INSTITUTE OF CELL THERAPY

INSTITUTE OF CELL THERAPY

GMP FACILITY

Equipment

With the term equipment we are referring to the ensemble of machinery, devices and micro-equipment necessary for both the construction and function of the GMP facility.

The equipment used for the construction of the facility is detailed in provided by the Bougatsos company that has carried out the construction of the facility. View PDF.

The management of the equipment used for collection, processing, cryopreservation, storage, transfer and infusion of cell products is thoroughly described in our SOPs files and more detailed in . View PDF.

The equipment required for the function of the facility is also listed in this Manual. This list contains the basic characteristics of each piece of equipment such as name, model, manufacturing company, supplying company, serial number, validation procedure, maintenance procedure, necessary tasks and observations.

GMP FACILITY

Equipment

With the term equipment we are referring to the ensemble of machinery, devices and micro-equipment necessary for both the construction and function of the GMP facility.

The equipment used for the construction of the facility is detailed in provided by the Bougatsos company that has carried out the construction of the facility. View PDF.

Main Processing and Cryopreservation Equipment

The processing and cryopreservation equipment is briefly presented in the table below.

Νο.	Abbreviation	Equipment	Model	S/N	Company	Location	Application	Fundraiser
1	GB	Glove box	H35 HEPA hypoxystation	HA0315172H	Whitley	Grade B or C	Cell Processing	John S. Latsis Public Benefit Foundation
2		Hood Biosafety II	JINAN BIOBASE BIOTECH BSC-1500IIA2-X MSC Class:II	BSC15A14110160	EQUIP ΕΠΕ	Grade B	Cell Processing
3	INC1	Incubator CO2	Memmert ICO150med	7210003	Phoenix	Grade B	Cell Processing	General Secretariat for Research and Innovation (GSRI, 81345)
4	INC2	Incubator CO2	Memmert ICO150med	7210234	Phoenix	Grade C	Cell Processing	ΑΔΑ: 6ΨΓΘ46906Γ-ΧΩ3
5	WB1	Waterbath	Memmert WΤB 50 with cable cover (WΤΒ50)	LF21.0008	Phoenix	Grade F	Cell Processing	General Secretariat for Research and Innovation (GSRI, 81345)
6	Τ1	Liquid Nitrogen Tank	HAIER YDD-300-326	933DOODAM	Labware	Grade F	Cryopreservation	Rector’s Donation
7	Sup1	Liquid Nitrogen Supply Tank	HAIER YDZ-200	939AOO	Labware	Grade F	Cryopreservation	Rector’s Donation
8	T3	Shipper LN2	Haier		Labware		Cryopreservation
9	DS/DSC	Dry Shipper	Voyager Plus (REF:VOYAGEUR20-2)	.000001127367	Revival/Cryopal	Grade F	Cryopreservation	General Secretariat for Research and Innovation (GSRI, 81345)
10	UFR2	Freezer -80οC	MRC / 218 liter Upright DW-86HL218		Lab Supplies	Grade F	Cryopreservation	KenFM Donation
11	UFR1	Freezer -80^οC	HAIER/ DW-86L490J	BE0FS4G1T00QGL9L0009	Phoenix	Grade F	Cryopreservation	General Secretariat for Research and Innovation (GSRI, Τ2ΕΔΚ-00474, 81346)
12	RFr	Fridge (Research)	Indesit	F2(R)		Grade F	Cryopreservation
13	S1	Oxygen Sensor	Analox O2NE+ Oxygen Depletion Monitor	110367	Labware	Grade F	Cryopreservation	General Secretariat for Research and Innovation (GSRI, 81345)
14	DL1	Data logger- Temperature & Humidity	LOG210-5005-0210-TS20PHL	21021020021	Link Lab	Grade F	Facility Monitoring	General Secretariat for Research and Innovation (GSRI, 81345)
15	DL2	Data logger- Temperature & Humidity	LOG210-5005-0210-TS20PHL	21021020024	Link Lab	Blood Center	Facility Monitoring	General Secretariat for Research and Innovation (GSRI, 81345)
16	DL3	Data logger dry shipper	Voyager-Τ-Tracker	1069	Revival/Cryopal	Grade F	Cryopreservation	General Secretariat for Research and Innovation (GSRI, 81345)
17	DL4	Data logger-Temperature	TEMPMATE- M1	TMM210302691	MAIN SOLUTIOS	Grade F	Facility Monitoring	SLSG18-301
40	DL5	Data logger dry shipper	Voyager-Τ-Tracker	1188	Revival/Cryopal	Grade F	Cryopreservation	Revival Donation
18		Sterile Tube Welder	TERUMO TSCD 11	201910537	Rontis	Grade F	Cell Processing	Rector’s Donation
19		Monitoring System FMS+BMS (3+5 entries), FMS impreachable.	TSI		Link Lab		Facility Monitoring
20	Μ1	Inverted Microscope	Axiovert	3846015257	Carl Zeiss	Grade B	Cell Processing	General Secretariat for Research and Innovation (GSRI, Τ2ΕΔΚ-00474, 81346)
21		Portable Luminometer	Junior LB 9509 Portable Luminometer	6506	Berthold	Grade C	Cell Processing	General Secretariat for Research and Innovation (GSRI, Τ2ΕΔΚ-00474, 81346)
22		Flow Cytometer	FACs CANTO II	V96300084	BD- Safeblood	Grade C	Cell Processing	Choose Life
23	FR	Freezer -20oC	Candy CCTUS 542WH	3700038814170135.		Grade F
24	C1	Centrifuge	Thermo Scientific SL16R	42824014	Antisel	Grade B	Cell Processing	ΑΔΑ: 6ΨΓΘ46906Γ-ΧΩ3
25		Cell Counter	Corning Cell CytoSmart	J21E0081	Antisel	Grade C	Cell Processing	Blood Cancer Charity- Choose Life
26	CRF	Controlled Rate Freezer	Planer Kryo10 Series III		Mediplan	Grade F	Cryopreservation	General University Hospital of Patras

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Equipment maintenance

The equipment maintenance is carried out by the technical service of the University General Hospital of Patras (UGHP). In detail:

The cryopreservation equipment (fridges, freezers, liquid nitrogen tanks) are maintained by the technical service of the UGHP in accordance to the decision 14862/9-6-21.
The technical service of the UGHP is always present during the liquid nitrogen supply in accordance with the decision 25867/8-10-21.
The rest of the equipment is supported by the Biomedical Service of the UGHP in accordance to the decision 14776/8-6-21

Equipment validation

The equipment validation entails the validation of proper function of the construction (HEPA filters etc) as well as calibration for every piece of equipment.

This validation is performed once annually by an external partner under the supervision of the QC Manager of the GMP facility.

INSTITUTE OF CELL THERAPY

INSTITUTE OF CELL THERAPY

GMP FACILITY

Equipment

GMP FACILITY

Equipment

Main Processing and Cryopreservation Equipment

Technical Support

Equipment maintenance

Equipment validation

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