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Laboratory Profile: MycoScience

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

25 Village Hill Road

Willington, CT 06279 US