class 5 Area

Particle Count

Air Sample**

Fingertip Sample**

Surface Sample**

(Maximum no. particles 0.5 micron or larger per m3 air)

(cfu*** per cubic meter [1000 liters] of air per plate)

(cfu per pair of hands)

(Contact Plate) (cfu/plate)

3,520 > 1

>3

>3

Buffer Zone

ISO Class 7

352,000 > 10

N/A

>5

Anteroom

ISO Class 8

3,520,000 > 100

N/A

> 100

* Cleanrooms and associated controlled environments - Part 1 : Classification of air cleanliness ** USP “Pharmaceutical Compounding: Sterile Preparations” 2008, US Pharmacopoeia, Rockville, MD *** CFU- Colony forming units

How Contec® can help Visit www.contecinc.com to download Contec’s helpful cleaning guides: Cleaning & Disinfecting Guide for Isolators, Cabinets & Hoods USP FAQs USP Product Guide

Since 1988, Contec has been a leading manufacturer of contamination control products used in biomedical, pharmaceutical and medical device manufacturing and other critical environments across the globe. Our extensive product line includes presaturated and dry wipes, sterile and non-sterile wipes, mopping systems, wall washing systems, sponges and swabs. Our products for sterile and aseptic environments are Validated Sterile in accordance with AAMI 11137:2006 Guidelines, one of the strictest guidelines put forth by the Association for the Advancement of Medical Instrumentation. Our ISO 9001:2008 registration ensures customers of consistent quality products— from development to delivery. While the many choices for cleaning products and the latest revisions to USP may seem overwhelming, Contec can help. We have developed a simple, yet comprehensive, product guide with recommendations for your pharmacy cleanroom as well as your equipment and anterooms. Visit www.contecinc.com or contact your local Contec sales representative.

Contec® Providing simple solutions to complex problems.

Product Guide

Contec offers many products specifically designed for cleaning in critical areas where USP compliance has been mandated. Several product recommendations are listed below. Contact your local Contec sales representative or visit www.contecinc.com to learn more about alternative products to meet your unique requirements.

ISO CLASS 5 Direct Compounding Area

For Your Cabinet, Isolator or Laminar Air Flow Hood Applications

USP Requirement

Glove Cleaning

Routine application of sterile 70% IPA

Surface Cleaning

Wiping with a residue-free disinfecting agent such as sterile 70% IPA

Dry Wiping & Spill Control

Low-shedding wipes; discard after one use

SterileSorb™ poly/cellulose nonwoven wipes, sterile C2-1212IR DuPont™ Sontara® Nonpyrogenic lyocell/poly nonwoven wipes, sterile NWPZ0001 Sterile Polynit Heatseal polyester knit wipes LWPS0006 Amplitude™ EcoCloth™ poly/cellulose nonwoven wipes AMEC0003

Isolator & Hood Cleaning

Cleaning and disinfecting surfaces frequently

EasyReach™ Cleaning Tool, stainless steel 2665SF Sterile EasyReach™ Cleaning Pads presaturated w/ 70% IPA PSME0001 Sterile EasyReach™ Cleaning Pads, dry MEQT0002 EasyReach™ Cleaning Pads MEQT0001

Disinfecting

Compatible, effective, non-residual disinfectant solution

Use with trigger sprayer ACCTRIGR

Applications

USP Requirement

Recommended CONTEC® Products

Hand Washing

Hand cleansing procedure before gowning

Sporicidin® Antimicrobial Soap CALS-2416

Glove Cleaning

Disinfection of contaminated gloved hands

PROSAT®Sterile ™ polypropylene nonwoven wipes, 70% IPA PS-911EB

Decontamination of cleaning supplies for DCA

Wipe outer surface with sterile 70% IPA

PROSAT®Sterile ™ polypropylene nonwoven wipes, 70% IPA PS-911EB

Surface Cleaning

Low-shedding wipes, discard after one use

PROSAT®Sterile ™ polypropylene nonwoven wipes, 70% IPA PS-911EB

Dry Wiping & Spill Control

Low-shedding wipes, discard after one use

Amplitude™ EcoCloth™ poly/cellulose nonwoven wipes AMEC0003

Floor Mopping Small space

Non-shedding mop heads, preferably discard after one use

EasySat™ Bucketless Mop BLMOP, BLVKMOP

Floor Mopping Large space

Non-shedding mop heads, preferably discard after one use

EasyCurve™ Mopping System EZMP0100, 2724, 2725

Wall Cleaning

Non-shedding mop heads, preferably discard after one use

VertiKlean® MAX™ Mopping System VKMX0200, 2652A, 2725

Disinfecting

Wipe supplies removed from cartons with a suitable disinfecting agent

Accel TB® Ready-to-Use Disinfectant ACCDISR-TB32, ACCDISR-TBG

Clean floor with disinfectant solution

Sporicidin® Disinfectant Solution RE-1284C, PS-2212C Accel TB® Ready-to-Use Disinfectant ACCDISR-TB32, ACCDISR-TBG

Recommended CONTEC® Products PROSAT®Sterile ™ polypropylene nonwoven wipes, 70% IPA PS-911EB PROSAT®Sterile ™ Polynit Heatseal polyester knit wipes, 70% IPA PSPS0076

Accel TB® Ready-to-Use Disinfectant ACCDISR-TB32

ISO CLASS 6-7 Buffer Zone

and

ISO CLASS 8 Anteroom

For Your Cleanroom

Note: Sterile part numbers are printed in blue throughout this guide.

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Wipes

Knitted Polyester Wipes

PROSAT® Sterile™ and PROSAT®

Sterile Cleanroom laundered wipes

Presaturated nonwoven and knitted polyester cleanroom wipes

Sterile Polynit Heatseal wipes are processed in Contec’s ISO Class 4 laundry. Available with heatsealed edges. Each product is double bagged with an embossed lot number on both inner and outer bags for lot traceability. Ultra clean, low linting polyester wipe is ideal for one-time use in Direct Compounding Areas for dry wiping and spill control.

Sterile Polynit Heatseal Heavyweight textured polyester knit wipes, sterile LWPS0006 9”x 9” (23 x 23cm) wipes, sterile

25 wipes/bag, 48 bags/case

Polynit Heatseal Heavyweight textured polyester knit wipes PN-99 9”x 9” (23 x 23cm) wipes

PROSAT® Sterile Wipes are comprised of meltblown polypropylene (PS-911EB) or knitted polyester wipes (PSPS0076) saturated with 70% Isopropyl Alcohol/30% DI Water, then sterilized by Gamma radiation. Ideal for gloves and surfaces, and routine application of sterile 70% IPA as mandated by USP. Resealable pouches with tamper-evident labels ensure product integrity and cleanliness. Presaturated wipes are convenient and safer to use than liquid IPA.

PROSAT® Nonwovens PS-911

9” x 11” (23 x 27cm) polypropylene wipes

PS-911EB

9” x 11” (23 x 27cm) polypropylene wipes, sterile

150 wipes/bag, 8 bags/case

PROSAT® Knits PSPS0076

30 wipes/pouch, 50 pouches/case 30 wipes/pouch, 48 pouches/case

20 wipes/pouch, 9”x 9” (23 x 23cm) knitted polyester wipes, 40 pouches/case half-folded, sterile

Contec offers a full line of wipes and mopping products for all of your critical cleaning needs. For more information, contact your area sales representative or visit www.contecinc.com.

VertiKlean® MAX™ mop heads can be used with many dry or presaturated Contec wipes for added versatility. 2

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Wiping Products

Nonwoven Wipes

EasyReach™ Cleaning Tool

Lyocell/polyester and polyester/cellulose nonwoven wipes

For isolators, cabinets and laminar air flow hoods

Contec’s sterile and non-sterile nonwoven wipes are made from strong and durable hydroentangled fabric with low levels of particles and extractables. Extremely absorbent; excellent for wiping spills and general purpose cleaning in ISO Class 5 isolators. Choose from a variety of substrates, sizes and packaging configurations. DuPont Sontara Nonpyrogenic wipes and SterileSorb wipes are Validated sterile at 10 -6 SAL, one of the strictest guidelines put forth by the Association for the Advancement of Medical Instrumentation (AAMI). Choose non-sterile Amplitude EcoCloth for dry wiping and spill control in Buffer Zones and Anterooms.

DuPont™ Sontara® Nonpyrogenic Sterile lyocell/polyester nonpyrogenic nonwoven wipes NWPZ0001 9”x 9” (23 x 23cm)

25 wipes/bag, 40 bags/case

NWPZ0002 12” x 12” (30.5 x 30.5cm)

25 wipes/bag, 40 bags/case

SterileSorb™ Sterile cellulose/polyester nonwoven wipes C2-99IR/25 9”x 9” (23 x 23cm)

25 wipes/bag, 60 bags/case

C2-1212IR 12” x 12” (30.5 x 30.5cm)

25 wipes/bag, 42 bags/case

Amplitude™ EcoCloth™ High sorbency nonwoven cellulose/polyester wipes AMEC0003 9”x 9” (23 x 23cm)

300 wipes/bag, 12 bags/case

AMEC0004 12” x 12” (30.5 x 30.5cm)

150 wipes/bag, 14 bags/case

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The EasyReach Cleaning Tool is designed to clean isolators, laminar air flow hoods, cabinets, and glove boxes. Made from lightweight stainless steel, the mop is fully autoclavable and easy to use with one hand. A swivel joint allows the mop head to pivot, enabling a user to easily reach corners, ceilings, walls and other hard-to-reach areas inside an isolator. Approximately 17” (43cm) long. Use with a variety of disposable EasyReach Cleaning Pads.

EasyReach™ Cleaning Tool & Cleaning Pads 2665SF 2685 2644 MEQT0001

EasyReach Cleaning Tool, stainless steel, 17” (43cm) , 1 each/case QuickConnect EasyReach mop head frame, 7.5” (19cm) , stainless steel, 1 each/case QuickConnect handle, 16” (41cm) extends to 30” (76cm) , 2 piece, 1 each/case EasyReach Cleaning Pads, quilted polyester, 4/bag, 15 bags/case MEQT0002 EasyReach Cleaning Pads, quilted polyester, sterile, 4/bag, 15 bags/case PSME0001 EasyReach Cleaning Pads, quilted polyester, sterile, presaturated with 70%IPA, 8/bag, 8 bags/case EasyReach™ is recommended for effective cleaning and disinfection of surfaces of separative devices such as: Isolators – rigid, flexible film, half suits, CAI, CACI Restricted Access Barrier Systems (RABS) Laminar Air Flow Hoods (LAF) Bio-Safety Cabinets (BSC) Glove Boxes Incubators Clean Air Hoods Filling Lines

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Mopping Systems

VertiKlean® MAX™ Mopping System Lightweight disposable polyester mop Designed for applying disinfectants to both horizontal and vertical surfaces, the lightweight VertiKlean MAX is ideal for general cleaning of ceilings, walls, and floors. The pivoting mop head frame makes it easy to clean around door and window frames as well as light fixtures and heavy equipment.

ing and disinfecting broad surfaces in cleanrooms and controlled environments. For added flexibility, the VertiKlean MAX mop can be used with Contec dry and presaturated wipes. VertiKlean® MAX™ Mop Heads VKMX0100 mop head, 8.4”(21cm) VKMX0150 mop head, 8.4”(21cm) , sterile VKMX0200 Med. mop head, 12.8”(32.4cm) VKMX0250 Med. mop head, 12.8”(32.4cm) , sterile

Available in two lengths: 8.4”and 12.8”. The smallest VertiKlean MAX is appropriate for cleaning tasks in confined spaces, such as cleaning and disinfecting fume hoods, isolators and mini environments. The larger VertiKlean MAX Medium is ideal for clean-

48 pieces/case 48 pieces/case 28 pieces/case 28 pieces/case

QuickConnect™ Mop Head Frames & Handles* 2651A 7.5”(19cm) frame, for VertiKlean MAX 1/case 2652A 11.5”(29cm) frame, for Med. VertiKlean MAX 1/case 2725 Handle, 60”(152cm) , stainless steel 1/case

EasyCurve™ Mopping System Lightweight mop for ceilings, walls and floors handles are available. The EasyCurve mop uses a separate “sling” style wringer that installs over an autoclavable 6.5 gallon polypropylene bucket to completely and easily remove liquid from the mop head.

The EasyCurve mop consists of a disposable flat, fabric-laminated mop head attached to a curved, stainless steel frame to provide superior performance, ease of use, and effectiveness compared to any other all-surface cleaning system. An ideal cleaning tool for ceilings, walls and floors, EasyCurve mop heads are available nonsterile and validated sterile. All hardware and mop heads are autoclavable. The EasyCurve mop head frame attaches to a 60” stainless steel handle. Additional

EasyCurve™ Mopping System EZMP0100 EasyCurve mop head 48 mops/case EZMP0150 EasyCurve mop head, sterile 48 mops/case individually bagged 2724 Pivoting mop head frame, stainless steel 1/case U.S. Design Patent No. D586,966 2725 Handle, 60”(152.4cm) , stainless steel 1/case

Additional handle and bucket options are available. Visit our web site or ask your representative for details. 2743 2769/67-KIT

Bucket Systems For VertiKlean MAX and EasyCurve ®

2769/67-KIT 2743

™

Two 5 gallon (20L) bucket system w/ stainless steel flat wringer sieve, red/gray Twin divided bucket w/ Slinger & Frame, 5.3 gal (20L) total volume, green

EasySat™ Bucketless Mop Ideal for non-sterile buffer zones and anterooms, the EasySat mop is simple to use and features a 52 oz. solution tank, eliminating the need for buckets, wringers and carts. Lightweight mop weighs 7 pounds with a full tank. Snug-fitting lid minimizes exposure to chemicals, solvents and cleaning fluids. Trigger flow control releases cleaning solution on demand or continuously.

4

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™

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1/case/case 1/case

With 52 oz. solution tank

Compatible with a wide range of solvents and disinfectants. The disposable mop head is made from laser-cut sealed edge polyester laminated to clean ester foam for absorbency and cleanliness. It attaches to mop hardware in seconds using traditional hook and loop fasteners. EasySat™ Bucketless Mop BLVKMOP EasySat mop head BLMOP EasySat mop hardware, 52 oz. (1.5L) tank www.contecinc.com

32/case 1/case

Disinfectants

Contec® Sterile 70% Isopropanol

Combat spores with the industry’s fastest sporicidal claim.

Sterile Alcohol Spray Contec Sterile 70% Isopropanol contains 70% by volume USP-grade Isopropanol (IPA) and 30% USPpurified water. Filtered to 0.2µ and induction sealed to assure sterility, the bottles are double-bagged and gamma-irradiated. Each bottle is lot coded and has an expiration date for easy record keeping. Validated per AAMI 11137:2006 Guidelines to a 10 -6 SAL. Compliant with USP guidelines. Made in the USA. SB167030IR 16 oz. (450ml) bottle w/ trigger sprayer

12/case

SB327030IR 32 oz. (0.9L) bottle w/ trigger sprayer

12/case

3-Minute Sporicide Claim at 99.9999% Efficacy

Accel TB® Ready-to-Use disinfectant Accel TB is an EPA registered intermediate level disinfectant that is safe and fast acting with a broad spectrum kill. It is based on Accelerated Hydrogen Peroxide technology (AHP), a synergistic blend of commonly used, safe ingredients that, when combined with low levels of hydrogen peroxide, dramatically increase its germicidal potency and cleaning performance. Compatible with an extensive list of common materials, including 316 & 304 stainless steel, natural & silicone rubber, and most plastics. Ideal for use on environmental surfaces in pharmaceutical cleanrooms, compounding pharmacies, labs and other GMP facilities. ACCDISR-TB32

32 oz. (0.9L) bottle

12 bottles/case

ACCTRIGR

trigger sprayer for 32 oz. bottle 12 sprayers/case

ACCDISR-TBG

1 gallon (3.8L) container

4 containers/case

ACCWIP1-TBUS Disinfectant wipes

160 wipes/canister; 12 canisters/case

Sporicidin® Antimicrobial Soap Alcohol-free Antimicrobial Lotion Soap Ideal for use in ISO Class 6 and 7 Buffer Zones and ISO Class 8 Anterooms in hospitals and compounding pharmacies, Sporicidin Soap has been categorized by the FDA as a Surgical Scrub and Health Care Personnel Handwash. It kills up to 99.9% of gram positive and gram negative pathogenic and odor-causing organisms. Alcohol-free Sporicidin Soap can be used daily for hand washing prior to donning gloves or beginning work in isolators. CALS-2416

Sporicidin Antimicrobial Soap, 24 bottles/case 16 oz. (0.5L) , w/ pump

ALS-1282

Sporicidin Antimicrobial Soap, 2 gallons/case 1 gallon (3.8L) container www.contecinc.com

Peridox® RTU Sporicidal Disinfectant 3-minute non-bleach sporicidal disinfectant and cleaner for pharmacy cleanrooms PeridoxRTU is a broad spectrum EPA-registered sporicide, bactericide, virucide, tuberculocide and fungicide one-step disinfectant and hard surface cleaner with a 3-minute Sporicide claim at 99.9999% efficacy. PeridoxRTU contains no alcohol or bleach and, unlike most other disinfectants, leaves minimal residue on surfaces. Patented, hyperactive chemistry provides fast results. With its shorter kill times and powerful wetting agents, PeridoxRTU stays wet and works faster. The result - assured efficacy against hard-to-kill spores and other dangerous pathogens. PeridoxRTU provides maximum effectiveness without the risks of bleach. Unlike bleach, PeridoxRTU will not cause damage to stainless steel or clothing, and is compatible with most surfaces found in the pharmacy compounding environment. An essential part of daily and monthly cleaning regimes, PeridoxRTU can be used in the ISO Class 5 direct compounding area, buffer zones and anterooms. Available in 32 oz. and 1 gallon bottles. Visit our web site for complete efficacy data. HC85336 PeridoxRTU, 1 gallon (3.8L) container

4/case

HC85335 PeridoxRTU, 32 oz. (0.9L) bottle

6/case



Includes 6 spray applicators. All bottles and applicators are sealed in plastic.

Compatible with most common surfaces in pharmacy cleanrooms, PeridoxRTU® will not damage stainless steel or clothing.

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Contec® Healthcare Advanced Cleaning Technology for Healthcare

2725E

Abrasion resistant, non-shedding and compatible with a wide variety of disinfectants, Contec’s QuicKlean™ Mop with MicroGenesis™ Microfiber meets all USP requirements for floor, wall and ceiling cleaning.

2745

TASK0100

QuicKlean™ with MicroGenesis™ Lightweight Mop with MicroGenesis Microfiber

The QuicKlean foam mop head easily attaches to the polypropylene mop head frame. A MicroGenesis wipe is then wrapped around the mop head and secured to the frame.

Contec’s QuicKlean Mop with MicroGenesis is changing the level of clean for the USP market. The combination of the lightweight, easy to maneuver hardware and particle pick-up capacity of the MicroGenesis microfiber wipe delivers unprecedented performance.

Compatible with a wide range of disinfectants, chemicals and solutions, the QuicKlean mop with MicroGenesis offer users a lightweight option for cleaning and disinfecting floors, wall and ceilings.

The QuicKlean with MicroGenesis flat mop system has 3 easy-to-use components:

QuicKlean™ Mop System

• A durable autoclavable plastic QuicKlean mophead frame. • A foam & abrasion-resistant knitted polyester mophead. • MicroGenesis microfiber wipes, which deliver the maximum amount of microfiber to pick-up and retain particles, dust and other contaminants.

LWMM0400 QuicKlean Kit 1 kit/cs 2 x (50) MicroGenesis wipes, (6) TASK0100 mop heads LWMM0300 MicroGenesis microfiber wipe, laundered, 10”x18” (25 x 46cm)

100 /bg; 4 bgs/cs

TASK0100

QuicKlean foam mop head

4 /bg; 8 bgs/cs

2745

QuicKlean flat mop head frame, 16” (40cm), blue polypropylene

2725E

QuickConnect handle, stainless, 60”(152cm) 1/cs

1/cs

2769/67-KIT Two 5 gallon (20L) bucket system 1/cs w/ casters and stainless steel flat wringer sieve

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