BioSafety Level-3 Facility & It's management

BioSafety Level-3 Facility & It's management


CONTENTS The International Vaccine Institute(IVI) BSL-3 facilities in Korea The IVI BSL-3 facility IVI BSL-3 Management systems and practices BioSafety culture: Training in BSL-3 practices Maintenance issues Systems upgrade and improvements Conclusions & Prospects INTRODUCTION OF INTERNATIONAL VACCINE INSTITUTE(I VI) To promote the health of people in develo

ping countries by the development, introd uction and use of new and improved vacci nes - From: Constitution of IVI (1996) IVI is a non-profit international organization, headquartered in Seoul, South Korea, and created under the auspices of the United Nations Development Program. BIOSAFETY & BSL-3 FACILITIES IN KOREA Since 2005: Korean government enforces national pathogen control & Bi

oSafety Acts on the Prevention of Infectious Diseases, for Highly dangerous pathogens Amended in 2005 to create a controlling system. Amended in 2010 to update & amend the list of risk pathogens Act on the Prohibition of Biological or Chemical Weapons and the Control of the Production, Export and Import of Special Biologicals or Chemical agents i n 2006 for Selective agents (Biologicals & Toxins) Act on Transnational Transportation of Living Modified Organisms, enacted i n 2008 BSL-3/4 facility certification requires inspection every half year & reaccredit ation every 3 years by KCDC

At present, 20 certified BSL-3 facilities in Korea INTRODUCTION OF BSL-3 FACILITY OF IVI History of BSL-3+ Project : Initiated in 2005, 3 yrs before the issuance of Korean regulations (LMO Act) : A call for tender in 2006 : Construction began in 2007 : Validation with international standards in 2008

: Certified by Korea Center of Disease Control & Prevention in 2009 : Certified & passed the KCDC inspections in 2010 : Opened ABSL-3/BSL-3 labs in 2010 : Annual revalidation in 2011 PACEMAKER OF BIOSAFETY in Korea Area : 349.9m2 Consists of ABSL-3 and BSL-3 areas BSL-3 MANAGEMENT SYSTEM Internal regulations : BSL-3 Manual & 19 SOPs Internal approval system

: Institutional BioSafety Committee approval required For adopting new infectious substance, animal and new or change experimental protocols into ABSL-3/BSL-3 : General Manager of ABSL-3/BSL-3 approval required For authorization of ABSL-3 / BSL-3 users accessibility Risk assessment INSTITUTIONAL BSL-3 REGULATIONS : BSL-3 MANUAL & SOP BIOSAFETY LEVEL 3 MANUAL (English) : Document no. L-BS-1-BL3-01 : provides the general knowledge on BioSafety, recomme nded work practices, safety equipment, operation & mainte nance of BSL-3 and administrative considerations to minimi

ze the risk of staff injury or illness. ABSL-3/BSL-3 Standard Operation Procedures (SO Ps) : 19 SOPs written in bilingual, English & Korean : Document no. L-BS-4-BL3-01 ~19 PURPOSE OF BIOSAFETY LEVEL 3 TRAINING BIOSAFETY TRAINING Gives researchers CONFIDENCE to work in a safe environment BIOSAFETY CULTURE: TRAININGS

Trainees : scientists, research assistants, maintenance enginee rs, institutional safety committee (ISC) members, etc. HAPPY & SAFE LAB LIFE BIOSAFETY CULTURE : STANDARD TRAININGS For BSL-3 users

BioSafety lecture including General BioSecurity BSL-3 training (Theoretical /Practical) Cleaning & Decontamination (Theoretical / Practica l) ABSL-3 training including animal training

Equipment training (ex. Autoclave) Training on Emergency : e.g. biological spills, clean-up & fire evacuation (Practic al drills) BIOSAFETY CULTURE: TRAININGS For Maintenance

BioSafety lecture (Summary) BSL-3 training for engineers Cleaning & Decontamination procedures

Emergency procedures: e.g. fire evacuation EXAMPLE OF BSL-3 TRAININGS FACILITY & EQUIPMENT MAINTENANC E Facility & Equipment IQ/ OQ/ PQ Periodic check-up & maintenance service

Daily / Weekly / Monthly / Annual Annual revalidation with general decontamination Shut down the facility = Close experiment At least 6 month notice to users Chemical decontamination

Revalidation of Facility & Equipment Renewal of BSL-3 training EXAMPLES OF FACILITY MAINTENANCE REP ORT Weekly report rt

Monthly repo SYSTEM UPGRADE BY RUNNING BSL-3 FACILITY Enforce liquid waste treatment system Basic thermal treatment system + Chemical back-up Emergency SMS system Basic CCTV & Automatic central monitoring system + Paging system (sending mobile message in emergency) Preparing User Protection Program Revising SOPs Upgrade training Follow up new national regulations and international guidelin

es ALARM SMS (SHORT MESSAGE SERVIC E) SYSTEM FOR EMERGENCY Escalation function USER PROTECTION SYSTEM AGAINST EMERGENCY CONCLUSION Assess the potential risk and correct defects by operat ing the facility for a year. Nurture a BioSafety culture by regular trainings and s

ustained communication between BSL-3 staff and endusers. Enforce emergency systems and procedures. Ensure regular maintenance PROSPECTS REGULATORY REACCREDITATION of BSL-3 facility: 2 012 THANK YOU FOR YOUR ATTENTION

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