Biological Indicators

Biological Indicators

Biological indicators (BIs) contain viable microorganisms that provide a defined resistance to a specified sterilization process.

Trusted by hospitals, pharmaceutical and medical device manufacturers, ambulatory surgical centers, dentists and more, BIs enable validation and verification of a sterilization cycle.

The CDC recognizes BIs to be ideal sterilization monitors that should be used in conjunction with mechanical and chemical indicators.

Dry Heat Sterilization

One of the earliest forms of sterilization practiced, dry heat sterilization is accomplished by conduction, where heat is absorbed by the exterior surface and passed inward to the next layer. Dry heat sterilization is ideal for heat-stable items such as glass, stainless steel, nonaqueous liquids, powders, etc. The essential cell components are destroyed and the organism is killed by oxidizing molecules.

CHEMICAL INDICATORS – DRY HEAT
Classification: Dry Heat – Type 4

Item Part Number Packaging
DryChecks Strips DRY CHECKS STRIPS 250/bag
Indicator Labels (Dry Heat) 510(k) Cleared at 160°C CI-DHI 1,000/roll

INDUSTRIAL USE BIS AND CULTURE MEDIA
Population:106
ATCC Number 9372

Item Part Number Packaging
Cotton Thread: 19mm x 1.5mm B. Atrophaeus 1-6100TT 100/package in Tyvek/Mylar
Paper Discs: 6mm B. Atrophaeus 1-10006mm 1000/bulk
1-10006mm 100/package

DRIAMP CULTURING KIT
Population:106
ATCC Number 9372

Item Part Number Packaging
DriAmp Biological Indicator Culturing Set DH/50 Box of 50 DriAmp Ampoules with 50 Relea

DRIAMP CULTURING MEDIA

Item Part Number Packaging
Releasat Media with Phenol Red for EtO/Dry Heat/ClO2 3.6ml Fill Volume in 16mm x 100mm Tubes RG/100 100/box

MesaStrips
A MESAStrip contains bacterial spores on a paper carrier sealed within a convenient, peel-open envelope.
Population: 106
ATCC Number 9372
Dimensions: Strip 0.25in x 1.0in, glassine envelope 1.03in x 3.0in

Item Part Number Packaging
B. Atrophaeus SGMG/6 100/bag

MICRO STRIPS
Micro Strips can be used in areas where other BIs are too large.
Population: 106
ATCC Number 9372

Item Part Number Packaging
1mm x 25mm B. Atrophaeus A1X25/6 100/package, bulk
A1X25/6G In Glassine, 100/package
2mm x 10mm B. Atrophaeus A2X10/6 100/package, bulk
A2X10/6G In Glassine, 100/package

SPORE STRIPS
The Spore Strip is inoculated with bacterial spores on a paper carrier sealed within a convenient, peel-open glassine envelope.

Dimensions: Strip 1.5in x 0.25in, glassine envelope 1.03in x 3.0in

Item Part Number Packaging Population ATCC Number
B. Atrophaeus Jan-00 100/bag 106 9372
Jan-00 500/bag
1-1000 1000/bag
Spore Strip Combined: Test B. Atrophaeus & G. Stearothermophilus 5-1000T 1000/bag 106 / 105 9372 & 7953
Spore Strip Combined: Control B. atrophaeus & G. Stearothermophilus 5-1000C 1000/bag
Spore Strip Combined B. Atrophaeus & G. Stearothermophilus May-00 100/bag

SPORE SUSPENSIONS
Mesa Labs’ Bacillus Atrophaeus Spore Suspensions are calibrated suspensions of bacterial spores appropriate for direct inoculation of roducts or preparing custom BIs for monitoring dry heat and EtO sterilization processes.

ATCC Number 9372 • Diluent: 40% Ethanol • Package Configuration: 10 ml vial

Item Part Number Population
Bacillus Atrophaeus SSGE/4 104 / 0.1 ml
SSGE/5 105 / 0.1 ml
SSGE/6 106 / 0.1 ml
SSGE/7 107 / 0.1 ml
SSGE/8 108 / 0.1 ml

Ethylene Oxide (EtO) / Gas Sterilization

EtO sterilization is one of the most common sterilization methods for medical device manufacturing including specialty device kits used for surgical procedures. The chemical process consists of four primary variables: gas concentration, humidity, temperature, and time. EtO is an alkylating agent that disrupts the DNA of microorganisms, which prevents them from reproducing.

EZTEST
EZTest is a self-contained BI that contains bacterial spores on a paper carrier, packaged within a small, thermoplastic culture tube with a sealed-glass ampoule. The specially-formulated soybean casein digest culture medium contains a color indicator, which turns a dramatic yellow when spores grow.
Visual results within 24 hours (steam or H2 O2) or 48 hours (EtO).
Population: 106
ATCC Number 9372

item Part Number Packaging
B. Atrophaeus 510(k) Cleared EZG/6 100/box
EZG/625 25/box

INDUSTRIAL USE BIS
Population: 106
ATCC Number 9372

Item Part Number Packaging
Cotton Thread: 19mm x 1.5mm B. Atrophaeus 1-6100TT 100/package in Tyvek/ Mylar
Paper Discs: 6mm B. Atrophaeus 1-10006mm 1000/bulk
1-61006mm 100/package

MESASTRIPS
MESAStrip contains bacterial spores on a paper carrier sealed within a convenient, peel-open envelope.
Dimensions: Strip 1.0in x 0.25in, glassine envelope 1.03in x 3.0in.
Population: 106
ATCC Number 9372

Item Part Number Packaging
MESAStrip for EtO/Dry Heat B. Atrophaeus SGMG/6 100/bag

MEDIA AND KITS

Item Part Number Population ATCC Number Packaging
Releasat Biological Indicator Culturing Set for EtO RG/100 106 9372 Box of 100 MESAStrips with 100 Releasat Media Tubes
Releasat Media with Phenol Red for EtO/Dry Heat/ClO2 3.6ml Fill Volume in 16mm x 100mm Tubes RM/100 N/A N/A 100/box
Tryptic Soy Broth with Bromocresol Purple 16mm Tubes TSB-BP16 N/A N/A 100/box

MICRO STRIPS
At 2mm x 10mm or 1mm x 25mm, Micro Strips can be used in areas where other BI’s are too large.
Population: 106
 • ATCC Number 9372

Item Part Number Packaging
Micro Strips: 1mm x 25mm B. Atrophaeus A1X25/6 100/package, bulk
A1X25/6G In glassine, 100/package
Micro Strips: 2mm x 10mm B. Atrophaeus A2X10/6 100/package, bulk
A2X10/6G In glassine, 100/package

SPORE STRIPS
The Spore Strip is inoculated with bacterial spores on a paper carrier sealed within a convenient, peel-open envelope.

Dimensions: Strip 0.25in x 1.5in, glassine envelope 1.03in x 3.0in.

Item Part Number Population ATCC Number Packaging
B. Atrophaeus Jan-00 106 9372 100/bag
Jan-00 106 9372 500/bag
1-1000 106 9372 1000/bag
Spore Strip Combined: Test B. Atrophaeus & G. Stearothermophilus 5-1000T 106 / 105 9372 & 7953 1000/bag
Spore Strip Combined: Control B. Atrophaeus & G. Stearothermophilus 5-1000C 106 / 105 9372 & 7953 1000/bag
Spore Strip Combined B. Atrophaeus & G. Stearothermophilus May-00 106 / 105 9372 & 7953 100/bag

SPORE SUSPENSION – BACILLUS ATROPHAEUS
Mesa’s Bacillus Atrophaeus Spore Suspensions are calibrated suspensions of bacterial spores appropriate for direct inoculation of products or preparing custom BIs for monitoring dry heat and EtO sterilization processes.
Package Configuration: 10 ml Vial
ATCC Number 9372 • Diluent: 40% Ethanol

Part Number Population
SSGE/4 104 / 0.1 ml
SSGE/5 105 / 0.1 ml
SSGE/6 106 / 0.1 ml
SSGE/7 107 / 0.1 ml
SSGE/8 108 / 0.1 ml

Process Challenge Devices (PCDs)

Mesa PCD® Technology products consist of commercial spore strips, discs or self-contained BIs in a proprietary EtO barrier pouch. For greater efficiency, PCDs packaged with self-contained biological indicators, enable you to see the results, without waiting for multi-day incubation periods or sending the indicator to the lab for results.

BARE BI PCDS

Part Number BI Manufacturer BI Type Packaging
PCD 0.6 3M Attest™ Self-Contained BI 300/package
PCD 09 Attest Rapid Readout BI 300/package
1-10006mm MESA BI Disc, 1-10006mm 1000/package
1-61006mm BI Disc, 1-10006mm 100/package
EZG/6 Steris EZTest Self-Contained BI 100/package
PCD 0.7 Spore Strip in Glassine 500/package

STANDARD PCDS
Packaging: 100

Part Number BI Manufacturer Description Nominal D-Value
Type 3 - Least Resistance
PCD 3.13 MESA EZTest Self-Contained BI 3
PCD 3.2 Steris Spore Strip without Glassine 3
PCD 3.5 MESA Spore Strip in Glassine 4
PCD 3.6 3M Attest Self-Contained BI 5
PCD 3.9 3M Attest Rapid Readout BI 5
Type 5 - Low Resistance
PCD 5.1 MESA BI Disc, 1-10006mm 4
PCD 5.13 MESA EZTest Self-Contained BI 13
PCD 5.2 Steris Spore Strip without Glassine 4
PCD 5.5 MESA Spore Strip in Glassine 6
PCD 5.62 3M Attest Self-Contained BI 13
PCD 5.92 3M Attest Rapid Readout BI 13
Type 4 - Medium Resistance
PCD 4.1 MESA BI Disc, 1-10006mm 21
PCD 4.13 MESA EZTest Self-Contained BI 50
PCD 4.19 MESA Mini Spore Strip in Glassine 32
PCD 4.2 Steris Spore Strip without Glassine 21
PCD 4.5 MESA Spore Strip in Glassine 32
PCD 4.6 3M Attest Self-Contained BI 50
PCD 4.7 Steris Spore Strip in Glassine 32
PCD 4.9 3M Attest Rapid Readout BI 50

STANDARD PCDS
Packaging: 100

Part Number BI Manufacturer Description Nominal D-Value
PCD 6.1 MESA BI Disc, 1-10006mm 12
PCD 6.13 MESA EZTest Self-Contained BI 35
PCD 6.2 Steris Spore Strip without Glassine 12
PCD 6.5 MESA Spore Strip in Glassine 17
PCD 6.6 3M Attest Self-Contained BI 35
PCD 6.7 Steris Spore Strip in Glassine 17
PCD 6.9 3M Attest Rapid Readout BI 35
Type 7 - Medium Resistance
PCD 7.1 MESA BI Disc, 1-10006mm 9
PCD 7.13 MESA EZTest Self-Contained BI 26
PCD 7.2 Steris Spore Strip without Glassine 9
PCD 7.5 MESA Spore Strip in Glassine 14
PCD 7.6 3M Attest Self-Contained BI 26
PCD 7.7 Steris Spore Strip in Glassine 14
PCD 7.9 3M Attest Rapid Readout BI 26
Type 2 - Most Resistance
PCD 2.1 MESA BI Disc, 1-10006mm 28
PCD 2.12 MESA Spore Strip without Glassine 28
PCD 2.13 MESA EZTest Self-Contained BI 58
PCD 2.2 Steris Spore Strip without Glassine 28
PCD 2.5 MESA Spore Strip in Glassine 37
PCD 2.6 3M Attest Self-Contained BI 58
PCD 2.7 Steris Spore Strip in Glassine 37
PCD 2.9 3M Attest Rapid Readout BI 58

Specialty Sterilization Processes

Mesa offers BIs for specialty sterilization processes, including chlorine dioxide (ClO2), gamma irradiation and hydrogen peroxide (H2O2).

Chlorine Dioxide (ClO2) Sterilization

Chlorine dioxide, known for producing less harmful byproducts than chlorine, is commonly used as a sterilizer, oxidizer or disinfectant.
It efficiently kills pathogenic microorganisms and spore-forming bacteria but also prevents and removes bio film.

Media

Item Part Number Packaging
Releasat Media with Phenol Red for EtO/Dry Heat/ClO2 3.6ml Fill Volume in 16mm x 100mm Tubes RM/100 104 / 0.1 ml

MESASTRIP
MesaStrip contains bacterial spores on a filter paper carrier sealed within a convenient, peel-open envelope.
Dimensions: Strip 0.25in x 1.0in, glassine envelope 1.03in x 3.0in.
Population: 106
ATCC Number 9372

Item Part Number Packaging
B. Atrophaeus - in Tyvek/Mylar ACD/6 100/bag

Gamma Irradiation Sterilization

Exposing products to a Cobalt 60 radiation field. gamma irradiation is known for its quick turnaround times, easy penetration of packaging and is ideal for many types of materials.

INDUSTRIAL USE BIS

Item Part Number Population ATCC Number Packaging
Stainless Steel Disc: 7mm - B. Pumilus DPSSC/3 103 27142 100/package in clear plastic
DPSS/6C 106 27143 100/package in clear plastic

MESASTRIP
MesaStrip contains bacterial spores on a filter paper carrier sealed within a convenient, peel-open envelope.
Dimensions: Strip 1.0in x 0.25in, glassine envelope 1.03in x 3.0in.
ATCC Number: 27142

Item Part Number Population Packaging
B. Pumilis SGMR/6 106 100/bag
SGMR/7 107 100/bag

Ozone (O3) Sterilization

SPORE STRIPS

Item Part Number Population ATCC Number Packaging
Bacillus Subtilis Spore Strip in Tyvek envelopes AOZ/3T 103 35021 100/package
Bacillus Atropheaus Spore Strip in Tyvek envelopes OZA/4T 104 9372 100/package
AOZ/6T 106 9372 100/package

Hydrogen Peroxide (H2O2) Sterilization

APEX
APEX BI products are designed specifically for the pharmaceutical, food and medical device industries, utilizing H2O2 vapor sterilization. The stainless steel carrier is used in multiple processes including isolator and filling line applications

Item Part Number Population ATCC Number Packaging
Stainless Steel Discs in Tyvek/Tyvek B. Atrophaeus - 9mm Diameter. GRS-090E3 103 9372 100/package
GRS-090 106 9372 100/package
Stainless Steel Discs in Tyvek/Tyvek G. Stearothermophilus - 9mm Diameter. HMV-091E3 103 12980 100/package
KCD-404 104 12980 100/package
HMV-091 106 12980 100/package
Bare Metal BI Stainless Steel Ribbon G. Stearothermophilus - 6mm x 80mm. SBC-327 106 12980 100/package
Tri-Scale BI; Tyvek Package BI with 104 , 105 and 106 Stainless Steel Carriers G. Stearothermophilus - 9mm Diameter LOG-456 104 , 105 , 106 12980 50/package
Stainless Steel Discs in Tyvek/Tyvek G. Stearothermophilus - 9mm Diameter. NAS-152E3 103 7953 100/package
NAS-152 106 7953 100/package
Sterile Tyvek Transfer Pockets for SBC-327 BMWK-750 N/A N/A 100/package
Spore Suspension for Gaseous Hydrogen Peroxide - G. Stearothermophilus LAU-196 107 / 0.1 ml 12980 10 ml vial
LPT-606 107 / 0.1 ml 7953 10 ml vial
Releasat Purple Media, for Use with G. Stearothermophilus Products 3.6ml Fill Volume in 16mm x 100mm Tubes PM/100 N/A N/A 100 units

STERRAD® H2O2

The STERRAD® H2O2 sterilization cycle is a low-temperature process that uses hydrogen peroxide gas plasma technology for sterilization. The process provides gentle sterilization for delicate instruments in about an hour or less. Temperatures do not exceed 50°C, and sterilization occurs in a low moisture environment.

EXPOSURE™
ExpoSure is a BI intended for use in the STERRAD Sterilizer. ExpoSure has received its 510(k) clearance making it suitable for healthcare and nonhealthcare settings. Its 24-hour incubation time and flexibility make it a powerful tool to help your facility maintain compliance and patient safety.
ExpoSure can be used in conjunction with existing incubators (55-60°C).
Population: 106
ATCC Number 7953

Item Part Number Packaging
G. Stearothermophilus 510(k) Cleared EXPO/6 30 indicators per box; 1 crusher

EZTEST
EZTest is a self-contained BI that contains bacterial spores on a paper carrier, packaged within a small, thermoplastic culture tube with a sealed-glass ampoule, specially-formulated soybean casein digest culture medium containing a color indicator, which turns a dramatic yellow when spores grow. Visual results within 24 hours (steam or H2O2) or 48 hours (EtO).
ATCC Number 7953 • Packaging: 100/box

Item Part Number Population
G. Stearothermophilus EZH/5 105
EZH/6 106

MESA PCD TECHNOLOGY
PCD patented products nominally consist of any commercial BI strip, disc or self-contained BI in a proprietary H2O2 barrier pouch.
Nominal D-Value: N/A • Available in quantities of 100

BI Type Part Number BI Manufacturer
EZTest EZH/6 PCD 8.13 MESA

Steam Sterilization

Steam is the most common sterilization method due to its nontoxic, inexpensive and sporicidal process properties. Sterilization is achieved by exposing products to saturated steam at high temperatures (from 121 to 135°C) at a required pressure for a specified amount of time. Saturated steam is a biphasic mixture of H2O in gas and liquid phases in thermal equilibrium. Because of the high heat involved in steam sterilization, it is not appropriate for all materials.

Liquid Loads

The sterilization of liquids is very different from a porous/hard load, as air removal is not critical. Sterilization is dependent upon steam contacting the container which houses the liquid product, therefore relying on the water inside of the product to create a steam environment within the container where the BI should be placed.

AMPOULES FOR STERILIZATION OF LIQUID LOADS
ProSpore Ampoule, MagnaAmp and SterilAmp II liquid submersible self-contained BIs and are ideal for validating the steam sterilization of liquid loads. Simply expose the unit to the sterilization process and incubate afterwards. These indicators are validated for 48-hour reduced incubation. However, SterilAmp II 5230 (Part# SASU/6) is validated for 72-hour incubation. Liquid Ampoules are refrigerated and require overnight shipping. See the Accessories page for ProSpore and MagnaAmp incubators.

Item Part Number Population ATCC Number Packaging
4 ml ProSpore - 510(k) Cleared 14.75mm x 52mm PS-4-10 104 7953 10/box
PS-4-50 104 7953 50/box
PS-5-10 105 7953 10/box
PS-5-50 105 7953 50/box
PS-6-50 106 7953 50/box
MagnaAmp - G. Stearothermophilus 10.6mm x 52mm MA/4 104 7953 50/box plus 10 negative controls
MA/5 105 7953 50/box plus 10 negative controls
MA/6 106 7953 50/box plus 10 negative controls
SterilAmp II - G. Stearothermophilus 6.75mm x 26.5mm SA/4 104 7953 100/bag plus 10 negative controls
SA/5 105 7953 100/bag plus 10 negative controls
SA/6 106 7953 100/bag plus 10 negative controls
SterilAmp II - G. Stearothermophilus 18mm SA18/5 105 7953 100/bag plus 10 negative controls
SA18/6 106 7953 100/bag plus 10 negative controls
SterilAmp II 5230 - B. Subtilis “5230” Low Temp (110°C-118°C) 6.75mm x 26.5mm SASU/6 106 35021 100/bag plus 10 negative controls

SPORE SUSPENSIONS
Mesa Spore Suspensions are calibrated suspensions of bacterial spores appropriate for direct inoculation of products or preparing custom BIs for monitoring steam, EtO, dry heat, H2O2, irradiation and other industrial sterilization processes.
Packaging: 10 ml vial

Item Part Number Population ATCC Number Diluent
Bacillus Subtilus “5230” SS5230E/4 104 / 0.1 ml 35021 40% Ethanol
SS5230E/5 105 / 0.1 ml 35021 40% Ethanol
SS5230E/7 106 /0.1 ml 35021 40% Ethanol
SS5230A/7 107 / 0.1 ml 35021 40% Ethanol
SS5230E/8 107 / 0.1 ml 35021 Aqueous
SSSE/4 108 /0.1 ml 7953 40% Ethanol
Geobacillus Stearothermophilus SSSE/5 104 / 0.1 ml 7953 40% Ethanol
SSSE/6 105 / 0.1 ml 7953 40% Ethanol
SSSE/7 106 / 0.1 ml 7953 40% Ethanol
SSSA/7 107 / 0.1 ml 7953 Aqueous
SSCS7955/4 104 7953 40% Ethanol
Clostridium Sporogenes SSCS7955/5 105 7953 40% Ethanol
SSCS7955/6 106 7953 40% Ethanol
SSCS7955/7 107 7953 40% Ethanol
SSCS11437/4 104 11437 40% Ethanol
SSCS11437/5 105 11437 40% Ethanol
SSCS11437/6 106 11437 40% Ethanol
SSCS11437/7 107 11437 40% Ethanol
SSCS19404/4 104 19404 40% Ethanol
SSCS19404/5 105 19404 40% Ethanol
SSCS19404/6 106 19404 40% Ethanol
SSCS19404/7 107 19404 40% Ethanol

Porous/Hard Objects

A porous/hard load refers to the items being sterilized (dry items). These items may be glassware, surgical instruments, syringes, tubing, fabrics, etc

Services

Mesa Labs offers D-value or Survival/Kill testing in state-of-the-art BIER Vessels. The D-value procedures used follow USP/ISO and can be obtained via Limited Holcomb Spearman Karber (fraction negative) method, Survivor Curve (direct enumeration) or with tumbo-Murphy-Cochran. Mesa can inoculate and perform D-value analysis on small items (e.g. coupons or stoppers), or we can verify a competitor’s label claim for D-value, Z-value and population. Isolate identification services available for most aerobic samples.

POPULATION ANALYSIS

POPULATION ANALYSIS
Population Verification Testing
Confirmation of labeled population on the Certificate of Analysis. Testing involves assaying four unexposed biological indicators individually per manufacturer or Mesa Lab procedures in adherence with ISO standards.
Individual Assays
Population enumeration on individual exposed or unexposed biological indicators. Testing conducted per manufacture or Mesa Lab procedures.
Pooled Assays
Population enumeration on four, pooled, custom-inoculated components and confirmation of labeled population on the Certificate of Analysis for MagnaAmp, SterilAmp and ProSpore 4mL BIs. Testing performed according to Mesa Lab procedures.

MAIL-IN SPORE TESTING
Our Mail-In Spore Testing services are available for steam, chemical vapor, dry heat and EtO sterilization cycles. Our service includes prompt notification on all failed tests and email test results upon completion in our laboratory. We perform a Gram-staining verification on all failed tests. Each test includes a matching control strip.

Weekley Bi-Weekly Monthly Quarterly
52 tests 26 tests 12 tests 4 tests
CUSTOM SOLUTIONS
Custom filled ampoules
Dry Heat D-value on a commercially prepared BI
EtO D-value on a commercially prepared BI
Inoculation of client provided carrier or solution
Organism Identification 16S rRNA
Population analysis of a commercially prepared BI
Steam D-value on a commercially prepared BI
SURVIVAL/KILL TESTING
Processes
DryHeat Sterilization
EtO Sterilization
Steam Sterilization

D-VALUE TESTING

Process Testing
Dry Heat D-value - Survivor Curve or Spearman/Karber
EtO D-value - Survivor Curve or Spearman/Karber
Steam D-value - Survivor Curve or Spearman/Karber

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