PharmaSystems’ Solutions for USP<797> ComplianceSterile Preparations for Compounding Pharmacies

• USP chapter <797>, Sterile Preparations for Pharmaceutical Compounding, details the quality standards, conditions and procedures for compounding sterile preparations (CSPs) of drugs and nutrients in a cleanroom

• USP >797> defines a cleanroom as 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

• A cleanroom standard is enforced to prevent harm to patients that could result from microbial contamination, excessive bacterial endotoxins, variability in intended strength, unintended chemical and physical contaminants, and ingredients of inappropriate quality

• Cleanroom classes vary based on the nature of the operation (ISO 14611-1:999 – Cleanrooms and associated controlled environments – Part 1: Classification of air cleanliness)

Filling Zone - For your Cabinet, Isolator or Laminar Air Flow Hood

Buffer Zone - For your Cleanroom

Anteroom – For your Cleanroom

ISO Class 5

ISO Class 7

ISO Class 8

Glove & Surface Cleaning

Isolator and Hood Cleaning

Dry Wiping and Spill Control

ISO Class 5

Glove & Surface Cleaning Product Recommendations

Sterile 70% Isopropanol Sterile Alcohol SprayItem # 17979

• 16 oz. sterile alcohol spray, induction sealed to assure stability• Contains 70% by volume USP Grade Isopropanol (IPA) and 30% USP Grade Purified

Water, filtered to 0.2µ• Includes trigger sprayer with mist and stream settings (packaged separately); bottle is

packaged double-bagged and gamma-irradiated• Each bottle is lot coded and has an expiration date for easy record keeping, validated per

the Association for the Advancement of Medical Instrumentation (AAMI) 11137:2006 Applications:

• Wipedown of isolators, cabinets, laminar flow hoods and surfaces• Use on gloved hands in sterile suites• Wipe down of products and equipment for pass through to controlled environments• Ideally suited for use with sterile cleanroom wipes

SatPax® 670-R Pre-Wetted 70% IPA WipersItem # 17880

• 9 x 9”, 75 sheets per package• Pre-wetted wipers are saturated with 70% isopropyl alcohol (IPA) and deionized water (DI)

filtered to 0.2 µm.• Made of 55% cellulose/45% polyester, nonwoven• Peel and reseal pouches allow for single wiper use and prevent evaporation• Lot number on each pouch for traceability & process accountability• Excellent strength and durability

Applications:• Designed for use in wet cleaning of critical surfaces where control of flammable solvents

and flammable solvent concentrations is required• Final cleaning of surfaces or products prior to manufacturing or packaging• High saturation level is ideal for removing cleaning and disinfecting residues in regulated

environments

PROSAT® Nonwoven WipesItem # 18712

• 9 x 11”, 30 wipes per pouch• Presaturated with 70% IPA/30% DI Water solvent blend• Conveniently packaged in a flat resealable pouch designed to preserve cleanliness and

solvent saturation level• Pouches are individually lot-numbered for traceability• PROSAT wipes help to reduce solvent usage and VOC emissions

Applications• ISO Class 5 compatible• General surface cleaning• Cleaning prior to decal application

PROSAT® Sterile™ Presaturated WipesItem # 18713

• 9 x 11”, 30 wipes per pouch• Nonwoven, meltblown polypropylene presaturated wipes• Saturated with 70% isopropyl alcohol/30% deionized water• Sterilized by Gamma Irradiation, validated sterile to a Sterility Assurance Level of 10-6 in

accordance with AAMI Guidelines (certificate of Sterility is available upon request)• Tamper evident label• Resealable pouch preserves cleanliness and solvent saturation levels• Each package is individually lot-numbered

Applications• Designed for sterile environments• Routine cleaning and wipe down of lab tools, instruments and other equipment• Cleanup following Rhodac plate sampling

Dry Wiping and Spill Control Product Recommendations:EcoClean® 100% Cotton Nonwoven Cleanroom Wiper Item # 17883 - 5 x 5” wipers, 100 per package Item # 17884 - 9 x 9” wipers, 300 per package

• 100% biodegradable environmentally friendly wipes made from 100% natural fiber (with no binders or additives), low ionic contamination

• Manufactured by a proprietary process for low fiber release and high strength• #17883 is quarter folded to fit the hand and promote proper wiping technique• Can be used in critical pharmaceutical, medical device, and semiconductor applications

where absorbency and softness are requiredApplications

• Cleaning high temperature production equipment and diffusion furnaces • Absorbent, low linting work surface material • Removing aqueous and solvent spills • Critical industrial applications where absorbency and softness are critical • Cleaning of support/less critical areas and manufacturing processes in regulated

environments • Wiping of optics and other sensitive surfaces • Steam autoclavable for aseptic applications

SterileSorb™ Sterile Cellulose/polyester nonwoven wipesItem # 18956 – 9 x 9”, 25 wipes per package Item # 18957 – 12 x 12”, 25 wipes per package

• Sterile cellulose/polyester nonwoven wipes• Strong and durable hydroentangled fabric• Low levels of particles and extractables• Extremely absorbent• Validated sterile to a Sterility Assurance Level of 10-6 in accordance with standards and

recommended practices of the AAMI Guidelines (certificate of Sterility is available)Applications

• Excellent for wiping and absorbing spills• General purpose cleaning in biotech, pharmaceutical, and medical device manufacturing

environments

ISO Class 5

ISO Class 5

ISO Class 7

ISO Class 8

ISO Class 5

ISO Class 5

151 Telson Road Markham, Ontario, Canda L3R 1E7Tel: 905.475.2500 • Toll Free: 1.888.475.2500 • Fax: 905.475.7155 • Toll Free: 1.888.475.7155www.pharmasystems.com • info@pharmasystems.com

PharmaSystems’ extensive product mix offers the latest technology and resources to help you achieve best practices in pharmacy.

Request a full catalogue, or view online at www.pharmasystems.com

Amplitude™ EcoCloth™ poly/cellulose nonwoven wipesItem # 18263 - 9 x 9”, 300 wipes per package Item # 18264 - 12 x 12”, 150 wipes per package

• 9 x 9”, 300 wipes per package• Lightweight, highly sorbent wipe• Strong and durable hydroentangled fabric• Good solvent compatibility• Low levels of particles and extractables• 15% usage reduction over traditional spunlace nonwovens

Applications• Recommended for use in ISO Class 6 and above cleanroom applications• Excellent for wiping and absorbing spills• General purpose cleaning in biotech, pharmaceutical, medical device and similar industries• Ideal for product wipe down prior to introduction into cleanroom environments• Designed for nonabrasive applications

Isolator and Hood Cleaning Product Recommendations

Easy Reach™ Cleaning ToolFor Isolators, cabinets and laminar air flow hoodsItem # 18273 - Easy Reach™ Cleaning Tool Item # 18274 – Quilted Polyester Cleaning Pads 60 per package (15 bags of 4 wipes)Item # 18275 – Sterile Quilted Polyester Cleaning Pads 60 per package (15 bags of 4 wipes)Item # 18276 – Sterile Presaturated Cleaning Pads, 70% IPA 64 per package (8 bags of 8 wipes)

• Specially designed tab on the cleaning pad enables quick and easy fitting to the frame with gloved hands

• Single piece stainless steel tool is easily passed through transfer hatches, requires no assembly and is maintenance-free

• Versatile low profile, 360 degree pivoting head ensures even the most awkward areas can be quickly reached with ease

• All components are chemical resistant, minimizing the risk of contamination from degradation

Applications:Easy to use EasyReach™ is recommended for effective cleaning and disinfection of surfaces in:

• Isolators - rigid, flexible film, half suits• Restricted Access Barrier Systems (RABS)• Filling Lines• Laminar Air Flow Hoods• Bio-Safety Cabinets• Glove Boxes

ISO Class 5

ISO Class 7

ISO Class 8