Karen Snow, (ASCP)BB, CQA(ASQ) Quality Assurance Officer Bone Marrow Transplant Program & Cellular Therapeutics & Transplantation Laboratory Massachusetts General Hospital Boston, Massachusetts, USA How Effective is your Cleaning and Sanitization Process A Review of Current Practices Bonjour, Je m’appelle Karen
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Karen Snow, (ASCP)BB, CQA(ASQ)Quality Assurance Officer Bone Marrow Transplant Program &Cellular Therapeutics & Transplantation LaboratoryMassachusetts General HospitalBoston, Massachusetts, USA
How Effective is your Cleaning and Sanitization Process
A Review of Current Practices
Bonjour, Je m’appelle Karen
Cleaning & Sanitization Practices
Maintaining a clean laboratory is a critical element of Quality Manufacturing for cell therapy products.
Review of cleaning and sanitization practices reported by ISCT survey participants
Examine how regulatory and accreditation requirements influence cleaning practices
Discuss the needs of processing laboratories for standardization in cleaning and sanitization across the industry
Standard Operating Procedure & Documentation of Cleaning Based on Laboratory Classification
5/12/2014ISCT Annual Meeting, Paris France 12
0%
20%
40%
60%
80%
100%
Unclassified ISO 8 ISO 7 ISO 6
94%
68%
77%
55%
75%
47%
37%
57%
Cleaning SOP Cleaning Documented
Are Cleaning Agents Rotated?
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0%
20%
40%
60%
80%
Unclassified ISO 8 ISO 7 ISO 6
25%
53%
63%
43%
75%
47%
37%
57%
YES
NO
Cleaning Agents Utilized
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Chlorhexidine or similar
Hydrogen peroxide based
Qauternary disinfectants
Fungicidal solutions
Detergent solvents
Isopropanol reagents
Germicidal wipes
Sporeklenz, sporicidin
Virex 256
10% Bleach
70 % Alcohol
LpH, vesphene, phenolic
Asepticare
Actisan biozidal IPA
Percept , alcohol
Asepticare and alcohol mixture for hoods
SaniMaster 4 for floors
Bench Top & EquipmentHow often General Cleaning is Performed
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LaboratoryClassification
Monthly Weekly Daily After Each Use
Unclassified 1% 13% 59% 27%
ISO 8 3% 7% 72% 14%
ISO 7 0% 8% 43% 49%
ISO 6 0% 6% 33% 56%
** No one answered “Never” ** No one answered “Quarterly”
Frequency of General Cleaning:Bench Tops, Lab Equipment
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0%
10%
20%
30%
40%
50%
60%
70%
80%
After each use Daily Weekly Monthly
Unclassified lab ISO 8 ISO 7 ISO 6
Personal Gowning Practices
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Use of reusable/sterile lab coats
‘Bunny Suit’
Scrubs or other “non-street” clothes
Gloves (non-sterile/sterile)
Hair cover, face mask, shoe covers
Variation in practices in general and with:
Laboratory classification
Product type
Who is Responsible for General Facility Cleaning?
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LaboratoryClassification
Lab Staff Hospital Staff Contract Staff
Unclassified 25% 51% 24%
ISO 8 39% 18% 43%
ISO 7 49% 26% 26%
ISO 6 67% 20% 13%
Employee training documentation on cleaning procedures is critical. This training should (shall) be conducted for all staff charged with cleaning functions and often extends beyond laboratory staff
Walls, floors, ceilings…
Training Documentation for Cleaning Staff
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0%
25%
50%
75%
100%
Training Documentation
61%
93% 91%
100%
Std Lab
ISO 8
ISO 7
ISO 6
Frequency of Extended Cleaning:Equipment, Walls, Ceilings
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0%
5%
10%
15%
20%
25%
30%
35%
40%
Never Quarterly Monthly Weekly Daily Aftereach use
Unclassified lab ISO 8 ISO 7 ISO 6
HVAC Vent Cleaning
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0%
5%
10%
15%
20%
25%
30%
35%
40%
Weekly Monthly Quarterly SemiAnnually
Annually Never
Unclassified lab ISO 8 ISO 7 ISO 6
Cleaning and Effectiveness
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Viable & non-viable particles
Air sampling
Settle plates/swabs/RODAC plates
Testing areas:
General facility cleaning
Personnel
Critical equipment: BSC, water baths, centrifuges
Hematology analyzer, cell sorter or other instrumentation
Small equipment: weight scale, heat sealer
Ventilation, HEPA filters (maintenance dept)
Bench tops
Environmental Monitoring
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Unclassified Lab
Class 100,000 (ISO 8)
Class 10,000 (ISO 7)
Class 1,000 (ISO 6)
Similar % for EM SOP
Not used as a measure of cleaning effectiveness *****