CONTAMINATION CONTROL IN HOSPITALS. Isabelle Pautrel Ingénieur Clean Concept Patriarche & Co i.pautrel@patriarche.fr
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1 CONTAMINATION CONTROL IN HOSPITALS Isabelle Pautrel Ingénieur Clean Concept Patriarche & Co 1
2 P&CO 120 person Agency Savoie 94 person Paris 15 person Lyon 9 person Montréal 2 person International Agency of Architecture, Town Planning and Engineering Our team gathers all the needed competencies to respond to your requests 2
3 Clean Concept in Patriarche & Co When architectural quality joigned regulatory quality 3
4 4 1. CLEAN AREA
5 Mainly : Clean area Hospital Pharmacy. Dedicated area for storage and distribution of drugs with area for the preparation of sterile surgical material. Unit of Cells and Gene therapy. Class room dedicated for cell therapy treatment (i.e.: cancers, hematological, cardiology...); for cell or tissue regeneration (i.e.: skin, cartilage, bones...). Tissue Bank (Repository) for graft surgery. Operating rooms for surgery carrying the higher risk of hospital acquired infections. (Transplant unit, intensive care area, cancer, graft, premature baby, large burned ) 5
6 Clean area Guidelines: Hospital Pharmacy French Guideline : Good Hospital Pharmacy Practice Unit of Cells and gene therapy : French Guideline : The BPF is the GMP guideline in French, Good Manufacturing Practice, Good Practice for the preparation, storage, transportation, distribution and disposal of tissues, cells and cell therapy preparations Tissue Bank. Good Practice for preparation, storage, transportation, distribution and disposal of tissues, cells and cell therapy preparations Surgical Room French Norm : S Health facility - Cleanrooms and associated controlled environments - Requirements for the control of airborne contamination 6
7 Clean area Clean room Guidelines : NF EN ISO à 9 «Cleanrooms and associated controlled environments» NF EN ISO à 3 «Clean room Technology Biocontamination Control» NF EN 779 «Particulate air filters for general ventilation. Determination of the filtration performance» WHO «Practical Guideline for infection control in Health Care Facilities» 7
8 What is the clean level searched needed? Clean area For Air, the proper term is «Class» Classes define what is the maximal quantity and particle's size in a representative sample, generally the sample is one cubic feet (ft 3 ) Remember that it is possible to distinguish inactive particles from active microbial particles. 8
9 9 2. CONTAMINANTS
10 Contaminants Particle : the limit of visibility 100 µ 100 µm in daylight 30 µ 30 µm in intense light but the particle to eliminate has a size below 5 µm 10
11 Contaminants Particles in one air liter Near a smoker In town In countryside At pole In clean room 100 Under laminar flow 1 True quantity depends on: season wind local emission The inter-day variation (between each day) is quite important 11
12 Contaminants Particle behavior in air is different according to their size: Large particle falls quickly on the ground (100 µm); Most particle are in suspension in the air and move freely; Little particle tends to aggregate into larger one. 0,50 m/s 100 µm 50µm 2 m 100µm 50µm 20µm 12
13 Particles emitted by a person in one minute Contaminants 13
14 Each minute, each person produce approximately: between 100 to CFU at rest and between 500 to 5000 CFU in activity. Contaminants 14
15 Air Contaminants: Outside air contains approximately bacteria per m 3 ; Contaminants In a clean room, bacterial load varies according to each individual and its health status. 15
16 Air contaminants: Contaminants Material Linen Expendable Patient Activity Staff Practitioner Service Visitors Environment Floor, wall, plafond Ambient air Water Pest, rodents 16
17 Contaminants Contamination transfert: Staff Air Area Critical material 17
18 2. CONTAMINATION CONTROL DESIGN 18
19 Contamination control «Maintaining air quality is defined as implementing simple and consistent practices and processes» On each slide, bottom right, the corresponding guideline is indicated 19
20 Contamination control Ventilation system must be consistent with : Architecture Circulation / Path Equipment Procedures Training Controls Maintenance 20
21 Clean area is maintained if: Contamination control Surfaces are clean, through regular cleaning; Air is clean, through appropriate filtering; Activity is not contaminating, through optimized processes. NF EN ISO
22 Contamination control Areas are not clean by miracle: The design has been conceived With materials that do not reject particles; In a way to avoid contaminant accumulation Smooth and easy to clean NF EN ISO
23 Contamination control To avoid contaminant accumulation: Avoid : Rough surface Cement seal Unfiled junctions between materials Sharp angles high horizontal surface Choose: Smooth surface Continuous surface Filled junction Connection with silicone seal NF EN ISO
24 Not relarguant materials: Contamination control Avoid : Parget Raw cement Wood Agglomerated particles Fibrous materials Choose: Enameled steel Stainless steel Laminate Polyester Resins NF EN ISO
25 Smooth and easy to clean : Contamination control Avoid: Tiled floors Porous thermoplastic materials Junctions between materials unfilled Protruding accessories Glass textile wall Choose: Electro polished stainless Glass Recessed lighting Skirting round Door or windows frames flush Resistant to cleaning and disinfectants agents NF EN ISO
26 Glazing and flooring are in continuity : Contamination control 26
27 Contamination control Glazing : 27
28 Contamination control Safety Access System are white, clean and luminous : 28
29 Furniture is integrated: Contamination control 29
30 Frame and utilities are integrated : Contamination control 30
31 Cable and piping are integrated: Contamination control 31
32 Contamination control Clean room are over pressured Air is filtered Particle rejection is limited Air is renewed in the clean room Air flow is mastered Clean room is regularly cleaned NF EN ISO
33 Overpressure Contamination control Only minimal overpressure is required to be efficient, few mm H 2 0 or deca Pascal is obtained by continuous intake of new air is maintained by using appropriate airlocks CTA LA SURPRESSION. Michel Combet Consultants NF EN ISO
34 Contamination control Overpressure o Door is lock ++ To maintain overpressure, doors must be closed Door is lock NF EN ISO
35 Contamination control Filter in ventilation system: the role of pre filter is to ensure air quality on the HVAC equipment The second filter in the HVAC protect the HEPA filter. the final filter (H14 for example) is to ensure the clean air, without particle and without germ in the clean room 35
36 Classification of general ventilation filters Contamination control High efficiency filter (F7 à F9) must be preceded by filters of medium efficiency (M5-M6) NF EN ISO
37 Classification of general ventilation filters Contamination control Very high efficiency filter must be preceded by the G, M or F filters NF EN ISO
38 Filter in HVAC: Are installed on slides with or without joint. Contamination control Have manometer to monitor the clogging and pressure transmitter for security. At the beginning, filtering capacity decrease slowly followed by a faster evolution over time. the filter life depends of dust quantity. Regular replacement of G and F filters enables making savings on HEPA Filters cost NF EN ISO
39 Contamination control Filters must have a visible identification that should last and should includes: Filter name, trademark, Manufacturer s identification, Type and serial number, The number of the corresponding guideline, Filter class, the nominal volume air flow. NF EN ISO
40 Contamination control The renewal of the air Contaminated air is gradually substituted by an air without particle at rest, air quality is still good When active, contamination level depends - of activity - of air renewing 40
41 Contamination control Cleanliness class is maintained by a balance between: Air change rate Number of person Type of dressing Personal behavior Stable parameter Variable parameter 41
42 Contamination control It must return to the initial cleanliness! Limit of particles class First day Night Second day Starting threshold 42
43 Contamination control Control Air Flow The supply air grills are positioned near the clean area The return air grills are positioned near the polluted area 43
44 Contamination control Turbulent flow : HVAC Temperature is homogenized by the air circulation and also removes particles. 44
45 Contamination control Principle of air diffusion Induction Air diffuseur Filter with diffuseur Laminar flow Mixed System Diffuseur + Flow NF EN ISO
46 Contamination control Principle of return air Air intake ceiling for Laminar Flow and equipment to release heat Wall thimble or filter with grill for other cases mainly for powdered product NF EN ISO
47 Low extraction air. Contamination control smoke goes down 47
48 Contamination control Laminar air flow The flow is laminar if : The air flow is - linear - parallel - in the same direction - at the same speed + Blower Plenum The speed must be 0,45 m/s Diffusion filter NF EN ISO
49 Horizontal Air Flow Indépendant Contamination control Overpressure Fresh air refreshed NF EN ISO
50 Integrated Vertical Air Flow Contamination control NF EN ISO
51 51 Thank You
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