a brief guide to pc - cockramcockram.com/wp-content/uploads/pc-book-july-2012.pdf5 physical...
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A brief guide to PC labs
www.cockram.com
Second edition: 2012
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2 PC3 Laboratory, School of Veterinary Science, James Cook University. Completed in 2010 by Cockram Construction.
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Cockram’s reputation for delivering facilities of the highest standards in construction and technical excellence is well deserved. Due to our proven expertise in the areas of laboratory and bio‐pharmaceutical facilities, in the fields of clean room design, construction, commissioning and validation, we have seen our operations expand globally as a result of client demand from around the world. Cockram’s team includes construction and technical professionals who have considerable experience in the delivery of Physical Containment laboratories (PC Laboratories). This guide has been prepared to share some insights into the requirements for the design, construction and testing of physical containment laboratories. This is not an exhaustive technical resource for PC laboratory design, construction and testing. It is simply to provide a useful resource within Cockram and also externally, to industry professionals who are directly involved in the design, delivery and ongoing management of this type of facility.
We hope that you find this guide to be of value as you plan for your next PC laboratory project, and we encourage you to contact Cockram Construction directly if we can be of assistance to you in the planning, design, construction and facility delivery processes.
Mal Batten Managing Director
Cockram Construction [email protected]
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What is ‘PC’ (physical containment)?
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Physical containment or ‘PC’ is a reference in the Aus‐tralian/New Zealand Standards (AS/NZS 2243.3: 2010—Safety in laboratories ‐ microbiological safety and containment) to the level of risk associated with microbiological work. This recognises four levels of physical containment. They are: PC 1: Practices & equipment appropriate for student and
undergraduate teaching laboratories Risk Group 1 as per the Standard Work that may be carried out on an open bench Organisms not known to cause disease in healthy
adults PC 2: Practices & equipment applicable for clinical, diag‐
nostic, industrial, teaching, and related purposes Risk Group 2 as per the Standard Work is with micro organisms which may be pre‐
sent in the community Micro organisms which may be associated with
animal, plant or human disease of moderate sever‐ity
Work which may be carried out on an open bench with good microbiological technique
If there is significant risk from aerosols, a biological safety cabinet shall be used
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PC 3: Practices & equipment applicable for clinical and
diagnostic work, includes indigenous or exotic micro organisms
Risk Group 3 as per the Standard Risk of serious infection to humans, animals and
plants Safeguards such as airlocks, door seals, security,
decontamination, pressure steam sterilisation, waste treatment, alarms & additional communica‐tion systems
PC 4: Practices & equipment applicable for dangerous
micro organisms posing a high individual risk of life‐threatening disease
Risk Group 4 as per the standard Life‐threatening diseases that may be spread to
the community Isolated from other laboratories Clothing change and shower rooms contiguous to
ventilation system Liquid waste decontamination required Work completed using a Class III biosafety cabinet
(exhausts venting outside the laboratory) or fully encapsulated positive pressure suits
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Level PC1 PC2 PC3 PC4
Risk within the facility
Low Low to moderate
High High
Risk outside the facility (to broader com‐munity)
Low Limited with low risk of spread
Limited Readily spread
Example Non pathogenic bacteria
Hepatitis, salmonella
SARS, Yellow fever.
Hendra virus, Ebola virus
Summary table of PC laboratory risk gradings
PC4 laboratory, Victorian Infectious Diseases Research Laboratory, by Cockram Construction.
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Design and regulatory authorities
Fully welded stainless steel exhaust ducts with carbon filtration, installed by Cockram. Complex, intense negative pressure systems such as this are typical of many PC4 or high end PC3 projects.
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The standards required of PC laboratories are rigorous, and post construction certification of the facility may not be achieved if sufficient steps aren’t taken during the design and construction phases to identify the requirements for certification. In our experience, the following provides a useful checklist for client teams when preparing to deliver a new PC laboratory: 1. Engage experienced architectural and
engineering teams, suited to the scale and complexity of the project
2. Consult early with the Australian Quarantine & Inspection Service (AQIS) (where applicable)
3. Consult early with the Office of the Gene Technology Regulator (OGTR)
4. Understand ALL of the applicable standards, and any foreshadowed changes
5. Correct classification within each QC or PC level is essential
6. Mechanical and electrical specifications will vary on interpretation
7. Be aware of latest equipment options
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Construction techniques
Vinyl floors are laid to avoid sharp angles and recesses where contaminants can be trapped and floors are sealed to walls to minimise any leakage.
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This brief summary of construction techniques critical for the correct delivery and certification of PC labs is not intended as an exhaustive checklist. Rather, it is intended to give readers an insight into some of the design and construction features of PC labs that deserve close attention. It is also important to understand that PC3 and PC4 laboratories must be physically separated from other areas and that specific signage is required for PC laboratories. Walls & Ceilings There are generally three types of material used: Insulated Panel Multi‐layered plasterboard Masonry Cockram typically prefer to work with insulated panels because they can be sealed more efficiently than alternative materials. Extra precautions are required if working with plasterboard or masonry.
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Above and below. Prior to installing walls, base channels should be thoroughly coated with polyurethane sealant.
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Above and below. Pictured are samples used on the University of Auckland PC3 laboratory project by Cockram. The images illustrate the panels, joints and sealing techniques which were used in lieu of the original plasterboard design.
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Doors and windows For PC labs, all doors and windows are generally of stainless steel construction. They are typically provided by a specialist manufacturer and are designed and manufactured to suit the particular level of PC laboratory they are intended for. Doors and windows are generally interlocked and alarmed. Higher grade PC labs (PC3 and PC4) require very high standards of lab entry doors and door sealing systems (such as pneumatic seals).
Air lock doors to PC3 laboratory completed by Cockram in 2010.
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Above: A pass through de‐contamination unit fitted in a PC3 area requires a sophisti‐cated barrier seal. Left: Air lock doors, such as this one installed at Auckland Univer‐sity by Cockram, are highly complex installations which require particular care and specialist expertise.
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Access to PC labs is typically controlled via push button controls (above) or electronic swipe cards which restrict unauthorised access. Windows (below) are sealed and doors are alarmed to alert for any falls in pressure which may affect the containment capabilities of the laboratory.
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Joinery Joinery for PC labs must be designed with ease of cleaning and hygiene standards top of mind. Joinery should be smooth and impervious to moisture, chemicals or cleaning agents. Bench tops must not have open seams. Joinery should not contain any enclosed spaces or voids where fumigants or contaminants may be trapped.
Joinery must be designed with ease of cleanliness foremost in mind. PC labs will also contain a variety of specialised equipment and laboratory users are trained in maintaining both equipment and surfaces etc to high standards of cleanliness.
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Mechanical systems PC laboratories require a constant negative internal pressure relative to external air pressure. This is needed to maintain the containment of the laboratory’s micro organisms (to prevent escape). This constant negative pressure reflects on the design of all mechanical systems where there is a penetration from outside to inside the laboratory. PC2 laboratories have no mandated minimum inward airflow pressure differential. PC3 and PC4 laboratories require a minimum of 50 Pascals and 25 Pascals between adjoining rooms of the facility (a pressure cascade). The use of bubble style dampers are required in PC3 and PC4 facilities. All ductwork must be pressure tested using a duct work integrity test (pressurised to 1,000 Pa with zero leakage over three minutes between the lab room and the HEPA filter canisters for PC3 and PC4 labs).
Fully welded stainless steel construction is often a require‐ment of PC lab mechanical ser‐vices.
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PC labs also require dedicated vacuum systems and no recirculation of air is allowed to non containment areas. Stand alone HVAC systems are usually used. HEPA filter boxes need to be pressure tested with a zero leakage requirement and have the ability to withstand a pressure of 2,500 Pa. Air movement within the PC area should be from the cleanest to the potentially more contaminated areas.
250 micron screens fitted to PC laboratory exhaust (left) and air supply (right).
Alarms and monitoring systems are required to maintain vigilance over the control of negative pressures of PC laboratory environments.
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In summary, typical mechanical systems requirements of PC laboratories include: HEPA filtration Interlocked air supply and exhaust to ensure
inward flow Fully welded stainless steel construction 100% exhaust to atmosphere Fumigation regimes Labs should also feature audible alarm systems and pressure displays so that the negative pressure status is constantly monitored.
Welded stainless steel ductwork.
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Hydraulic systems Hydraulic systems within PC laboratories should be designed with the following in mind: Hands‐free operation at washing stations Safety showers – no floor waste Back‐flow prevention (use of R.P.Z. devices) Fully sealed/welded trade waste pipe systems and
double containment pipe systems Approved waste regime Waste removal is performed frequently via a sealed container.
Part of the waste decontamination system for a PC3 Lab completed by Cockram in 2010.
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Above: Waste treatment via a sealed container. Below: HEPA filter boxes installed in a plant room adjacent to a PC3 laboratory.
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23 Complex electrical services are a feature of PC lab design.
Electrical systems Electrical systems design for PC labs, as with hydraulic systems, should provide for the following: Back‐up power for the ventilation system. This is
strongly recommended Back‐up power for Biological Safety Cabinets
(BSCs) Ducted systems Warning systems – designed for both occupants
and equipment. Penetrations associated with electrical systems should be minimal, sealed and have a single point of entry for each cable.
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24 User safety is a constant and paramount concern.
Laboratory equipment PC laboratories feature advanced biological equipment and every laboratory will feature different equipment depending on the nature of its use. Biological safety to lab users is the one constant irrespective of lab equipment. As a general rule: Autoclaves must be fitted with bioseals in PC3 and PC4 laboratories For PC4 labs, protective suits with air breathing systems and/or isolators are required Positioning of BSC’s should bear in mind supply and return air locations Provision should be made for automatic shutdown of sterilizers Identify equipment requiring back‐up power—freezers, ovens, etc
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Penetrations and seals
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The greatest challenge with wall, floor or ceiling penetrations in a physical containment environment is obvious: every penetration increases the risk of an air leak. PC3 and PC4 labs cannot have air leaks greater than 2 litres per second. Trying to find a leak and rectify it post construction can be arduous and expensive. This means that every penetration of every type— electrical, hydraulic, mechanical, fire services etc—must be fully sealed. It is advisable that penetrations through surfaces are cut as close as possible to the services to be installed so that less caulking is required. It is also advisable to investigate all approaches that potentially remove or eliminate penetrations. Screwed ceiling light fixtures, for example, are in our experience often specified in drawings but alternatives that eliminate the risk of air leaks through screw holes are available and are preferable.
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The goal of a fully sealed laboratory is why penetrations are kept to a minimum and where required, careful attention is paid to sealing these penetrations.
The room pressure test for air leaks in PC3 & PC4 laboratories is 200 Pascals with an allowable leakage of 120 litres per minute. The approach in summary is therefore two fold: 1. Minimise penetrations wherever possible.
2. Pay close attention to detail for any required penetrations.
The examples illustrated on the following pages are generally those associated with PC3 laboratory environments but serve to highlight a variety of approaches and construction techniques suited to the standards required generally of physical containment laboratories.
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Above: A typical penetration sleeve for hydraulic services. Below: Thoroughly coat both sides of the wall with polyurethane sealant prior to installing the stainless steel sleeve.
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Above and left: Care should be taken with penetrations associated with gases and compressed air. Below: Even simple installations like lab coat hooks should avoid any penetrations created by screws and instead form part of solid plates which are fixed to walls with poly‐urethane sealant and double sided tape.
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Above: Electrical and communication systems must also take into account the importance of sealing the penetration into the PC labo‐ratory. Below left: Penetrations details for hydraulic services. Below right: typical penetration sleeve.
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Above: Laboratory gas valves and regulators. Note the sophisti‐cated nature of the fitting which involves zero wall penetrations. Below: Fumigation port detail for a PC3 Laboratory. Ports are sand‐wiched between sealed stainless steel plates either side of the wall.
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Avoiding mistakes
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With physical containment laboratories, the most obvious and most concerning error can be if the lab does not hold pressure within the room pressure test‐ing acceptance criteria stipulated by the regulator. This can result from design or delivery errors, the wrong choice of components or the use of subcon‐tractors or suppliers who are not closely supervised by experienced containment laboratory builders. It can be very difficult, if not impossible to locate— let alone repair—a leak if a lab does not hold pressure within the acceptable parameters (the permissible leakage cannot exceed 2 litres per second at a room pressure of 200pa). In fact, Cockram have in the past been called onto projects where other contractors have not succeeded with sealing and certification standards, meaning the client was required to rebuild new containment labs using the correct construction techniques.
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We believe we have built more PC labs in Australia than any other builder. Our checklist of things to watch for to avoid mistakes is based on experience and includes the following: Choose an architect/design team who have
successfully detailed physical containment laboratories
Choose a builder who has experience in the successful delivery of a physical containment lab facility
Select services contractors and other contrac‐tors involved with the laboratory envelope who have previously worked on PC facilities
Become as knowledgeable as you can about commissioning and what is involved
Ask a lot of seemingly self evident questions Be prepared to show your ignorance Think in first principles about what the sys‐
tems are needing to achieve Ensure all contractors are specifically inducted
into the works and the nature of the PC re‐quirements
Always focus on detail, detail, detail.
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Contact the leadership team
Darren Milne Operations Manager Australia 0418 101 181 [email protected] Michael Read New South Wales State Manager 0400 013 458 [email protected] Chris Meade Queensland State Manager 0439 037 017 [email protected] Michael Clemenger Victorian State Manager 0407 535 672 [email protected] Greg Mithen WA State Manager—Esslemont Cockram 0417 644 647 [email protected]
If you need some advice or have some further ques‐tions, please don’t hesitate to contact the following people.
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Completed early 2012, the $43 million Elizabeth Macarthur Agricultural Biosecurity (EMAI) Upgrade Project designed by S2F for NSW Public Works (Department of Finance and Services) is of significant importance to Australia as a first line of defence to a catastrophic disease such as an outbreak of foot and mouth disease. The project features two new buildings with 1,625 sqm of Physical Containment (PC) or Quarantine Containment (QC) standards PC2/QC2 laboratories, and 775 sqm of PC3/QC3 laboratories, plus the upgrade of existing infrastructure and trade waste treatment and disposal system, as well as the refurbishment of six (6) existing laboratory buildings totalling 600sqm to either PC2 or QC2 standard.
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Selection of PC laboratories by Cockram
PC4. Victorian Infectious Dis‐eases Research Laboratory. Western Health Care Network. $4.4million. 1998.
PC3. Goddard Building TERN & Insectary, University of Queen‐sland. $1.7 million. 2010.
PC3. Faculty of Medicine and Health Science, University of Auckland, NZ. $2.3 million.
PC3 & PC2. Illawarra Health and Medical Research Institute, Wollongong. $22 million. 2010.
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PC2. Monash Health Research Precinct. $14.8 million. 2005.
PC3. Institute of Health & Bio‐medical Innovation. QUT. $813,000. 2010.
PC3. School of Veterinary Sci‐ence. JCU Townsville. $955,000. 2010.
PC3 & PC2; QC3 & QC2. Eliza‐beth Macarthur Agricultural Institute, Biosecurity Upgrade, NSW. $43 million. 2012.
PC3 & PC2. SmithKline Beecham Biologicals, Shang‐hai, China.
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PC2. Monash University STRIP. $70.7million. 2009.
PC2. Deakin University Shared Laboratories. $11.3 million. 2010.
PC2. CSL Building 4 HVB – R&D Refurbishment. $6.9 million. 2009.
PC2. Cancer Biology Imaging Facility, Institute for Molecular Bioscience University of Queensland. $545,000. 2009.
PC2. Blacktown Clinical School, Education and Research Cen‐tre. $16 million. 2011.
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PC2. Victorian Agribiosciences Centre. $16.5 million. 2005.
PC2 + Class 100 & Class 10,000. Melbourne Centre for Nanofabrication. $13.5 million.
PC2 + Cyclotron. Centre for Advanced Imaging, University of Queensland. $32.5 million. 2012.
PC2. Australian Red Cross Blood Service—Melbourne Processing Centre. $57.1 mil‐lion. 2011.
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Melbourne Office Ground Floor 675 Victoria Street Abbotsford, Vic 3067 Tel: +61 3 8862 8888 Fax: +61 3 8862 8900 Sydney Office Level 2, 500 Pacific Highway St Leonards NSW 2065 Tel: +61 2 9818 6099 Fax: +61 2 9818 6155 Brisbane Office Unit 2, William Jolly Place 309 North Quay BRISBANE QLD 4000 Tel: 07 3229 0288 Fax: 07 3229 5827 Perth Office 57 McCoy Street Myaree WA 6154 Tel: +61 8 9330 2344 Shanghai Office Suite 14E, Hua Min Empire Plaza, No. 728 Yan An (West) Road, Shanghai, 200050, People’s Republic of China Tel: +86 21 5238 3666 Fax: +86 21 5239 7318 Tianjin Office A3‐705, TEDA New Skyline, No. 12 Nanhai Road, Tianjin, 300457, People’s Republic of China Tel: +86 22 6628 3452/53 Fax: +86 22 6628 3451
Suzhou Office Room 1216, Genway Building, No. 188 Wangdun Road, Suzhou Industrial Park, Suzhou, 215123, People’s Republic of China Tel: +86 512 6660 7400 Fax: +86 512 6660 7401 Guangzhou Office Room 2112, China Shine Plaza, No. 9 Linhe (West) Road, Guangzhou, 510610, People’s Republic of China Tel: +86 20 3801 0245/46 Fax: +86 20 8527 0717 India India Private Limited Level 4, Dynasty Business Park, Andheri – Kural Road. Andheri (East) Mumbai – 400 059 Telephone: +91 22 4030 9118 Kalamazoo ‐ Michigan 8175 Creekside Drive Suite 260, Portage, MI 49024 Tel: +269 321 5068 Fax: +269 321 5069 Puerto Rico Office Metro Office Park Street 1, Building 11, Suite 106 Guaynabo PR 00968 ‐ 1705 Tel: +1 787 273 2277 Fax: +1 787 273 2279
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42 Australian Red Cross Blood Service, Melbourne Processing Centre, completed in 2011 by Cockram Construction. The ARCBS facility included extensive PC laboratory areas.
www.cockram.com