Good Manufacturing Practice - Equipment

5 good_manufacturing_practice Cell Counter Countess LifeTechnologies

The Countess™ automated cell counter uses state-of-the-art optics and image analysis to automate cell counting. The Countess™ automated cell counter is a benchtop counter designed to measure cell count and viability (live, dead, and total cells) accurately and precisely, using the standard trypan blue technique.
Using the same amount of sample that you currently use with the hemocytometer, the Countess™ automated cell counter takes less than a minute per sample for a typical cell count and is compatible with a wide variety of eukaryotic cells and provides information on cell size.
The Countess™ automated cell counter offers an intuitive user interface, and provides the option to save and print cell count data using the Countess™ software (download from www.invitrogen.com/countess) and USB drive supplied with the instrument or available separately.
The Countess™ automated cell counter is supplied with disposable Countess™ cell counting chamber slides that contain two enclosed chambers to hold the sample to allow you to measure two different samples or perform replicates of the same sample. The cell counting occurs in the central location of the counting chamber and the volume counted is 0.4 μL, the same as counting four (1 mm × 1 mm) squares in a standard hemocytometer.

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Cell Counter

Countess (LifeTechnologies)

The Countess™ automated cell counter uses state-of-the-art optics and image analysis to automate cell counting. The Countess™ automated cell counter is a benchtop counter designed to measure cell count and viability (live, dead, and total cells) accurately and precisely, using the standard trypan blue technique.
Using the same amount of sample that you currently use with the hemocytometer, the Countess™ automated cell counter takes less than a minute per sample for a typical cell count and is compatible with a wide variety of eukaryotic cells and provides information on cell size.
The Countess™ automated cell counter offers an intuitive user interface, and provides the option to save and print cell count data using the Countess™ software (download from www.invitrogen.com/countess) and USB drive supplied with the instrument or available separately.
The Countess™ automated cell counter is supplied with disposable Countess™ cell counting chamber slides that contain two enclosed chambers to hold the sample to allow you to measure two different samples or perform replicates of the same sample. The cell counting occurs in the central location of the counting chamber and the volume counted is 0.4 μL, the same as counting four (1 mm × 1 mm) squares in a standard hemocytometer.

CRTD 3.120
11 good_manufacturing_practice Cell Processing Devices CliniMACS® plus Miltenyi Biotec

The CliniMACS® plus Instrument is an electromechanical device intended to separate human cells from heterogeneous hematologic cell populations in combination with the CliniMACS® Reagents, CliniMACS® Tubing Sets, and CliniMACS® PBS/EDTA Buffer.

The key components of the CliniMACS® plus Instrument are an integrated computer, a magnetic separation unit, a peristaltic pump, a liquid sensor, and pinch valves. The integrated microcomputer controls all electromechanical components of the instrument and directs the system to perform procedures in a standard sequence. During the separation, the peristaltic pump controls the flow rate through the CliniMACS® Tubing Sets. The liquid sensor monitors the flow of labeled cell suspension into the tubing set. Disruption of continuous fluid flow through the sensor automatically advances the separation program to the next phase of the separation process.

The CliniMACS® plus Instrument and CliniMACS® Tubing Sets allow the operator to perform cell separations in a closed and sterile system. The CliniMACS® plus Instrument software offers the operator the choice between various separation programs.

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Cell Processing Devices

CliniMACS® plus (Miltenyi Biotec)

The CliniMACS® plus Instrument is an electromechanical device intended to separate human cells from heterogeneous hematologic cell populations in combination with the CliniMACS® Reagents, CliniMACS® Tubing Sets, and CliniMACS® PBS/EDTA Buffer.

The key components of the CliniMACS® plus Instrument are an integrated computer, a magnetic separation unit, a peristaltic pump, a liquid sensor, and pinch valves. The integrated microcomputer controls all electromechanical components of the instrument and directs the system to perform procedures in a standard sequence. During the separation, the peristaltic pump controls the flow rate through the CliniMACS® Tubing Sets. The liquid sensor monitors the flow of labeled cell suspension into the tubing set. Disruption of continuous fluid flow through the sensor automatically advances the separation program to the next phase of the separation process.

The CliniMACS® plus Instrument and CliniMACS® Tubing Sets allow the operator to perform cell separations in a closed and sterile system. The CliniMACS® plus Instrument software offers the operator the choice between various separation programs.

CRTD 3.127
12 good_manufacturing_practice CliniMACS® Prodigy Miltenyi Biotec

The CliniMACS system offers a set of tools that enables high-quality standardized cell separations for different applications. The CliniMACS system is based on the magnetic cell separation technology (MACS technology) developed by Miltenyi Biotec.

The CliniMACS Prodigy represents the next generation in automated cell processing. With its integrated fluid transfer, centrifugation, and magnetic separation capability, the CliniMACS Prodigy enables fully automated cell processing and culture applications, as well as fluid handling. This instrument offers advanced integrated solutions to streamline cell-processing workflows: from cell fractionation through cell culture to formulation of the final product. The CliniMACS Prodigy offers a flexible platform enabling the separation of virtually any cell type, as well as customized separation protocols that meetspecific sample requirements.

The CliniMACS Prodigy is used in combination with the following components: CliniMACS Reagents or CliniMACS MicroBeads, CliniMACS Prodigy Tubing Sets, and CliniMACS PBS/EDTA Buffer.

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CliniMACS® Prodigy (Miltenyi Biotec)

The CliniMACS system offers a set of tools that enables high-quality standardized cell separations for different applications. The CliniMACS system is based on the magnetic cell separation technology (MACS technology) developed by Miltenyi Biotec.

The CliniMACS Prodigy represents the next generation in automated cell processing. With its integrated fluid transfer, centrifugation, and magnetic separation capability, the CliniMACS Prodigy enables fully automated cell processing and culture applications, as well as fluid handling. This instrument offers advanced integrated solutions to streamline cell-processing workflows: from cell fractionation through cell culture to formulation of the final product. The CliniMACS Prodigy offers a flexible platform enabling the separation of virtually any cell type, as well as customized separation protocols that meetspecific sample requirements.

The CliniMACS Prodigy is used in combination with the following components: CliniMACS Reagents or CliniMACS MicroBeads, CliniMACS Prodigy Tubing Sets, and CliniMACS PBS/EDTA Buffer.

CRTD 3.127
9 good_manufacturing_practice Centrifuges Biofuge Fresco21 Thermo Scientific

The Biofuge 21R is a small volume, high speed, refrigerated universal centrifuge.

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Centrifuges

Biofuge Fresco21 (Thermo Scientific)

The Biofuge 21R is a small volume, high speed, refrigerated universal centrifuge.

CRTD 3.127
6 good_manufacturing_practice Cryofuge™ 5500i Thermo Scientific

The Cryofuge 5500i is a large volume, refrigerated universal centrifuge, optimized for the automatic laboratory processes in clinical central labs.
The Cryofuge 5500i is also a compact centrifuge for the separation of blood components. A special
wind shield rotor allows to process up to eight quintuple blood bag systems.

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Cryofuge™ 5500i (Thermo Scientific)

The Cryofuge 5500i is a large volume, refrigerated universal centrifuge, optimized for the automatic laboratory processes in clinical central labs.
The Cryofuge 5500i is also a compact centrifuge for the separation of blood components. A special
wind shield rotor allows to process up to eight quintuple blood bag systems.

CRTD 3.127
7 good_manufacturing_practice Megafuge 40R Thermo Scientific

The Megafuge 40R is a large volume, refrigerated universal centrifuge, certified as an in-vitro diagnostics device (98/79/EG).
It comes along with different adapters for the centrifugation of tubes, ranging from 5ml to 250ml, deep-well plates and blood bags.

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Megafuge 40R (Thermo Scientific)

The Megafuge 40R is a large volume, refrigerated universal centrifuge, certified as an in-vitro diagnostics device (98/79/EG).
It comes along with different adapters for the centrifugation of tubes, ranging from 5ml to 250ml, deep-well plates and blood bags.

CRTD 3.127
13 good_manufacturing_practice Cryopreservation MVE 1536P – 190AFGB BB MDD CHART MVE

The MVE High Efficiency / Vapor Series freezers will maintain a vapor storage temperature of -190°C with minimal LN2 evaporation while accommodating a wide variety of inventory systems.

To fulfill the needs of cellular therapies a rack system for 2ml cryovials and a storage system for blood bag cassettes is installed.

The MVE 1536 is connected with a TEC 3000 controller to meet regulatory requirements.

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Cryopreservation

MVE 1536P – 190AFGB BB MDD (CHART MVE)

The MVE High Efficiency / Vapor Series freezers will maintain a vapor storage temperature of -190°C with minimal LN2 evaporation while accommodating a wide variety of inventory systems.

To fulfill the needs of cellular therapies a rack system for 2ml cryovials and a storage system for blood bag cassettes is installed.

The MVE 1536 is connected with a TEC 3000 controller to meet regulatory requirements.

CRTD 3.127
14 good_manufacturing_practice IceCube 14M SY-LAB

The IceCube 14M is the routine Controlled Rate Freezer for clinical applications. It is available with MDD approval. Its large chamber takes up a wide variety of racks including AutoSeeding for straws and vials up to the newly designed device for freezing multiple Data Sample Matrix Racks used in bio banking.  

The 14M is used in many top medical facilities in the daily routine. Its operation allows simple one touch control but also gives the operator vast possibilities of choosing special programs or different operation modes.

IceCube Series has a rigorous safety concept. It is backed up by an internal Risk Processor who performs continuous operation even if the Tablet-PC is inoperabel.

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IceCube 14M (SY-LAB)

The IceCube 14M is the routine Controlled Rate Freezer for clinical applications. It is available with MDD approval. Its large chamber takes up a wide variety of racks including AutoSeeding for straws and vials up to the newly designed device for freezing multiple Data Sample Matrix Racks used in bio banking.  

The 14M is used in many top medical facilities in the daily routine. Its operation allows simple one touch control but also gives the operator vast possibilities of choosing special programs or different operation modes.

IceCube Series has a rigorous safety concept. It is backed up by an internal Risk Processor who performs continuous operation even if the Tablet-PC is inoperabel.

CRTD 3.127
8 good_manufacturing_practice Incubators BBD 6220 Thermo Scientific

The BBD 6220 is a a large 220 liter (8.5 cubic foot) incubator capable of normoxic / hypoxic / hyperoxic culture conditions.

The BBD 6620 is equipped with an active humidity control system allowing for an external humidity water supply.   This humidity vapor generation system sterilizes the chamber, preventing contamination within the incubator. The external water reservoir allows continuous thermal decontamination with cyclical heating to 80°C.

Another great feature included is the fully automatic 180°C hot-air disinfection. Moreover, this model incubator has been designed for optimal growth conditions including a number of features such as precise temperature, CO2 and O2 regulation for long term stability.

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Incubators

BBD 6220 (Thermo Scientific)

The BBD 6220 is a a large 220 liter (8.5 cubic foot) incubator capable of normoxic / hypoxic / hyperoxic culture conditions.

The BBD 6620 is equipped with an active humidity control system allowing for an external humidity water supply.   This humidity vapor generation system sterilizes the chamber, preventing contamination within the incubator. The external water reservoir allows continuous thermal decontamination with cyclical heating to 80°C.

Another great feature included is the fully automatic 180°C hot-air disinfection. Moreover, this model incubator has been designed for optimal growth conditions including a number of features such as precise temperature, CO2 and O2 regulation for long term stability.

CRTD 3.127
15 good_manufacturing_practice Microscopes Axiovert 40 CFL Carl Zeiss

The Axiovert 40 microscope is a universally applicable, modular light microscope of inverted design (inverted microscope). It is used for the examination of eukaryotic cells and/or tissue specimens. Observation and cultivation vessels include, for instance, culture bottles, Petri dishes and microtiter plates.

The following microscopy techniques are possible:

Transmitted light Brightfield
Phase contrast
Incident light (Fluorescence) DAPI
FITC
TRITC
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Microscopes

Axiovert 40 CFL (Carl Zeiss)

The Axiovert 40 microscope is a universally applicable, modular light microscope of inverted design (inverted microscope). It is used for the examination of eukaryotic cells and/or tissue specimens. Observation and cultivation vessels include, for instance, culture bottles, Petri dishes and microtiter plates.

The following microscopy techniques are possible:

Transmitted light Brightfield
Phase contrast
Incident light (Fluorescence) DAPI
FITC
TRITC
CRTD 3.123
16 good_manufacturing_practice PrimoVert Carl Zeiss

The PrimoVert microscopes are inverted transmitted-light microscopes of compact design with a small footprint. They are used for the examination of eukaryotic cells and/or tissue specimens. Observation and cultivation vessels include, for instance, culture bottles, Petri dishes and microtiter plates. Important features of the microscope are:

  • Stand equipped with a binocular phototube (50 % vis, 50 % doc) with an ergonomically favorable tube angle of 45°. The binocular part can be tilted upward and downward and adapted to the individual eye distance. As there is an upper and lower binocular part position, the user can choose between two viewing heights.
  • Long-distance objectives for the examination of large cell culture vessels.
  • Illumination by LED.
  • Brightfield and Phase contrast
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PrimoVert (Carl Zeiss)

The PrimoVert microscopes are inverted transmitted-light microscopes of compact design with a small footprint. They are used for the examination of eukaryotic cells and/or tissue specimens. Observation and cultivation vessels include, for instance, culture bottles, Petri dishes and microtiter plates. Important features of the microscope are:

  • Stand equipped with a binocular phototube (50 % vis, 50 % doc) with an ergonomically favorable tube angle of 45°. The binocular part can be tilted upward and downward and adapted to the individual eye distance. As there is an upper and lower binocular part position, the user can choose between two viewing heights.
  • Long-distance objectives for the examination of large cell culture vessels.
  • Illumination by LED.
  • Brightfield and Phase contrast
CRTD 3.125
10 good_manufacturing_practice Sterile Work Benches / Safety cabinets HERAsafe KSP18 Thermo Scientific

The Herasafe KSP 18 biological safety cabinets deliver maximum safety, comfort and convenience. Featuring an advanced design for easy operation and maximum safety.

Safety and Protection

  • HEPA filters guarantee maximum filtration efficiency of 99.995% at the most penetrating particle size (MPPS)
  • Segmented H14 HEPA filter system directly below work area protects inner air ducts, plenums and fans; provides a cumulative filtration efficiency of 99.99999975% to downflow and exhaust airflow
  • Pressure sensor monitoring ensures safe airflow across the entire work surface
  • SmartFlow™ digital technology maintains constant airflow during normal filter loading or temporary airflow obstruction due to foreign objects
  • Independent alarm system immediately alerts to any airflow obstruction

Performance and Operation

  • Interior eye-level display on rear wall for “at-a-glance” monitoring of safety parameters
  • Performance factor (PER) indicates: cabinet is safe, cabinet is safe but time for service, cabinet should not be used
  • Display parameters include downflow air velocity, cabinet malfunction, time of day, operating time of UV-C lights, total operating hours
  • Timer for delayed start
  • Stopwatch function
  • Handheld control for use inside cabinet eliminates glove changes before changing cabinet settings

Construction

  • Motorized front window with adjustable 25cm working aperture slopes 10°
  • DC motor technology uses energy efficiently with lower heat output
  • Aerosol-tight window sealing for additional protection when cabinet is in stand-by mode
  • Frameless front sash and side glass window yields unobstructed view of the total work area
  • Scratch-resistant stainless-steel work surface with indentations that trap spilled liquids
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Sterile Work Benches / Safety cabinets

HERAsafe KSP18 (Thermo Scientific)

The Herasafe KSP 18 biological safety cabinets deliver maximum safety, comfort and convenience. Featuring an advanced design for easy operation and maximum safety.

Safety and Protection

  • HEPA filters guarantee maximum filtration efficiency of 99.995% at the most penetrating particle size (MPPS)
  • Segmented H14 HEPA filter system directly below work area protects inner air ducts, plenums and fans; provides a cumulative filtration efficiency of 99.99999975% to downflow and exhaust airflow
  • Pressure sensor monitoring ensures safe airflow across the entire work surface
  • SmartFlow™ digital technology maintains constant airflow during normal filter loading or temporary airflow obstruction due to foreign objects
  • Independent alarm system immediately alerts to any airflow obstruction

Performance and Operation

  • Interior eye-level display on rear wall for “at-a-glance” monitoring of safety parameters
  • Performance factor (PER) indicates: cabinet is safe, cabinet is safe but time for service, cabinet should not be used
  • Display parameters include downflow air velocity, cabinet malfunction, time of day, operating time of UV-C lights, total operating hours
  • Timer for delayed start
  • Stopwatch function
  • Handheld control for use inside cabinet eliminates glove changes before changing cabinet settings

Construction

  • Motorized front window with adjustable 25cm working aperture slopes 10°
  • DC motor technology uses energy efficiently with lower heat output
  • Aerosol-tight window sealing for additional protection when cabinet is in stand-by mode
  • Frameless front sash and side glass window yields unobstructed view of the total work area
  • Scratch-resistant stainless-steel work surface with indentations that trap spilled liquids
CRTD 3.127
17 good_manufacturing_practice Tube Sealer CompoSeal® Mobilea ll Fresenius

The CompoSeal Mobilea II is a light weight, portable radio frequency (RF) sealer designed to seal medical PVC tubing in both mobile donation settings and processing environments.
The power management system uses lithium-ion battery technology to combine quality sealing performance, high battery capacity and fast charging.
The CompoSeal Mobilea II accomplishes all of this in a small, light weight portable unit.

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Tube Sealer

CompoSeal® Mobilea ll (Fresenius)

The CompoSeal Mobilea II is a light weight, portable radio frequency (RF) sealer designed to seal medical PVC tubing in both mobile donation settings and processing environments.
The power management system uses lithium-ion battery technology to combine quality sealing performance, high battery capacity and fast charging.
The CompoSeal Mobilea II accomplishes all of this in a small, light weight portable unit.

CRTD 3.127
18 good_manufacturing_practice TSCD-II Terumo

The Terumo Sterile Connecting Device (TSCD-II) is used to connect two closed internally sterile components such as a blood collection container, apheresis set, transfer set or needle set by making a sterile weld in the tubing connected to these components. These welds may consist of dry-to-dry, wet-to-dry or wet-to-wet connections. The resulting sterile component may be used in blood collection, blood component processing or transfusion applications. Uses include, but are not limited to:

  • Attaching additional blood component containers to a blood collection set to enable component separation or division of the original component into smaller aliquots
  • Attaching containers of processing or additive solutions to a blood component to perform a process such as cell washing or freezing or to extend the storage time of the component
  • Attaching blood component containers to a pooling set to enable pooling of components from multiple donations
  • Attaching a leukocyte reduction filter to a red blood cell or platelet component container to enable removal of leukocytes from the component
  • Attaching a sampling pouch to a blood component container to enable the removal of samples of the component for testing
  • Replacing the original needle on a collection set with a new needle of the same or smaller gauge to enable the use of the set or to facilitate a therapeutic procedure such as plasma exchange
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TSCD-II (Terumo)

The Terumo Sterile Connecting Device (TSCD-II) is used to connect two closed internally sterile components such as a blood collection container, apheresis set, transfer set or needle set by making a sterile weld in the tubing connected to these components. These welds may consist of dry-to-dry, wet-to-dry or wet-to-wet connections. The resulting sterile component may be used in blood collection, blood component processing or transfusion applications. Uses include, but are not limited to:

  • Attaching additional blood component containers to a blood collection set to enable component separation or division of the original component into smaller aliquots
  • Attaching containers of processing or additive solutions to a blood component to perform a process such as cell washing or freezing or to extend the storage time of the component
  • Attaching blood component containers to a pooling set to enable pooling of components from multiple donations
  • Attaching a leukocyte reduction filter to a red blood cell or platelet component container to enable removal of leukocytes from the component
  • Attaching a sampling pouch to a blood component container to enable the removal of samples of the component for testing
  • Replacing the original needle on a collection set with a new needle of the same or smaller gauge to enable the use of the set or to facilitate a therapeutic procedure such as plasma exchange
CRTD 3.127