For manufacturers, it is critical to understand how the recent harmonization of the USP, EP, JP, PTC and 21 CFR requirements affects the processing of raw materials and finished products. It’s also essential for manufacturers to be well aware of the considerations to examine when establishing a microbial limits testing policy.
As a pioneer in the microbiology outsourcing industry, Microbiasci Product Testing offers a comprehensive range of microbiology services with strict adherence to cGMP requirements in support of sterile and non-sterile product testing and facility monitoring for many drug substances, drug products and medical devices. We offer both clean room and isolator technologies for sterility testing, enabling application of the most appropriate technology for your products. with fully trained cGMP staff and qualified lab environment, Microbiasci bring the highest level of quality and attention to detail to our clients to assure that their sterility testing program will be successfully executed.
We have an assortment of specific service to suit your specific requests. If you are interested in Rapid Microbial Detection & Sterility Testing, please do not hesitate to contact us. We shall be very pleased to be of assistance in every way we can.
• Particulate Matter
• Microbial Immersion Studies
• H2O2 D-value Studies
• AAMII Sterilization Validation
• Media Fills
• Microbial Limits
• Antimicrobial Preservative Effectiveness
• Antibiotics Potency Assays
• Bioburden Studies
• Water Activity
• Process Water Testing
• Environmental Monitoring
• Disinfectant Efficacy Testing
• Biological Indicator Analysis
• Organism Identification