Hayward, Calif., contract manufacturing neighbors Plastikon Healthcare, a Division of Plastikon Industries, a leader in Blow-Fill-Seal (BFS) and Control Liquid Filling manufacturing processes, and Hantel Technologies Inc., a specialist in medical device and biotech product design and engineering, have taken a step to strengthen their companies and enhance their levels of service by agreeing upon a Memorandum of Understanding.
This agreement is based upon the mutual desire of both companies to improve their capacity to market, and deliver products and services for injection molding and blow fill seal through full turnkey operations (contract finished device manufacturing).
Both contract-manufacturing companies bring individual strengths and value propositions to this important collaboration. Plastikon has an established and highly ranked global diversified plastics contract-manufacturing footprint throughout the U.S. and Asia, including Plastikon Healthcare’s state of the art aseptic and blow fill seal and liquid control filling operations. Plastikon is a certified Minority Owned Business.
Hantel Technologies has established itself as a medical device manufacturing service offering a unique value proposition that includes in depth knowledge and expertise in medical device design and engineering. Hantel counts Stanford University, UC Berkeley, and Lawrence Livermore Lab among the world-class organizations it has helped to bring products to market. Hantel is registered with the FDA for device manufacturing and development, CA FBD for medical device and drug manufacturing.
Plastikon Healthcare and Hantel will collaborate in marketing and sales, exhibitions, conferences, proposals, quotations, projects/contracts, staff capacity, and health research.
Plastikon Industries, a privately held corporation founded in 1982, is currently celebrating their 30th anniversary. Their mission statement is “To provide the best quality products and turn-key services at globally competitive prices for our customers by developing and implementing new technologies and building trust and teamwork among our employees.” Plastikon is dedicated to the continual improvement of its Environmental Management System (EMS), which includes waste minimization, pollution prevention, and compliance with all applicable laws and regulations. The company serves customers in Medical and Healthcare, Electronics and Telecom, Packaging, Automotive, and Consumer & Industrial markets.
Plastikon Healthcare was formed in January 2011 and operates a state of the art blow fill seal, aseptic processing and liquid control filling facility in Lawrence Ks., a full analytical chemistry support laboratory for formulation development including HPLC, dissolution testing and physical characterization, and maintains ISO 9001, 14001, 13485, 16949 Certified Facilities. Their liquids contract-manufacturing suite has the capability of manufacturing a wide range of bulk liquids, including ampoules, glass, and syringe filling of suspensions and emulsion. Plastikon’s machine models are designed to manufacture containers ranging in size from 0.2mL to 1000mL at production rates of up to 15,000 units per hour. Their specialty services include product distribution for stock to dock.
Hantel Technologies Inc., also based in Hayward Calif., was founded in 1999 with a vision of being a company that would bring medical devices to market with all services provided under one roof. Their mission is to provide a company culture and structure that facilitates rapid project turnaround, and provides the flexibility in service needed to meet the unique needs of an extremely diverse clientele. Their strong program management and product development process allows them to create a well-defined project plan with high visibility for timely delivery. In addition, their flexible processes allow them to change course, quickly, and to address challenges proactively. Hantel is licensed by the State of California and registered with the FDA as a manufacturer of Class I, II, and III medical devices.
Hantel is also ISO-13485 registered. For products that require FDA clearance prior to entering the market, they can actively manage IDE applications, IRB approvals and 510(k) applications. In addition, Hantel can assist clients in obtaining their CE mark, helping to expedite entry into the European market. Hantel is a leading expert in medical product development, contract manufacturing, and quality/regulatory affairs. Hantel has developed and produced more than 100 different types of clinical-use devices using cutting-edge technologies, including disposable devices, implants, drug delivery systems, brachytherapy devices, surgical instrumentation, catheters, consumer devices, IVD analytical instruments, and clinical trials.