Introduction to AB Medical

Transcription

1 Superb Blood Collection Tube Introduction to AB Medical AB Medical Co., Ltd Office: #109 venture plaza, 2 nd FL, Trade Tower, 511 Yeongdong daero, Gangnam-gu, Seoul, KOREA Tel: Fax: Factory : Tel: Fax:

2 AB MEDICAL Co. History Feb Establish company Mar Contract for transfer of technology with Chonnam National Univ. BIO-IT Center July 2012 Start V-TUBE mass production Dec Certify clinical test by Chonnam National Univ. Hwasun Hospital Dec Domestic sales through 7 regional distributor Aug Yearly supply contract with Korean Red Cross Blood Services Aug Certify ISO13485 & CE DOC May GMP approval by KFDA Apr Establish capacity of 8,000,000 per month Apr EPC(Excellent Performance Certificate) Marking approval by Gvmt. Business Product BIO-IT based IVD Medical appliances Blood Vacuum Tube POCT devices Employee 13 Persons Capacity 96million tubes / year 2

3 Organization C E O Sales / Marketing Quality Assurance Production Engineering Admin. / Accounting R&D 3 / 19

4 Vacuum Blood Collection Tube? Device for collecting blood more safely and easily Glass or PET tube with additives Vacuum for draw volume of blood Disposable FUNCTION Persisting Vacuum Color - additives Product Information Patient Information Blood container Sprayed Additives ESSENTIAL TECHNOLOGY Reagent, Accuracy & speed spray of additives, Automation Serum separation Characteristic : Must-item and commodity(growth) Essential for diagnosis(demand) Disposable(Quantity) 4

5 Manufacturing Process Input Tube 0 Label Array 4 Reagent 4 Reagent 5 Dry 6 7 Pack Finish Gel Vacuum Cap Gel dispensing Tube arraying Drying Labelling Reagent spraying Vacuuming & Capping 5

6 Factory figure Material Stock Gel dispensing Entrance

7 Factory figure Machine #4 Product stock

8 Solutions Manufacturing Problem Failure Solution over under none Unstability of gel & additives Lack of dispensing volume uniformity Diagnostic data inaccuracy Blood assay fail Knowhow of reagent Use Sekisui gel Control reagent spraying precisely Assembly defects Defective parts Capping defects Lack of vacuum Blood volume inaccurate High quality of parts & accurate assembly manual discontinuing process Low productivity Wide space Complexity of control Weak competence High speed continuing process automation Needs of stable reagent, gel and high speed accurate manufacturing technology 8

9 Product Line-up 32 products Full Line-Up. On-demand Tube practicable also. 9 / 19

10 Technology Product Technology Approved quality and performance by clinical test in Chonnam National Univ. Hwasun Hospital Producing Technology 6 patented formulas for producing blood vacuum tube have transferred patent title date remark Theme Evaluation of AB MEDICAL V-TUBE in clinical test Period ~ Manager Laboratory Medicine Rusult Approved ( ) Conclusions A total of 100 volunteers (79 patients and 21 healthy person) Conclusions : Newly developed V- TUBE provided a suitable alternative to BD tubes in common clinical laboratory. Abstract posted in AACC EXPO 2013 Houston Manufacturing method of vacuum tubes Tube arraying device for manufacturing vacuum tubes Assembly device for cap and tubes of vacuum tubes Reagent spray device of vacuum tubes Nozzle apparatus for accurate dispensing Cork of blood collection tube Exclusive rights owned by AB Medical Patents by AB Medical / 19

11 Clinical test report 11 / 19

12 Certification 12 / 19

13 EPC Mark Excellent Performance Certification Mark ( ~ ) It has preferred purchasing right to Government Procurement. 13 / 19

14 Quality Assurance System Keep in mind that products of great quality are result of perfect inputs and processes, and make it sure to eliminate any flaws in the initial stage Never ship our products to market, without enough confidence as a perspective of our customers Process Inspection Outgoing Inspection Customer complaints Daily Validation Random sampling by lot Monitoring market quality and claim Reagent-dispensing Inspection for every tube using inspection tool Initial, Middle, Final sample inspection every 2 hours Detail inspection of packing Detail inspection of Whole Instruction Prompt action against defect lot (exchange) Collect defects and reproducibility test Initial sample Vacuuming test every 2 hours Decision Corrective action 14 / 19

15 Characteristics of V-TUBE Using SEKISUI s Serum Separation Gel for stable assay Own Blood Coagulation Accelerator approved by clinical test Uniform superb quality by own full automatic machine (patent technology) Dispensing regulated dose of additives Superb vacuum persistence Quick clotting time 15 / 19

16 Product example (CA 6.0ml) Transparent label Paper label 16 / 19

17 Product example (CAG 5.0ml, 8.0ml) 8.0 ml (Ø16) 5.0 ml (Ø13) 17 / 19

18 Product example (EDTA, Coagulation) Coagulation 1.8ml, 2.7ml (Each Inner Tube) 18 / 19

19 Thank you