TRM-plan “Temperature Risk Management” – guidelines on thermal blankets usage – 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® 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.

Cold chain and material engineering