| australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C1 | Work not permitted in the facility | The facility must not be used for: (a) work with a GMO that the Act or a licence condition requires to be contained abov... |
| australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C10 | Telling people their admission conditions | Under C9, the holder must tell anyone being admitted on conditions what those conditions are before letting them in. |
| australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C11 | Submissions on exclusion or conditional access | Where the Regulator invites the holder to comment on whether a person or class of persons should (a) be kept out of the... |
| australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C12 | Authority to admit and exclude where the holder is not the owner | A holder that does not own the facility and lacks power to admit people to, or exclude them from, the premises must not... |
| australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C13 | Entry for the Regulator | The Regulator, or someone the Regulator authorises, must be let into the facility and given access to the LWTS at all re... |
| australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C14 | Pest prevention strategy | Effective strategies for preventing pests must be written down and put into practice. The guideline notes that C68 requi... |
| australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C15 | Inspection at least every 12 months | At least once every 12 months the facility, LWTS included, must be inspected by a person whose training, qualifications,... |
| australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C16 | Keeping the containment equipment requirements met | The certification holder must keep the physical features of the facility and fittings maintained so that the Part A cont... |
| australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C17 | Keeping the LWTS requirements met | The certification holder must keep the physical features of the facility and fittings maintained so that the Part A LWTS... |
| australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C18 | Before structural changes | Before any structural change that will affect how GMOs are contained in the facility, the applicant has to either (a) as... |
| australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C19 | Inspection before a suspension is lifted | Before a suspension of certification can be lifted, the facility, LWTS included, must be inspected by a person whose tra... |
| australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C2 | Keeping the facility and fittings requirements met | The certification holder must keep the physical features of the facility and its fittings maintained so that the Part A... |
| australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C20 | No dealings until the suspension is lifted | Dealings with GMOs that need a certified facility must not restart in a suspended facility until the Regulator lifts the... |
| australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C21 | Integrity testing of reusable closed systems | A qualified person must inspect and test the integrity of each reusable closed system before every use, and again after... |
| australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C22 | Reusable closed system that fails its test | If testing shows a reusable closed system cannot achieve containment and the defect has not been fixed, the equipment mu... |
| australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C23 | Integrity testing of single-use components | Single-use components must have their integrity inspected and tested in place before GMOs are loaded into them, as R16 d... |
| australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C24 | Single-use component that fails its test | If testing shows a single-use component cannot achieve containment, that component must not be used for GMO dealings. |
| australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C25 | Monitoring and calibrating heat-based decontamination equipment | Each autoclave or other heat-based unit in the facility (not counting the LWTS) used to decontaminate GMOs must be (a) m... |
| australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C26 | Monitoring and inspecting the LWTS | Any LWTS, its pipes included, must be (a) monitored for effectiveness every month and (b) given a yearly inspection by a... |
| australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C27 | Testing biological safety cabinets | Every installed biological safety cabinet, Class I or Class II, that is used for GMO dealings must be inspected and test... |
| australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C28 | Cabinet that fails its test | If testing shows a cabinet falls short on (a) for Class I, its inward air velocity or the integrity of its HEPA filter,... |
| australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C29 | Annual testing of testable backflow devices | Any testable backflow prevention devices fitted (under AS/NZS 3500.1) need testing at least once every 12 months, follow... |
| australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C3 | Signs at each entry point | Every entry point to the facility needs, on or beside each access door, (a) the OGTR-supplied PC2 Large Scale facility s... |
| australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C30 | Faulty backflow device | Where a backflow prevention device turns out to be defective and has not yet been repaired, all equipment connected to t... |
| australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C31 | Training before dealings | Anyone who intends to deal with GMOs in the facility has to be trained in the Part B conditions of certification, with a... |
| australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C32 | Content of the training | Training under C31 must cover, where applicable: (a) how the GMOs dealt with in the facility are transported, stored and... |
| australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C33 | Doors closed and locked | Facility doors must stay shut while GMO dealings are in progress and be locked whenever the facility is unattended. |
| australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C34 | Windows closed | Windows must stay closed. |
| australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C35 | Gloves off and hands decontaminated before leaving | People who have been doing GMO dealings in the facility must take off their gloves and decontaminate their hands before... |
| australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C36 | Personal protective equipment | Anyone performing GMO dealings in the facility has to wear, as a minimum, this personal protective equipment: (a) protec... |
| australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C37 | Removing protective equipment before leaving | Personal protective equipment must come off before the person leaves the facility and be either put in the designated st... |
| australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C38 | Aerosol-producing work in a cabinet | Any dealing in the facility outside an LWTS or closed system that generates aerosols carrying Risk Group 2 GM microorgan... |
| australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C39 | Installing and using cabinets | Class I and II biological safety cabinets have to be installed and used as AS/NZS 2252.4 requires. |
| australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C4 | Disinfectants available and labelled | Disinfectants effective against the facility's GMOs must be kept available there for decontamination, and their containe... |
| australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C40 | Sampling, additions and transfers without release | Taking GMOs out of a closed system, adding materials to one, and transferring fluids between closed systems all have to... |
| australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C41 | Process waste decontamination method lodged first | Before any proposed method of decontaminating process waste is used, its details, with evidence that it is effective, mu... |
| australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C42 | Decontamination without release | Every decontamination procedure, including treatment through the LWTS, must be done in a way that stops GMOs, including... |
| australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C43 | In situ decontamination of closed systems | Closed systems, continuous flow centrifuges included, must be decontaminated in place by a method such as steam or chemi... |
| australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C44 | Trained people decontaminate | Every decontamination procedure, spill decontamination included, has to be done by trained personnel. |
| australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C45 | Decontaminating benches, surfaces and equipment after dealings | Work benches, surfaces and equipment, single-use parts of closed systems included, used for GMO dealings have to be deco... |
| australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C46 | Decontaminating before maintenance | All work surfaces and equipment due for maintenance must be decontaminated before the maintenance takes place. The guide... |
| australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C47 | Decontaminating liquid and solid waste | All liquid and solid wastes that may contain GMOs must be decontaminated before they are disposed of or discharged. The... |
| australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C48 | Decontaminating filters before disposal | Filters that may be contaminated with GMOs, for example filters on an autoclave, closed system, aerosol containment devi... |
| australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C49 | GMOs made non-viable before disposal | Before disposal, GMOs, and organisms infected with GMOs, have to be rendered non-viable. |
| australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C5 | Keeping the facility management requirements met | The certification holder must make sure the Part A facility management requirements (R13, the spill procedures and means... |
| australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C50 | Decontaminating equipment before it leaves | Equipment must be decontaminated before it is taken out of the facility. The guideline notes that items free of GMO cont... |
| australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C51 | Removing and treating contaminated protective equipment | As soon as practicable, any personal protective equipment that GMOs have contaminated has to be taken off, and it must b... |
| australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C52 | Decontamination methods | GMOs, and material or equipment contaminated with them, may be decontaminated by any of: (a) autoclaving (pressure steam... |
| australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C53 | Chemical treatment effective against the GMO | Where chemical treatment is used to decontaminate, it must work against the particular kind of GMO being treated. The gu... |
| australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C54 | Validated time and temperature for heat treatment | If an autoclave or other heat treatment (the LWTS included, if there is one) is needed for decontamination, a time and t... |
| australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C55 | Telling processed loads from unprocessed | If an autoclave or other heat treatment (not counting the LWTS) is needed for decontamination, steps must be taken so th... |
| australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C56 | Decontamination equipment status labelled | Each autoclave or other heat-based unit meant for decontaminating GMOs, an LWTS included, must carry a clear label showi... |
| australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C57 | Defective decontamination equipment | Decontamination equipment found defective and not yet fixed must be clearly labelled as defective and kept out of use fo... |
| australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C58 | Decontaminating cabinets | Class I and II biological safety cabinets have to be decontaminated as AS/NZS 2252.4 requires. |
| australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C59 | Spill inside the facility | If GMOs are spilled inside the facility, the R13 spill procedure must be put into action to decontaminate the spill. |
| australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C6 | Access limited to authorised persons | Whenever GMO dealings are under way in the facility, the holder must ensure only authorised persons can get into the fac... |
| australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C60 | Spill outside the facility | If a spill happens outside the certified facility, the procedures in the Regulator's GMO transport, storage and disposal... |
| australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C61 | LWTS failure causing a spill outside the work area | Where the external LWTS fails and the failure causes a spill beyond the work area, the R25(i) contingency plan must be p... |
| australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C62 | Labelling GMO containers | Each container holding GMOs needs a clear label showing that it holds GMOs, and any unlabelled material that may be viab... |
| australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C63 | No removal of over 25 litres without permission | GMO-containing culture in volumes above 25 litres must not leave the facility unless the Regulator has given written per... |
| australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C64 | Removing 25 litres or less | Culture volumes of 25 litres or less containing GMOs that do not qualify as an exempt dealing must not be taken out of t... |
| australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C65 | Storing 25 litres or less outside the facility | Culture volumes of 25 litres or less containing GMOs that do not qualify as an exempt dealing may be kept in storage out... |
| australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C66 | Removing non-GMOs while dealings are under way | While a GMO dealing is going on in the facility, non-GMO organisms must not be taken out unless (a) procedures that keep... |
| australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C67 | Incidents reported to the Regulator | The Regulator must be told of each of these incidents as soon as reasonably practicable: (a) a critical closed system de... |
| australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C68 | Records kept for five years or as long as relevant | Records of the actions other conditions require must be made, kept for five years from creation unless stated otherwise,... |
| australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C7 | Supervising non-dealing entrants | While the facility is operating, a C6(b) entrant who goes into the facility or gets access to the LWTS has to be under t... |
| australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C8 | Excluding a person on the Regulator's direction | If the Regulator directs the holder to keep a person or class of persons out of the facility, or away from the LWTS, bec... |
| australia-ogtr-guidelines-for-certification-of-a-pc2-large-scale-facility-version-3-1::C9 | Conditional admission on the Regulator's direction | If the Regulator directs that a person or class of people be admitted to the facility subject to extra conditions, the h... |