What is it? Why is it important?
Equipment maintenance are reoccurring checks (e.g. usually yearly) to ensure biobanking equipment performs as intended.
Equipment maintenance checks can include:
- Calibration tests for accuracy, such as the ability for:
- Pipets to aspirate an exact amount of liquid
- Centrifuges to rotate and maintain a given preset speed(s)
- Laboratory scales to correctly weigh products to the smallest mg
- Functional tests, such as:
- Freezers able to reach a minimum predefined temperature (e.g. -80°C)
- Alarms able to respond within a given timeline upon being triggered
- Laminar hood blower able to reach maximum expected hair flow
- Emergency generators in the event of electricity blackout
Guaranteeing optimal equipment performance requires that monitoring systems continuously run in the background (e.g. 24 hours/ 7 days a week). Upon excursions from the norm (e.g. changes in temperature, humidity, CO2 levels) an alarm is triggered notifying a response team. Thus, sensors record and relay information back to a control center (e.g. person or machine), initiating follow-up activities.
What do I need to do?
Based on your equipment:
- Establish a calibration and maintenance plan (e.g. write an Equipment Surveillance (ES) manual, SOP or WI)
- In the plan include manufacturer or technical experts able to provide support in the calibration and maintenance of equipment
- Reappraise and adapt ES schedules to ensure that equipment maintains optimal performance over time
- Label equipment that has undergone maintenance
- Keep an ES log book (e.g. include findings and improvement measures)
- Train staff on ES procedures
Based on risk-assessment, define critical equipment that requires a high level of ES, due to far reaching consequences in the event of equipment failure. Additional activities for critical equipment include:
- Ongoing surveillance systems with access to a response team 24 hours / 7 days a week
- The definition of applicable emergency plans (e.g. freezer emergency plan)
- The availability of back-up equipment in the event equipment downtime
The required calibration and maintenance frequency is provided by the equipment manufacturer. Other aspects that should be taken into consideration are:
- The frequency of use
- Defined risks, based on the seriousness of potential consequences due to equipment malfunction or breakdown
Where can I get help?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.usz.ch
The Swiss Biobanking Platform (SBP) can provide you with support on this topic.
SOPs, Forms and Templates – see in particular
- Equipment calibration record
- Equipment maintenance record
ISO 20387:2018 Biotechnology - Biobanking (access liable to cost) - General Requirements for Biobanking – see in particular section
- 6.3 Facilities / dedicated areas and environmental conditions