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Development, manufacture and validation of cooling solutions for temperature-sensitive life-science products

DE

delta T Gesellschaft für Medizintechnik mbH & Co. KG

Fernwald (DE)New on Amplifa

2000Founded
15Employees
2.000 qmProduction area at the Fernwald site
-50°C to +37°CTemperature range of the cooling fluids
up to 120 hrsTemperature stability of the transport systems

About delta T

delta T Gesellschaft für Medizintechnik mbH & Co. KG develops and manufactures transport solutions for temperature-sensitive products in the life-science sector. The portfolio includes cooling packs and fluid elements for temperature ranges from -50°C to +37°C, insulated containers, insulated bags, vacuum boxes, pallet shippers and ThermoScan data loggers for temperature monitoring. The passive transport systems keep temperatures stable for up to 120 hours depending on configuration and, for example, safeguard the cold chain (2°C to 8°C) for blood products, organs, vaccines and protein-based pharmaceuticals. The shells of the cooling packs are blow-molded from plastic and filled manually or by machine with water or the company's own special fluids; large volumes are filled by machine, smaller series by hand. In addition, delta T offers the development of customer-specific cooling transport packaging as well as validations and temperature measurements in its own climate chambers or under real conditions as a service. The company was founded in 2000, is headquartered in Fernwald near Gießen and supplies customers such as pharmaceutical companies, pharmaceutical wholesalers, biotech firms, hospitals, blood banks and laboratories worldwide.

Site
Fernwald
Processes
Manufacture of cooling packs (shell blow-molded from plastic, filled with liquid – water packs, Development of cooling transport packaging (customer- and market-oriented new development), Validation & measurement of transport systems (temperature measurement in climate chambers and under, Manufacture of passive transport solutions (insulated containers, tempering elements) for, Development of cooling transport packaging, Manufacture of cooling packs (fluids -50°C to +37°C), Validation & measurement (climate chambers, ThermoScan, validation as a service), Pre-tempering and configuration of pallet shippers
Materials
Polyethylene (PE natural), Polypropylene, Polystyrene (EPS), Polycarbonate (IP68 waterproof), Aluminum composite foil (closure), Metal (metal cladding of data loggers), delta T special fluids (-50°C to +37°C), Polycarbonate (IP68)
Certificates
ISO 9001:2015, DIN EN ISO 13485:2021, ISO 9001, ISO 13485
Founded
2000
Employees
15
Industries
Pharmaceutical industry, Pharmaceutical wholesale, Biotechnology, Blood donation services/blood banks, Hospitals, Laboratories
  1. 01

    Development of cooling transport packaging

  2. 02

    Manufacture of the plastic shells of the cooling packs

  3. 03

    Filling with water or special fluids (manual or machine)

  4. 04

    Configuration and pre-tempering of pallet shippers

  5. 05

    Qualification and validation with ThermoScan data loggers and climate chambers

  6. 06

    Worldwide sales

Materials & Processes

PE

Polyethylene (PE natural)

Material of the cooling pack shells and TempShell elements, e.g. for 4°C packs with blue fluid.

PP

Polypropylene

Material of the BlueLine insulated boxes with 50-mm insulation.

EPS

Polystyrene (EPS)

Insulation material of the Neopor boxes and EPS pallet shippers.

PC

Polycarbonate (IP68)

Waterproof housing material of the ThermoScan TempRec readout device.

VIP

Vacuum insulation (VIP)

Highly efficient insulation for vacuum boxes and VIP pallet shippers with long runtime.

FLUID

delta T special fluids (-50°C to +37°C)

Proprietary thermal storage fluids whose temperature range is identifiable by the fluid color.

Locations

Fernwald

DE

Headquarters, production of cooling packs and insulated boxes, validation & measurement

Lot size
Small series (manual filling) to large volumes (machine filling)
Materials
Polyethylene, polypropylene, polystyrene (EPS), vacuum insulation, special fluids
  • Climate chambers
  • Filling machine for cooling packs

Industries

Pharmaceutical industryPharmaceutical wholesaleBiotechnologyBlood donation services/blood banksHospitalsLaboratoriesPharmaciesClinical studiesLogisticsHospitals/clinicsLogistics providers

Processes & technical limits

ProcessesToleranceMax. partWeightLot sizeMaterials
Manufacture of cooling packs (shell blow-molded from plastic, filled with liquid – water packsPlastics–––smaller series (manual filling) – large volumes (machine filling)Plastic (shell), Special fluids, Water
Development of cooling transport packaging (customer- and market-oriented new development)Engineering–––––
Validation & measurement of transport systems (temperature measurement in climate chambers and underTestingResolution down to 0.1 °C––––
Manufacture of passive transport solutions (insulated containers, tempering elements) forPlastics––––Polyethylene (PE), Polypropylene (insulation 50 mm), Polystyrene (EPS), Vacuum insulation (VIP)

2 Anlagen & Maschinen

MachineManufacturer / modelQuantityWorking areaYear builtSite
Climate chamber––––Fernwald
Filling machine for cooling packs (machine filling)––––Fernwald

Additional services

Development of cooling transport packagingManufacture of cooling packs (fluids -50°C to +37°C)Validation & measurement (climate chambers, ThermoScan, validation as a service)Pre-tempering and configuration of pallet shippersTemperature recording with data loggers (ThermoScan, myThermoScan.info platform)Customer-specific transport solutions

Reference customers

Global players of the pharmaceutical industry and pharmaceutical wholesaleBiotech companiesHospitalsBlood banksBlood donation servicesLaboratoriesPharmacies/retail distributorsLogistics providers

Quality

The quality management system is certified to EN ISO 9001:2015 and DIN EN ISO 13485. Measurements and validations are carried out to scientific standards with calibrated ThermoScan probes (resolution down to 0.1°C) in climate chambers or under real conditions.

EvidenceFernwald
ISO 9001
ISO 13485

History

  1. 2000

    Founding of delta T Gesellschaft für Medizintechnik mbH in Fernwald near Gießen

  2. 2010

    Operation of the cooling pack and insulated box production on 2,000 sqm at the Fernwald site with 15 employees

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