1. The purpose of our procedure
This procedure outlines the responsibilities and practices for the appropriate management of controlled environment devices and the safe storage of research and teaching materials, including high-risk activities such as biobanking.
This procedure gives effect to the Controlled Environment Devices and Storage Policy and outlines procurement and insurance processes to mitigate risk of adverse events as a result of damage to or loss of controlled environment devices and research and teaching materials.
Controlled environment devices and associated research or teaching materials that breach this procedure may not be insured in the event of damage or loss.
This procedure should be read in conjunction with:
- Controlled Environment Devices and Storage Policy
- Research Operations Policy
- Research Integrity Policy
- Procurement Policy
- Hazard Management Procedure
2. Who our procedure applies to
Inclusions
This policy applies to the Adelaide University community.
Exclusions
This policy does not apply to controlled environment devices managed by a third party, unless expressly governed by an agreement with Adelaide University.
3. Our controlled environment devices and storage procedure
3.1 Procurement
The procurement of all controlled environment device will be conducted in accordance with the Procurement Policy.
Procurement of controlled environment devices will be through approved suppliers that are chosen via a tender process to be managed by Procurement Office/Team.
Before purchasing a controlled environment device, staff must submit to the Technical Services Team a completed Controlled Environment Device Pre-Purchase Form to ensure that the device is:
- fit for purpose, with digital temperature monitoring and alert systems
- cost-appropriate to the research and teaching objectives
- compatible with existing infrastructure
- able to meet all alarm, monitoring and oversight requirements outlined in this procedure and relevant ISO Standards.
If approved, the purchase must be recorded by the Device Manager, including the following asset details:
- description
- unique identifier
- site information
- equipment Barcode Number and/or Serial Number.
3.2 Insurance
Insurance coverage for controlled environment devices, including stored research and teaching materials, is contingent on staff meeting the requirements of this procedure and taking reasonable steps to mitigate damage or loss. Controlled Environment devices and associated research or teaching materials that breach this procedure may not be insured in the event of damage or loss.
Minimum mitigation standards, include but are not limited to:
- temperature monitoring and alarms
- power monitoring and alarms
- backup power supply or equivalent, including available backup storage
- accurate after-hours emergency contact information
- up-to-date maintenance, compliance and records management
- identification of contents (sample management)
- emergency response training relating to device failure
- estimated value of the contents of each controlled environment
- compliance with relevant regulations, legislation, and international standards.
3.2.1 Claims process
Within 1 business day of discovering damage, relevant staff will report damage via the Staff Portal, including photographs, asset ID, incident description, and estimated value of loss.
Information regarding the claim should be updated in the Laboratory Information Management System (LIMS).
3.2.2 Installation of controlled environments
Before controlled environment devices can be installed, the Principal Investigator or Lead Researcher will determine a risk rating of the relevant research or teaching material in accordance with the [Risk Assessment Template].
The Principal Investigator or Lead Researcher must submit a request, including the completed risk assessment, to the Manager, Research Infrastructure] to enable connection to the approved alarm system and back-up power.
Backup power (UPS, generator or equivalent), duplicate storage, or cloud-based alert systems will be used for critical freezers.
The Manager, Research Infrastructure will liaise with certified technicians and oversee the proper installation of controlled environments consistent with the approval of the Pro Vice Chancellor, Research Services and Infrastructure.
The Manager, Research Infrastructure, will record the relevant information into the Relevant Facilities Register within 24 hours of installation, including BAS port number where applicable.
3.3 Maintenance of controlled environments
The Delegated Authority will coordinate a Research Asset Maintenance Log to ensure controlled environments are tagged, calibrated and serviced on schedule and in accordance with the manufacturer’s specifications and relevant AS/ISO Standards.
At the direction of the Delegated Authority, approved maintenance activities will be conducted to minimise the risk of malfunction.
Staff will also conduct routine maintenance of controlled environment devices, including but not limited to cleaning, defrosting, de-icing, and professional maintenance in accordance with relevant AS/ISO Standards.
3.4 Risk assessment and mitigation
Biobanks holding irreplaceable samples will require a risk assessment that includes:
- temperature monitoring strategy
- backup storage locations
- emergency contact protocols.
Researchers and academic staff who use controlled environment devices will assign a risk rating to the stored materials, as per the Risk Assessment Template, and ensure storage aligns with the principles of the Controlled Environment Device and Storage Policy.
The risk rating determined by this risk assessment will be communicated to Delegated Authority to record the information and determine the appropriate safeguards required.
All controlled environment devices containing research or teaching material must have additional safeguards, as including:
- connection to an approved back-to-base alarm that is capable of detecting a change in the environment and is monitored 24 hours a day, for example, BAS or approved wireless technology and should be connected to emergency power or have adequate battery back-up to enable ongoing power supply in the event of an extended power outage
- back-up power in the event of a loss of regular power to the device
- clearly displayed contact details of the on-call list in the event of alarm activation
- where there is no such infrastructure available to provide power back-up, an appropriate risk management strategy will be approved by the Delegated Authority.
Before sharing samples with external parties, a Material Transfer Agreement (MTA) will be arranged by the [Principal Investigator / Lead Researcher] and reviewed by Delegated Authority.
3.4.1 Storage of materials in controlled environment devices
Researchers must record the storage of research and teaching materials in controlled environment devices in the Laboratory Information Management System (LIMS)] within 24 hours.
All hazardous chemicals stored in controlled environment devices must be recorded in the Adelaide University chemical manifest (ChemWatch GoldFFX), and the appropriate hazardous chemical symbols displayed on the outside of the controlled environment device.
The Principal Investigator/Lead Researcher/Academic is responsible for ensuring the chemical register is updated throughout the lifecycle of the stored material.
If the controlled environment contains a Controlled Substance S8 safe, the safe must be securely attached inside the device. The controlled environment device must be secured to the floor, wall or ceiling, and must not be used to store any item other than the designated drug.
The storage of hazardous chemicals in controlled environment devices must be audited annually, to ensure devices are fit for purpose, and that mitigation measures are in place and operational. Please refer to the Chemical Safety Protocol.
The Principal Investigator/Lead Researcher is responsible for ensuring staff update the LIMS throughout the lifecycle of the stored research material.
Where possible, staff will maintain back-ups or duplicates of research and teaching materials in alternate controlled environment devices. Staff should contact the relevant local area support team to access alternate controlled environment devices if needed.
Staff requiring storage of research or teaching material in the Adelaide University Biobank should consult the relevant section of this procedure and contact the Delegated Authority for additional information about access requirements.
Research or teaching material housed in a controlled environment device as part of an externally funded research project must comply with the requirements of the external funding body.
3.4.2 Valuation
The Principal Investigator/Lead Researcher will determine a replacement value’ for all research or teaching materials stored in controlled environments. Staff should consult the Research Material Valuation Guideline for guidance in determining the replacement value of materials.
The valuation of materials will be determined and recorded within 24 hours of storage and communicated to relevant staff. The risk rating and associated valuation will be recorded and provided to the local area research support team upon request.
3.4.3 Disposal
Staff will destroy or dispose of material stored in controlled environment devices in accordance with Adelaide University policies, procedures and applicable legislation.
Controlled environment devices will be decommissioned in accordance with relevant WHS policies and procedures, environmental waste regulations, and Australian/New Zealand Standard 2243.
Researchers and academic staff are able to benefit from the use of the Biobank which is a highly specialised facility and offers long-term protection and storage for valuable ultra-cold research and teaching materials, including but not limited to:
- archival materials (irreplaceable or valuable samples from past research)
- backup materials (critical or valuable samples from current research)
- materials from longitudinal and long-term studies (current and future research resources)
The Biobank is a "storage only" facility and no active work on samples is undertaken.
Materials stored are for long-term storage and not "reasonably expected" to be required and accessed within 6 months from the time they are placed in the Biobank. Researchers can, however, retrieve samples at any time when required.
3.4.4 Research Material Risk Assessment
All research and teaching materials must be assigned a risk rating, which defines the impact they would have on research and teaching activities if the materials were lost. Research and teaching materials that are rated as Irreplaceable are required to be stored in the Biobank. Materials that are rated as Major are strongly encouraged to have duplicates or aliquots stored in the Biobank as backup.
| Rating | Impact description | Examples |
|---|---|---|
| 5 Extreme or Irreplaceable | Potentially disastrous impact on research and teaching activities
| Material that is impossible to replace/collect again due to:
|
| 4 Major | Critical event or circumstance that can be endured with proper management Major impact on research and teaching activity over a sustained period Major problems meeting research and teaching targets Serious impact on the reputation of the affected researcher(s) and the University | Can be replaced but with major impact in loss of research funds and time, loss of teaching time, student experience e.g.:
|
| 3 Moderate | Significant event or circumstance that can be managed under normal circumstances Significant impact on research and teaching activity over a sustained period Significant problem meeting research and teaching targets | Can be replaced but with moderate impact in loss of research funds and time, teaching time, student experience e.g.: Repeat a short term study to collect and analyse new samples |
| 2 Minor | Event with consequences that can be easily absorbed but requires management effort to minimise the impact Minor impact on research and teaching activity Temporary problems meeting some research and teaching targets | Can be easily replaced and has minor impact in loss of research funds and time, teaching time, student experience e.g.:
|
| 1 Insignificant | Some loss; existing controls and procedures should cope with circumstance or event Negligible impact on research and teaching activity or achievement of teaching/research targets | Can be easily replaced and has no impact in loss of research funds and time, teaching time, student experience e.g.:
|
3.4.5 Suitable material for storage in the Biobank
The Biobank accepts storage of the follow materials:
- biological specimens/samples for which a risk assessment has been undertaken, by the [Principal Investigator / Lead Researcher], and that risk assessment has determined that the material is suitable to be stored in a Physical Containment Level 2 (PC2) facility
- microorganisms in Risk Group 1 or Risk Group 2, (as per the Australian/New Zealand Standard 2243, Safety in laboratories Part 3: Microbiological safety and containment, AS/NZS 2243:3:2022)
- genetically Modified Organisms (GMO), providing storage meets requirements of corresponding legislation and all relevant Institutional Biosafety Committee (IBC)/Office of Gene Technology Regulator (OGTR) approvals are in place and approval documentation is provided.
The Biobank does not accept the following materials:
- microorganisms classified as Risk Group 3 or 4, or requiring Physical Containment Level 3 or 4
- infectious or biohazard materials not suitable for storage at physical containment level 2
- materials likely to degrade in storage and produce hazardous by-products (such as chemicals or toxins)
- radioactive materials
- quarantine materials requiring Department of Agriculture, Fisheries and Forestry (DAFF) certification.
3.4.6 Storage and access
Researchers are strongly encouraged to store backup duplicates or aliquots of all critical materials in the Biobank.
Where materials are stored in ultra-cold freezers or cold storage vessels not owned by Adelaide University, researchers are strongly encouraged to store backup duplicates or aliquots in the Biobank regardless of the risk rating.
Adelaide University Research Grant Acceptance Forms require confirmation that research samples are catalogued and stored in accordance with this procedure and the Controlled Environment Devices and Storage Policy.
Materials approved for storage in the Biobank will be catalogued at the sample level in the LIMS before transfer from local freezers.
Only material that is owned by Adelaide University, where responsibility also resides with the University, may be stored in the Biobank. Other materials may be stored subject to approval by the Biobank Manager on a case-by-case basis, taking into account capacity, risk, cost recovery and other relevant factors.
Specimens must be stored in validated freezers or fridges with backup power and monitoring systems.
Access to the Biobank is managed by the Biobank Manager, who will conduct a monthly review of the access list to ensure access is restricted to authorised personnel.
Data associated with biospecimens will be stored in secure, access-controlled, and locally stored databases.
Biospecimens will be labelled with unique identifiers and logged in the LIMS.
3.5 Incident management and reporting an adverse event or loss of research material
Staff must immediately notify the Researcher, following the approved emergency contact protocol, if there is any change in the condition of a controlled environment device. The Researcher will initiate incident management procedures.
Changes in condition include variation in temperature, humidity, or other metric outside the device’s normal parameters.
Staff will report any loss or damage of research or teaching material to the Delegated Authority immediately and initiate a claims process in accordance with section 3.2.3 of this procedure.
Research Safety Officers will coordinate the investigation and report findings to the Delegated Authority within timeframe.
3.6 Monitoring and continuous improvement
3.6.1 Annual reviews
The Delegated Authority will conduct an annual safety audit to ensure the integrity and ongoing compliance of controlled environment devices, including performance, alarm systems, maintenance logs.
The Delegated Authority will conduct an annual procurement review, involving a random audit of large-equipment purchases (for example, items over $5,000), to confirm adherence to procurement policy and value-for-money principles.
The Senior Manager, Biobank, will conduct an annual Biobank storage review to assess the biobank’s infrastructure, risk profile and long-term storage capacity.
These monitoring and continuous improvement reviews will be submitted to the Delegated Authority, for example, the DVC.
4. Who holds a responsibility within this procedure
4.1 The Executive Director Research Infrastructure is required to:
- ensure the allocation of resources for the safe management of controlled environment devices
- review and endorse relevant policies and procedures.
4.2 The [Principal Investigator/Approved Researcher] is required to:
- implement and monitor controlled environment devices within their research and teaching teams
- ensure that all team members are trained in controlled environment devices protocols
- report controlled environment devices incidents and hazards promptly.
4.3 The Senior Manager Biobank is required to:
- evaluate controlled environment devices performance, including backup systems and alarm responses
- liaise with vendors and certified technicians to ensure controlled environment devices are procured, installed and maintained in accordance with this procedure
- conduct annual audits of controlled environment devices.
4.4 The Insurance Team is required to:
- ensure appropriate insurance arrangements are in place to safeguard controlled environment devices.
4.5 The Procurement Manager is required to:
- oversee the acquisition of controlled environment devices in accordance with related policies and procedures
- ensure all controlled environment devices comply with work health and safety, sustainability, and supplier accreditation standards.
4.6 All Researchers, academics and facility users are required to:
- adhere to all controlled environment devices protocols and procedures
- manage the contents of controlled environment devices and related inventory
- manage emergency contact information for controlled environment devices
- maintain accurate records about the status of controlled environment devices on relevant Adelaide University registers, including additions and disposals
- participate in safety training and awareness programs
- report hazards, incidents, and near-misses promptly.
5. Definitions used in our procedure
Please refer to our Adelaide University glossary for a full list of our definitions.
Adelaide University community means a broad range of stakeholders who engage with Adelaide University and includes (but is not limited to) all students, staff, and non-staff members of Adelaide University including alumni, honorary titleholders, adjuncts, visiting academics, guest lecturers, volunteers, suppliers and partners who are engaging with and contributing to the work of Adelaide University.
Controlled environment devices means any device that is used for the purpose of changing temperature and/or humidity and/or oxygen level in order to store research and teaching materials that are required to be kept at a certain temperature/conditions. These devices include, but not limited to, +4-degree fridge; -20-degree freezer; -40-degree freezer; -80-degree freezer; walk-in fridge; walk-in freezer; and liquid nitrogen vessel.
Cold storage means temperature-controlled units used for research and teaching sample storage (e.g., freezers, refrigerators, cryogenic tanks).
Critical materials means those items used for research and educational purposes which have a risk impact rating of major or extreme/irreplaceable. The risk rating relates to the level of impact on a research or educational program if the materials were lost or damaged. These may include, but are not limited to, tissues, cell lines, blood, faeces, urine samples and their derivatives.
Incident is any unplanned or unintended event, situation or occurrence, regardless of severity, that disrupts, or has the potential to disrupt, normal operations or processes at Adelaide University.
6. How our procedure is governed
This procedure is categorised, approved and owned in line with the governance structure of Adelaide University and the offices and officers listed below.
| Parent policy | Controlled Environments Devices and Storage Policy |
|---|---|
| Policy category | Academic |
| Approving authority | co-Vice Chancellors/Vice Chancellor and President |
| Policy owner | Deputy Vice Chancellor - Research and Innovation |
| Responsible officer | Pro Vice Chancellor, Research Services & Infrastructure |
| Effective from | 1 January 2026 |
| Review date | 3/4/5 years after date this version is approved, TBC |
| Enquiries | Interim Central Policy Unit staff.policy.enquiries@adelaideuni.edu.au |
| Replaced documents | None |
7. Legislation and other documents related to this procedure
| Category | Documents |
|---|---|
| Associated policies and procedures | Risk Management and Legal Compliance Policy |
| Risk Management Procedure | |
| Research Integrity Policy | |
| [Records Management Procedure] | |
| Privacy Policy | |
| [Research Data Management Procedure] | |
| Related legislation | Adelaide University Act 2023 |
| National Code of Practice for Providers of Education and Training to Overseas Students 2018 | |
| Compliance and Legislative Framework |
|
8. History of changes
| Date approved | To section/clauses | Description of change |
|---|---|---|
| 25 November 2025 | N/A | New procedure |
At the time of writing, Adelaide University’s organisational structure, position titles, and committee names have not been confirmed. Square brackets [ ] indicate placeholders for these details. Brackets are also used to identify policy elements that are subject to further decision-making or confirmation. These will be updated once final decisions are made.
Appendices (Proposed / TBD)
A. Controlled Environment Pre-Purchase Form
B. Asset Insurance Declaration Form
C. Sample/Material Storage Valuation Template
D. Risk Assessment Template