ASEPTIC AWARENESS Training Objectives: To further increase awareness about the microbial...
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![Page 1: ASEPTIC AWARENESS Training Objectives: To further increase awareness about the microbial contaminants found on our bodies and in the environment. To discuss.](https://reader030.fdocuments.us/reader030/viewer/2022013011/5516b9f6550346f6208b55a4/html5/thumbnails/1.jpg)
ASEPTIC AWARENESS Training
Objectives:
• To further increase awareness about the microbial contaminants found on our bodies and in the environment.
• To discuss behaviors to minimize contamination by personnel.
• To perform lab exercises to reinforce the concepts learned in class.
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ASEPTIC AWARENESS Training
What is Aseptic Processing?
What processes are most vulnerable to contamination?
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ASEPTIC AWARENESS Training
Types of Contamination
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ASEPTIC AWARENESS Training
What are SPORES
Why are they a A MAJOR CHALLENGE!!!!
http://www.samedanltd.com/members/archives/PMPS/Spring2003/graphics/f1_p12.gif http://micro.med.harvard.edu/faculty/rudner.html
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ASEPTIC AWARENESS Training
Sources of Contamination
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ASEPTIC AWARENESS Training
CONTROLLING
contamination
• Facility design • Personnel AND visitors wear gowns appropriately • Personnel AND visitors behave appropriately
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ASEPTIC AWARENESS Training
Facility Design: Clean Area Classification
FS209 Cleanroom classification
ISO 14644-1 Cleanroom classification ≥0.5um particles/m3
Microbiological Active Air Action Levels
(cfu/m3)
Microbiological Settling Plates Action Levels (diam.
90mm; cfu/4hours)100,000 8 3,520,000 100 5010,000 7 352,000 10 51000 6 35,200 7 3100 5 3,520 1 1
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ASEPTIC AWARENESS Training
Facilities: General Cleanroom Design
• HEPA/ULPA filters on ceiling• Exhaust vents on floor• Drains in aseptic processing areas are inappropriate• Airlocks and interlocking doors to control air balance• Seamless and rounded floor to wall junctions• Readily accessible corners• Floors, walls, and ceilings constructed of smooth hard
surfaces that can be easily cleaned• Limited equipment, fixtures and personnel• Layout of equipment to optimize comfort and movement
of operators
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ASEPTIC AWARENESS Training
Facilities: HEPA Filters
http://people.deas.harvard.edu/~jones/lab_arch/nano_facilities/hepa.gif
High Efficiency Particulate Air
Minimum particle collection efficiency: 99.97% for 0.3µm diameter particles.
Disposable
Filter made of pleated borosilicate glass microfiber
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ASEPTIC AWARENESS Training
Class 10,000 cleanroom
http://www.americancleanrooms.com/am/photogallery_08.html Class 100 cleanroom
Facilities: Cleanroom Classification
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ASEPTIC AWARENESS Training
Facilities: Cleanroom Classification
FS209 Cleanroom
classification
ISO 14644-1 Cleanroom
classification≥0.5um
particles/m3
Viable Microbes(cfu/m3)
Ave Airflow Velocity
(fpm)Air
changes/hr
100,000 8 3,520,000 100 5-10 5-48
10,000 7 352,000 10 10-15 60-90
1000 6 35,200 7 25-40 150-240
100 5 3,520 1 40-80 240-480
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ASEPTIC AWARENESS Training
Facilities: Pressure Differentials
• Used to maintain airflow in the direction of higher cleanliness to adjacent less clean areas
• A minimum of 10-15 Pascals should be maintained between the aseptic area and an adjacent rooms with differing cleanroom classifications (doors open)
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ASEPTIC AWARENESS Training
http://news.thomasnet.com/images/large/451/451402.jpg
Facilities: Air Lock
Permits the passage of objects and people into a cleanroom.
Consists of two airtight doors in series which do not open simultaneously.
Spray down materials with 70% IPA before placing in the airlock
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ASEPTIC AWARENESS Training
• Fiber-shedding materials such as cardboard and paper– Cardboard packaging must be removed and items placed into
non-cardboard containers.
• Wood (i.e. wooden pallets)• Undesignated charts
Facilities: Material NOT permitted in a Cleanroom
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ASEPTIC AWARENESS Training
Facilities: Cleaning
Water should be changed FREQUENTLY
1. Vacuum all accessible surfaces
3. Mop floors using a lint free polyester mops attached to stainless steel handles
2. Wipe surfaces with a cleaning solution
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ASEPTIC AWARENESS Training
http://www.rit.edu/
http://www.imi.org.uk/
Avoid Cleanrooms When Sick!!!
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ASEPTIC AWARENESS Training
• Avoid cleanrooms when ill• Frequent bathing and shampooing• Avoid getting sunburned• Avoid cosmetics such as face powder, hair sprays,
perfumes and aftershave• Clothing should be clean, nonfrayed and nonlinting• Avoid smoking
Personnel: Hygiene
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ASEPTIC AWARENESS TrainingINCORRECT
3
21
4
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ASEPTIC AWARENESS Training
FOREHEAD
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ASEPTIC AWARENESS Training
http://www.engenderhealth.org/IP/surgical/sum4.html
Personnel: GlovesWhen are gloves worn?What compromises gloves?How often should gloves be examined and sanitized?
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ASEPTIC AWARENESS Training
Qualifying Personnel
• Assess after gowning/gloving
• Microbiological surface sampling of several locations– Glove fingers– Facemask– Forearm– Chest– Periodic requalification is necessary
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ASEPTIC AWARENESS Training
Biological Safety Cabinets
Small benchtop sized
class 100 clean area
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ASEPTIC AWARENESS Training
Vertical Laminar Flow Area
http://www.terrauniversal.com/products/hoods/vlfstation.php
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ASEPTIC AWARENESS Training
ISOPROPYL ALCOHOL
• Powerful disinfectant and antiseptic
• Mode of action: denatures proteins, dissolves lipids and can lead to cell membrane disintegration
• Effectively kills bacteria and fungi
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ASEPTIC AWARENESS Training
Particles >= 0.3µm emitted per minute
PersonnelActivity
SnapSmock
MembraneCoverall
No Movement 100,000 10
Light Movement 500,000 50
Heavy Movement 1,000,000 100
Change Position 2,500,000 250
Slow Walk 5,000,000 500
Personnel: Behaviour
Austin Contamination IndexSource: Encyclopedia of Clean Rooms, Bio-Cleanrooms and Aseptic Areas, Dr. Philip Austin,
PE, 2000
Minimize movement: Work slowly and purposefully
Note: Light/heavy movement refer to partial body movements (motioning with arm, tapping toes, etc.).Change of position refers to whole body motion (standing up, sitting down, etc.).
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ASEPTIC AWARENESS TrainingINCORRECT
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ASEPTIC AWARENESS TrainingCORRECT
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ASEPTIC AWARENESS TrainingINCORRECTASEPTIC AWARENESS Training
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ASEPTIC AWARENESS TrainingCORRECT
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ASEPTIC AWARENESS TrainingINCORRECT
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ASEPTIC AWARENESS TrainingCORRECT
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ASEPTIC AWARENESS TrainingINCORRECT
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ASEPTIC AWARENESS TrainingCORRECT
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ASEPTIC AWARENESS TrainingINCORRECT
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ASEPTIC AWARENESS TrainingCORRECT
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ASEPTIC AWARENESS TrainingINCORRECT
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ASEPTIC AWARENESS TrainingCORRECT
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ASEPTIC AWARENESS TrainingINCORRECT
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ASEPTIC AWARENESS TrainingCORRECT
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ASEPTIC AWARENESS TrainingINCORRECT
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ASEPTIC AWARENESS TrainingCORRECT
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ASEPTIC AWARENESS TrainingINCORRECT
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ASEPTIC AWARENESS TrainingCORRECT
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ASEPTIC AWARENESS Training
ENVIRONMENTAL MONITORING
“In aseptic processing, one of the most important laboratory controls is the environmental monitoring program”
Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing-Current Good Manufacturing Practice,FDA, September 2004
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ASEPTIC AWARENESS Training
Microbial Monitoring MethodsTouch or Contact plates
– RODAC Plates
Swabs
www.esa.int
Environmental Monitoring: Surface Monitoring
http://www.blood.co.uk/hospitals/services/Micro/Bact2.htm
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ASEPTIC AWARENESS Training
Environmental Monitoring: Particulate Air Monitoring
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ASEPTIC AWARENESS Training
Active Air MonitoringRCS Plus
Passive Air MonitoringSettling Plates
RCS: Rotor Centrifugal Sampler
Environmental Monitoring: Viable Microbial Air Monitoring
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ASEPTIC AWARENESS Training
Environmental Monitoring: Trending Data
• Why is it important?• Evaluate the disinfection efficiency• Are certain microbes migrating into the aseptic processing area from
a lesser controller area?• Long and short term• Data by:
– Shift– Room – Shift– Operator – Product– Container type– Filling line– Sampling– Testing personnel
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ASEPTIC AWARENESS Training
http://www.arches.uga.edu/~kristenc/cellwall.html
QC Micro: Identifying Microbes
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ASEPTIC AWARENESS Training
Gram Stain
QC Micro: Identifying Microbes
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ASEPTIC AWARENESS Training
Metabolic Based Assays
Vitek
QC Micro: Identifying Microbes
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ASEPTIC AWARENESS Training
QC Micro: Identifying Microbes Metabolic Based Assays
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ASEPTIC AWARENESS Training
Staphylococcus xylosus
Reduction of Tetrazolium Violet
QC Micro: Identifying Microbes Metabolic Based Assays
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ASEPTIC AWARENESS Training
QC Micro: Identifying Microbes Metabolic Based Assays
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ASEPTIC AWARENESS Training
QC Micro: Identifying Microbes Genotype Based Assay: MicroSeq
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ASEPTIC AWARENESS TrainingQC Micro: Identifying Microbes
Genotype Based Assay: MicroSeq
PCR: Polymerase Chain Reaction
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ASEPTIC AWARENESS Training
SEQUENCE THE DATA
QC Micro: Identifying Microbes Genotype Based Assay: MicroSeq
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ASEPTIC AWARENESS Training
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ASEPTIC AWARENESS Training
Sepsis: Progression of Symptoms
FeverDecreased Blood PressureRapid Breathing and Heart RateSkin LesionsSpontaneous Blood Clotting Organ FailureDeath
http://www.emedicinehealth.com/images/4453/4453-4482-12996-21147.jpg
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ASEPTIC AWARENESS Training
http://pathmicro.med.sc.edu/fox/lps.jpg
QC Micro: LAL Assay
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ASEPTIC AWARENESS Training
Endotoxin MACROPHAGE
Tumor Necrosis Factor
Interleukins (1,6,8)
QC Micro: LAL Assay
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ASEPTIC AWARENESS Training
ENDOTOXIN LIMIT FOR WFI IS 0.25EU/ml
QC Micro: LAL Assay
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ASEPTIC AWARENESS Training
The Lysate
QC Micro: LAL Assay
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ASEPTIC AWARENESS Training
Associates of Cape Cod, Inc.
Reading the Results: Gel-clot Test
Lysate clots when endotoxin is present.
Turbidimetric - increase in turbidity. Chromogenic - addition of a peptide that when cleaved during the assay turns a distinct color.
Endpoint - Measure turbidity/absorbance after a definitive time period.Kinetic - Measure rate of increased turbidity/absorbance.
Gel Clot – a clot forms and stays intact at the bottom of the assay tube when it is inverted
QC Micro: LAL Assay
TYPES of LAL ASSAYS
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ASEPTIC AWARENESS Training
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