Proudly supported by Healthcare HVAC - AIRAH · Part 1 –Classification of air cleanliness by particle concentration ... Airborne Particles and Bacteria New Technology Re-evaluation

Andrew WatsonCentre for Biopharmaceutical Excellence

Cleanroom HVACRight & Wrong

Andrew Watson - CBE

AIRAH - Sydney

20th March 2019

About me…

My career – 25 years covering:• Production• Design• Construction• Consulting• Standards preparation

Committees• Ex-president ISPE Australasian Affiliate• Independent chair – Standards Australia “Controlled Atmospheres”

committee ME-060• Australian recognised expert for ISO TC/209 standards committee.

Participating in WG1, 3, 4, 12, 13 & 14

Topics

• Introduction to Cleanrooms

• Standards and Guidelines

• Getting it right

• Getting it wrongHVAC Focus

Cleanrooms 101

Definition from AS ISO 14644 Part 1:2017

3.1.1 Cleanroom

Room within which the number concentration of airborne particles is controlled and classified, and which is designed, constructed and operated in a manner to control the introduction, generation and retention of particles inside the roomNote 1 to entry: The class of airborne particle concentration is specified.

Where are cleanrooms essential?

Legislated or required by Standards:

• Medicinal Products

• Medical Devices

• Sterile compounded products– Cytotoxic compounds

– Antibiotics, analgesics etc.

• Radiopharmaceuticals

• Autologous preparations

• Sterile Animal Products

Where might they be useful?

No specific legislated or Standards requirements• Operating theatres• Theatre preparation areas• Non-sterile compounded products• PCR work• IVF Clinics• Other laboratory processes• Micro, nano based technologies• FMT?

Key components

Architectural influence• Layout• Internal building fabric• Fixtures and fittings

Mechanical engineering influence• Supply air flow rate• Air flow direction• Room pressure• Temperature & humidity

Installer influence• Quality of work• Control of site• Commissioning

Owner influence• Process• Gowning• Behaviour• Cleaning and sanitation• Monitoring

Important concepts

Air supply rate – unidirectional• Clean air displaces contamination as it is generatedAir supply rate – non-unidirectional• Clean air dilutes contamination as it is generatedAir flow direction• Contamination directed away from critical areasRoom pressures• Primary purpose – keep contamination out• Secondary purpose – keep contamination in (while keeping contamination

out)Particle deposition• Particles <5 micron are easily entrained into moving air and removed from

room• Particles >5 micron settle to the floor, can be entrained back into air by

movement• Microbes typically attach to particles >10 micron

Legislated Standards & Guidelines

For TGA Licensed Manufacturers• PE009-13 (14 soon) – Guide to Good

Manufacturing Practice for Medicinal Products• Annexes also important• ISO 13485 Medical Devices• Also guidelines for biologicals, blood and human

tissue and in-vitro diagnosticsFor Veterinary Products – regulated by APVMA• Australian code of Good Manufacturing Practice

for veterinary chemical products (2007)

Other Industry Specific Guidelines

Compounding Pharmacies (Sterile)• Pharmacy Board of Australia Guidelines on Compounding

Medicines– From 1 February 2018, pharmacists must adhere to principles outlined

in either• the PIC/S Guide to Good Practices for the Preparation of Medicinal Products in

Healthcare Establishments (PE 010), or• the PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PE

009), or• the USP–NF 〈797〉 Pharmaceutical Compounding - Sterile Preparations.

Note: USP 797 is a US guideline• Easiest and cheapest guideline to follow• Cleanroom testing must be performed twice a year• Particle counts performed in operation• Update due out in June

Key Standards – ISO 14644

Part 1 – Classification of air cleanliness by particle concentration

Part 2 – Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration

Part 3 – Test Methods (Update soon)

Part 4 – Design, Construction and Start-Up (Update soon)

Part 5 – Operations (Undergoing revision)

Part 7 – Separative Devices (Up for review)

Referenced in PE009

Other ISO 14644 Standards

Parts 8-15 – Other cleanliness attributes

• Nanoparticles, chemicals, etc

Part 16 – Energy Efficiency

• New standard – in development

Part 17 – Particle Deposition Rate

• Possible new standard

Australian Standards

AS and AS/NZS versions of ISO 14644 Parts 1, 2, 3, 4, 5 & 7

AS 1807 - Cleanrooms, workstations, safety cabinets and pharmaceutical isolators—Methods of test (multiple documents)• Soon to be split into single document for testing of clean air

devices• Cleanrooms to be tested to AS/NZS 14644 Part 3

AS2252 Series• Biological Safety Cabinets, Cytotoxic Drug Safety Cabinets,

Clean Workstations and Pharmaceutical Isolators (Future)• Both equipment and installations

National Association of Testing Authorities, Australia - NATA

• Assesses companies against ISO 17025 -General requirements for the competence of testing and calibration laboratories

• NATA accredits testing laboratories to use particular local and international standards

Getting it right

Fundamentals• Understand what is being performed in the cleanroom

– Processes– Personnel– Surrounding activities– Appropriate standards and guidelines

• Right material selection– “Smooth and impervious”– Resistance to cleaning chemicals– Calibration and maintenance

• Don’t overthink it– Careful with controls– GET ADVICE IF YOU NEED IT

Characteristics of a well-designed cleanroom HVAC system

• Sufficient air supply rate– Take into consideration activities in cleanroom– Have ability to “turn down” at a later date

• Stable characteristics– Supply air rate– Room pressures– Temperature and humidity

• Careful consideration of supply, return and exhaust locations– Air supply location always trumps light locations– Air supply always located above the “clean side” of an airlock– Low level returns far superior to high level– Swirl diffusers good for large open cleanrooms

Construction considerations

• Access to AHU, dampers, prefilters etc MUST be from outside the cleanroom

• All penetrations into cleanroom must be sealed

• When balancing ensure that there is sufficient leakage at a defined location of adjustable area

• Location of air intakes & exhausts important

Being a good corporate citizen

Alarms• If something goes wrong, operators need to know about it,

immediately

Commissioning• Use calibrated equipment• Make sure it is right

– Don’t cherry-pick data– Long term trend is what should be accepted

• Provide documentation swiftly

Post commissioning care• Be prepared for extended troubleshooting, even after

handover

Getting it wrong

Common issues• Outdated or just bad design• Not thinking through consequences• Overly complicated design• Condensation issues• Unstable facilities• Redundant equipment• Testing facilities• Standards and guidelines - challenges

Outdated or bad design

HEPA Filter Selection• Old design

• Provides minimal protection during ceiling cleaning

• Anodized aluminium corrosion risk

AHU Configuration• Secondary filter should be in final stage of AHU

• Essential for low grade, non-HEPA’d cleanrooms

• If upstream of fan, can draw in contaminated

air between filter and fan

Secondary Filter

Primary Filter

Not thinking through consequences

+

++Hole in Duct

Overly complicated design

Building Management System

• Controls

• Interlocks

• Lock-outs

• Auto vs Manual

• Turn down / Turn off

• Energy saving measures

Note:- Pointless trying to control pressure when a door is open

Condensation issues

Liquid water in a cleanroom is a huge problem

• Humidifiers

• High humidity

• Blocked condensate drains

• Poor insulation

• Leaking chilled/heating hot water

Unstable facilities

Parameters such as:• Temperature• Humidity• PressurePressure is the usually the hardest to get right• In-experienced balancing staff• Facility too air-tight• Poorly specified fans• Hidden controls

Redundant equipment

Having redundant equipment available is a good idea

For example – exhaust fan

• When does the swap over occur (9:00am Tuesdays?)

• Does each fan provide identical conditions

• If the fan fails, facility cannot be used anyway –must undergo special clean

Testing facilities

Huge issues with the quality of cleanroom certifiers

• Errors with reports

• Mis-interpretation of standards

• Minimal communication with clients

• Short-cuts

• Fraud

Question – Is NATA certification the only way?

Important test – always missed

Cytotoxic Drug Safety Cabinet (CDSC)• Required test under

AS2252.5• Ensures cabinet exhaust is

completely removed from the room

• Room exhaust removes ~110% of cabinet exhaust

• No-one does this• A critical test for the health

of operators

Standards & Guidelines -challenges

PE009 – Draft Annex 1

• No more certification of cleanrooms using particles ≥5.0µm

• Significant changes and complications

WHO guidelines on surgical site infection

Thanks…

Andrew Watson B.Eng (Chem)

DIRECTOR

16 Acacia Place Abbotsford

Victoria 3067 Australia

+61 [0] 417 364 663

[email protected]

www.cbe-ap.com.au

mailto:[email protected]

http://www.cbe-ap.com.au/

Ken McCarthy, F.AIRAHAirLight Concepts

New Thinking for operating theatre HVAC

Ken McCarthy

AIRAH STG “Infection control and operating theatre HVAC

Infection Prevention and Workplace Safety in Operating Theatres

Airborne Particles and Bacteria

New Technology

Re-evaluation of Existing Standards

Hospital acquired infections affect 10% to 20% of all patients and claim:

- approx 20,000 deaths p.a. in Germany

- approx 30,000 deaths p.a. in UK

- approx 90,000 deaths p.a. in USA

Issues when patients contract an infection whilst in hospital

• Revisionary surgery costs NHS an additional approx 2 to 3 times the original procedure per case.

• Wasted cost and time of original surgery.

• Danger to patient under longer anaesthetic a second time.

• Reduction in theatre capacity and extension of elective waiting lists

• Up to 14 days additional bed recovery time and associated costs

• Trauma and inconvenience to patient.

Hospital Acquired Infections (UK Data)

Approx 60% of the prosthesis-related infections are caused by direct contaminationduring the operative procedures. Bacteria come from the patient’s skin, airbornepathogens, implants, instruments and staff.

Infections occurring in the first three months after surgery are usually caused byvirulent microorganisms such as S. aureus.

Delayed infections (3-24 months after surgery) are in most of the cases caused by lowvirulent microorganisms such as coagulase-negative staphylococci.

Poly-saccharide intercellular adhesin (PIA) produced by staphylococci has beendemonstrated to be a crucial virulent factor that helps staphylococci to form biofilm in implants or orthopedic biomaterials.

Source of Surgical Site Infection (SSI)

36

Nosocomial Infections

37

CFU Particle Size

ISO 14644-1 (Class 5) ISO 14644-1 (Class 7)

Worldwide we differentiate two types of airflow

Unidirectional Airflow Turbulent Mixing Ventilation

(German DIN 1946-4 Class Ib, Dilution Mixing System)- No protected zone- 20-25 ACH - Recovery-Time < 20 min (Particles 100:1 recovery)

Turbulent Mixing Ventilation (ISO 14644-3 Class 7)

(German DIN 1946-4 Class Ib, Dilution Mixing System)- No protected zone- 20-25 ACH- Recovery-Time < 20 min. (Particles 100:1 recovery)

Turbulent Mixing Ventilation (ISO 14644-3 Class 7)

(German DIN 1946-4 Class Ia, Laminar Flow, Low Turbulent Displacement Flow)- Protected Zone System- 300-400 ACH in protected zone, approx. 60 ACH in the room- Recovery-Time < 2 min (Particles 100:1 recovery)

Unidirectional Downward Airflow (ISO 14644-3 class 5)

(German DIN 1946-4 Class Ia, Laminar Flow, Low Turbulent Displacement Flow)- Protected Zone System- 300-400 ACH in protected zone- Recovery-Time < 2 min (Particles 100:1 recovery)

Unidirectional Downward Airflow (ISO 14644-1 class 5)

Size of Protected Zone marked on the floor

Video shows the Unidirectional Downflow (Laminar Flow)… the segregation of the protected zone from the periphery area by preventing entrainment of ambient room air.

Tasks of a Unidirectional Airflow Protection of wound area, instruments and sterile clothed personnel(Size of protected zone: acc. Positioning Analyses, min. 3 x 3 m)

Unidirectional Downward Airflow: How it works

Infection Prevention

45


Study: Turbulent Mixing Ventilation compared with Unidirectional Displacement Flow


Result: “Protected Zone Systems“ (Unidirectional Airflow) reduces the bacterial burden by more than 90 %.

Unidirectional Airflow

Turbulent Mixing Ventilation


Study: Turbulent Mixing Ventilation compared with Unidirectional Displacement Flow

Set-up preparation room/area (for instruments)

German DIN 1946-4: “Rooms/areas where sterile packed instruments are opened, stored, checked and arranged on the trollies must have the same air cleanliness as they have during surgery“



New Technology


Workplace Safety:Health risks for surgeons due to surgical smoke

Surgical Smoke:- Arises from High Frequency (HF) Surgery- Emerging health risks of surgeons due to

increasing numbers of HF-surgeries

Studie:Tjeerd de Boorder et. al. Netherlands

Health risks for surgeons due to surgical smoke. Study Netherlands


Health risks for surgeons due to surgical smoke. Study China


Standard Solution:Smoke evacuation by hose

Note: max. 50 % can be taken in by the hose

Surgical smokeSurgical smoke from HF surgical tools

Harmful gases coming from High Frequency Surgery

The video shows down-flow velocity of 0.25 m/s(based on German DIN 1946/4 Standard).Note: 0.25 m/s cannot protect the surgical team!!!

Surgical smoke from HF surgical tools- Canopy downward air velocity

?

Harmful gases coming from high frequency surgery

The video shows down-flow velocity of 0.35 m/s (based on UK HTM 03-01 Standard).Note: 0.35 m/s can protect the surgical team!!!

What is the right Surgical smoke from HF surgical tools- Canopy downward air velocity

surgical smoke ?

BMS

0,25 – 0,35 m/s (0.82 – 1.15 ft/s)

Air flow management automatically follows the HF device (switch on/off)

Solution 1: Vary downwardair velocity

y increasing of Airflow by HF-Device

Benefit:

• Optimum protection of surgeons against surgical smoke, aerosols,

nanoparticles and other hazardous substances

• No odours due to the connection to the exhaust air (no recirculating air)

• Low noise emission as the fan is outside the operating theatre

Solution 2 : Surgical Smoke Extractionintegrated in a Laminar Flow Canopy

Solution 2 : Surgical Smoke Extractionintegrated in a Laminar Flow Canopy

Benefit:

• Clear view thanks to direct extraction and possibility to work

independently without additional staff

Continuous Particle Monitoring

Monitor CFUsat instrument table

Show the cleanliness

Quality control andrisk management

Benefit:

• Prevention of infection through the continual monitoring of the air quality

• Light-screen display to show the current air quality

• Increasing awareness among the surgical staff and protection of the sterile chain

Benefit:

• Clean air supply automatically adapted to suit requirements

• Quality management possible for every operation thanks to documentation

Diagram of a continuous particle monitoring system

Airflow Stabilizer made of Glass

The longer the glass pane the larger the protected zoneThe longer the glass pane the bigger the risk of collision (equipment, pendants)

Air Curtain System Screenless Solution

Air Curtain System (Instead of Glass)

With Air Curtain System no risk of collision with pendants or equipment

Air Curtain System

Fans inside

Fans inside

Operating Theatre With Latest Technology

UnidirectionalAirflowCanopy

Protected Zone

Continuous ParticleMonitoring

Air CurtainSystem

Benefit:

• Reduced energy consumption• Reduction of the duct profile coming from the air -conditioning unit• Air flow rate adjustment possible independently of air -conditioning

unit and duct system (via CPM) • For retrofitting of existing installations

Diagram of protected zone system with Recirculating Canopy

System with Recirculating Wall-Modules

Benefit:

• Reduced energy consumption• Reduction of the duct profile coming from the air -conditioning unit• For retrofitting of existing installations

System with Recirculating Wall-Modules



New Technology


Laws, Regulations and Standards

NCC / BCA 2016

AS/NZS 1668.2-2012. Cl 5.3

20 air changes per hourOutside air - 10 air changes per hour or 20 L/s /pers @ 5m2/persHEPA filters (AS4260 Type 1 Grade 2 min efficiency 99.99%)Positive air pressure (may need more than 10 AC/H)Return and exhaust grille locations(31 lines including headings)

AUSTRALIAN NATIONAL

Always check latest publications, issues and amendments


NCC / BCA 2016

Queensland Health Capital Infrastructure RequirementsVol 4 Engineering and Infrastructure Section 3: Specifications

AS1668.2, +ve pressure, Min 20 a/ch/hr, G4/F8/HEPA filters, no recirc (internal A/C units),RH 30-60%, T 16-27°C (42°C and controlled RH for burns surgery)Air vel at table 0.2 to 0.3 m/sExtraction for laser, diathermy (HF) tools (+ warning light)Fan systems 24/7 in pressurised roomsUltra Clean Systems < 0.5 CFU/m3

Downflow 0.3 m/s at tableCrossflow 0.4 m/s at 1m from outlet

QUEENSLAND


NCC / BCA 2016NSW Health Engineering Services Guidelines 2016

Health Infrastructure form the view that irrespective of the nature of operating theatres, there is no need for the use of UCV systems (fully suited theatre staff)

Airflow into the operating theatre will be by means of a distribution system that provides a flow of clean supply air over the operating area first then away. Entry of air will be from the ceiling to deliver a downward air movement with a minimum velocity 0.2 m/s at the level of the operating table (0.3 m/s max).

NSW


NCC / BCA 2016

Victoria Health Design guidelines for hospitals and day procedure centres Part E – Building services and environmental design

AS 1668.2, min 20 a/ch/hr, 50% outside airAirflow into the operating theatre will be by means of a distribution system that provides a flow of clean supply air over the operating area first then away. Entryof air will be from the ceiling to deliver a downward air movement with a minimum velocity 0.2 m/s (Cl 6.77.00), minimum velocity 0.3 m/s (Cl 6.84.00) at the level of the operating table. Crossflow minimum 0.4 m/s at 1m from outlet

VICTORIA


NCC / BCA 2016

WA Department of Health Building Guidelines – Engineering Services

14.0 AS/NZS 1668.1, AS/NZS 1668.2HB 260 – Hospital acquired infections

– Engineering down the riskFilters, 1800x1800 ”ultra clean zone”Velocity 0.15 – 0.2 m/s at table. 20 a-ch/hr, 50% OAPositive pressure, H&L level exhaust, OA purgeLaser surgery, OR setup room

WESTERN AUSTRALIA


NCC / BCA 2016

SA Health Clinical Services Capability Framework – Surgical Services

(New regulations being prepared)

SOUTH AUSTRALIA


NCC / BCA 2016

Health Services Establishment Code 2012

TASMANIA


GERMANY - DIN 1946-4 (new 2018) (about 73 pages)

USA - ASHRAE 170-2017

UK - HTM 03-01

INTERNATIONAL

AUSTRALIA

AIRAH STG – Design guide – national acceptance - Standard

Ken McCarthy

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Proudly supported by Healthcare HVAC - AIRAH · Part 1 –Classification of air cleanliness by particle concentration ... Airborne Particles and Bacteria New Technology Re-evaluation