Biobank
Infrastructure
INTRODUCTIE: PROFIEL EN FUNCTIE
2
Bimetra biobank facility
• Fund of the Flemish government (FFEU) for the
realisation of a biobank with cryogenic storage capacity of
25.000L
Planning and realisation
Temporary facility
-1P8
(end of 2012 until
dec 2014)
Total investment plan : 1.326.000,00 € (FFEU)
- Jan 2014: initial building
plan
- March 2014: refining,
detailing and finalising the
building plans
Fase 1: 832.543,69 €
- Apr to Nov 2014:
Renovation basement
(matching funds UZG)
and realisation of the
building plans
- Nov 2014: Move into
the new biobank facility
- Quality audit (CMI) :
Nov 2014
Fase 2: 493.456,31 €
- Implementation service level
conditions
- Implementation of quality
control tests
- Purchase file digital pathology
scanning device
- Sample collection: cradle-tograve analyse= mutual effort
3
Location facility
Bimetra biobank
DWG R, -1
4
How to reach the biobank?
• DWG R: in renovation
• Temporary access road:
• Through building B3
• Go to -1 (basement)
• Follow the signs: go in the direction of “dwarsgebouw”
• Separate temporary access road to the biobank
• Through the underground network of tunnels
• Tunnel connecting K1-K2-K3
• From K3 to building B3
• Follow to the end
• Separate temporary access road to the biobank
5
Virtual tour: general building plan
High quality biobank facility:
- Entrance: sas
- Sample reception area
- Laboratory for sample preparation
- Cryogenic facility:
- 45 ULT (-80°C) freezers
- 6 storage LN2-vessels
Invoegen algemeen grondplan met zonering uit iDOCs
6
Access to the biobank: changing area
Bimetra biobank:
•
•
•
Area with limited/
controlled access
(badge reader)
Visitors: login
register
Changing area
7
Changing area: keeping it clean
• Changing area:
• Put on shoe covers (anti-slip)
• Remove “outer wear” (jackets, scarfs…) and put on “inner wear” overcoat
• Hand wash facility
8
Overview: entrance – sample reception
area - cryofacility
9
Sample reception area
10
Sample reception area
• Right zone: “dirty area”
• Sample delivery
• Transport boxes
• Flow:
• Unpacking/uncasing of
samples
• Intake in datamanagement
system
• Labelling according to
following procedures
11
Sample reception area
• Go to the “clean area”, sorted
according to further procedures
Preparation of
samples
Direct freezing
Color coded
On dry ice
Temporary label
Cryovial label
12
Laboratory: sample preparation and QC
• Laboratory
overview
13
Laboratory: sample preparation and QC
• Zone 1: sample prep
• Aliquoting of liquid
samples
• Serum preparation
• Cell culture
• …
14
Laboratory: sample preparation and QC
• Zone 2: sample prep QC
• DNA- and RNA extractions
• QC on samples
• …
15
Laboratory: sample preparation and QC
• Zone 3: sample processing
• FFPE slide preparation
• Cryoslide preparation
• future: digital scanning device
for slides
• …
16
Cryogenic facility: area 1 (ULTs)
• Facility for 45 ULT (-80°C) freezers
• Existing freezers from P8 < New Brunswick (mixture of models)
• New freezers for short/temporary storage of samples < framework
agreement with TCPS (Panasonic MDF-U700VX-PE)
• New freezers for longterm sample storage < framework agreement
with Thermo Fisher Scientific (88600V and 820CV models, with
storage racks and boxes)
17
Cryogenic facility: area 1 (ULTs)
• Storage racks:
• High sample storage efficiëncy
• 0,5ml eps, 2 ml cryovials, 4 ml cryovials
• PAX, EDTA, 15ml tubes
• Ease in traceability of samples < linked in data
management system SLims
18
Cryogenic facility: area 1 (ULTs)
• High quality facility
• “tailormade” airconditioning according to capacity
• Maintenance regime: preventive
• Monthly maintenance of freezers (registration logbooks):
• Ice removal and drying
• Checking and cleaning of valves, closures and rubbers
• Checking and cleaning of filters
• Yearly planned preventive maintenance by the company
19
Cryogenic facility: area 1 (ULTs)
• Power supply: separate circuits for each freezers and emergency
power
• Double monitoring control:
• Device generated alarms:
• Through potential-free contact < facility management system
• Internal device monitoring system (Thermo Fisher Scientific):
• short term registration of temperature and events/alarms < USB port
• Device generated alarm if case of too high surrounding temperature
20
Cryogenic facility: area 1 (ULTs)
• Double monitoring control:
• Device independent alarms: Aeroscout
• Independent temperature sensor Aeroscout in each ULT < Wifi-network <
continuous temperature monitoring and –registration
• Independent temperature sensors Aeroscout in the facility < Wifi-network <
continuous environment temperature monitoring and –registration
21
Cryogenic facility: area 2 (LN2)
• LN2 facility: adapted to safety requirement
• LN2 specific flooring
• LN2 lines for automatic filling
• Oxygen detection (visual/auditive alarms)
• Emergency masks for evacuations
• Personal safety means
22
Cryogenic facility: area 2 (LN2)
• CBS Isothermal freezers
(patented new technology)
• High storage capacity (± 35.000 2
•
•
•
•
ml cryovials/vessel)
Automatic filling with build-in
monitoring device
Small access port
Sample tower carrousel
Double monitoring
Biobank:
Quality
management
system
INTRODUCTIE: PROFIEL EN FUNCTIE
24
Quality management system
• Quality norm: CMI-CRC guidelines (published oct 2010)
• Quality audit Nov 2014: highly positive
• Implemented systems:
• IDOCs: ZH wide document management system
• IML: ZH wide registration system for quality deviations or
abnormalities and audit reports
• Future objective: ISO-norm for biobanks (involved in ISO working
group)
• ISO15189 & ISO17025: test labs NOT biobanks
25
Quality system
•
•
•
•
•
•
Use of ZH wide system
iDOCS and IML
Procedure/ process
validations
Device validations
Quality control of samples
Full sample traceability and
audit trail
Following directives and
decrees regarding us of
HBM
•
•
•
Access control (badge)
On site back-up freezers,
emergency procedures and
contracts
Double monitoring of all storage
devices
•
•
•
•
Sample and data management
through Slims
Use of minimal datasets (MDS)
and international SPREC coding
for sample history
Software validation
Automatic data retrieval by
coupling of other datasystems
•
•
•
Involved with local policy
HBM < autonomy
General flows for sample
access
Harmonised MTAs and
cost models
In conclusion:
Cryogenic biobank facility
is fully operational
High quality standards