Manufacturing
Consistency + Attention to Detail = Quality
Manufacturing is all about consistency and attention to detail. Our brand new state-of-the-art manufacturing rooms are designed to give us the capability to develop quality products with absolute precision. Our 45 manufacturing kettles, which include computerized, jacketed vacuum vessels with counter rotating mixing paddles, provide flexibility to achieve the scalability required in today’s fast paced competitive market.
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We can produce batch sizes from 5 gallons to 2000 gallons. Our ancillary compounding equipment can be fitted with various homogenizers and other specialty processing equipment to produce a wide variety of products.
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.
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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.
quality
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:
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- 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
Biogenesis Paterson
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Tel. 201-678-1992
444 Marshall St, Paterson NJ 07503
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