Slider 1 We hereby declare that Temax can guarantee the flow of thermal packaging for pharmaceuticals and health products to our international customers during the COVID-19 pandemic. This guarantee is provided by our three international factories and separate warehouses where continuous stock flow and QA is provided. COVID-19 Manufacturing Stability Declaration Slider 1 Hierbij verklaren wij dat Temax de flow van thermische verpakkingen voor farmaceutica en healthcare naar onze internationale klanten kan garanderen. Deze garantie wordt geboden door onze drie internationale fabrieken en afgescheiden magazijnen waar continue voorraadstromen en QA worden verzorgd. COVID-19 Productie stabiliteitsverklaring Slider 1 Hiermit erklären wir dass Temax die Anlieferung von Thermoverpackungen für Pharmazeutika und Gesundheitsprodukte an unsere internationalen Kunden garantieren kann. Diese Garantie bieten unsere drei internationalen Produktionen und separaten Lager, in denen für kontinuierliche Warenflüsse und Qualitätssicherung gesorgt ist. Erklärung zur Produktionsstabilität Slider 1 Nous déclarons par la présente que Temax peut garantir le flux d'emballages thermiques pour les produits pharmaceutiques et de santé à nos clients internationaux. Cette garantie est fournie par nos trois usines internationales et nos entrepôts séparés où les flux de stock continus et l'assurance qualité sont pris en charge. Déclaration de stabilité de la production

Slider 1 TEMPERATURE PROTECTION HOT-COLD DESIGNING/MANUFACTURING/IMPLEMENTATION/MAPPING/TRAINING ETC... COLD CHAIN solutions for PHARMACEUTICALS GLOBAL PRESENTS EUROPE-USA
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TRM-plan “Temperature Risk Management”

Het doel van dit Krautz-Temax gepubliceerde T.R.M.-plan “Temperature Risk Management” is richtlijnen en aandachtspunten aan te reiken bij het gebruik van thermal blankets als passieve koeling voor de temperatuurbescherming van temperatuurgevoelige farmaceutische producten, zonder het gebruik van extra thermische energiegeneratoren (gel packs of PCM’s Phase Change Material). In de ontwikkeling van deze richtlijnen werd rekening gehouden met volgende G.D.P. “Good Distribution Practice” voorschriften voor het transport van farmaceutische producten en healthcare producten:

  • European Commission: G.D.P. Guidelines 05.11.2013: pharmaceuticals for human use
  • WHO “World Health Organization”: G.D.P. Guidelines 2010: Annex5 – pharmaceuticals

Dit T.R.M.-plan bevat de geschreven instructies inzake de handling van de Temax thermal blankets en fungeert als algemene documentatie tot de G.D.P. voorschriften. Dit T.R.M.-plan fungeert tevens als “master” documentatie en overschrijft enige andere Temax informatie.

TRM-plan “Temperature Risk Management” – richtlijnen voor het gebruik van thermal blankets – ISBN 9789048439560

The purpose of the Krautz-TEMAX® T.R.M.-plan “Temperature Risk Management” is to offer guidelines and attention points when Temax® thermal blankets are used as a passive cooling system for the temperature protection of time-temperature sensitive pharmaceuticals in transport, storage and distribution, without the use of extra thermal energy generators (gel packs, P.C.M.’s “Phase Change Materials”, Dry-Ice, etc…). In the development of these guidelines the following G.D.P. “Good Distribution Practice” guidelines were considered for the transport of pharmaceuticals and healthcare products:

  • European Commission: G.D.P. Guidelines 05.11.2013: pharmaceuticals for human use
  • WHO “World Health Organization”: G.D.P. Guidelines 2010: Annex5 – pharmaceuticals

This T.R.M.-plan contains the written instructions on handling Temax® thermal blankets and functions as general documentation to the G.D.P. guidelines. This T.R.M.-plan functions as a master documentation and overwrites any other Temax® information.

Published ISBN – 9789048439560
Guidelines thermal blankets – 52 pages – English language
This book is available on special email request: see page contact

This book will be personally dedicated to the receiver (GDP documentation guideline)
This book is yearly re-published with up-to-date information

INDEX

  1. Scope TRM-plan “Temperature Risk Management”
  2. Temax-4000 as thermal blanket
  3. T.R.P.’s Temperature Risk Procedures
  4. Supply chain of Temax insulation material
  5. S.O.P’s Standard Operation Procedures
  6. Temperature measurement and validation
  7. G.M.P. Good Manufacturing Practice contribution
  8. Quality assurance and control
  9. Transport of finished products
  10. Recycling – ecological footprint – New use
  11. Training and certification
  12. Internal and external audits
  13. Notifications
  14. Worksheets
  15. Remarks and notes

Temax toepassingen in farmaceutica en healthcare
De Temax thermal blankets worden gebruikt in de luchtvracht teneinde tijd-temperatuur gevoelige farmaceutische producten en healthcare producten te beschermen tegen externe temperaturen. Volgende groepen farmaceutische producten kunnen hierbij van toepassing zijn:

Ambient farmaceutische producten

  • Low risk pharmaceuticals (+0°C to +40°C) or (32°F to 104°F)
  • Medium risk pharmaceuticals (+2°C to +30°C) or (35°F to 86°F)
  • High risk pharmaceuticals (+15°C to +25°C) or (59°F to 77°F)

Gekoelde farmaceutische producten

  • High risk pharmaceuticals (+2°C to +8°C) or (35°F to 46°F)
  • Low risk pharmaceuticals

Luchtvracht koelketen logistiek
De richtlijnen en aandachtspunten in dit T.R.M.-plan zijn toegewijd aan de luchtvracht koelketen, doch de geïntegreerde richtlijnen kunnen tevens van toepassing zijn op andere transportmethoden zoals zeevracht en wegtransport waar Temax thermal blankets worden gebruikt.

INDEX

  1. Scope TRM-plan "Temperature Risk Management"
  2. Temax-4000 as thermal blanket
  3. T.R.P.'s Temperature Risk Procedures
  4. Supply chain of Temax insulation material
  5. S.O.P's Standard Operation Procedures
  6. Temperature measurement and validation
  7. G.M.P. Good Manufacturing Practice contribution
  8. Quality assurance and control
  9. Transport of finished products
  10. Recycling - ecological footprint - New use
  11. Training and certification
  12. Internal and external audits
  13. Notifications
  14. Worksheets
  15. Remarks and notes

Temax® applications in Pharmaceuticals
The Temax® thermal blankets are used in the airfreight cold chain logistics of time-temperature sensitive pharmaceuticals. The following pharmaceuticals and healthcare products are temperature protected with the Temax® thermal blankets according to specific configurations:

Ambient pharmaceuticals

  • Low risk pharmaceuticals (+0°C to +40°C) or (32°F to 104°F)
  • Medium risk pharmaceuticals (+2°C to +30°C) or (35°F to 86°F)
  • High risk pharmaceuticals (+15°C to +25°C) or (59°F to 77°F)

Chilled pharmaceuticals

  • High risk pharmaceuticals (+2°C to +8°C) or (35°F to 46°F)
  • Low risk pharmaceuticals

Airfreight cold chain logistics
The guidelines and attention points in this T.R.M.-plan are dedicated to airfreight cold chain logistics, yet they may also apply to other transport systems such as sea freight or road transport in which the Temax® thermal blankets are used.

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