SBIR-STTR Award

Commercialization potential for unit-dose vials with shaft applicator and applicator tip is extremely promising. There is emerging market demand for this product, but no such products are presently available. The project investigates the optimum configuration(s), material(s) and attachment method(s) for both shafts and applicator tips, the end result being the manufacture of a variety of prototype unit-dose plastic vials with intergral applicators. This project will foster critically needed economic development in a chronically depressed rural region by leveraging and expanding technology-based entrepreneurial activities already underway. OBJECTIVES: The overall objective of this proposal is to provide high-quality, stable employment for residents of Bonner County, Idaho, and Boundary County, Idaho. These are rural counties currently in transition from resource-based economies to service-based and small business manufacturing-based economies. The overall objective of this project will be fulfilled by developing a blow-fill-seal (BFS) unit-dose vial with an integral applicator to meet an emerging market opportunity. Phase I of the project will establish the overall technical feasibility by identifying key components, conducting experiments on material compatibility and joining methods, and determining the most effective methods for manufacturing the end product at a competitive cost. All work involving the integration of the applicator with the current unit-dose vial as well as the material compatibility studies will be performed at Unicep Packaging. Tips & shafts may be formed and assembled at the outside experts facilities, due to their experience. The specific Phase I Technical Objectives are as follow: Identify Key Market Segments Demonstrate Applicator Shaft Configuration & Blow-Fill-Seal Integration Establish Design of Modified Blow-Fill-Seal Vial Establish Applicator Type & Material Establish Techniques for Joining Applicator & Applicator Shaft Assemble Complete Modified Blow-Fill-Seal Vial with Incorporated Applicator Establish Effective Links and Plan for Links with Bonner County Economic Development Corporation (BCEDC)for Workforce Training in Phase II and Phase III Prepare a Plan for Phase II Implementation The tasks to achieve the technical objectives are designed to answer the following questions: What is the ideal material(s) to use as an applicator shaft? Which applicator tips will be most effective for use with a unit-dose application? What is the method of manufacture most likely to be effective in cohesively bonding the applicator and vial while retaining a hermetic seal? How can this process be automated? How can the assembly process be optimized for production? What machinery is required for cost-effective production with high quality control? What is the optimal relationship with BCEDC for job training in Phase II (This task to be paid for by BCEDC) APPROACH: The work plan to achieve the technical objectives outlined above consists of eight sequential tasks: Task 1 Market Segment Identification consists of analyzing enough data to make informed decisions on what type of product (liquid or gel) to put in the unit-dose vial(s). Task 2 Applicator Shaft Configuration & Blow-Fill-Seal Integration primarily involves following a test plan to choose not only the best type of applicator shaft configuration and material but the best method of joining the applicator to the current modified BFS unit-dose vial. The entire testing procedure will use dedicated modified BFS machines and trained machine technicians. Task 3 Design and molding of MBFS vial, optimized for integration with applicator using results from Task 2 and past design history and experience, the Design Engineering department will model several concepts of vials. These concepts will be reviewed; the best (based on manufacturing considerations) will be chosen, modeled and used to generate molds. Task 4 Applicator type and materials, a down selection process for specialized applicators will occur. Based on the products chosen in Task 1, a series of compatibility tests will be done. These tests will follow a plan summarized in a test matrix. A test procedure with specified inspection criteria and intervals will be defined. Engineering will run the test using trained technicians, and QA will inspect. All test data will be recorded and samples will be kept in labeled bags. Task 5 Techniques for joining applicator to applicator shaft, Task 2 results will determine the type(s) of applicator shaft that can be used. Task 4 results will determine the compatible applicator(s) that can be used. This task investigates various methods available to join applicator(s) to shaft(s) and will be a combined effort between Unicep Packaging and outside industry experts. A detailed test plan, summarized on a matrix, will be followed. Task 6 Incorporation of down selected applicators attached to shafts into MBFS unit-dose vials, Using product defined by Task 1, machine parameters defined by Task 2, the vial configuration defined by Task 3 and the applicator/shaft combination defined in Task 5, specialized modified BFS unit-dose vials will be produced. Automated techniques will be used as much as possible; however, some manual operations will be required. Standard Quality Assurance techniques will be used to assure package integrity. Task 7 Partnership with BCEDC, Unicep Packaging will consult with and use the resources of the BCEDC on an ongoing basis to identify and pursue workforce training activities that Unicep Packaging cannot provide using in-house resources. Plan a human resources training program in Phase I for implementation in Phases II and III. Task 8 Plan for Phase II Implementation, The plan will be generated by the Project Director and Design Engineering, and will summarize all test results, including machine set-up parameters, any drawings generated (fixtures, vials, applicators, and/or shafts), and will include a timeline and work schedule for Phase II. A project manager will be assigned to the project

Bonner and Boundary Counties, Idaho, are rural areas in transition. The people in these areas currently rely on increasingly fewer timber and forestry jobs as well as low-paying, seasonal tourist industry positions. The purpose of this project is to foster critically needed economic development in a chronically depressed rural region by leveraging and expanding technology-based entrepreneurial activities already underway. The project will have a significant and lasting impact in stabilizing these rural economies. OBJECTIVES: During Phase II, Unicep Packaging will design, assemble, and validate a production machine that will manufacture a new Applicator Twist-Tip unit -dose vial product. The following are technical objectives of the Phase II: Unicep Packaging will design, engineer, and assemble Automated Applicator Modification and Insertion equipment. The designed equipment will operate synchronously with developed MBFS production equipment to produce a new Applicator Twist-Tip Vial product for consumers. The equipment will handle off the shelf applicators, i.e. swabs or brushes, transfer applicators through a heating and modification process, and insert modified applicators into vials located on MBFS production equipment. Unicep Packaging will develop Modified Blow-Fill-Seal production equipment that will accept modified applicators inserted into the MBFS process. The developed production equipment will be integrated with the Applicator Modification and Insertion equipment to operate simultaneously. The manufactured product from the integrated production equipment will be the Applicator Twist-Tip Vial. Unicep Packaging will validate developed production equipment as well as qualify the end products. To ensure that the end Applicator Twist-Tip Vial product is reliable and repeatable, Unicep Packaging will create procedures to validate developed production equipment and qualify end products have consistent, reproducible characteristics. It is imperative for the development, growth, and sustainability of Unicep Packaging to develop validated machinery and qualified packages to provide consistent and dependable products to customers. Additionally, this project will foster critically needed economic development in a chronically depressed rural region by leveraging and expanding technology-based entrepreneurial activities already underway. The project will have a significant and lasting impact in stabilizing rural economies that currently rely on increasingly fewer timber and forestry jobs as well as low-paying, seasonal tourist industry positions. Community benefits include providing a comprehensive benefit package to the workforce, providing stable, high-quality jobs, and adding stability to the tax structure in rural Bonner and Boundary Counties, Idaho. APPROACH: The research for automating the production of a a modified blow-fill-seal unit-dose vial will take place in seven related tasks: Task one will include the definition and design of automated applicator modification equipment. During task two automated applicator modification equipment will be assembled and tested. Task three is the definition and design of the Applicator Twist-Tip Vial production machinery. During task four the engineering team will assemble and test the Applicator Twist-Tip Vial production machinery. Task five involves integrating the applicator modification equipment with the production machine, then testing and modifying the integration. Task six is a major milestone. The integrated production machinery will be tested for the production of modified blow-fill-seal Applicator Twist-Tip Vials. The final task will be to validate the machinery and the Applicaltor Twist-Tip Vial product and develop detailed documentation for all processes. PROGRESS: 2005/09 TO 2006/09 Unicep Packaging's goal for the Phase II SBIR program is to design, assemble, and validate a production machine that will manufacture a new Applicator Twist-Tip Vial (ATV) product. The successful implementation of the automated equipment will help bolster the region's economic growth by creating jobs for local residents as well as those in surrounding communities. The following three technical objectives were defined to meet our goal. 1.Unicep Packaging will design, engineer, and assemble automated Applicator Modification and Insertion Equipment (AME). 2.Unicep Packaging will develop Modified Blow-Fill-Seal (MBFS) production equipment that will accept modified applicators inserted into the MBFS process. 3.Unicep Packaging will validate developed production equipment as well as qualify the end products. Unicep Packaging has made significant progress already in the first of the three technical objectives stated in our proposal. The achievement of the first five tasks of this project, will complete the first two objectives. Unicep Packaging is in the process of assembling and testing the AME (Applicator Modification Equipment) designed in Task 1. The majority of the machinery, equipment, and controls defined and designed in Task 1 to construct the AME have been purchased or are currently on order. The majority of all machined parts designed are completed or currently being machined. The table to mount all equipment continues to be filled up with required stations, mechanical parts and components. Unicep Packaging is on track to meet an internal milestone to have the AME operational on its own and functioning by December 2006. Task 2 is approximately 65% complete as of the date of this report. The final assembly of the machine, as parts and components are received, will take place in the months of November and early December 2006. Unicep Packaging has moved forward in designing a vial that will run on the defined ATV production equipment and accept a modified applicator from the developed AME. The vial required specific design elements to accept the modified applicators as well as run effectively on the ATV production machinery. The vial design has been completed. During 2006, Unicep has taken several marketing initiatives to introduce the Applicator Twist-Tip vials to a number markets with the objective of finding a partner for the first production run. Unicep has shown prototype units of the Applicator Twist-Tip vial to selected prospects at New York City trade shows in two industries. Prototype vials were shown to prospects from the pharmaceutical industry at INTERPHEX 2006 and to prospects from the cosmetics and personal care industry at Health and Beauty America 2006. Unicep also featured the vials in a company newsletter that was emailed to approximately 3,100 industry professionals in the pharmaceutical, personal care, cosmetics, dental, nutraceutical, and in vitro diagnostic industries. Additionally, Foresight Science and Technology, specialists in technology transfer and marketing, prepared a marketing study for Unicep Packaging. IMPACT: 2005/09 TO 2006/09 The successful implementation of the automated equipment will help bolster the region's economic growth by creating manufacturing jobs for local residents as well as those in surrounding communities. These jobs will pay above average wages for the area and will provide a full benefits package that will include health and dental insurance