Integrated Process

BioZone offers our customers efficient, reliable “one-stop shopping”; With in-house expertise, equipment, experience, and our full commitment to your project, we truly are your partner from concept to shelf.

Custom Formulation

Our customers’ success begins with the products we develop. With a state-of-the-art in-house lab, seasoned scientists, and quality/assurance professionals, we control the process and any challenges along the way.

We have our pulse on trends in all the industries we serve and continuously look for ways to improve upon existing techniques and formulations. Efficient, economical, evolutionary – endless possibilities.

Scale-up

Our formulators and manufacturing teams interface to reproduce products in small quantities. From there, we scale commercial batches 40 gallons (150 kilos) up to 1500 gallons (6,000 Kilos) per customer needs. Each step is monitored, ensuring GMP compliance.

Manufacturing

BioZone’s 100,000 sq ft facility houses 9 stainless steel mixing tanks with flexible configurations, capable of producing batch sizes from 40-1500 gallons (~100 gallon increments.) Dedicated weighing suites prevent cross contamination, and our process water is specified/maintained as USP purified water. Quality control professionals perform cleaning validation on the tanks for all products.

Packaging

A 60,000 sq ft, cGMP compliant packaging and warehouse facility encompasses 6 discrete production lines with capacity of 163,000 units filled per day in tubes, jars and bottles with varying container and cap configurations. Labels are separately stored and carefully handled. BioZone’s expertise in shrink wrapping, sleeving, unit and outer cartoning, and palletizing allows us to literally ‘finish the job’ with comprehensive packaging services for our customers. A 5 oz. tube? A 32 oz. bottle?…. yes, we can!

The BioZone Work Flow

What to Expect:

  • Initial project discussion and Confidentiality Agreement execution
  • Continued discussions with BioZone Project Rep to identify product parameters and requirements
  • Feasibility/economies of scale review by BZ Product Assessment Committee (PAC)
  • Communication of PAC findings, preliminary price quote, and detailed project roadmap; You give the go-ahead.
  • Active development partnership ~ We make lab samples. You provide feedback; Repeat. Together, we get it right.
  • Final sample formulation approval and written purchase order. Pilot batch or commercial production scheduled, as appropriate.
  • 90 day stability testing of OTC drugs in commercial packaging, per FDA guidelines.
  • 6-8 weeks manufacturing turnaround for standard projects with readily available raw materials.

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