Microbiology Testing Services

MicroWorks has set up a state of the art Microbiology testing laboratory in Crown Point, Indiana to support our clients’ testing needs. The laboratory is focused solely on Microbiology and is based on customer service and quick turn-around times. We do not charge additional fees to get testing initiated in a timely manner and will make every attempt to initiate testing the day samples arrive at the lab.

Scroll to the bottom of this page to view our current capabilities list. We are adding new capabilities every week. We specialize in testing for Pharmaceutical, Medical Device, Biotech, and Nutraceutical companies. Call us today to discuss your needs.

Antibacterial Effectiveness Testing

USP <51> methodology or custom protocols.

Bioburden Testing

We can test all types of materials for bioburden. We can develop, validate, and perform routine testing.

Culture Collection Maintenance

We will store your environmental or product isolated organisms for future reference and future use in disinfectant or comparison testing. We will maintain your cultures in a -80°C freezer and retrieve them for you when you need them.

Disinfectant Testing Studies

MicroWorks can set up a disinfectant efficacy study encompassing all the variables unique to your facility such as surface types, disinfectant types, concentrations and facility isolates.

Environmental Testing

MicroWorks can incubate and enumerate the plates from your facility, analyze your swab samples, or come out to your facility and perform environmental monitoring as needed. We are experts in the field of environmental monitoring and can answer your questions or assist you in setting up an effective and compliant EM program. We have EM sampling kits available to take the guesswork out of EM sampling.

Growth Promotion Testing

MicroWorks can perform growth promotion testing on your non-selective or selective media as needed for your application.

Microbial Limits Testing

MicroWorks can perform complete Microbial Limits testing on your non-sterile products and raw materials using USP <60>, <61> and <62> compliant methods.

Non-Routine Testing

MicroWorks can do the Microbiological testing that is not considered routine in your laboratory. We can set up challenge studies, do disinfectant challenges to determine if your isolates are susceptible to your disinfectants, perform interface lethality or microbial ingress methods and more. If you have a unique Microbiology testing need, call us. We will design a protocol to accommodate your request.

Sterility Testing

MicroWorks has an ISO classified cleanroom where we perform USP <71> Sterility testing and set up samples for rapid sterility testing by BacT/ALERT. In most cases samples can be tested within 48 hours of receipt. Same day testing is also available with prior notice and no rush fees.

New Laboratory Services:

Rapid Quantitative Testing using the BacTAlert 3D® System
Identifications using the Vitek® V2C
USP <60> Testing for Burkholderia cepacia complex

Laboratory Capabilities

Below is a list of our current laboratory capabilities. We make every effort to keep this list up to date, but our newest capabilities may not be included yet. If you are interested in a laboratory service not listed here, please contact us to see if we are able to assist you.

Current Capabilities:

Antimicrobial effectiveness testing, USP 51
Bacterial Filter Retention Testing
Bioburden analysis for water, raw materials, in-process samples
Bioburden testing and method validation for medical devices
Bioburden testing for packaging components including stoppers and vials
Biological Indicator testing and enumeration
Bradford protein analysis
Cleaning validation studies
Compressed gas testing for particulate, viable airborne bioburden, moisture, and hydrocarbons
Conductivity
Container closure testing/Microbial ingress
Contract training facility for instrumentation such as V2C, BacTAlert
Disinfectant qualification studies
Dye Ingress Testing
EM Data trending and analysis
EM monitoring at client sites
EM plate incubation
Endotoxin spiking and recovering for depyrogenation studies
Endotoxin testing of WFI, In-process, Finished Product, stoppers and Vials
Endotoxin testing by KTA or KCA
Endotoxin method validation
Gel Clot Endotoxin testing and method validation
Growth promotion of microbiological media
Identification of Microorganisms using the Vitek 2 V2C
Method development and validation for bioburden, USP 1227
Method validation of surface sampling using contact plates
Microbial limits testing including E.coli, Staphylococcus aureus, Pseudomonas aeruginosa, Salmonella, TAMC, TYMC, USP 61 and 62
Nutritional supplement testing” to “Nutritional supplement testing, USP 2021 and 2022
pH
Preparation of proficiency samples to show lab competency
Product inoculation studies
Provide EM test kits to industry
Sterility testing method validation
Sterility testing and method validation using the BacTAlert
Sterility testing of medical devices (Bacteriostasis Fungistasis)
Sterility Testing, USP 71
Sterilization dose audit testing of medical devices Swab Recovery Method Validation
Swab sample analysis by MicroWorks or client method
Support for testing according to USP <797>
Total Organic Carbon (TOC) analysis for water and cleaning samples
Training facility for courses in Microbiology
Water testing for bioburden, heterotrophic plate count, coliform, fecal coliform

®Vitek and BacTAlert 3D are Registered Trademarks of BioMerieux Industry ™

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Our Services

Laboratory Design

MicroWorks can design your new lab and assist you with getting it commissioned.

Training Programs

MicroWorks can design training programs in EM, Aseptic technique and test methods.

Environmental
Monitoring Programs

MicroWorks can design, implement, and validate an EM program.

LAL Testing

MicroWorks performs endotoxin testing by USP <85> kinetic turbidimetric and chromogenic methods.

Sterility Testing

USP <71> and BacT/ALERT testing are available.

Disinfectant Efficacy Studies

MicroWorks has extensive expertise in USP <1072> disinfectant testing studies.

Finished Product Release Testing

MicroWorks can test your non-sterile products for release by USP <60>, USP <61> and USP <62> methods.

New Method Development

MicroWorks can develop and validate microbiological methods for all types of products.

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