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MycoScience

25 Village Hill Road

Willington, CT 06279 US


MycoScience Services:

STERILIZATION AND STERILITY ASSURANCE

* Sterility Testing
* Dose Verification Audits
* LAL Pyrogen Testing
* Bioburden Testing
* Sterilization Validations: ETO, Radiation, and Steam
* Validation of Reusable Devices: Cleaning, Disinfection, and Sterilization

GENERAL MICROBIOLOGY

* USP Preservative Effectiveness
* USP Microbial Limits
* AOAC/EPA Disinfectant and Sanitizer Testing
* Bacterial and Fungal Identification
* D-value Studies
* Contact Lens Disinfection Guidelines
* Microbiological Research and Development

PACKAGE TESTING AND STABILITY PROGRAMS

* Product and Package Shelf-Life
* Accelerated Aging
* Microbial Package Challenges
* ASTM Burst, Leak, and Creep Testing
* Simulated Transport Testing

ENVIRONMENTAL MICROBIOLOGY

* Air and Surface Sampling
* Water Testing and Coliform Screening
* Clean Room Sampling: Viable and Non-Viable Particulates
* Customized Monitoring Programs

Consulting
* 510K, IDE, PMA SubmissionsTwo people meeting
* QSR/ISO Training & Mock FDA Audits
* QA Systems and Design Review
* Sterilization and Packaging Validations
* Laboratory Consultations and GLP Audits
* Process Validations

Environmental Testing
* Viable Sir Sampling
* Surface Sampling
* Water Testing and Water System Validations
* Airborne Particle Counts
* Cleanroom Testing, Certification, and Training
* Environmental Monitoring Programs
* Bacterial, Mold, and Yeast Identification
* Technical Support and Consultation
* Disinfectant Efficacy

Contract Manufacturing
* Research and Development
* Batching and Filling Services
* Class 100 - Class 100,000 Manufacturing Areas
* Prototypes and Clinical Samples
* Packaging and Sterilization
* Aseptic Filling of Syringes and Vials
* Air-Overpressure Steam Sterilization
* Dedicated Filling Suites