Testing Services

Pharmaceutical Testing

cGMP Extractables and Leachables Testing

Extractables & Leachables (E&L) analysis is performed to determine the safety of a product that involves direct contact, during manufacturing or various stages of storage, with food or pharmaceutical products or medically implanted devices. The testing processes provide assurance that a device or packaging material will not contribute harmful components as the result of contact . Microbac Laboratories conducts a full range of Extractables and Leachables testing on a variety of products. Possessing multiple discipline experience, Microbac is capable of experimental protocols that involve atypical materials, while fully considering the manufacturing process utilized. Microbac works closely with clients to identify the critical considerations and required protocols.

Microbac is FDA registered, DEA registered, cGMP compliant, and ISO/IEC 17025:2005 accredited. GMP Extractables and Leachables testing is required by the FDA and other regulatory agencies for many pharmaceutical packaging materials and drug delivery devices, along with their associated drug formulations, to determine the potential of patient exposure to undesirable compounds arising from the packaging or device.

 

The typical types of devices and materials evaluated for E&L include:

  • Pharmaceutical and food packaging
  • Biomaterials
  • Inhalation products (metered dose and dry powder inhaler products)
  • Medical devices
  • Nasal delivery systems
  • Drug delivery 
  • Parenterals
  • Materials placed in-situ in patients
  • Disposable products 
  • Ocular drugs
  • Maxilloficial reconstruction 
  • Transdermal delivery systems
  • Tissue Engineering
  • Scaffolds 
  • Other packaging and closure systems
Extractables testing is performed on the actual material that may contact a food or pharmaceutical product.  The process involves rigorous chemical extraction and analysis of the packaging and device materials (e.g. polymers, adhesives, labels, closures, device components, primary and secondary packaging of drug product), typically using a range of extraction solvents such as water, isopropanol, and methylene chloride. Microbac's experienced scientists perform Extraction studies and identification of Extractables using USP methods and state-of-the-art instrumentation, including GC/MS, LC/MS, LC/MS/MS, ICP/MS, and IC. Compound classes identified in Extractable testing include:
 
  • polymer additives
  • degradants
  • colorants
  • adhesives
  • lubricants
  • silicones
  • polymers and monomers
  • metals
  • nitrosamines
  • polynuclear hydrocarbons
Leachables testing is a series of analysis performed under conditions that mimic the intended use of a product in order to establish the amount of chemical compounds, if any, that are available to leach and, therefore, may enter the body or contaminate a pharmaceutical or food product. Microbac is experienced with the needed analytical method development, validation, and stability studies that product leachable testing requires.

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