Services
Mycoscience specializes in contract manufacturing services and R&D process for the pharmaceutical industry. We also perform a variety of regulatory testing services in microbiology, EO residuals, cleaning validation, bioburden, accelerated aging and package integrity for medical device and allied industries.
Manufacturing
MycoScience is the logical choice for contract manufacturing services. We specialize in environmentally controlled, low volume, clinical production of diagnostics, pharmaceuticals and devices.
MycoScience’s resources and expert staff are the best support for your research and development activities that will forward new products and develop new assets for your company.
Laboratory Testing
Determine whether your reusable medical device has been cleaned of enough contaminants for re-sterilization during the cleaning process.
PET determines effectiveness of preservative during its shelf life and evaluates how well a product withstands microbial contamination during use.
Microbial aerosol testing evaluates the package integrity through exposing the packaged product to aerosolized bacteria.
Amounts of Ethylene Oxide residuals present on product post sterilization.
Determination of seal strength and integrity of seals used in packaging.
Population of viable microorganisms on or in product and/or sterile barrier system.
Validation or requalification to determine the presence or absence of microorganisms on product.
Population and identification of microorganisms present on a product or device.
Evaluation of the toxicity of medical devices, products, and materials.
Evaluation of products for the presence of endotoxins, like gram-negative bacteria.
Use accelerated aging testing to determine expiration date claims for your sterile barrier system integrity.
Our Expertise
Feel secure with your manufacturing and laboratory testing services.
MycoScience brings a wealth of experience having over 30 years in the medical device and allied industries.
Regulatory Support
510K, IDE, PMA Submissions
QSR/ISO Training & Mock FDA Audits
QA Systems and Design Review
Laboratory Consultations and GLP Audits
Sterilization and Packaging Validations
Process Validations
Laboratory Testing
Sterilization Validation
Preservative Efficacy Testing (PET)
Microbial Arosol Challenge Testing
EO Residual Testing
Package Integrity Testing
Bioburden
Sterility
Environmental Monitoring
General Microbiology
Environmental Testing
Viable Air 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
Disinfectant Efficacy
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
Get One Step Ahead Of The Competition
Are you looking for expert guidance, better communication and faster testing turnaround times with your contract manufacturing partners? Or are you simply looking for reasonable prices for quality services? You have come to the right place. We offer competitive prices for simple routine testing, prompt communication regarding test status and results, and expertise with syringe & vial fillings for unique, highly viscous products.
