Newsletter Issue 01 June 2013

Transcription

1 Newsletter Issue 01 June 2013 this issue facility leakage new aquatic Standard from our regulators SSBAs Welcome Hello and welcome to the first issue of the ABSANZ newsletter. The editorial committee hopes that you will find it a valuable industry resource and a valuable communication tool. This first issue is experimental and we welcome feedback from our members as to what you would like to see in the publication, what you think of the format and if you find the content appropriate. In this issue we focus on changes that have occurred within the standards as well as the activities of two of our key regulators DAFF and OGTR. There is also a feature article on pressure testing of high level containment facilities from Dr Gordon McGurk and a basic guide to SSBA compliance and requirements. Next issue we will be presenting a feature article on gaseous facility decontamination to attempt to demystify the process, give an unbiased overview of each technology and describe the limitations and the benefits of each technology and technique. I hope you enjoy the publication and remember your feedback is important to us - please let us know what you would like to see. Stephen Coulter (Editorial Committee Chair) the pressure myth next issue gaseous decontamination and fumigation explained

2 Air-tightness testing of high level containment facilities: regulatory necessity or simply nice to know? Gordon McGurk Ph.D. This article is a summary of a presentation from the 2012 ABSANZ conference The majority of guidelines and standards that are applicable to the construction or design of biocontainment facilities in Australia contain either guidance on, or relate to, a requirement around the air-tightness of the facility. However, given the way in which high-level containment facilities operate, by maintaining the facility at negative pressure, the rationale for this requirement is uncertain. Does it relate to containment of micro-organisms, or is it more about the ability to decontaminate the facility following the use of the microorganisms without jeopardising the health and safety of personnel outside the facility? From a regulatory perspective, there was a lack of airtightness information available with respect to facilities currently in operation. Therefore, in order to address the information gap regarding the air-tightness of PC3 biocontainment facilities, and perhaps provide evidence to support any relevant regulatory change, a project to quantify the structural and seal integrity of laboratory and small animal PC3 containment facilities by means of an air-tightness test was conducted. Air-tightness was measured by calculating the amount of air leaking from the facility when pressurised to a positive pressure of 200Pa over a 20 minute period. Of the 20 facilities tested 10 had an air-leakage rate which was within or better than the range (120 L/min L/min.) advised for PC3 level containment facilities in Part 3 of the Australian and New Zealand Standard for Safety in Laboratories (AS/NZS [2010]). A further 8 facilities had an air-leakage rate of approximately 1400 L/min. or more. The remaining two facilities were unable to be measured due to structural issues. The results of this testing indicated that the air-tightness of facilities varies due to the combination of a number of factors including age of the facility, construction method, and number of penetrations through the containment barrier. In general, air-tightness decreased with the increasing age of the facility, with the most recently constructed facilities having air-leakage rates of <100L/min. However, the method used in facility construction also appears to have a significant effect on the long term seal durability of the facility. This was particularly noticeable in that those facilities constructed of single gyprock sheets did not retain structural integrity for more than 5 years, whereas those facilities constructed of double overlapping gyprock sheets were more resilient and had excellent structural integrity characteristics, matching those of newer materials such as sandwich panel. A more prosaic discussion concerns the relationship between air-tightness, escape of micro-organisms and the protection of human health and safety. To cut a long story short, there is a tenuous relationship between facility air-tightness and the ability of micro-organisms to cross the containment barrier under normal operating conditions (-50Pa), especially if they are being manipulated in a Biological Safety Cabinet (BSC). Indeed, even if the whole facility was to have an exhaust fan failure such that the facility was under positive pressure, the use of a BSC would mitigate much of the risk. This would not of course be the case in large animal facilities where the barrier was the primary containment. Thus, air-tightness may be more important in the protection of human health and safety during the decontamination process. During decontamination, gaseous particles can move across a facility barrier, though this is dependent on the air-tightness. The results from this experiment seem to demonstrate two things: firstly, that high level containment facilities need not be over-engineered, and certainly not from expensive materials; secondly, that air-tightness can be used as a measure of structural integrity of the facility and as a measure of deterioration of the facility over a period in which joints are constantly subjected to the forces of negative pressure. It may be that structural integrity is an aspect that regulators are or should be concerned about, especially when the room forms the primary containment barrier. However, the relevance of air-tightness to containment continues to be the subject of debate in the biocontainment community. Disclaimer: The above article represents the views of the author and not the organisation with which he is associated.

3 Considering Becoming a Member? Membership details Individual - annual fee of $110 incl. GST per Member Corporate - $495 incl. GST for the first 5 Members and $420 incl. GST per additional 5 Members. For Corporate Membership, individual names and contact details must be supplied. The Member names can each be changed once during the membership year. Renewal: Membership is for one year, beginning 1 February. Who are our members? Currently we have over 200 members: Architects Engineers Microbiologists Scientists Facility owners Facility operators Maintenance Managers and staff Regulators Consultants Suppliers Inspectors What are the benefits of becoming a member? Receive regular industry updates Access to Members Only section of website, which includes educational materials, discussion papers and useful website links Discounts on conferences, training and workshops run by the Association Exclusive opportunities to provide conference and workshop materials at ABSANZ run events Access to LinkedIn Group, providing a secure chat space to access and share expertise, network with other biosafety professionals and keep abreast of developments in biosafety Receive news of significant changes and events affecting biosafety Voting rights to elect ABSANZ key members, President, Vice President, Secretary and Treasurer Input into the development of ABSANZ Strategic Plan Join Standing Committees; and Ability to influence the direction and future of biosafety in Australia and New Zealand What are Security Sensitive Biological Agents, and who is DoHA? Stephen Coulter stephen.coulter@amec.com SSBAs are biological agents and toxins that have been determined to be a potential bioterrorist risk. This list and the legislation is covered in the National Health Security Act 2007 that is administered by the Department of Health and Ageing (DoHA). SSBA agents are divided into two groups, which are determined as Tier 1 and Tier 2 by the Minister of Health. Tier 1 agents are considered the highest Biosecurity risk. Tier 2 agents are agents that pose a moderate biosecurity risk and are subject to proportionally moderate regulatory requirements. Those facilities holding either Tier 1 or Tier 2 agents are required to register with DoHA. Those laboratories are required to comply with the SSBA Regulations and with the SSBA Standards, which are a management tool. As a result it requires SSBAs to be managed safely and securely, with regular reports to DoHA. Because the SSBA Standards is a management standard that depends on risk assessments and management policies to attain the outcomes of the Act, there is some concern expressed by designers, facility owners and inspectors that the requirements for buildings are not spelt out in detail but

4 offers the possibility of various options to achieve these outcomes. In essence the premise of SSBA agent protection is twofold: One: Keep the SSBAs secure (including all documentation relating to the products), know who has accessed them (samples and documentation) and when Two: Provide levels of active and passive protection built into the facilities to ensure unauthorized access is either eliminated or delayed sufficiently for law enforcement agencies to attend. The second item represents the biggest challenge, because designers and facility owners must consider many factors, including: prevention of coerced tailgating (preventing registered staff being forced under duress to access areas), prevention of multiple entry under one access control (intentional or unintentional internal tailgating) access protection including securing ceiling spaces, securing mechanical ducts that are large enough to crawl through, securing windows and walls that would ordinarily not represent a challenge to unauthorized malicious access. What if I am a diagnostic laboratory? Unless you know that you will be routinely encountering known SSBAs there is generally no expectation that the facility needs to comply with the requirements of the National Health Security Act. However you must have procedures in place such that if a sample is found to be SSBA positive you know how you are going to handle it from that point forward. The laboratory must notify DoHA and either destroy, ship to an appropriate registered laboratory or become a registered laboratory. The first item can be addressed relatively simply using conventional tracking devices such as registers, logs, electronic access control (ingress and egress), and security cameras. It is important that all laboratory plans are discussed with the authorities in the planning phases to ensure any requirements can be met should the need arise. Current standards, templates, guidelines and check sheets are available at the DoHA SSBA website. ( The ABSANZ Professional Development Standing Committee (PDSC) has been busy in 2013 Joanna Gray Joanna.gray@rcpaqap.com.au The committee is working to establish the training biosafety requirements of current and future Australian and New Zealand members whilst keeping a keen interest in the activities of international organisations such as the International Federation of Biosafety Associations (IFBA). To date the Committee has: reviewed 2012 Conference Feedback produced a Charter to establish the direction of the committee developed a Training Model conducted an assessment of training synergies and opportunities, in particular the IFBA group who are working on training competencies and examination schedules, reviewed the content with plans to adopt a Principles and Practices document that outlines potential module offerings agreed to assess who will receive the Neil Walls Consulting Scholarship in 2013 commenced preparations for the ABSANZ Conference in Auckland, 2013 We will continue to provide ABSANZ members with PDSC updates in ongoing Newsletters.

5 Conference 2013 Dates: 29 October November 2013 Cost: Early bird registration (prior to 13 September 2013) $860 AUD (members) / $970 (non members), $1060 / $1170 Location: The Heritage Auckland New Zealand Preliminary Program Link: A preliminary Program is available on the ABSANZ website The Neil Walls Consulting Pty Ltd ABSANZ Scholarship for attendance at the 2013 ABSANZ conference in Auckland, New Zealand Board member and foundation supporter of ABSANZ Mr Neil Walls has generously offered to provide a scholarship for an individual to attend the 2013 ABSANZ conference in Auckland New Zealand. Submissions are to be made in accordance with the criteria listed below and the final recipient decision will be made by the Professional Development Standing Committee (PDSC). Good luck to all prospective applicants and thanks to Neil for his generosity in supporting both the industry and the growth of our association. Purpose: To support an employee of a Not for Profit Research Organisation who would otherwise be unable to attend the conference for cost reasons. Terms: The successful applicant will receive up to AUD$2,200 towards travel, accommodation and conference registration. Receipts totalling up to AUD$2,200 are to be provided to ABSANZ within four weeks of the conference concluding. These expenses will then be refunded. The successful applicant will be asked to prepare either a poster or a short 10 minute presentation at the conference. Applying: Applications should be in writing, no longer than one A4 page in length, stating the organisation, position and work/duties of the applicant and the reason for applying for the scholarship to attend the conference and ed to admin@absanz.org.au by 1 July The successful applicant will be advised in writing by Thursday 1st August No discussion will be permitted between applicants and ABSANZ Professional Development Standing Committee concerning the scholarship. Subject to mutual agreement, the successful applicant will also be announced on the ABSANZ web site. Cancellation: If, for some reason, the successful applicant is unable to accept the scholarship or is unable to attend the conference, ABSANZ should be notified immediately. The ABSANZ Professional Development Standing Committee will attempt to offer the scholarship to an alternative applicant if time permits. Notification: The successful applicant will be determined by the ABSANZ Professional Development Standing Committee. The decision will take into account the nature of the work being carried out by the applicant and the reason for the application as stated by the applicant.

6 A new aquatic containment standard for Australia and New Zealand? Neil Walls The current 6 th edition of AS/NZS 2243 part 3: 2010 Safety in laboratories, part 3: Microbiological safety and containment was published on 17 September The committee responsible for this is known as Joint Technical Committee CH-026. It should be noted that this information is still very much a draft and that it does not constitute a formal Standards Australia Limited draft release. There will be further opportunity for comment from stakeholders should a formal Standards Australia release become a reality. Support for progressing the document to a formal draft stage requires us to make a formal Project Proposal submission to Standards Australia. In this edition, the requirements for animal, plant and invertebrate containment facilities were revised to make them independent of the requirements for laboratories. During its development, the committee noted the absence of aquatic facilities in these revisions. This is referred to by a note in the preface. It was considered too late to develop these prior to the release of edition 6 as this could have resulted in an unacceptable delay. Neil Walls, as a representative of this committee, agreed to develop a first step draft aquatic standard for circulation and review. This early draft was completed on 03 May 2012 and circulated for comment amongst a small number of specialist aquatic facility professionals. Comments from this initial circulation were incorporated and the draft has now been updated to a point where wider circulation and invitation for comment is appropriate. It is currently posted on the ABSANZ web site, and is also available from Neil s web site, This is an open invitation for any of our readership to download the document and provide critical comment. In order for this to gain traction, our ABSANZ readership is encouraged to provide comments and/or supporting statements to acknowledge the importance of such an inclusion into AS/NZS Any comments are welcome, and should be titled A new aquatic containment standard for Australia and New Zealand They may be sent to ABSANZ admin@absanz.org.au or to Neil Walls directly neil@nwalls.com. Please assist ABSANZ to make this a success.

7 From Our Regulators OGTR Issue of Revised PC2 Facility Guidelines On 1 March 2013, the Gene Technology Regulator issued revised Guidelines for the Certification of PC2 Laboratories, and Animal, Aquatic, Plant and Invertebrate Facilities. Copies of these guidelines are available on the OGTR website at: / DAFF Review of Biosecurity Containment Criteria Jeff Cates Jeff.cates@daff.gov.au More than 1200 Quarantine Approved Premises (QAPs) across Australia are required to conform to an array of construction, quality and risk management criteria in order to be approved by the Department of Agriculture Fisheries and Forestry (DAFF) to contain and handle specific biosecurity risk materials. These materials include biological products, soil, animals, plants and animal and plant products. Most of these facilities are analytical and research laboratories, but there are also a number of premises such as insectaries, live animal operations and plant handling facilities. QAP containment criteria were last reviewed in Since that time Standards Australia have developed new editions of Australian New Zealand standards (AS/NZS) incorporating expanded structural and procedural requirements for laboratories and containment facilities. DAFF is currently undertaking a review of QAP containment criteria with a view to aligning criteria to the AS/NZSs as much as possible. The review will focus on: 1. Harmonising requirements with the AS/NZS for physical containment. The relevant Standards are: AS/NZS 2982:2010 (Laboratory design and construction) and AS/NZS :2010 (Safety in laboratories, Microbiological safety and containment). 2. Streamlining criteria and where possible removing requirements which do not directly affect containment. 3. Potential audit efficiencies through harmonisation and alignment of DAFF and related agency audits with business operations. As part of this review DAFF will be engaging with relevant QAP operators and industry stakeholders to ensure the alignment of the standards impose a minimal burden on industry while maintaining biosecurity integrity. The draft containment criteria will be forwarded to all relevant QAP operators for comment and will be published on the DAFF website. ABSANZ members will also be invited to comment. Information on the draft criteria and consultation period will be provided in future ABSANZ newsletters.

8 The pressure myth Stephen Coulter QC3 and PC3 facilities require (by code) to be at least 50Pa below adjacent spaces to maintain containment. 50Pa in itself is not considered much pressure sucking water up 10cm long straw for example requires almost 1000Pa of strength something most of us can do with not too much trouble. However, the stress that 50Pa puts on a facility is not to be underestimated. Consider a small laboratory say 10m x 7m a ceiling area of 70m 2. The effect of 50 Pa across 70m 2 equates to an equivalent force of 3500 Newtons or 360kg exerted on the ceiling. Hardwired interlocks are often set at 200Pa which can balloon the force out to a massive 1500kg. This is why it is vital that emergency independent pressure controls are installed to ensure that facility pressures are not exceeded in the event of a controller failure or some other cause. The other added stress on the facility is caused by people opening and closing doors which leads to the pressure within the facility fluctuating. So while 50Pa may not seem like a high pressure the stress that it puts on our containment facilities is not to be underestimated. Want a bigger role? The Editorial committee is a small group of dedicated industry savvy individuals who would really appreciate additional support from the ABSANZ members. If you have a desire to contribute articles or have a series of topics that you would like to see us research and publish information on please let us know - we welcome all input. We would also welcome members who would be interested in becoming part of the editorial committee to not only share the duties but to provide a greater diversity in views and opinions on ABSANZ printed material. Editorial Committee Stephen Coulter, AMEC Denise Elson, Deakin University Neil Walls, Neil Walls Consulting Contact Details The contact details for ABSANZ are as follows: Telephone: Fax: admin@absanz.org.au Postal Address: PO Box 1620 Geelong Victoria 3220 Australia ABN: Disclaimer. Articles published in this newsletter reflect the opinions of individual authors and are not necessarily those of ABSANZ. All items presented in this newsletter have been published in accordance with the ABSANZ Editorial Committee Charter. Copies of the Charter are available on the ABSANZ website or can be made available by contacting the ABSANZ office.