Forced Extaction Report

Identify and estimate the amount of compounds that may be extracted from key components under extreme conditions. Leverage the baseline data in Thermo Scientific™ Nalgene™ and Thermo Scientific™ Nunc™ Forced Extraction Study Reports to help determine what further leachable studies are may be necessary to meet applicable regulatory requirements or expectations. The qualification and validation of production, harvest and containment supplies is an integral part of any Biopharmaceutical application process. Regulatory guidelines around the world recommend that the production, storage and packaging components be assessed for extractables or leachables that may interact with or impact the product being manufactured.

Forced Extraction Study Reports are baseline data made available to customers as a reference to support the
evaluation of products.

Description:

  • Thermo Scientific™ Nalgene™ PETG Square Media Bottles and Closures (natural and white HDPE)
  • Thermo Scientific™ Nalgene™ PC Biotainer™ Bottles and Closures (silicone liner and PP closure)
  • Thermo Scientific™ Nalgene™ PP Carboys and Closures (TPE gasket and PP white closure)
  • Thermo Scientific™ Nalgene™ PETG Biotainer and Closures (PP liner and HDPE closure)
  • Thermo Scientific™ Nalgene™ HDPE Bottles and Carboys System (sterile and non-sterile)
  • Thermo Scientific™ Nunc™ Cell Factory™ System
  • Thermo Scientific™ Nunc™ EasyFill™ Cell Factory™ System
  • Thermo Scientific™ Nalgene™ PET Square Media Bottles and Closures (natural HDPE)

 

Three extraction solvents and one acid matrix (for metal detection) were used on each unit for the forced extraction process:

  • Water
  • Ethanol
  • Hexanes
  • 10% nitric acid or 5% nitric acid / 5% hydrochloric acid matrix
     

Note:
To better simulate conditions of use, Nunc Cell Factory Systems were tested with two extraction solvents; (20% isopropyl alcohol and PBS) and these same solvents were used for the metal detection.

   

Each extracted solution was subsequently analyzed by:

  • Headspace Gas Chromatography/Mass Spectrometry (Headspace GC/MS) for volatile organic compounds
  • Gas Chromatography / Mass Spectrometry (GC/MS) for semi-volatile organic compounds
  • Liquid Chromatography / Mass Spectrometry (LC/MS) for non-volatile organic compounds
  • Inductively Coupled Plasma (ICP) for metals and elemental extractables using an acid digested solution.

Major chemical components were identified using NIST98K, Wiley and other databases. The methods utilized provide a semi-quantitative estimation of analytes identified by these techniques.


Ordering Information:

Forced Extraction Studies can be requested by contacting rocregsupport@thermofisher.com and are made available pursuant to
a Confidentiality Agreement.*

105-0001 PETG Bottles and Closures
  105-0001
PETG Bottles and Closures (Irradiated at 19-28 kGy)
 
105-0002 PC Biotainer Bottles
  105-0002
PC Biotainer Bottles (System, US Resin)
 
 
105-0003 PP Carboys
 

105-0003
PP Carboys (System)


 
105-0004 PETG Biotainer Bottles
  105-0004
PETG Biotainer Bottles (System)
 
 

105-0007 HDPE Bottles and Carboys System
 

105-0007
HDPE Bottles & Carboys System (Sterile and Non-Sterile)

Request report

 
105-0008 Cell Factory Systems
 

105-0008
Cell Factory Systems (US Resin)
 

Request report

 
105-0009 EasyFill Cell Factory Systems
  105-0009
EasyFill Cell Factory Systems (EU Resin)

 
105-0010 PETG Bottles and Closures, Irradiated at 20-45 kGy
  105-0010
PETG Bottles and Closures (Irradiated at 20-45 kGy)
 

105-0011 Nalgene PET Bottles and Closures
 

105-0011
Nalgene PET Bottles and Closures (US Resin) (Irradiated at 19-28 kGy)

Request report

 
105-0012 Nalgene PET Bottles and Closures
 

105-0012
Nalgene PET Bottles and Closures (US Resin) (Irradiated at 20-45 kGy)

Request report

 
105-0013 Nalgene PET Bottles and Closures
 

105-0013
Nalgene PET Bottles and Closures (EU Resin) (Irradiated at 20-45 kGy) 

Request report

 

Resources

   Brochure: Nalgene Forced Extraction Study Reports
 

Disclaimer:
* Following your request submission, a Confidentiality Agreement will be forwarded to you for completion. Studies are non-GMP and provided for informational purposes only. The identify and quantity of extractables may vary with routine changes made to the manufacturing process. Product information contained within the Forced Extraction Studies are provided to the best of our knowledge and belief, but without obligation or liability. Forced Extraction Studies are not a product warranty statement or recommendation for product usage. Any information or advice provided by Thermo Fisher Scientific in Forced Extraction Studies is for reference purposes only, and does not relieve customer or users of their responsibility for determining the suitability of our products for the customer’s or user’s intended use. Forced Extraction Studies are not a substitute for any part of the customer’s or user’s own internal validation, nor may any such studies or documents from Thermo Fisher Scientific be submitted to regulatory bodies.

105-0007 HDPE Bottles & Carboys System
 

105-0007
HDPE Bottles & Carboys System (Sterile and Non-Sterile)

Request report

 
105-0002 PC Biotainer Bottles
 

105-0002
PC Biotainer Bottles (System, US Resin)

Request report

 
105-0011 Nalgene PET Bottles and Closures
 

105-0011
Nalgene PET Bottles and Closures (US Resin) (Irradiated at 19-28 kGy)

Request report

 
105-0012 Nalgene PET Bottles and Closures
 

105-0012
Nalgene PET Bottles and Closures (US Resin) (Irradiated at 20-45 kGy)

Request report

 
105-0013 Nalgene PET Bottles and Closures
 

105-0013
Nalgene PET Bottles and Closures (EU Resin) (Irradiated at 20-45 kGy) 

Request report

 
105-0001 PETG Bottles and Closures
 

105-0001
PETG Bottles and Closures (Irradiated at 19-28 kGy)

Request report

 
105-0004 PETG Biotainer Bottles

 

105-0004
PETG Biotainer Bottles (System)


Request report

 
105-0003 PP Carboys
 

105-0003
PP Carboys (System)
 

Request report

 
105-0008 Cell Factory Systems
 

105-0008
Cell Factory Systems (US Resin)
 

Request report

 
105-0009 EasyFill Cell Factory Systems
  105-0009
EasyFill Cell Factory Systems (EU Resin)

 
105-0001 PETG Bottles and Closures
  105-0001
PETG Bottles and Closures (Irradiated at 19-28 kGy)
 
105-0002 PC Biotainer Bottles
  105-0002
PC Biotainer Bottles (System, US Resin)
 
 
105-0003 PP Carboys
 

105-0003
PP Carboys (System)


 
105-0004 PETG Biotainer Bottles
  105-0004
PETG Biotainer Bottles (System)
 
 

105-0007 HDPE Bottles and Carboys System
 

105-0007
HDPE Bottles & Carboys System (Sterile and Non-Sterile)

Request report

 
105-0008 Cell Factory Systems
 

105-0008
Cell Factory Systems (US Resin)
 

Request report

 
105-0009 EasyFill Cell Factory Systems
  105-0009
EasyFill Cell Factory Systems (EU Resin)

 
105-0010 PETG Bottles and Closures, Irradiated at 20-45 kGy
  105-0010
PETG Bottles and Closures (Irradiated at 20-45 kGy)
 

105-0011 Nalgene PET Bottles and Closures
 

105-0011
Nalgene PET Bottles and Closures (US Resin) (Irradiated at 19-28 kGy)

Request report

 
105-0012 Nalgene PET Bottles and Closures
 

105-0012
Nalgene PET Bottles and Closures (US Resin) (Irradiated at 20-45 kGy)

Request report

 
105-0013 Nalgene PET Bottles and Closures
 

105-0013
Nalgene PET Bottles and Closures (EU Resin) (Irradiated at 20-45 kGy) 

Request report

 

Resources

   Brochure: Nalgene Forced Extraction Study Reports
 

Disclaimer:
* Following your request submission, a Confidentiality Agreement will be forwarded to you for completion. Studies are non-GMP and provided for informational purposes only. The identify and quantity of extractables may vary with routine changes made to the manufacturing process. Product information contained within the Forced Extraction Studies are provided to the best of our knowledge and belief, but without obligation or liability. Forced Extraction Studies are not a product warranty statement or recommendation for product usage. Any information or advice provided by Thermo Fisher Scientific in Forced Extraction Studies is for reference purposes only, and does not relieve customer or users of their responsibility for determining the suitability of our products for the customer’s or user’s intended use. Forced Extraction Studies are not a substitute for any part of the customer’s or user’s own internal validation, nor may any such studies or documents from Thermo Fisher Scientific be submitted to regulatory bodies.

105-0007 HDPE Bottles & Carboys System
 

105-0007
HDPE Bottles & Carboys System (Sterile and Non-Sterile)

Request report

 
105-0002 PC Biotainer Bottles
 

105-0002
PC Biotainer Bottles (System, US Resin)

Request report

 
105-0011 Nalgene PET Bottles and Closures
 

105-0011
Nalgene PET Bottles and Closures (US Resin) (Irradiated at 19-28 kGy)

Request report

 
105-0012 Nalgene PET Bottles and Closures
 

105-0012
Nalgene PET Bottles and Closures (US Resin) (Irradiated at 20-45 kGy)

Request report

 
105-0013 Nalgene PET Bottles and Closures
 

105-0013
Nalgene PET Bottles and Closures (EU Resin) (Irradiated at 20-45 kGy) 

Request report

 
105-0001 PETG Bottles and Closures
 

105-0001
PETG Bottles and Closures (Irradiated at 19-28 kGy)

Request report

 
105-0004 PETG Biotainer Bottles

 

105-0004
PETG Biotainer Bottles (System)


Request report

 
105-0003 PP Carboys
 

105-0003
PP Carboys (System)
 

Request report

 
105-0008 Cell Factory Systems
 

105-0008
Cell Factory Systems (US Resin)
 

Request report

 
105-0009 EasyFill Cell Factory Systems
  105-0009
EasyFill Cell Factory Systems (EU Resin)