Introducing 3P Culture Media

Pharmaceutical Proven Performance

Introducing 3P Culture Media

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Flexible storage conditions (2-25◦C)

enabling storage inside your cold room, clean

room, laboratory or warehouse

Impermeable packaging system which manages

moisture content in the media, enabling superior

quality, long shelf life and isolator compatibility

Excellent growth promotion characteristics

over the shelf life confirmed by testing from a

library of over 100+ organisms to include, USP, EP

and JP required and wild (plant) isolates

Excellent neutralization characteristics for

CT plates confirmed by testing against USP

organisms and plant isolates

Formulated to deliver optimum performance for

critical environments while minimizing the chance

that our product will introduce contamination into

your environment

Supported by 50 years of global microbiological experience- with scientists, process

engineers, support teams, and manufacturing technicians who understand the critical role

culture media represents for your environmental monitoring programs

Conceived and developed specifically for the

challenges encountered by the pharmaceutical

industry

Developed for Pharmaceutical Cleanrooms

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Tested over 40 different formulation combinations for best possible combination to

manage moisture, deliver long shelf life and enable flexible storage conditions

Evaluated 9 different plate presentations and

4 different inner wrapping films to optimize performance, shelf life and storage conditions

Tested over 100+ organisms for growth promotion from a library of EP/USP/JP organisms

and wild (plant) isolates

Confirmed neutralization capability against 10 commonly used disinfectants for use in clean

rooms

Complete control over manufacturing and raw materials to ensure consistent

performance over the entire shelf life

Product Shelf lives from manufacture

have been recently extended:

CT 3P : now 27 weeks

TSA 3P+N: now 52 weeks

Flexible storage conditions enabling

storage between 2-25◦C

3P Culture Media – Product Basics

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Product References:

43691 : Count Tact 3P - 20 plates

43699 : Count Tact 3P - 100 plates

43811 : TSA3P with neutralizers - 20

plates

43819 : TSA3P with neutralizers - 100

plates

Batch capacity is over 40,000 plates for

CT 3P and 30,000 plates for 90mm refs

90mm plates are deep-filled with 30mL

of media for long laminar flow exposures

and extended incubation times

QC microbiology test performed with

>75% recovery rate expected for all

ATCC pharmacopoeia strains

90mm plates with our proven LockSure

locking plate system

LockSure coming soon to CT 3P range!

Gamma Irradiated plates – 8-12 KGy

Validated with Vaporous Hydrogen

Peroxide (VHP ) and Peracetic Acid

gassing cycles for isolator compatibility

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3P Culture Media – Growth Promotion

3P media has been developed and proven to have consistent performance across a

diverse library of microorganism types that can be encountered in pharmaceutical clean

room environments

Graph shows 3P media performance for all organisms tested (N=127) from a

collection of commercial strains and wild (plant) isolates

3P Culture Media - Neutralization

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Non-irradiated TSA was used to ensure a

“worst-case” control

Both USP organisms and selected wild

(plant) isolates were evaluated to prove

neutralisation efficacy

Neutralization study performed to test the

ability of 3P culture media to adequately

promote growth even when exposed to

common clean room disinfectants

Testing performed using different

concentrations of disinfectants

Disinfectant Active compounds

Soproper Peracetic acid, acetic acid

H2O2

Amphospray Ethanol, Polyhexanide,

Alkylaminoalkylglycine and Didecyl

Dimethyl Ammonium Chlorid

Ultrasan H2O2

Virkon Potassium Monopersulfate 21.4%

Biocide B Chlorine dioxide

Quaternary ammonium compound.

Bacterianos Didecyl Dimethyl Ammonium Chloride,

Formaldehyde, Glutaraldehyde

IPA 70% Alcohol

3P Culture Media - Neutralization

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Graph represents 3P performance for USP

and Wild Type Organisms compared

against exposure to a range of typical and

representative disinfectant cocktails available

on the market

Results show consistent recovery across both

plate type formats compared to non-irradiated

TSA as a control that is not exposed to

disinfectant

3P Culture Media - Exudation/Condensation

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Reproducible- needs to be managed /

controlled through product formulation and

process conditions

Testing performed across the full

temperature range- (2-25◦C)

Natural mechanism of condensation during

the media cooling process, product storage

and shipping

Generated by temperature variation

within the environment

bioMerieux measuring system for presence of moisture

Condensation

score Drawing Description

Droplet

Diameter

Condensation

Mass (mg) Picture

0 – Dry No visible fog or water droplets 0 0

1 – Fog and / or

Tiny Droplets

Presence of fog or foggy patches

with no separate drops of water <1mm 1 – 100

2 – Small Drops Distinguishable small droplets 1 – 4mm 100 – 400

mg

3 – Full Drops One or more drops larger than 4mm >4mm 401 – 700

mg

4 – Water Droplets pooling to form large areas

of visible moisture

large

connected

droplets

(Pooling of

water)

Around

1g

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3P Culture Media - Exudation/Condensation

Storage condition 2-8°C

Storage condition 15-25°C

In the lid In the wrap

3P Culture Media – Dehydration

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Tested for both active and passive air sampling

followed by worst case incubation conditions to

show the media resistance to cracking and

shrinkage

Occurs when plates are subjected to harsh

conditions during air sampling or laminar flow

exposure, followed by extended incuabtion

bioMerieux measuring system for Dehydration

Scores

Intact

Plate

Meniscus

Break

Shrinkage <2 Cracks <2 Shrinkage > 2 Cracks > 2

1 3 2 4

Endpoint for Stability = Laminar flow

test failure for 90 mm plate format.

90 mm plate format s have a 30mL fill volume

optimized for air sampling applications to boost

resistance to dehydration effects

No Signs of Dehydration at the beginning,

middle, even when tested at the end of the

shelf-life

Endpoint for Stability = Meniscus loss

for CT plates

3P Culture Media – Improved Shelf life

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Growth Promotion testing conducted with

100+ microorganisms to include Yeast,

Moulds, Bacilli Gram+ and Gram-, Cocci Gm+

, Anaerobic bacteria and Wild (plant) Isolates

from our collection library

Table 1: Displays 3P performance for Pharmacopoeia mandated organisms plus E. coli . All

organisms tested resulted in greater than 70% recovery when compared to anon-irradiated TSA

control

During development, each strain is challenged

against a “gold standard” non-irradiated TSA

plate to ensure the the most sensitive media

for pharmaceutical isolates

Beginning of the shelf life Last day of the shelf life

Table 1: % Recovery Rate TSA (non irr.) Count-Tact 3P TSA 3P w/

neutralizers Count-Tact 3P

TSA 3P w/ neutralizers

Candida albicans ATCC 10231 96% 98% 97% 142%

Aspergillus brasiliensis ATCC 1640 73% 75% 74% 84%

Pseudomonas aeruginosa ATCC 9027 83% 91% 147% 108%

Escherichia coli ATCC 8739 81% 122% 169% 119%

Staphylococcus aureus ATCC 6538 87% 80% 67% 91%

Bacillus subtilis ATCC 6633 113% 182% 74% 105%

Acceptance criteria: Pharmacopeia strains 100% recovery >70%

Conform Conform Conform Conform

3P Culture Media – Stability and Shelf Life

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Stability data - performed in real time - now permits an extension of product

shelf-lives (from manufacture) to 27 weeks for CT 3P and 39 weeks for

TSA 3P with Neutralizers

Stability studies are performed to evaluate culture media performance against performance

specifications to qualify performance for products after they ship from our facilities

Thermal stress is applied to mimic changing conditions that could occur from shipment, storage

conditions and changing temperatures related to weather

Procedure accounts for extreme conditions we expect to encounter

All Products are shipped to our distribution hub under controlled temperature conditions

Stability data is gathered as part of our quality and product development process to qualify the

shelf life

Three batches are required and monitored for performance at regular intervals to determine

the shelf life

3P Culture Media – Thermal Stress

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bioMérieux Thermal Stress Procedure – Craponne Manufacturing

2-8°C

15-25°C

≥ 2 days

Thermal Stress #1

Storage initiated at our

manufacturing site to confirm

product storage at specified

conditions of 2-8C and 15-

25C

2-8°C

≥ 2 days

Thermal Stress #2

Performed to qualify cold

storage transportation from

Lombard MFG site to central

distribution hub followed by

media evaluation

#3

2-8°C

15-25°C

≥ 1 day

Thermal Stress #3

Performed to confirm

specified product storage

conditions are maintained

after transport to distribution

hub

#4 #5

2-8°C

15-25°C

Until expiration

Thermal Stress #5

Culture media samples

maintained at specified

storage conditions and

evaluated until expiration to

confirm performance over

the product shelf life

2-8°C

15-25°C

≥ 1 day

Thermal Stress #4

Performed to qualify possible

conditions that could be

encountered during shipping

to customer sites- with

temperature ranges to

account for changing

weather conditions

35-39°C

6 days

8 hours

#1 #2

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