Previous major projects:

A. Paintball Consulting:

· A small paintball manufacturing company was experiencing several product performance defects, low production yields, and poor customer satisfaction. Design of Experiments methods were employed in the encapsulation process to determine the causes of paintball performance defects and implement corrective actions. Process controls were added to the fill and gelatin manufacturing processes which improved quality and reduced cycle time. Product testing procedures and product quality specifications were implemented. Shell color formula changes were implemented to avoid color fading issues. Production staff was trained on new procedures and techniques so progress could continue after the consulting project was complete. Visited customers to resolve product complaints and determine requirements for new products. As a result of the changes production defects were reduced to less than 2%, several new products were sent to market, returned goods incidences were greatly reduced, and customer satisfaction was significantly improved. The company went from annual production of 20 million paintballs to over 300 million paintballs.

B. Softgel Product and Process Quality Improvement:

· The company had a Docusate laxative product with historical problems of capsule leakage after several months in the field. Without changing the existing encapsulation die or altering FDA approval information, experiments were performed on the encapsulation process which eliminated the leakage defect. Design of Experiments methods were employed to identify root causes of the capsule leakage. Statistical Process Control methods were used to implement in-process checks and finished product tests to insure the defects would not occur in subsequent capsule lots. Capsule leakage complaints were eliminated for this product which saved the company over $300,000 per year in returned goods costs.

· Worked with major paintball manufacturers to evaluate all aspects of the manufacturing process, make recommendations to correct major sources of customer complaints, and implement corrective actions into the manufacturing process. These measures resulted in improved product quality, improved process consistency, and 95% reduction in customer complaints and returned goods costs.

· Developed, validated, and implemented processes to recycle gelatin netting which resulted in a 33% production cost reduction for some paintball products.

C. Technology Transfer:

· Served as project leader to transfer production of fragrance sampler softgel capsules to an existing paintball facility. The project challenges included establishing specialized gelatin manufacturing processes and controls, plant resource allocation, project scheduling, interacting with other department managers, and regular project updates to upper management. The project was completed successfully and resulted in improved capsule quality and production of capsule shapes that the original facility was unable to manufacture.

· Worked with a team to implement paintball production into an Italian facility. The project consisted of adapting gelatin manufacturing, encapsulation, capsule drying, packaging, quality assurance, and manufacturing documentation processes to an existing softgel plant. Successful completion of the technology transfer increased the company's paintball capacity by about 35%.

· Worked with a team to implement pharmaceutical softgel manufacturing into a new plant in Syria. The project objectives included training chemists in color formulation techniques, establishing gelatin manufacturing processes using new equipment, implementing in-process specifications, and establishing Quality Assurance procedures. This plant had the first softgel capsule manufacturing capabilities in Syria and continues to expand their product line.

D. Product and Process Development:

· Acted as project leader to develop and validate a new gelatin dissolution process for a major Softgel manufacturer. The company was completing a new pharmaceutical softgel facility and applying for FDA approval of the facility. Historically, gelatin solutions were prepared by combining the chilled ingredients and then heating the mixture, unstirred, to form the gelatin solution for use in encapsulation. The new gelatin manufacturing process used a stirred vacuum vessel with PLC to manufacture the gelatin solution. Procedures were developed and validated for the new process, process documentation was written, and production operators were trained in the new process.

· FDA approval of the new gelatin manufacturing process required data to show that the material from the proposed process was chemically equivalent to material from the existing gelatin process. The project consisted of comparing gelatin solutions from both processes using Gel Permeation Chromatography to show that the molecular weight distribution was not adversely effected by the new manufacturing process. The analysis was performed for each of the five pharmaceutical products seeking approval in the new facility. A comprehensive project report was written for inclusion in the FDA approval request documents.

· Developed many paintball fill and shell color formulas as well as new gelatin formulas to eliminated specific customer complaints. Developed and implemented gelatin manufacturing procedures which improved batch-to-batch consistency and optimized manufacturing cycle time. Implemented gelatin viscosity control procedures which totally eliminated gelatin-related encapsulation downtime at one facility.

· Developed and managed a quality control system for a major paintball manufacturer. The system enabled the facility to become independent of the pharmaceutical QC department and establish separate standards and specifications more relevant to paintball products. This resulted in reduced QC release time for incoming raw materials since the materials were tested and released in-house. The system allowed establishment of separate paintball raw material specifications so that industrial grade ingredients could be purchased at lower costs and it enabled faster implementation of new products.

Bayless Technologies, Inc.
4113 N. Forbes Rd. Plant City, FL 33565
Phone / FAX: (813)707-1770