PHARMACEUTICALENVIRONMENTAL MONITORING

When your product qualitymatters most

Measuring the e� ectiveness of contamination control is an essential component for environmental risk management. Accurate Envi-ronmental Monitoring data is crucial when making product release decisions.

Culture media must be robust enough to wit-hstand the rigorous conditions in today’s phar-maceutical cleanrooms. Culture media needs to be both reliable and sen-sitive to promptly detect stressed organisms inherent to aseptic manufacturing areas.

With over 50 years of microbiolo-gy experience, bioMérieux has developed a solution speci� cally designed for pharmaceutical environmental monitoring….

The 3P™ range represents state-of-the-art culture media

technology from both a formulation and

packaging perspective

PROVENValidated for use

by pharmaceutical manufacturers world-wide for

their most critical manufacturing environments

PERFORMANCESMedia formulations

optimised for maximum sensitivity and

reproducibility within the same lot, and

from batch to batch

PHARMACEUTI-CAL

Designed to meet the needs of

the pharmaceutical industry for the highest

quality culture media for use in clean room and

isolator manufacturing areas

closure system

Measuring the e� ectiveness of contamination control is an essential component for environmental risk management. Accurate Envi-ronmental Monitoring data is crucial when making product release decisions.

Culture media must be robust enough to wit-hstand the rigorous conditions in today’s phar-maceutical cleanrooms. Culture media needs to be both reliable and sen-sitive to promptly detect stressed organisms inherent to aseptic manufacturing areas.

With over 50 years of microbiolo-gy experience, bioMérieux has developed a solution speci� cally designed for pharmaceutical environmental monitoring….

The 3P™ range represents state-of-the-art culture media

technology from both a formulation and

packaging perspective

PROVENValidated for use

by pharmaceutical manufacturers world-wide for

their most critical manufacturing environments

PERFORMANCESMedia formulations

optimised for maximum sensitivity and

reproducibility within the same lot, and

from batch to batch

PHARMACEUTI-CAL

Designed to meet the needs of

the pharmaceutical industry for the highest

quality culture media for use in clean room and

isolator manufacturing areas

closure system

Measuring the e� ectiveness of contamination control is an essential component for environmental risk management. Accurate Environmental Monitoring data is crucial when making product release decisions.

Culture media must be robust enough to withstand the rigorous conditions in today’s pharmaceutical cleanrooms. Culture media needs to be both reliable and sensitive to promptly detect stressed organisms inherent to asepticmanufacturing areas.

With over 50 years of microbiology experience, bioMérieux has developed a solution speci� cally designed for pharmaceutical environmental monitoring the 3P™ range.

• Validated with comprehensive thermal shocks during shelf-lifetesting to guarantee consistent performance from the beginning of the shelf-life to the date of expiry

• Developed using both pharmacopoeia and wild-type strains from real clean room environments – be sure no contamination gets missed

• Completely controlled manufacturing process: from the basic rawmaterials to the � nal plate, ensures consistent reliability betweenall batches

• Unparalleled recovery expectation ≥75% during routine QC

The 3P™ range represents state-of-the-art culture media

technology from both a formulation and packaging perspective

THE 3P™ RANGE

• Maximum convenience for storage and inventory management - Flexible storage between 2 - 25°C- Long Shelf-life- Large monolot capacity (50 000 plates)

• Validated with Vaporous Hydrogen Peroxide (VHP) and Peracetic Acid gassing cycles forisolator compatibility

• Secure your crucial Environmental Monitoring samples during critical transport and incubation steps with bioMérieux’s unique LOCKSURE® (90mm) closure system - Quick and intuitive use – single locking position, no risk of incorrect incubation conditions- No need for additional para� lm or adhesive tape wrapping of plates – saves time and reduces risk

• Wide range of accessories- Sterile BI-BOX™ for security and reduced secondary contamination risk during transport and incubation- COUNT-TACT® applicator – remove the variability between technicians – completely consistent time

and pressure of exposure for contact plate sampling

PHARMACEUTICALDesigned to meet

the needs of the pharmaceutical

industry for the highestquality culture media

for use in clean room andisolator manufacturing

areas

PROVENValidated for use

by pharmaceutical manufacturers world-wide for

their most critical manufacturing environments

PERFORMANCESMedia formulations

optimised for maximum sensitivity and

reproducibility within the same lot, and

from batch to batch

Superneutralizingmedia

Environmental Monitoring media must be carefully validated to ensure compatibility with the selected disinfectants. Stringent biocides can leave behind residuals that must be neutralized to ensure correct detection of cleanroom microbes.

• Enhanced Neutralizers media is designed to deactivate the toughest disinfectant combinations and persistent residues

• Available with our known � exible storage conditions of 2 - 25°C

• Easy inventory management with long shelf life (6 -12 months) and monolot availability

• Secured transport with our uniqueLOCKSURE® (90mm) and FIX (COUNT-TACT®) closing systems

Description Reference Presentation Storage

Count-Tact® 3P™43691 2 x 10 (55mm) 2-25°C

43699 10 x 10 (55mm) 2-25°C

TSA 3P™43711 2 x 10 (90mm) 2-25°C

43169 10 x 10 (90mm) 2-25°C

TSA 3P™ with neutralizers43811 2 x 10 (90mm) 2-25°C

43819 10 x 10 (90mm) 2-25°C

TSA 3P™ with β-lactamase43287 2 x 10 (90mm) 2-25°C

43288 2 x 10 (55mm) 2-25°C

Sabouraud Dextrose Agar 3P™43812 2 x 10 (55mm) 2-25°C

43814 2 x 10 (90mm) 2-25°C

TSA 3P™ with Enhanced Neutralizers 410927 2 x 10 (55mm) 2-25°C

APP COUNT-TACT® Applicator 421895 1 applicator Ambient

BI-BOX™ CT 96301 1 x 10 BI-BOX™ CT Ambient

BI-BOX™ 90 96311 1 x 10 BI-BOX™ 90 Ambient

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bioMérieux S.A. • 69280 Marcy l’Étoile • France • Tel.: + 33 (0)4 78 87 20 00 • Fax: +33 (0)4 78 87 20 90www.biomerieux.com • www.biomerieux-industry.com