Introducing 3P Culture Media

Proven Pharmaceutical 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

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

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 USP 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

Flexible storage conditions enabling

storage at both:

2-8◦C and 15-25◦C

3P Culture Media – Product Basics

4

Product References:

410250: CT3P pack of 20 plates

418049: CT3P pack of 100 plates

410251: TSA3P pack of 20 plates

418140: TSA3P pack of 100 plates

Normal batch sizes for CT plates will be

near 20,000 plates per batch

Normal batch sizes for monoplates will

be near 10,000 plates per batch

Fill volume for monoplates will be 30mL

Available in packs of 20 and boxes of

100 plates with 10 plates per sleeve

Packaging designed to protect product

and enable consistent transport

Carton label and inner sleeve label

designed with irradiation indicator which

will turn reddish-brown upon exposure

3P Culture Media – Growth Promotion

5

Plate Inoculation and reading were performed

using automated streaking and reading instruments

to ensure reproducibility and uniformity across the

results

Growth Promotion testing conducted with 100+

microorganisms to include Yeast, Molds, Bacilli

Gm+ and Gm-, Cocci Gm+ , Anaerobic bacteria

and Wild (plant) Isolates from our collection library

Each microorganism was compared in duplicate to

non-irradiated TSA- to establish a growth gold

standard from calibrated stock solutions

Table 1: demonstrates 3P performance for USP mandated organisms plus e coli with 100%

recovery of all organisms greater than 70% when compared to non-irradiated TSA, DE and

selected commercially available media

Table 1: % Recovery Rate TSA (non irr.) CT3P Media A Dey Egley Media B Media C Media D

Candida Albicans ATCC 10231 at 30-35°C 71.6% 82.8% 75.0% 79.3% 103.5% 70.7%

Candida Albicans ATCC 10231 at 20-25°C 121.0% 132.3% 122.6% 148.4% 154.8% 100.0%

Aspergillus brasiliensis ATCC 1640 at 30-35°C 93.5% 94.6% 5.4% 59.8% 102.2% 68.5%

Aspergillus brasiliensis ATCC 1640 at 20-25°C 84.6% 83.5% 0.0% 83.5% 86.8% 60.4%

Pseudomonas aeruginosa ATCC9027 97.1% 93.3% 88.5% 88.5% 66.3% 77.7%

Escherichia coli ATCC 8739 95.5% 86.5% 95.5% 82.9% 80.2% 132.9%

Staphylococcus aureus ATCC6538 102.2% 115.4% 112.1% 84.6% 123.1% 126.8%

Bacillus subtilis ATCC 6633 78.9% 72.5% 92.7% 97.2% 84.4% 87.6%

Acceptance criteria

Pharmacopeia strains

100% recovery >70%

100% 100% 75% 87.50% 87.50% 75%

6

3P Culture Media – Growth Promotion

Graph demonstrates 3P performance

for all organisms tested (N=113) from a

collection of commercial strains and

wild (plant) isolates

3P media also demonstrates consistent

performance across a diverse library

of microorganisms:

88% recovery at > 75% compared

to TSA non irradiated

11% recovery at > 50-75% compared

to TSA non irradiated

3P Culture Media - Neutralization

7

Testing performed using different

concentrations of disinfectants when

applicable

Non irradiated TSA used as a control

Neutralization study performed to test the

ability of 3P culture media to adequately

promote growth when exposed to common

clean room disinfectants

USP organisms and selected wild (plant)

isolates were evaluated

Alcohols Oxidizing Agents Phenolic Quaternary

Ammonium

70% IPA Clorox

H2O2

Peracetic Acid

Vesphene

Sporicidin

Decon Quat 100

TX 650

3P Culture Media - Neutralization

8

Graph represents 3P performance for USP

Organisms compared against exposure to a

common preparation of oxidizing agents

Results show consistent recovery when

compared to DE media and selected

commercially available products

Graph represents 3P performance for Wild

(plant) Isolates also compared against

exposure to the same preparation of oxidizing

agents

Results also show consistent recovery when

compared to DE media and selected

commercially available products

0%

20%

40%

60%

80%

100%

120%

140%

160%

TSA Control CT3P Dey Egley CT L&P80 Media A CT L&P80 Media B CT L&P80 Media C

Neutralization of H2O2 w/1% Peracetic Acid USP Organisms

C. albicans ATCC 10231

A. brasiliensis ATCC 16404

P. aeruginosa ATCC 9027

B. subtilis ATCC 6633

S. aureus ATCC 6538

0%

20%

40%

60%

80%

100%

120%

140%

TSA Control CT3P Dey Egley CT L&P80 Media A CT L&P80 Media B CT L&P80 Media C

Neutralization of H2O2 w/1% Peracetic Acid Plant Isolates

S. paucimobilis STL 108706

C. striatum ATCC BAA-1293

K. rhizophila ATCC 9341

B. pumilus STL 200111

3P Culture Media - Exudation/Condensation

9

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

10

3P Culture Media - Exudation/Condensation

Score 0

Score 1

Score 2

Score 3

Score 4

Moisture evaluation scores demonstrate consistently dry plates when compared to selected competitive products

3P Culture Media – Dehydration

11

Tested for both active and passive air sampling

followed by worst case incubation conditions

Occurs when plates are subjected to harsh

conditions during air sampling followed

by incubation

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 Monoplates

Monoplates will have a 30mL fill volume

optimized for air sampling applications

No Signs of Dehydration at the beginning,

middle, and up to this point in the stability study

Endpoint for Stability = Meniscus loss

for CT plates

3P Culture Media – Stability and Shelf Life

12

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

13