ESTABLISHMENT OF A NEW MEDICAL DEVICE PACKAGING LABORATORY

Size: px

Start display at page:

Download "ESTABLISHMENT OF A NEW MEDICAL DEVICE PACKAGING LABORATORY"

Gary Mills
6 years ago
Views:

1 ESTABLISHMENT OF A NEW MEDICAL DEVICE PACKAGING LABORATORY Asit K Ray Professor of Chemical and Biochemical Engineering & Coordinator of Packaging Certificate and Laboratory Christian Brothers University

2 INTRODUCTION Packaging science and/or engineering is relatively a new discipline with only six college- universities offering BS in packaging in the USA CBU School of Engineering offers Packaging Certificate requiring two packaging courses and a Special Project plus some prerequisites Second packaging course currently offered have two parts, distribution & medical device packaging The class-room teaching of medical device packaging was not supplemented by hands-on laboratory

3 INTRODUCTION (cont d) Packaging lab was needed to upgrade current courses taught on medical device packaging -For the new courses to be taught under the BS program in Engineering Management with Packaging Concentration offered since last fall -Will complement the medical device and polymer courses that will be required for the BS program in packaging that may be offered later

4 PROPOSED LABORATORY Medical Device Packaging lab: thermoformer for making trays and blisters, tray sealer, pouch sealer, tensile testing machine, burst testing machine, bluedye package integrity tester Existing Polymer Lab: compression molder, rheometer, MDSC, temperature- humidity chamber, temperature-altitude chamber Plus all the existing standard distribution test equipment (drop, compression, vibration and shock) Proposed Food Packaging lab: Vertical form-fill seal (VFFS) machine, gas permeability measuring instrument, torque tester, plastic bag sealer etc.

5 LAB RESEARCH THERMOFORMER Contact established with Plastics Ingenuity, Madison Wis., 3rd largest thermoformer user in North America They decided to donate a lab-scale thermoformer Visited their facility in Madison followed by a team of expert visiting us to finalize details of manufacture, installation and training involving the thermoformer Machine was delivered and installed followed by a training session for the laboratory staff (Jan16, 2008) The cost of the machine plus electricals ~$100,000

7 CBU FACULTY DEVELOPMENT GRANT With thermoformer as the center-piece decision was made to establish a medical device laboratory Applied and received a Faculty Development grant for the Summer ands fall of 2008 towards above Required visits to Clemson and Indiana State Universities and the Southpak in Charlotte, NC Required contacting medical device companies in greater Memphis and Northern Mississippi areas for donation of equipment for the medical device lab

8 VISITS TO CLEMSON & INDIANA STATE Visit to Indiana State Univ Packaging dept led to personal contact with Dr. Marion Schafer, dept head Dr. Schafer offered to donate one of the surplus vertical form-fill-seal (VFFS) machines provided we furnish the transportation and other costs Visit to Clemson University Packaging Science dept with Dr. Pong Malasri was interesting and fruitful They use micro size equipment for their Flexible Packaging (mostly plastics) Section which are very cost effective and fit with university-sized budgets

10 POLYMER LABORATORY AND OTHER EXISTING EQUIPMENT Most of the packging forms (containers) in medical device packaging are made of plastics Existing polymer lab consisting of MDSC, compression molder, rheometer, thickness measurement gage etc. are definite pluses Existing temperature-humidity & temperaturealtitude chambers can simulate varied environments that medical devices can be subjected to

14 NEW EQUIPMENT FOR MEDICAL DEVICE LABORATORY Pouch (and bag) sealer : table top heated bandsealing type; a bigger version is now available Tensile tester : Tinius Olsen model, used to measure strength of tray-lid seals and pouch seals and mechanical properties of plastics Dye-penetration test : used to measure integrity of tray-lid seal and pouch seals

20 COMPREHENSIVE LAB REPORT INCLUDES Uniqueness of medical device packaging - description Overall account of different packaging forms used Short introductions, pictures and descriptions of tray & pouch-making machines (not available at CBU) Introduction to package sealing and integrity testing Short intros, pictures, descriptions and test procedures of package sealing & integrity testing equipment Same for compression molder, temperature-humidity and temperature-altitude chambers Package shelf-life estimation by laboratory testing

21 USES OF NEW MEDICAL DEVICE LAB It was used to hold two successful hands-on medical device packaging high school workshops on 13 th November, 2008 and 22 nd January 2009 It is used to supplement the class room teaching of medical device packaging starting this spring It will be used to supplement the class room teaching of medical device packaging for the packaging BSEM When expanded and ISTA certified it will be used to provide testing services to local medical device comp. It will be used to pursue needy short-term researches

22 FUTURE PLANS Start developing a food packaging lab with a few equipment donated by ACH food company Procure, transport and install the vertical form-fillseal machine to be donated by Indiana State Univ Expand current medical device lab to include a tray sealer and burst tester for package integrity testing Have the medical device lab certified by ISTA Acquire micro-scale plastics processing machines (extrusion casting and blown-film) to make plastic films used in thermoforming; pouch making machine

26 ACKKNOWLEDGEMENT The author would like to thank CBU for the Faculty Development grant for the Summer and fall of 2008 for this project. Special thanks are due to Plastics Ingenuity, Madison WI for donating the excellent lab research grade thermo-former and providing the molds, plastics sheets and knowhow for operating the machine and continued support towards using it as a teaching and research tool. Special thanks are due to Dr. Siripong Malasri of CBU for coordinating the delivery, installation of the thermo-former and arranging for special training sessions and publicizing the event. Thanks are due to Wright Medical Technology, Smith and Nephew and ACH Food co. for lab equipment donated and will be donated.

Campus Map:

Campus Map: 2014 HPC Spring Meeting Friday, April 11, 2014 Sabbatini Lounge, 2 nd Floor of Thomas Center, Christian Brothers University 650 East Parkway South, Memphis, TN 38104 8:00 a.m. 8:45 a.m. Check-in/Continental