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TEMAX Published books
- Cold Chain Implementation Plan
- Advanced Temperature Trailer Mapping
- TRM - Temperature Risk Management
Cold Chain services
- Training and education
- Trailer Mapping
Cold Chain Engineering
- CCRM Cold Chain Temperature risk engineering
- Cold Chain Automation
Material engineering
- Multilayer insulation technique
- Heat transfer engineering
- Insulation configuration blankets
- Building insulation engineering
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
- Scope TRM-plan "Temperature Risk Management"
- Temax-4000 as thermal blanket
- T.R.P.'s Temperature Risk Procedures
- Supply chain of Temax insulation material
- S.O.P's Standard Operation Procedures
- Temperature measurement and validation
- G.M.P. Good Manufacturing Practice contribution
- Quality assurance and control
- Transport of finished products
- Recycling - ecological footprint - New use
- Training and certification
- Internal and external audits
- Notifications
- Worksheets
- 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.