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Introducing 3P Culture Media
Pharmaceutical Proven Performance
Introducing 3P Culture Media
2
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
3
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
4
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
5
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
6
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
7
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
8
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
9
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
10
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
11
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
12
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
13
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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