Stem Cell Laboratory 8/F, Li Ka Shing Institute of Health Sciences
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1 Stem Cell Laboratory 8/F, Li Ka Shing Institute of Health Sciences
2 Constructed : Australian Therapeutic Goods Administration (TGA) standard (Orthocell Proprietary Limited Company, consultant for GMP setup) Certificated : International Standard ISO
3 Stem Cell Laboratory - Layout Cleanroom ISO 7 Positive Pressure Pa ISO >0.5μm >1μm >5μm Clean Room 1 and 2 Buffer Zone Gown-up Area ISO 7 352,000 83,200 2,930 ISO 8 3,520, ,000 29,300 SIO 9 35,200,000 8,320, ,000
4 Stem Cell Laboratory - Layout Cleanroom ISO 7 Positive Pressure Pa Buffer Zone ISO 8 Positive Pressure Pa ISO >0.5μm >1μm >5μm Clean Room 1 and 2 Buffer Zone Gown-up Area ISO 7 352,000 83,200 2,930 ISO 8 3,520, ,000 29,300 SIO 9 35,200,000 8,320, ,000
5 Stem Cell Laboratory - Layout Cleanroom ISO 7 Positive Pressure Pa Gown-up Area ISO 9 Buffer Zone ISO 8 Positive Pressure Pa ISO >0.5μm >1μm >5μm Clean Room 1 and 2 Buffer Zone Gown-up Area ISO 7 352,000 83,200 2,930 ISO 8 3,520, ,000 29,300 SIO 9 35,200,000 8,320, ,000
6 Stem Cell Laboratory - Layout Preparation Lab Cleanroom ISO 7 Positive Pressure Pa Gown-up Area ISO 9 Buffer Zone ISO 8 Positive Pressure Pa ISO >0.5μm >1μm >5μm Clean Room 1 and 2 Buffer Zone Gown-up Area ISO 7 352,000 83,200 2,930 ISO 8 3,520, ,000 29,300 SIO 9 35,200,000 8,320, ,000
7 Stem Cell Laboratory - Layout Preparation Lab Gown-up Area ISO 9 Cleanroom ISO 7 Positive Pressure Pa Buffer Zone ISO 8 Positive Pressure Pa Plant Room Control: Temp Pressure Humidity ISO >0.5μm >1μm >5μm Clean Room 1 and 2 Buffer Zone Gown-up Area ISO 7 352,000 83,200 2,930 ISO 8 3,520, ,000 29,300 SIO 9 35,200,000 8,320, ,000
8 Stem Cell Laboratory Management Management Board Prof Dennis Lo (Chairman) Prof Gang Li Prof Karen Li Dr Kent Tsang Dr Simon Lee Ms Cecilia Leung (Secretary) Establishing policies Approval of proposals (With effect from 5 January 2012) Administration Manager (Dr Simon Lee) Quality Control Officer (Christine Wong) Lab-in-charge Co-ordinate interactions of key personnel in lab Oversees the administration of the laboratory Oversees applications and research proposals Authorization of SOPs Monitor compliance with GMP standard, perform audits Arrange staff training Advise on major policies Production Officer (Carol Szeto) Technical Officer (Eve Choi) Operational Advisors: (Prof Gang Li Prof Karen Li) Monitor compliance with GMP standard Give advise Review audits with administration manager Advise on major policies Quality control of products Evaluate batch records Approve specifications, sampling instructions, test methods and any QC procedures Ensure training for lab personnel Validation of equipments and production procedures Designate and monitoring of storage conditions for materials and products Daily operation of clean room Laboratory hygiene Maintenance of premises and equipment Ensure products are produced and stored according to the appropriate documentation Approve instructions relating to production operations and to ensure their strict implementation Validation of production Assist Production and QC officer in daily operation of clean room Share responsibilities: Document control system Laboratory housekeeping Assist administration manager in audits and continue quality improvement of the lab
9 Application Procedure
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11
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13 Standard Operation Procedure (SOP) Stem Cell Laboratory
14 For Clean Room Suite In-house Commissioning Determine the capability of the Clean Room air handling system with HEPA filter installed Maintain the air temperature and relative humidity within specified limits
15 Monthly test report Laser particle counter
16 Cleaning Procedure in Clean Room Clean equipments and necessary surfaces in Clean Room with alternate use of different sterile cleaning detergent every week
17 Premier Klercide-CR Sterile Biocide B Premier Klercide-CRTM Sterile Filtered Biocide C
18 Monthly cleaning log sheet Weekly cleaning log sheet
19 SOP for Sterility Test in Clinical Laboratory Suite Ensure the environment of Clean Room is free of contamination Protect the reagents, medium and cell cultures of users from contamination
20 Microbiology test on various sites quarterly
21 Daily Monitoring of Clean Room Clean Room : temperature / pressure / humidity CO2 incubator : temperature / CO2 level Fridge and freezer : temperature Plant room : air-handling system
22 Daily temp, pressure, humidity log sheet
23 Daily CO2 incubator log sheet Preparation Lab Gownup Area ISO 9 Cleanroom ISO 7 Positive Pressure Pa Buffer Zone ISO 8 Postive Pressure Pa Plant Room Cotnrol: Temp Pressure Humidity
24 Fridge and freezer weekly recorder chart
25 Daily plant room check log sheet Preparation Lab Gownup Area ISO 9 Cleanroom ISO 7 Positive Pressure Pa Buffer Zone ISO 8 Postive Pressure Pa Plant Room Cotnrol: Temp Pressure Humidity
26 Inspection and Testing Proper materials and products transfer into Clean Room
27 Pass through box with UV light
28 Labeling of Reagents, Chemicals, Culture Vessels Proper labeling of reagents, chemicals and culture vessels
29 Production Identification and Traceability Proper product identification and traceability of all the final products Such as bacteria, virology, mycoplasma
30 Handling, Storage, Packaging, Preservation and Delivery Proper handling, storage, packaging and preservation of all the materials during production and delivery in Preparation Room A. Quarantine area B. Material reception area C. Quality control area D. Product packaging area B A C D
31 User Responsibility and Training Training of laboratory users Checklist after training
32 Security Security measures of Clean Room for protection of staff in Stem Cell Laboratory CCTV monitoring and recording Access right Inventory Investigation Ethical issue Confidentiality
33 General Laboratory Procedures General safety issues Restricted materials Entry and exit procedure for restricted areas General tissue culture techniques
34 Protective gown and gown up procedure
35 Equipment Operation Procedures Operation of equipments in Clean Room and Stem Cell Laboratory
36 Laboratory Housekeeping and Waste Management Housekeeping measures of the Clean Room and Stem Cell Laboratory Biohazard waste with goose-neck tie
37 Contingency Plan Incident report Spills Alarm Power failure Incident report
38 Welcome to Stem Cell Laboratory Li Ka Shing Institute of Health Sciences
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