© 2017 Validation Systems

Laboratory Services

Validation Systems, Inc. Laboratory Services is an independent testing laboratory offering a range of microbiological and chemistry services to the pharmaceutical, biotechnology, and medical device industries.

VSI Laboratory Services include the following:

  • Routine Environmental Monitoring

  • Compressed Gas Sampling and Analysis

  • Water Sampling and Analysis

  • Microbiological Analysis

  • Microbiological Assay Development and Method Validation

  • Qualification of cleanrooms, gas, clean air, and water systems

     

    The VSI Laboratory is registered with the FDA and received ISO certification in 2018.

    All testing is performed in accordance with applicable Good Laboratory Practices (GLPs) and an established Quality System. A comprehensive Quality Manual, Standard Operating Procedures (SOPs) and Training Program regulate and monitor all aspects of our laboratory practices. We encourage our clients and potential clients to visit and audit our facility and quality programs to ensure complete confidence and trust in our qualifications.

    Quality customer service, flexibility, on-site service, and fast turnaround times are integral to our program. All final reports and supporting documents are held in strict confidence.

Routine Environmental Monitoring
Compressed Gas Sampling and Analysis

Click here for link to our VSI Sample Submission Form. Click here for a link to our VSI Sample Submission Instructions.

Monitoring programs for controlled environments are established to assess the effectiveness of cleaning practices and to ensure that control is being maintained.

Total airborne particulate, viable airborne particulate and viable surface particulate counts are collected to obtain representative levels of contaminants and bioburden of the environment. Continuation of environmental monitoring on routine basis provides the necessary information for assessment of control and trending over time to ensure maintenance of the state of control.

 

VSI Laboratory Services can provide clients with complete services for routine and nonroutine environmental monitoring.

VSI Laboratory Services provides the following testing

  • Total Airborne

  • Viable Airborne

  • Oil Content / Hydrocarbon

  • Moisture / Dewpoint

 

We can provide turnkey sampling and analysis including calibrated test equipment and test supplies, and sample analysis.

 

VSI can also work with established in-house departments to provide any level of service.

Water Sampling and Analysis

All water systems used for pharmaceutical, biotech, and medical device purposes must be monitored to ensure that the system is in control and continues production of water with acceptable chemical and microbial quality. The VSI Laboratory has the experience to provide our clients with complete water system services. Not only have we assisted our clients with water system validation planning and protocol writing, we complete the service with sample collection and analysis.

Our water testing includes:

  • Total Heterotrophic Count (membrane filtration method)

  • Total Coliform (membrane filtration method)

  • LAL Bacterial Endotoxin (gel clot)

  • Conductivity

  • Total Organic Carbon (TOC)

  • pH, Chlorine, Hardness, Silica

Microbiological Analysis

VSI Laboratory Services provides the following testing:

  • Antimicrobial Preservative Effectiveness Test

  • Bacteriostasis/Fungistasis

  • Colony Morphology and Gram Staining

  • Microbial Identifications of Bacteria, Yeast and Mold

  • Bioburden Testing of Raw Materials, Components and Devices

  • Biological Indicator Enumeration/Sterility Testing

  • Growth Promotion Testing

  • Disinfectant Efficacy Testing

Performance Qualification Testing

The culmination of Installation and Operational Qualification (IOQ) testing of a GMP environment and it utilities often requires analytical confirmation. Whether the medium is air, water, gas, or controlled environmental spaces, our laboratory services continues beyond IOQ phases, with a Performance Qualification (PQ), making complete the IQ-OQ-PQ triumvirate.

 

VSI corporation is a tightly integrated company where when the technical nature of our clients’ needs requires laboratory analysis, VSI provides a directly accessible solution to our client by providing guidance on qualification strategies and methods which reflect regulatory and industry trends in area of laboratory testing solutions.  VSI specializes in developing customized qualification protocols reflecting industry standards, which include but are not limited to ISO, ANSI, and USP. Moreover, specialties also include development of non-standard testing such as disinfectant efficacy and cleaning qualifications for client partnerships.

 

Customized reports can also be provided per client requirements. Testing results and reports are fully supported with materials traceability, calibration certificates, and validated processing equipment.