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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.

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.

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 -80οC

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

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

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.

Funding

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