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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.
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 |
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 |
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 |
Mesa offers BIs for specialty sterilization processes, including chlorine dioxide (ClO2), gamma irradiation and hydrogen peroxide (H2O2).
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 |
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 |
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 |
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 |
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 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.
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 |
A porous/hard load refers to the items being sterilized (dry items). These items may be glassware, surgical instruments, syringes, tubing, fabrics, etc
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 |
