About Us

Microbiologists with Real-Life Experience

MicroWorks started out in 1996 as a pharmaceutical consulting firm with expertise in Microbiology.  Since then, we have assisted companies with developing environmental monitoring programs, have successfully executed many EMPQ protocols to get pharmaceutical and Medical Device facilities up and running, assisted manufacturers with regulatory issues and associated remediation and have developed microbiological testing procedures for difficult products developed by our customers.

In 2008, we opened and validated a cGMP testing laboratory from the ground up, using our knowledge from our consulting experience.  We are a cGMP, FDA registered and inspected laboratory. We are DEA registered and approved for handling controlled substances. We also have approval from Health Canada for testing products imported to Canada.  

With our unique combination of consulting and testing experience, we are well equipped to assist our clients who need advice on determining their testing needs. 

Our mission at MicroWorks is:

To serve the Pharmaceutical, Medical Device, Biotech and Nutraceutical industries by providing accurate, reliable laboratory and consulting services, along with innovative products, which meet or exceed our customer’s expectations while maintaining adherence to current regulations and incorporating advancing technologies within the field of Microbiology.

Microbiology Laboratory Capabilities

MicroWorks is a cGMP compliant and DEA licensed Microbiology laboratory located in Crown Point, IN. We perform all types of microbiological testing to support the needs of the pharmaceutical, Medical Device, Biotech and Nutraceutical industries. We focus on technical expertise, customer service and quick turnaround times.

We have a qualified cleanroom on-site for performing USP <71> sterility testing with immediate availability.  We perform all microbiological release testing including USP <85> Endotoxin testing utilizing kinetic methods and USP <60> <61> and <62> Microbial Limits testing.

We are leaders in the industry in USP <1072> disinfectant efficacy testing and can help our clients design cost-effective compliant testing protocols. 

Contact us to discuss your testing needs. Our prices are very competitive and our customer service is unmatched in the contract testing business.

Consulting Capabilities

Our consultants are experts in their fields. We have consultants with expertise in Microbiology, Contamination Control, Cleaning Validation, cGMP Manufacturing, Regulatory Remediation and more Contact us to discuss your consulting 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.

Our Services

Laboratory Design
Laboratory Design

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

Training Programs
Training Programs

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

Environmental Monitoring Programs
Monitoring Programs

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

Protocols, SOPs, and Reports
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.

Contact Us

To discuss your testing and consulting needs.

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