Our sterility testing methods will evaluate your compounded sterile products for the presence of viable bacteria as required by USP<797>.
USP<71> is our road map for analysis. Your products are tested within an ISO 5 environment by aseptically trained technicians.
Based on your testing requirements, we can peform and provide a Certificate of Method Suitability according to USP<71>for your formulation.
We offer bacterial endotoxin testing methods to screen your compounded products for the presence of pyrogen as required by USP<797>.
Our Microbiology Department is able to complete bacterial endotoxin analysis within a 24 hour period. We are able to help you determine the Minimum Valid Concentration, Maximum Valid Dilution and the Endotoxin Release Limit for your specific product.
Based on your testing requirements, we can perfomr and provide a Certificate of Verification according to USP<85> for your formulation.
Knowing the correct concentration of your active ingredient within a compounded product is an important component in the quality control process for any compounding pharmacy. In fact, it is required per USP<795> and <797>.
Our chemistry department uses USP-Verified Methods, USP<1226>, or In-house Validated Methods, USP<1225>, to ensure your products are tested correctly. In every test possible we use USP-sourced reference standards.
The following is just an example of the comprehensive testing we can provide:
- Stability Studies - both real-time and accelerated
- Compendial API Testing
- Bulk and In-process analysis
- Chemical Identification
- Preservative Effectiveness and Efficacy
- Karl Fischer
- Specific Gravity
- Microbial Identification (fungal, yeast, bacterial) to genus-species
- Environmental and Personnel Monitoring Samples (incubation, enumeration and identification)
- Process Validation - media fills, personnel, washing, etc.
- Equipment Validation - depyrogenation, sterilization, etc.
- Method Development
- Bio-burden/Total Plate Count
- Container Closure Integrity - both microbiological and physical
- Growth Promotion
- Formulation and Product Consultation
- Aseptic and Environment Consultation