NHS QA Symposium 25 th /26 th September 2012 Environmental Monitoring in NHS Facilities Tim Triggs Director of ACT Ltd & Slide 1 Lighthouse Worldwide Solutions R3 Nordic
Speaker introduction - Tim Triggs Committee Member of UK Pharmaceutical Healthcare Sciences Society (PHSS) Technical Expert for British Standards Institute LBI/030 Cleanroom standards ISO14644-1 & 3, and BS8568 Trainer for Irish Cleanroom Society, CTCB-I and ACT Director of DOP Solutions, Academy for Cleanroom Testing and Cleanroom Equipment Suppliers Member of IHEEM, SAFHE & ISPE Pharmaceutical Scientist and Mechanical Engineer Background in Cleanrooms, sterilisation(aps), GSK pharma Slide 2
Company introduction DOP Solutions Technically based instrument and training company solely focused on delivering solutions for testing and monitoring clean air and containment systems. >20 years old, privately owned. UK based manufacturing and supply. South Africa office for service/calibration, local sales agents 20+ UK staff, c.30 overseas distributors/agents Equipment and System design, manufacturing, supply and installation Standard setting for BSI, EN and ISO Training provider to industry, hospitals and CTCB-I Consultancy and design On site or workshop service/repair and calibration Slide 3
Company introduction DOP Solutions Who we work with Pharma Hospitals Food and drink Hi-tech Containment Nuclear Testers/certifiers HEPA Filter manufacturers Clean air/hvac equipment OEMs Designers/consultants What we provide Instrumentation Training courses Service and calibration Instrument hire Technical Support Consumables Accessories Consultancy Slide 4
Company introduction DOP Solutions UK A World Leader in HEPA Filter Testing Slide 5
Company introduction DOP Solutions France California Cleanroom Testing & Monitoring Solutions Slide 6
Company introduction DOP Solutions Germany & Italy Biodecontamination Solutions Slide 7
Academy for Cleanroom Testing Slide 8
Where hospitals are measuring or monitoring Pharmacy Emergency Room Fertility Clinics Surgery Centers Food Service Stem Cell Banks Blood Centers Tissue Banks Medication Storage Transport Warehouse Laboratory Radio Pharmacy Slide 9
Radio Pharmacy Cold cells Refrigerators Freezers Incubators Hot Cells Slide 10
Particle monitoring in Radio Pharmacy Slide 11
Laboratories Cold cells Refrigerators Freezers Incubators Isolators Safety Cabinets LAF Cabinets Slide 12
Pharmacy Aseptic Rooms Grade ABCD LMS-Express LMS-Pharma Slide 13
Pharmacy 1. Same requirements as a commercial Pharmacy 2. Need to comply with GMP 3. Validation lifecycle URS/FS/DS/FAT/IQ/OQ 4. Small systems; typical 5-10 particle counters and various environmental sensors 5. After-sales highly respected (training/calibration/service) Slide 14
Monitoring Particles at 0.5µm and 5.0µm & Bacteria (CFUs) Slide 15
Surgery Room monitoring Slide 16
New EU guidelines emerging 1. Monitoring and storing relevant operational and environmental parameters for 5 years 2. Differential pressure in Surgery rooms and all adjacent rooms. 3. Temperature of incoming HEPA air (downflow) 4. Temperature of outgoing return air 5. Relative humidity of incoming and outgoing air 6. Number of Air changes per hour 7. Door openings and duration 8. Particle counting (airborne contamination) Slide 17
Document references: New EU standard: CEN/TC 156 N 916 (Draft) UK: NHS QA Protocol and HTM03 Netherlands: Surgery Room Control Document Germany: DIN 1946-4: Ventilation and air conditioning; Ventilation in hospitals Switzerland : SWKI 99-3: Heating, ventilation and airconditioning in hospitals Worldwide: Guidelines on Prevention and Control of Hospital Associated Infections.(WHO) Switzerland: Environmental controls in operating theatres Slide 18
Real-time Monitoring Systems Slide 19 19 Lighthouse Worldwide Solutions R3 Nordic
Plenum 2 Plenum 1 68.2ºF pressure Endfilter 66.2ºF 1625m³ 225 Pa Operation Room Volume Air velocity 13 Pa 69.1ºF 61% 0,34m/s OT=OK Doorcounting status Touchscreen 12x Last hour Open 23 sec Particles/M³ CFU/M³ Slide 20
Our Goals Supporting reduction in Hospital Acquired Infections Improve Awareness of Contamination Conditions, or risk, in Real-Time Implement GMP compliant systems that meet the coming regulations Slide 21
Awareness of Contamination Hazards Surgery room staff made aware of contamination hazards in real-time Improves behaviours and promotes self regulation Improves local knowledge and understanding, and reduces facilities related calls Total Environmental Condition of the room is improved during surgery. Slide 22
Who wants this? Who is the User? Head of the Surgery Rooms and all the people working in that department. Infection Control (Microbiologists, Hygienists, etc ) Facilities Management Slide 23
Graphics can look like this Operation Room Plenum 2 66.2ºF 1625m³ Volume Air velocity Plenum 1 68.2ºF pressure Endfilter 225 Pa 13 Pa 69.1ºF 61% 0,34m/s OT=OK Doorcounting status Touchscreen 12x Last hour Open 23 sec Particles/M³ CFU/M³ Slide 24
Or this Slide 25
Microbial contamination Slide 26
Particle concentrations Manual Built in (Real time) Slide 27
Guidelines for Surgery rooms ISO-14644-1: OR Class 1 (ISO-6) Orthopaedic surgery CFU< 10 OR Class 2 (ISO-7) CFU< 200 Other not infection-sensitive surgery OR Class 3 (ISO-8) CFU< 500 Treatment rooms Slide 28
Control Limits for OR s in operation Maximum number of Airborne particles/m 3 Under Plenum Not under Plenum OR Type > 0.5µm > 5.0µm > 0.5µm > 5.0µm Class 1 (ISO-6) 35200 293 352000 2930 Class 2 (ISO-7) 352000 2930 3520000 29300 Class 3 (ISO-8) 3520000 29300 35200000 293000 OR at Rest: allowed limit is 10x lower. This should be tested on a regular basis. Slide 29
Slide 30
Manual particle counting OR measurement at rest: To prove the incoming air is HEPA filtered. OR is in control between the yearly validation. After construction/change in the OR. OR measurement in operation: Collect data to get an overview on the contamination hazards. Knowledge of particle levels at different stages. Slide 31
Wizard for Automatic Report Calculations Report Function will Calculate: # of Samples # of Locations Volume of Air Needed to meet Cleanroom Class Selected Slide 32
Real-time particle counting Remote Particle counters implemented in the return airflow: Worst case measurement (aggregate) Gives an indication if cleaning has been effective Constant view of process control Remote Particle counter implemented under the plenum: To prove the incoming air is HEPA filtered Slide 33
Non-Viable Particles Slide 34
Measurement data patterns and trends Slide 35
Measurement data Alarming over time or by event Slide 36
Microbial risk Slide 37
Easy visual indicators and reference panel All is ok Slide 38
Differences from Building Management Systems Only the important parameters are made visible to the people working in the surgery room. Increased awareness of contamination hazards/risk Continuous improvement opportunities System is validated according to GMP regulations Includes Particle counting Includes Microbial monitoring data Slide 39
Some Considered Objections Why should we spend money if we don t see anything in return. Our infection rates are very low so no issue here. There is no regulation on this so why should we monitor. We have a BMS Slide 40
Some considered answers One post-operative infection costs as much as an average real-time monitoring system, in increased hospital time/resources. Decreases the number of out of action surgery rooms The system gives understanding on the process in order to apply preventive actions/maintenance instead of corrective actions/maintenance. It s compliance we need it!! Slide 41
Future-proofing There will be a regulation in the near future so better to be prepared for it, pioneer instead of chasing others especially if projects or construction activities are in the pipeline GMP way of working for your Hospital Easy to expand to other departments/hospitals Slide 42
Summary Real Time response to alerts leads to cleaner environments. Universal data accessibility leads to increased social controls, and improved behaviours. Improves collaboration from the Surgeon and OR Manager in decisions to hold or proceed with surgeries based on environmental conditions. Historical information can be accessed on specific surgeries in the case of post operative infections Decreases the number of post operative infections IMPROVES PATIENT CARE Slide 43
Without monitoring there is no control!! Slide 44
Thank You Tim Triggs timtriggs@dopsolutions.com Slide 45