Equipment & Capacity
We can produce test batches at 5 Gallons and full-scale batches up to 2000 Gallons, which allows us to produce a run of any volume to meet your market needs. Our kettles are all equipped for ease of scaling, allowing you to manage your inventory and keep products fresh.
We use state-of-the-art compounding equipment, which includes computerized, jacketed, vacuum kettles with counter-rotating mixing paddles that can be fitted with various homogenizers.
CUSTOMER SAFETY IS AT THE FOREFRONT OF OUR OPERATIONS
We meticulously inspect raw materials and test products throughout the manufacturing process to ensure consistent quality. Biogenesis is registered with the FDA as a manufacturer and packager of Over-The-Counter (OTC) products. We adhere to cGMPs pursuant to 21 CFR parts 211 (Current Good Manufacturing Practices for Finished Pharmaceuticals) in the manufacturing of the products produced at our facility. As a registered establishment, we are subject to statutory inspections by the FDA and by the Quality Assurance Departments of our clients to verify compliance with cGMPs. Biogenesis ensures product and plant quality through the implementation of the following processes & procedures:
- Product Inspection
- Qualification and audits by third-party laboratories
- Method development and validation
- Forced degradation studies
- Final product release testing
- Dosing solution analysis for OTC
- Environmental Monitoring Programs
- Cleaning/Sanitization Program Upgrades
- Cross-contamination prevention
- Equipment Upgrades and maintenance
- All raw materials entering our facility undergo meticulous inspection